Publications by authors named "Lee M Ritterband"

72 Publications

Liar! Liar! Identifying eligibility fraud by applicants in digital health research.

Internet Interv 2021 Sep 9;25:100401. Epub 2021 May 9.

University of Virginia School of Medicine, Center for Behavioral Health & Technology, Department of Psychiatry & Neurobehavioral Sciences, 560 Ray C Hunt Dr, Charlottesville 22903, VA, USA.

Online studies enable researchers to recruit large, diverse samples, but the nature of these studies provides an opportunity for applicants to misrepresent themselves to increase the likelihood of meeting eligibility criteria for a trial, particularly those that provide financial incentives. This study describes rates of fraudulent applications to an online intervention trial of an Internet intervention for insomnia among older adults (ages ≥55). Applicants were recruited using traditional (e.g., flyers, health providers), online (e.g., Craigslist, Internet searches), and social media (e.g., Facebook) recruitment methods. Applicants first submitted an interest form that included identifying information (name, date of birth, address). This data was then queried against a national database (TransUnion's TLOxp) to determine the application's verification status. Applications were determined to be verified (i.e., information from interest form matched TLOxp report), potentially fraudulent (i.e., potential discrepancy in provided information on interest form versus TLOxp report), or fraudulent (i.e., confirmed discrepancy). Of 1766 total interest forms received, 125 (7.08%) were determined to be fraudulent. Enrollment attempts that were fraudulent were detected among 12.22% of applicants who reported learning of the study through online, 7.04% through social media, 4.58% through traditional, and 4.27% through other methods. Researchers conducting online trials should take precautions, as applicants may provide fraudulent information to gain access to their studies. Reviewing all applications and verifying the identities and eligibility of participants is critical to the integrity of online research trials.
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http://dx.doi.org/10.1016/j.invent.2021.100401DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8164029PMC
September 2021

Addressing sexual concerns of female breast cancer survivors and partners: a qualitative study of survivors, partners, and oncology providers about Internet intervention preferences.

Support Care Cancer 2021 Jun 2. Epub 2021 Jun 2.

UVA Cancer Center, University of Virginia, Charlottesville, VA, USA.

Purpose: Sexual side effects after breast cancer treatment are common and distressing to both survivors and their intimate partners, yet few receive interventions to address cancer-related sexual concerns. To direct intervention development, this qualitative study assessed the perceptions of female breast cancer survivors, intimate partners of breast cancer survivors, and breast cancer oncology providers about how an Internet intervention for couples may address breast cancer-related sexual concerns.

Methods: Survivors (N = 20) responded to online open-ended surveys. Partners (N = 12) and providers (N = 8) completed individual semi-structured interviews. Data were inductively coded using thematic content analysis.

Results: Three primary intervention content areas were identified by the key stakeholder groups: (1) information about and strategies to manage physical and psychological effects of cancer treatment on sexual health, (2) relationship and communication support, and (3) addressing bodily changes and self-image after treatment. Survivors and partners tended to express interest in some individualized intervention private from their partner, although they also emphasized the importance of opening communication about sexual concerns within the couple. Survivors and partners expressed interest in an intervention that addresses changing needs across the cancer trajectory, available from the time of diagnosis and through survivorship.

Conclusion: Internet intervention for couples to address cancer-related sexual concerns, particularly one that provides basic education about treatment side effects and that evolves with couples' changing needs across the cancer trajectory, was perceived as a valuable addition to breast cancer care by survivors, partners, and providers.
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http://dx.doi.org/10.1007/s00520-021-06302-wDOI Listing
June 2021

The effect of sleep-wake intraindividial variability in digital cognitive behaviour therapy for insomnia: A mediation analysis of a large-scale RCT.

Sleep 2021 May 8. Epub 2021 May 8.

Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.

Study Objectives: Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) is an effective treatment for insomnia. However, less is known about mediators of its benefits. The aim of the present study was to test if intraindividual variability in sleep (IIV) was reduced with dCBT-I, and whether any identified reduction was a mediator of dCBT-I on insomnia severity and psychological distress.

Methods: In a two-arm randomized controlled trial (RCT), 1720 adults with insomnia (dCBT-I = 867; patient education about sleep = 853) completed the Insomnia Severity Index (ISI), the Hospital Anxiety and Depression Scale (HADS) and sleep diaries, at baseline and 9-week follow-up. Changes in IIV were analysed using linear mixed modelling followed by mediation analyses of ISI, HADS, and IIV in singular sleep metrics and composite measures (Behavioural Indices (BI-Z) and Sleep-disturbance Indices (SI-Z)).

Results: dCBT-I was associated with reduced IIV across all singular sleep metrics, with the largest between-group effect sizes observed for sleep onset latency (SOL). Reduced IIV for SOL and wake after sleep onset had the overall greatest singular mediating effect. For composite measures, SI-Z mediated change in ISI (b = -0.74; 95% Confidence Interval (CI) -1.04 to -0.52; 13.3%) and HADS (b = -0.40; 95% CI -0.73 to -0.18; 29.2%), whilst BI-Z mediated minor changes.

Conclusion: Reductions in IIV in key sleep metrics mediate significant changes in insomnia severity and especially psychological distress when using dCBT-I. These findings offer important evidence regarding the therapeutic action of dCBT-I and may guide the future development of this intervention.
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http://dx.doi.org/10.1093/sleep/zsab118DOI Listing
May 2021

Randomized controlled trial of the mySmartSkin web-based intervention to promote skin self-examination and sun protection among individuals diagnosed with melanoma.

Transl Behav Med 2021 Apr 27. Epub 2021 Apr 27.

Department of Medicine, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.

Adherence to regular, thorough skin self-examination (SSE) and consistent sun protection behaviors among melanoma survivors is relatively low. This study reports on the impact of an online intervention, called mySmartSkin (MSS), on engagement in SSE and sun protection behaviors among melanoma survivors, as well as the mediators of the intervention effects. The intervention was compared with usual care (UC), and primary outcomes were assessed at 24 and 48 weeks. Short-term outcomes were also evaluated at 8 weeks postbaseline. Results demonstrate a significant effect on SSE and sun protection. At all three follow-up assessments, the proportion of participants reporting conducting a thorough SSE in the time since the previous assessment was significantly greater in MSS than in UC. In addition, both multivariate and univariate analyses indicated that engagement in sun protection behaviors was significantly higher in MSS than UC at 24 weeks, but the effect on sun protection at 48 weeks was significant only in multivariate analyses. Beneficial effects of MSS were significantly mediated by knowledge about melanoma and characteristics of suspicious lesions, as well as self-efficacy. Participant engagement in MSS was satisfactory, with approximately two-thirds of participants completing at least two of the three core components. Content was rated as highly trusted, easy to understand, easy to navigate, and helpful. In conclusion, MSS illustrated significant and durable effects on SSE and mixed results on sun protection. Future studies should consider ways to further enhance treatment effects and engagement in MSS.
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http://dx.doi.org/10.1093/tbm/ibaa103DOI Listing
April 2021

Feasibility of ecological momentary assessment to study depressive symptoms among cancer caregivers.

Psychooncology 2021 May 28;30(5):756-764. Epub 2021 Jan 28.

Department of Psychiatry and Neurobehavioral Sciences, Center for Behavioral Health and Technology, University of Virginia, Charlottesville, Virginia, USA.

Objective: Ecological momentary assessment (EMA) may help with the development of more targeted interventions for caregivers' depression, yet the use of this method has been limited among cancer caregivers. This study aimed to demonstrate the feasibility of EMA among cancer caregivers and the use of EMA data to understand affective correlates of caregiver depressive symptoms.

Methods: Caregivers (N = 25) completed a depressive symptom assessment (Patient Health Questionnaire-8) and then received eight EMA survey prompts per day for 7 days. EMA surveys assessed affect on the orthogonal dimensions of valence and arousal. Participants completed feedback surveys regarding the EMA protocol at the conclusion of the week-long study.

Results: Of 32 caregivers approached, 25 enrolled and participated (78%), which exceeded the a priori feasibility cutoff of 55%. The prompt completion rate (59%, or 762 of 1,286 issued) did not exceed the a priori cutoff of 65%, although completion was not related to caregivers' age, employment status, physical health quality of life, caregiving stress, or depressive symptoms or the patients' care needs (ps > 0.22). Caregivers' feedback about their study experience was generally positive. Mixed-effects location scale modeling showed caregivers' higher depressive symptoms were related to overall higher reported negative affect and lower positive affect, but not to affective variability.

Conclusions: Findings from this feasibility study refute potential concerns that an EMA design is too burdensome for distressed caregivers. Clinically, findings suggest the potential importance of not only strategies to reduce overall levels of negative affect, but also to increase opportunities for positive affect.
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http://dx.doi.org/10.1002/pon.5627DOI Listing
May 2021

Effects of digital cognitive behavioural therapy for insomnia on insomnia severity: a large-scale randomised controlled trial.

Lancet Digit Health 2020 08;2(8):e397-e406

Department of Health Promotion, Norwegian Institute of Public Health, Bergen, Norway; Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway; Department of Research and Innovation, Helse-Fonna HF, Haugesund, Norway.

Background: Although several large-scale randomised controlled trials have shown the efficacy of digital cognitive behavioural therapy for insomnia (dCBT-I), there is a need to validate widespread dissemination of dCBT-I using recommended key outcomes for insomnia. We investigated the effect of a fully automated dCBT-I programme on insomnia severity, sleep-wake patterns, sleep medication use, and daytime impairment.

Methods: We did a parallel-group superiority randomised controlled trial comparing dCBT-I with online patient education about sleep. The interventions were available through a free-to-access website, publicised throughout Norway, which incorporated automated screening, informed consent, and randomisation procedures, as well as outcome assessments. Adults (age ≥18 years) who had regular internet access and scored 12 or higher on the Insomnia Severity Index (ISI) were eligible for inclusion, and were allocated (1:1) to receive dCBT-I (consisting of six core interactive sessions to be completed over 9 weeks) or patient education (control group). Participants were masked to group assignment and had no contact with researchers during the intervention period. The primary outcome was the change in ISI score from baseline to 9-week follow-up, assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02558647) and is ongoing, with 2-year follow-up assessments planned.

Findings: Between Feb 26, 2016, and July 1, 2018, 5349 individuals commenced the online screening process, of which 1497 were ineligible or declined to participate, 2131 discontinued the screening process, and 1721 were randomly allocated (868 to receive dCBT-I and 853 to receive patient education). At 9-week follow-up, 584 (67%) participants in the dCBT-I group and 534 (63%) in the patient education group completed the ISI assessment. The latent growth model showed that participants in the dCBT-I group had a significantly greater reduction in ISI scores from baseline (mean score 19·2 [SD 3·9]) to 9-week follow-up (10·4 [6·2]) than those in the patient education group (from 19·6 [4·0] to 15·2 [5·3]; estimated mean difference -4·7 (95% CI -5·4 to -4·1; Cohen's d -1·21; p<0·001). Compared with patient education, the number needed to treat with dCBT-I was 2·7 (95% CI 2·4 to 3·2) for treatment response (ISI score reduction ≥8) and 3·2 (2·8 to 3·8) for insomnia remission (ISI score <8). No adverse events were reported to the trial team.

Interpretation: dCBT-I is effective in reducing the severity of symptoms associated with the insomnia disorder. These findings support the widespread dissemination of dCBT-I. Future research is needed to identify the moderators of response and to improve targeting.

Funding: Norwegian Research Council; Liaison Committee for Education, Research and Innovation in Central Norway.
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http://dx.doi.org/10.1016/S2589-7500(20)30135-7DOI Listing
August 2020

Developing a Process for the Analysis of User Journeys and the Prediction of Dropout in Digital Health Interventions: Machine Learning Approach.

J Med Internet Res 2020 10 28;22(10):e17738. Epub 2020 Oct 28.

Center for Behavioral Health & Technology, University of Virginia School of Medicine, Charlottesville, VA, United States.

Background: User dropout is a widespread concern in the delivery and evaluation of digital (ie, web and mobile apps) health interventions. Researchers have yet to fully realize the potential of the large amount of data generated by these technology-based programs. Of particular interest is the ability to predict who will drop out of an intervention. This may be possible through the analysis of user journey data-self-reported as well as system-generated data-produced by the path (or journey) an individual takes to navigate through a digital health intervention.

Objective: The purpose of this study is to provide a step-by-step process for the analysis of user journey data and eventually to predict dropout in the context of digital health interventions. The process is applied to data from an internet-based intervention for insomnia as a way to illustrate its use. The completion of the program is contingent upon completing 7 sequential cores, which include an initial tutorial core. Dropout is defined as not completing the seventh core.

Methods: Steps of user journey analysis, including data transformation, feature engineering, and statistical model analysis and evaluation, are presented. Dropouts were predicted based on data from 151 participants from a fully automated web-based program (Sleep Healthy Using the Internet) that delivers cognitive behavioral therapy for insomnia. Logistic regression with L1 and L2 regularization, support vector machines, and boosted decision trees were used and evaluated based on their predictive performance. Relevant features from the data are reported that predict user dropout.

Results: Accuracy of predicting dropout (area under the curve [AUC] values) varied depending on the program core and the machine learning technique. After model evaluation, boosted decision trees achieved AUC values ranging between 0.6 and 0.9. Additional handcrafted features, including time to complete certain steps of the intervention, time to get out of bed, and days since the last interaction with the system, contributed to the prediction performance.

Conclusions: The results support the feasibility and potential of analyzing user journey data to predict dropout. Theory-driven handcrafted features increased the prediction performance. The ability to predict dropout at an individual level could be used to enhance decision making for researchers and clinicians as well as inform dynamic intervention regimens.
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http://dx.doi.org/10.2196/17738DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7657718PMC
October 2020

Effects of an Internet-Based Cognitive Behavioral Therapy for Insomnia Program on Work Productivity: A Secondary Analysis.

Ann Behav Med 2021 Jun;55(6):592-599

Center for Behavioral Health and Technology, University of Virginia School of Medicine, Charlottesville, VA, USA.

Background: Cognitive-behavioral therapy for insomnia (CBT-I) may improve productivity along with insomnia symptoms, but the long-term duration of productivity gains is unknown.

Purpose: In this secondary analysis, effects of Internet-delivered CBT-I on work-related and daily activity productivity were examined through 1 year post-treatment.

Methods: Adults with chronic insomnia (N = 303) were randomized to Internet-delivered CBT-I (Sleep Healthy Using the Internet [SHUTi]) or to patient education (PE). Participants reported interference with attendance (absenteeism) and productivity (presenteeism) at paid employment and in daily activities outside work on the Work Productivity Activity Impairment scale at baseline, 9 weeks later for postintervention assessment (post-assessment), and 6- and 12-month follow-ups.

Results: Participants randomized to SHUTi were about 50% less likely than those in the PE condition to report any absenteeism (logistic regression odds ratio [OR] = 0.48 [95% confidence intervals {CI} = 0.24,0.96]), total impairment (OR = 0.52 [95% CI = 0.29,0.93]), or activity impairment (OR = 0.50 [95% CI = 0.30,0.85]) at post-assessment; however, differences were not detected at 6- or 12-month follow-ups. SHUTi participants also reported lower overall levels of presenteeism (constrained longitudinal data analysis MDiff = -6.84 [95% CI = -11.53, -2.15]), total impairment (MDiff = -7.62 [95% CI = -12.50, -2.73]), and activity impairment (MDiff = -7.47 [95% CI = -12.68, -2.26]) at post-assessment relative to PE participants. Differences were sustained at 6-month follow-up for presenteeism (MDiff = -5.02 [95% CI = -9.94, -0.10]) and total impairment (MDiff = -5.78 [95% CI = -10.91, -0.65]). No differences were detected by 12-month follow-up.

Conclusions: Findings suggest that Internet-based CBT-I may help accelerate improvement in work-related and daily activity impairment corroborating prior research, but did not find that CBT-I has persistent, long-term benefits in productivity relative to basic insomnia education.

Trial Registration: NCT00328250 "Effectiveness of Internet Cognitive Behavioral Therapy Intervention for Treating Insomnia" (https://clinicaltrials.gov/ct2/show/NCT00328250).
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http://dx.doi.org/10.1093/abm/kaaa085DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8171799PMC
June 2021

Consensus statement on the problem of terminology in psychological interventions using the internet or digital components.

Internet Interv 2020 Sep 2;21:100331. Epub 2020 Jun 2.

Department of Psychology, Stockholm University, Frescati Hagvag 8, 114 19 Stockholm, Sweden.

Since the emergence of psychological interventions delivered via the Internet they have differed in numerous ways. The wealth of formats, methods, and technological solutions has led to increased availability and cost-effectiveness of clinical care, however, it has simultaneously generated a multitude of terms. With this paper, we first aim to establish whether a terminology issue exists in the field of Internet-delivered psychological interventions. If so, we aim to determine its implications for research, education, and practice. Furthermore, we intend to discuss solutions to mitigate the problem; in particular, we propose the concept of a common glossary. We invited 23 experts in the field of Internet-delivered interventions to respond to four questions, and employed the Delphi method to facilitate a discussion. We found that experts overwhelmingly agreed that there were terminological challenges, and that it had significant consequences for conducting research, treating patients, educating students, and informing the general public about Internet-delivered interventions. A cautious agreement has been reached that formulating a common glossary would be beneficial for the field to address the terminology issue. We end with recommendations for the possible formats of the glossary and means to disseminate it in a way that maximizes the probability of broad acceptance for a variety of stakeholders.
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http://dx.doi.org/10.1016/j.invent.2020.100331DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7305336PMC
September 2020

The Model of Gamification Principles for Digital Health Interventions: Evaluation of Validity and Potential Utility.

J Med Internet Res 2020 06 10;22(6):e16506. Epub 2020 Jun 10.

Department of Public Health Sciences, University of Virginia, Charlottesville, VA, United States.

Background: Although gamification continues to be a popular approach to increase engagement, motivation, and adherence to behavioral interventions, empirical studies have rarely focused on this topic. There is a need to empirically evaluate gamification models to increase the understanding of how to integrate gamification into interventions.

Objective: The model of gamification principles for digital health interventions proposes a set of five independent yet interrelated gamification principles. This study aimed to examine the validity and reliability of this model to inform its use in Web- and mobile-based apps.

Methods: A total of 17 digital health interventions were selected from a curated website of mobile- and Web-based apps (PsyberGuide), which makes independent and unbiased ratings on various metrics. A total of 133 independent raters trained in gamification evaluation techniques were instructed to evaluate the apps and rate the degree to which gamification principles are present. Multiple ratings (n≥20) were collected for each of the five gamification principles within each app. Existing measures, including the PsyberGuide credibility score, mobile app rating scale (MARS), and the app store rating of each app were collected, and their relationship with the gamification principle scores was investigated.

Results: Apps varied widely in the degree of gamification implemented (ie, the mean gamification rating ranged from 0.17≤m≤4.65 out of 5). Inter-rater reliability of gamification scores for each app was acceptable (κ≥0.5). There was no significant correlation between any of the five gamification principles and the PsyberGuide credibility score (P≥.49 in all cases). Three gamification principles (supporting player archetypes, feedback, and visibility) were significantly correlated with the MARS score, whereas three principles (meaningful purpose, meaningful choice, and supporting player archetypes) were significantly correlated with the app store rating. One gamification principle was statistically significant with both the MARS and the app store rating (supporting player archetypes).

Conclusions: Overall, the results support the validity and potential utility of the model of gamification principles for digital health interventions. As expected, there was some overlap between several gamification principles and existing app measures (eg, MARS). However, the results indicate that the gamification principles are not redundant with existing measures and highlight the potential utility of a 5-factor gamification model structure in digital behavioral health interventions. These gamification principles may be used to improve user experience and enhance engagement with digital health programs.
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http://dx.doi.org/10.2196/16506DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7315368PMC
June 2020

Intraindividual variability in sleep schedule: effects of an internet-based cognitive-behavioral therapy for insomnia program and its relation with symptom remission.

Sleep 2020 12;43(12)

Center for Behavioral Health and Technology, University of Virginia, Charlottesville, VA.

Study Objectives: Sleep schedule consistency is fundamental to cognitive-behavioral therapy for insomnia (CBT-I), although there is limited evidence suggesting whether it predicts treatment response. This analysis tested whether: (1) an Internet-based CBT-I program affects intraindividual variability (IIV) in sleep schedule and (2) sleep schedule IIV predicts insomnia symptom remission.

Methods: This secondary analysis compares participants (N = 303) randomized to an Internet-based CBT-I program (SHUTi-Sleep Healthy Using the Internet) or Internet-based patient education (PE). Participants reported daily bedtimes and rising times on 10 online sleep diaries collected over 2 weeks at baseline and 9-week post-intervention assessment. Participants completed the Insomnia Severity Index (ISI) at post-assessment and 6-month follow-up; symptom remission was defined by ISI < 8. Mixed effects location scale modeling was used to examine the effect of SHUTi on bedtime and rising time IIV; a novel two-staged analysis examined the effect of bedtime and rising time IIV on insomnia symptom remission.

Results: At post-assessment, SHUTi participants reported about 30% less bedtime and 32% less rising time variability compared to PE (ps < 0.03). Bedtime and rising time IIV was not independently associated with likelihood of insomnia symptom remission at the subsequent time point (ps > 0.18), nor did sleep schedule IIV moderate treatment response (ps > 0.12).

Conclusions: Findings demonstrate that an Internet-delivered CBT-I program can effectively increase users' sleep schedule consistency relative to an educational control. This consistency, however, was not related to treatment outcome when defined by insomnia symptom remission, suggesting that enforcing rigid sleep schedules for patients may not be necessary for treatment success.

Clinical Trial Registration: NCT00328250.
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http://dx.doi.org/10.1093/sleep/zsaa115DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7734473PMC
December 2020

Dyadic Psychosocial eHealth Interventions: Systematic Scoping Review.

J Med Internet Res 2020 03 4;22(3):e15509. Epub 2020 Mar 4.

Center for Behavioral Health and Technology, University of Virginia School of Medicine, Charlottesville, VA, United States.

Background: Dyadic psychosocial interventions have been found beneficial both for people coping with mental or physical health conditions as well as their family members and friends who provide them with support. Delivering these interventions via electronic health (eHealth) may help increase their scalability.

Objective: This scoping review aimed to provide the first comprehensive overview of dyadic eHealth interventions for individuals of all ages affected by mental or physical illness and their family members or friends who support them. The goal was to understand how dyadic eHealth interventions have been used and to highlight areas of research needed to advance dyadic eHealth intervention development and dissemination.

Methods: A comprehensive electronic literature search of PubMed, EMBASE, Cochrane, Cumulative Index to Nursing and Allied Health Literature, and PsycINFO was conducted for articles published in the English language through March 2019. Eligible records described a psychosocial eHealth intervention that intervened with both care recipients and their support person.

Results: A total of 7113 records were reviewed of which 101 met eligibility criteria. There were 52 unique dyadic eHealth interventions identified, which were tested across 73 different trials. Of the unique interventions, 33 were conducted among dyads of children and their supporting parent, 1 was conducted with an adolescent-young adult care recipient population, and the remaining 18 were conducted among adult dyads. Interventions targeting pediatric dyads most commonly addressed a mental health condition (n=10); interventions targeting adult dyads most commonly addressed cancer (n=9). More than three-fourths of interventions (n=40) required some human support from research staff or clinicians. Most studies (n=64) specified one or more primary outcomes for care recipients, whereas less than one-fourth (n=22) specified primary outcomes for support persons. Where specified, primary outcomes were most commonly self-reported psychosocial or health factors for both care recipients (n=43) and support persons (n=18). Results of the dyadic eHealth intervention tended to be positive for care recipients, but evidence of effects for support persons was limited because of few studies specifying primary outcomes for supporters. Trials of dyadic eHealth interventions were most commonly randomized controlled trials (RCTs; n=44), and RCTs most commonly compared the dyadic eHealth intervention to usual care alone (n=22).

Conclusions: This first comprehensive review of dyadic eHealth interventions demonstrates that there is substantial, diverse, and growing literature supporting this interventional approach. However, several significant gaps were identified. Few studies were designed to evaluate the unique effects of dyadic interventions relative to individual interventions. There was also limited assessment and reporting of outcomes for support persons, and there were no interventions meeting our eligibility criteria specifically targeting the needs of older adult dyads. Findings highlight areas of research opportunities for developing dyadic eHealth interventions for novel populations and for increasing access to dyadic care.
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http://dx.doi.org/10.2196/15509DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7081137PMC
March 2020

A secondary analysis of the role of geography in engagement and outcomes in a clinical trial of an efficacious Internet intervention for insomnia.

Internet Interv 2019 Dec 14;18:100294. Epub 2019 Nov 14.

Department of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, USA.

Background: Online interventions for insomnia can increase access to treatments for those with limited access to services. What remains unknown is whether individuals from more isolated (vs. more densely populated) regions engage with, and benefit as much from, an online intervention. This secondary analysis examined the relationship of geographical indices with engagement and outcomes of an efficacious, fully automated online cognitive behavioral therapy for insomnia (CBT-I) program (Sleep Healthy Using the Internet-SHUTi).

Method: 303 participants (  = 43.3;  = 11.6) were randomly assigned to SHUTi or an online patient education condition and assessed at baseline and post intervention. Rural code of participants was determined using participant zip codes. Distance to the nearest sleep medicine provider was calculated as the distance between the center of the nearest provider's city (from a publicly available list of CBT-I providers) and the center of the participants' zip code. Adherence outcomes were number of intervention core completions, sleep diaries, and logins. Sleep outcomes were insomnia severity as well as sleep onset latency and wake after sleep onset derived from online sleep diaries.

Results: Individuals were from a range of geographic locations. Most lived in fairly densely populated areas; however, there was a large variation in distance to the nearest sleep medicine provider. Findings indicate that the efficacy, adherence, and engagement with SHUTi were not impacted by where people lived. Controlling for age and gender did not impact any of the relationships among geography variables (i.e., distance, ruralness) and adherence or sleep related outcomes.

Conclusions: Internet interventions must demonstrate that they can overcome obstacles posed by geography. This is the first study to examine the geographic location of participants and its association with engagement with, and outcomes of, online CBT-I.
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http://dx.doi.org/10.1016/j.invent.2019.100294DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6926280PMC
December 2019

Informal Caregivers' Use of Internet-Based Health Resources: An Analysis of the Health Information National Trends Survey.

JMIR Aging 2018 Dec 18;1(2):e11051. Epub 2018 Dec 18.

Center for Behavioral Health & Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, Charlottesville, VA, United States.

Background: Informal caregivers express strong interest in technology innovations to help them in their caregiving role; however, divides across sociodemographic characteristics in internet and technology access may preclude the most vulnerable caregivers from accessing such resources.

Objective: This study aims to examine caregivers' internet use, both generally and for seeking health-related information, and whether usage differs as a function of caregivers' characteristics.

Methods: Data were analyzed from the Health Information National Trends Survey 5 Cycle 1. Participants were included in analyses if they self-identified as providing uncompensated care to a close individual. Caregivers reported internet use factors, age, education, rurality, general health, distress, and objective caregiving burden. We used chi-square tests of independence with jackknife variance estimation to compare whether internet use factors differed by caregivers' characteristics.

Results: A total of 77.5% (303/391) caregivers surveyed reported ever using the internet. Of internet users, 88.1% (267/303) accessed from a home computer and 83.2% (252/303) from a mobile device. Most caregivers accessed health information for themselves (286/391, 73.1%) or others (264/391, 67.5%); fewer communicated with a doctor over the Web (148/391, 37.9%) or had a wellness app (171/391, 43.7%). Caregivers reporting younger age, more education, and good health were more likely to endorse any of these activities. Furthermore, two-thirds of caregivers (258/391, 66.0%) endorsed trust in health information from the internet.

Conclusions: Computers and mobile devices are practical platforms for disseminating caregiving-related information and supportive services to informal caregivers; these modalities may, however, have a more limited reach to caregivers who are older, have less education, and are in poorer health.
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http://dx.doi.org/10.2196/11051DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6715019PMC
December 2018

Short and long-term effects of unguided internet-based cognitive behavioral therapy for chronic insomnia in morning and evening persons: a post-hoc analysis.

Chronobiol Int 2019 10 1;36(10):1384-1398. Epub 2019 Aug 1.

Department of Health Promotion, Norwegian Institute of Public Health , Bergen , Norway.

A post-hoc analysis comparing morning and evening persons with insomnia on sleep and mental health characteristics was conducted in order to investigate whether an Internet-based cognitive behavioral therapy for insomnia (ICBTi) was effective both for morning and evening persons. Adult patients (N = 178, mean age = 44.8, 67% females) with insomnia were randomized to either ICBTi (N = 92; morning persons = 41; evening persons = 51) or a web-based patient education condition (N = 86; morning persons = 44; evening persons = 42). All patients were assessed with sleep diaries, the Insomnia Severity Index (ISI), the Bergen Insomnia Scale (BIS), the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16), the Hospital Anxiety and Depression Scale (HADS) and the Chalder Fatigue Scale (CFQ). Patients were characterized as morning or evening persons based on a median split on the Horne-Östberg Morningness Eveningness Questionnaire. Short and long-term effects of treatment were examined with mixed-model repeated-measures analyses. Morning and evening persons did not differ in terms of age, gender or educational status. At baseline, morning persons had more wake time after sleep onset (= 0.54, < .001) and more early morning awakening (= 0.38, < .05) compared to evening persons, while evening persons reported longer sleep onset latency (= 0.60, < .001), more time in bed (= 0.56, < .001), longer total sleep time (= 0.45, < .01), more fatigue (= 0.31, < .05) and more dysfunctional beliefs and attitudes about sleep (= 0.47, < .01). Despite these differences at baseline, both morning and evening persons receiving ICBTi benefitted more across most measures compared to morning and evening persons who received patient education. For morning persons in the ICBTi group, ISI scores were reduced from 17.3 at baseline to 8.8 (d = 2.48, < .001) at post-assessment, and to 10.0 at 18-month follow up (d = 2.13, < .001). Comparable results were found for evening persons in the ICBTi group, with a reduction in ISI scores from 17.4 at baseline to 8.6 (d = 2.24, < .001) at post-assessment, and to 8.7 at 18-month follow up (d = 2.19, < .001). Similar results were found on the BIS, DBAS, HADS, CFQ and sleep diary data. Despite different insomnia symptomatology between the two groups, the current study suggests that ICBTi is effective across scores on the morningness-eveningness dimension. The study was pre-registered at: ClinicalTrials.gov Identifier: NCT02261272.
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http://dx.doi.org/10.1080/07420528.2019.1647435DOI Listing
October 2019

Randomized controlled trial of the mySmartSkin web-based intervention to promote skin self-examination and sun protection behaviors among individuals diagnosed with melanoma: study design and baseline characteristics.

Contemp Clin Trials 2019 08 27;83:117-127. Epub 2019 Jun 27.

Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, Charlottesville, VA, United States.

>1.2 million people in the United States have a personal history of melanoma skin cancer and are at increased risk for disease recurrence and second primary melanomas. Many of these individuals do not follow recommendations to conduct regular, thorough skin self-examinations that facilitate early disease detection and do not sufficiently engage in sun protection behaviors. In this project, we are conducting a randomized controlled trial of an innovative, tailored, theory-driven Internet intervention-called mySmartSkin-to promote these behaviors among melanoma patients. This paper outlines the study design and characteristics of the study sample. A total of 441 patients were recruited (40.9% response rate) and randomized to the mySmartSkin or a Usual Care condition. Participants complete surveys at baseline and 8 weeks, 24 weeks, and 48 weeks later. The primary aim of the project is to examine the impact of mySmartSkin versus Usual Care on skin self-examination and sun protection behaviors. The secondary aim focuses on identifying mediators of the intervention's effects. In an exploratory aim, we will examine potential moderators of the impact of the intervention. At baseline, the recruited participants had a mean age of 61 years, 49% were female, 7.5% met criteria for having conducted a recent, thorough skin self-examination, and the mean score on the index of sun protection behaviors was 3.3 (on a scale from 1 to 5). The results of the project will determine whether the mySmartSkin intervention is efficacious in promoting skin self-examination and sun protection behaviors among individuals diagnosed with melanoma. Trial registration: ClinicalTrials.govNCT03028948.
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http://dx.doi.org/10.1016/j.cct.2019.06.014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6690854PMC
August 2019

Kids SIPsmartER, a cluster randomized controlled trial and multi-level intervention to improve sugar-sweetened beverages behaviors among Appalachian middle-school students: Rationale, design & methods.

Contemp Clin Trials 2019 08 21;83:64-80. Epub 2019 Jun 21.

University of Virginia, Department of Public Health Sciences, UVA Cancer Center Research and Outreach Office, 16 East Main Street, Christiansburg, VA 24073, USA.

The intake of sugar-sweetened beverages (SSB) is disproportionately high in Appalachia, including among adolescents whose intake is more than double the national average and more than four times the recommended daily amount. Unfortunately, there is insufficient evidence for effective strategies targeting SSB behaviors among Appalachian youth in real-world settings, including rural schools. Kids SIPsmartER is a 6-month, school-based, behavior and health literacy program aimed at improving SSB behaviors among middle school students. The program also integrates a two-way short message service (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes. Kids SIPsmartER is grounded by the Theory of Planned Behavior and health literacy, media literacy, numeracy, and public health literacy concepts. Guided by the RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance), this type 1 hybrid design and cluster randomized controlled trial targets 12 Appalachian middle schools in southwest Virginia. The primary aim evaluates changes in SSB behaviors at 7-months among 7th grade students at schools receiving Kids SIPsmartER, as compared to control schools. Secondary outcomes include other changes in students (e.g., BMI, quality of life, theory-related variables) and caregivers (e.g., SSB behaviors, home SSB environment), and 19-month maintenance of these outcomes. Reach is assessed, along with mixed-methods strategies (e.g., interviews, surveys, observation) to determine how teachers implement Kids SIPsmartER and the potential for institutionalization within schools. This paper discusses the rationale for implementing and evaluating a type 1 hybrid design and multi-level intervention addressing pervasive SSB behaviors in Appalachia. Clincialtrials.gov: NCT03740113.
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http://dx.doi.org/10.1016/j.cct.2019.06.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6713199PMC
August 2019

Do treatment effects of a web-based cognitive behavioral therapy for insomnia intervention differ for users with and without pain interference? A secondary data analysis.

J Behav Med 2020 06 31;43(3):503-510. Epub 2019 May 31.

Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, PO Box 801075, Charlottesville, VA, 22908, USA.

Cognitive-behavioral therapy for insomnia (CBT-I) shows treatment benefits among individuals with pain interference; however, effects of Internet-delivered CBT-I for this population are unknown. This secondary analysis used randomized clinical trial data from adults assigned to Internet-delivered CBT-I to compare changes in sleep by pre-intervention pain interference. Participants (N = 151) completed the Insomnia Severity Index (ISI) and sleep diaries [sleep onset latency (SOL); wake after sleep onset (WASO)] at baseline, post-assessment, 6- and 12-month follow-ups. Linear mixed-effects models showed no differences between pain interference groups (no, some, moderate/severe) for changes from baseline to any follow-up timepoint for ISI (p = .72) or WASO (p = .88). There was a small difference in SOL between those reporting some versus no or moderate/severe pain interference (p = .04). Predominantly comparable and sustained treatment benefits for both those with and without pain interference suggest that Internet-delivered CBT-I is promising for delivering accessible care to individuals with comorbid pain and insomnia.
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http://dx.doi.org/10.1007/s10865-019-00065-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6885103PMC
June 2020

Principles of gamification for Internet interventions.

Transl Behav Med 2019 11;9(6):1131-1138

Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, School of Medicine, University of Virginia, Charlottesville, VA, USA.

Gamification is a popular method used to add entertaining and appealing dimensions to nongaming activities. Researchers of technology-based behavioral and mental-health-focused interventions have shown considerable interest in gamification to enhance engagement and adherence. There have been a number of gamification frameworks proposed, each with differences in focus but with overlapping similarities. A review of these frameworks highlight critical issues in gamification-lack of clear definitions, standards, and a need for an overarching model for applying gamification, rather than simply describing gamification. These issues leave researchers challenged to apply gamification to its full potential. This paper explores gamification as a construct and endeavors to define its core features. A useful way of evaluating the potential utility of gamification features in the context of an intervention is by distinguishing between exogenous applications of gamification (layering game mechanics externally upon a system) and endogenous application of gamification (developing mechanics intrinsic to the given experience). By then comparing and contrasting six gamification frameworks, components are identified that lay at the intersection and a theoretical model is proposed. A theory-driven set of gamification principles, organized into four categories, is developed and presented. Of particular interest is the utilization of this model as it relates to behavioral and mental-health-focused Internet-based interventions. To demonstrate the potential of this gamification framework, the generated principles are overlaid onto the established Model for Internet Interventions, extending it, and providing a more concrete foundation for researchers of Internet interventions. The presented model will assist researchers and developers who are interested in applying gamification to Internet interventions.
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http://dx.doi.org/10.1093/tbm/ibz041DOI Listing
November 2019

Examining the relationship between changes in personality and depression in older adult cancer survivors.

Aging Ment Health 2020 08 3;24(8):1237-1245. Epub 2019 Apr 3.

Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, School of Medicine, Charlottesville, VA, USA.

Despite widespread agreement that personality traits change across the lifespan into older adulthood, the association between changes in personality and depression among older adult cancer survivors is unknown. It was hypothesized that older adults with (vs. without) a past cancer diagnosis would experience an increase in neuroticism, and decreases in conscientiousness, agreeableness, openness, and extraversion, and that changes in these traits would mediate the relationship between receiving a cancer diagnosis and change in depression. Two hypotheses were tested in a cancer survivor sample. First, that increased chronic stressors and decreased physical health would mediate the link between personality change and increased depression. Second, that personality change would mediate the link between changes in chronic stressors/health and increased depression. Secondary data analysis utilizing three waves of data from the Health and Retirement Study. Data was compiled from 5,217 participants, among whom 707 received a cancer diagnosis. Older adults with (vs. without) a cancer diagnosis decreased in conscientiousness, which was associated with increased depression. Among cancer survivors, worsening chronic stressors/health mediated many pathways between personality change and an increased depression. Increased neuroticism mediated the link between worsening health/chronic stressors and increased depression. With the exception of conscientiousness, changes in personality did not mediate the link between cancer survivor status and depression. Among older adult cancer survivors, changes in personality traits may increase depression through worsening physical health and chronic stressors, potentially informing targeted interventions. Interventions that target increased neuroticism may be particularly useful in older adult cancer survivors.
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http://dx.doi.org/10.1080/13607863.2019.1594158DOI Listing
August 2020

Solving insomnia electronically: Sleep treatment for asthma (SIESTA): A study protocol for a randomized controlled trial.

Contemp Clin Trials 2019 04 27;79:73-79. Epub 2019 Feb 27.

School of Nursing, University of Pittsburgh, Pittsburgh, PA, United States of America. Electronic address:

Background: Chronic insomnia is associated with poor asthma control. Cognitive-behavioral treatment for insomnia (CBT-I) is an efficacious and durable treatment for comorbid insomnia in medical and psychiatric disorders. However, the efficacy and potential accompanying mechanisms of CBT-I have not been examined in asthma. The purpose of this study is to test the efficacy of a CBT-I intervention on sleep and asthma control in adults with insomnia and asthma. We will also explore airway inflammation (i.e., exhaled nitric oxide, blood eosinophils) as a potential biological mechanism linking improvements in sleep with improvements in asthma control.

Methods: The study is a single center, parallel group, randomized controlled trial. Two hundred and ten adults with insomnia and asthma that is not well-controlled will be randomized to either a 9-week Internet-based CBT-I program (Sleep Healthy Using the Internet (SHUTi)) or an enhanced usual care condition which utilizes an online educational video about insomnia. The primary sleep outcome is insomnia severity measured by the Insomnia Severity Index. Secondary sleep outcomes are sleep quality and wrist actigraph-recorded sleep parameters. Asthma control will be assessed by the Asthma Control Test, Asthma Quality of Life Questionnaire, pulmonary function testing, and self-report of asthma exacerbations and asthma-related healthcare utilization. Treatment outcomes will be measured at baseline, 9 weeks, and 6 months.

Discussion: This trial has the potential to identify a novel strategy for improving asthma control. Findings may advocate for the inclusion of treatment of comorbid insomnia into current asthma management practice guidelines.
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http://dx.doi.org/10.1016/j.cct.2019.02.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6563833PMC
April 2019

Long-Term Effects of an Unguided Online Cognitive Behavioral Therapy for Chronic Insomnia.

J Clin Sleep Med 2019 01 15;15(1):101-110. Epub 2019 Jan 15.

Norwegian University of Science and Technology, Department of Mental Health, Faculty of Medicine and Health Sciences, Trondheim, Norway.

Study Objectives: The aim of this study was to test the efficacy of fully automated Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) 18 months after the intervention period on sleep, daytime functioning, and beliefs about sleep for adults with chronic insomnia.

Methods: Participants in this study had participated in a randomized controlled trial comparing the efficacy of unguided Internet CBT-I with web-based patient education. Participants who had received Internet CBT-I (n = 95) completed online questionnaires and online sleep diaries 18 months after the intervention period. We used linear mixed models to study changes from baseline to postassessment and to 18-month follow-up, and a separate mixed-models analysis to study changes from postassessment to 18-month follow-up.

Results: Mean age of the participants was 45.5 years (standard deviation = 12.6) and 64% were females. Sixty-six participants (70%) completed the 18-month follow-up assessment. There were significant improvements from baseline to 18-month follow-up on the Insomnia Severity Index (ISI) (Cohen = 2.04 [95% confidence interval (CI) 1.66-2.42]) and the Bergen Insomnia Scale (BIS) ( = 1.64 [95% CI 1.30-1.98]), levels of daytime fatigue ( = 0.85 [95% CI 0.59-1.11]), psychological distress ( = 0.51 [95% CI 0.29-0.73]), and beliefs about sleep ( = 1.44 [95% CI 1.15-1.73]). Moderate to large effect size improvements were also shown on the diary-derived sleep variables. All improvements from baseline to postassessment were essentially maintained to 18-month follow-up.

Conclusions: Unguided Internet CBT-I appears to have sustained effects on sleep, daytime functioning, and beliefs about sleep up to 18 months after the intervention period.

Clinical Trial Registration: This study presents long-term follow-up data of a previous clinical trial. Registry: ClinicalTrials.gov, Title: Internet-based Treatment for Insomnia in Norway, Identifier: NCT02261272, URL: https://clinicaltrials.gov/ct2/show/NCT02261272.
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http://dx.doi.org/10.5664/jcsm.7580DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6329541PMC
January 2019

Online cognitive behavioral therapy for insomnia (CBT-I) for the treatment of insomnia among individuals with alcohol use disorder: study protocol for a randomized controlled trial.

Pilot Feasibility Stud 2018 10;4:183. Epub 2018 Dec 10.

1National Institutes of Health Clinical Center, Bethesda, USA.

Abstract: Alcohol use disorder (AUD) is characterized by problematic drinking that becomes severe. Individuals with AUD often experience insomnia and other sleep disturbances at various phases of recovery. Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious non-pharmacological treatment for insomnia and is recommended as a first-line treatment for adults with chronic insomnia. Internet-based CBT-I could play a key role in the dissemination of this behavioral sleep intervention, given the paucity of trained clinicians able to provide CBT-I in person and other logistical/cost concerns. SHUTi (Sleep Healthy Using The Internet) is the most tested and empirically-sound Internet intervention for insomnia. Despite the promise of Internet-based CBT-I interventions, to date, no randomized controlled trials (RCTs) exist examining the feasibility/efficacy of an Internet-based CBT-I program among treatment-seeking individuals recovering from AUD. This is a two-phase RCT assessing feasibility/acceptability and efficacy of the SHUTi program among individuals with AUD in recovery with insomnia. Phase I will focus on assessing the feasibility and acceptability of program delivery and data collection ( = 10). Phase II will be an RCT powered to examine preliminary intervention efficacy ( = 30 per group). Participants for this study must meet criteria for "moderate to severe" insomnia. Individuals randomized to the intervention group will receive the SHUTi intervention (initiated while inpatient and completed while outpatient), and individuals randomized to the control group will receive an educational web-based program. The goals of the study are as follows: (1) assess the feasibility and acceptability of Internet-based CBT-I among individuals with AUD in recovery with insomnia (phase I), (2) compare the preliminary efficacy of CBT-I versus control group with respect to primary and secondary outcome variables (phase II), and (3) explore specific domains associated with improved outcomes, e.g., demographic, psychiatric, and drinking-related factors (phase II). Primary outcome measures include changes in insomnia severity over time and changes in actigraphy-recorded sleep efficiency over time.

Trial Registration: NCT#03493958; registered 1 June 2018.
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http://dx.doi.org/10.1186/s40814-018-0376-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6287341PMC
December 2018

Internet-Based Cognitive-Behavioral Therapy for Insomnia in Adults With Asthma: A Pilot Study.

Behav Sleep Med 2020 Jan-Feb;18(1):10-22. Epub 2018 Sep 25.

University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.

: Insomnia is common among adults with asthma and is associated with worse asthma control. Cognitive-behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia with medical comorbidities, but it has not been tested in asthma. The purpose of this study was to assess the feasibility and acceptability of an Internet-based CBT-I intervention, called Sleep Healthy Using the Internet (SHUTi), among adults with asthma and comorbid insomnia, and to gather preliminary efficacy data on changes in insomnia severity, sleep quality, asthma control, and asthma-related quality of life. : A single-group, pretest-posttest design was employed, where all participants completed the SHUTi program. Online questionnaires were completed pre- and postintervention. Individual telephone interviews were conducted after posttreatment data collection to obtain participants' experiences with SHUTi and suggestions for improvement. : The sample ( = 23) comprised men and women aged 18-75 years with moderate to severe, not well-controlled asthma, and comorbid insomnia. Nineteen (83%) completed postintervention assessments. Improvements on the Insomnia Severity Index, Pittsburgh Sleep Quality Index, Asthma Control Test, and Asthma Quality of Life Questionnair-Marks were observed at postintervention. Data from the telephone interviews suggest that most participants had a positive experience with SHUTi. Participants suggested incorporating asthma-specific content into future versions of the intervention. : Internet-based CBT-I is a potential treatment option for adults with asthma and comorbid insomnia.
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http://dx.doi.org/10.1080/15402002.2018.1518229DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6433549PMC
March 2020

Treatment engagement in an internet-delivered cognitive behavioral program for pediatric chronic pain.

Internet Interv 2018 Sep 19;13:67-72. Epub 2018 Jul 19.

Center for Child Health, Behavior & Development, Seattle Children's Research Institute, Seattle, WA, USA.

Internet-delivered cognitive-behavioral therapy (iCBT) is a promising treatment for chronic pain among youth, but effect sizes are small, and strategies aimed at enhancing treatment effects are needed. Participants' engagement with the program may be an important factor in determining treatment outcomes. The primary aim of the current study was to examine the relationship between treatment engagement and treatment outcomes. Secondarily, we sought to characterize participant engagement in an iCBT program for adolescents with chronic pain and their parents. Participants included 134 adolescents randomized to the intervention arm of a controlled trial examining iCBT for chronic pain. Overall engagement with the intervention by adolescents and parents was high. Parental engagement (number of modules completed by parents and number of parent logins) predicted adolescent activity limitations change scores at post-treatment. Contrary to our expectation, adolescent treatment engagement was not predictive of treatment outcomes. Results indicate that parental engagement with the program may be an important predictor of treatment outcomes. Further research is needed to better understand influences of treatment engagement on outcomes in iCBT for youth.
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http://dx.doi.org/10.1016/j.invent.2018.07.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6112105PMC
September 2018

Internet-delivered cognitive-behavioral therapy for insomnia and comorbid symptoms.

Internet Interv 2018 Jun 21;12:11-15. Epub 2018 Feb 21.

Department of Health Promotion, Norwegian Institute of Public Health, Bergen, Norway.

Background: Cognitive-behavioral therapy for insomnia (CBTi) is considered the standard treatment. The internet has proven to be a useful and successful tool of providing CBTi. However, few studies have investigated the possible effect of unguided internet-delivered CBTi (ICBTi) on comorbid psychological symptoms and fatigue.

Methods: Based on a randomized controlled trial, we investigated whether unguided ICBTi had an effect on comorbid psychological symptoms. Adults with insomnia ( = 181; 67% women; mean age 44.9 years [SD 13.0]) were randomized to ICBTi ( = 95) or to an online patient education condition ( = 86) for a nine-week period.

Results: The results from mixed linear modelling yielded medium to large between-group effect sizes from pre- to post-treatment for symptoms of anxiety or depression ( = -0.57; 95% CI = 0.79-0.35) and fatigue ( = 0.92; 95% CI = 1.22-0.62). The ICBTi group was reassessed at a 6-month non-randomized follow-up, and the completing participants had on the average a significant increase (from the post-assessment) on symptoms of anxiety or depression, while the reduction in symptoms of fatigue (on post-assessment) was maintained. However, due to high dropout attrition and no control group data, caution should be made regarding the long-term effects. In conclusion, the present findings show that unguided ICBTi positively influence comorbid symptoms in the short-term, thereby emphasizing the clinical relevance of unguided ICBTi.

Trial Registration: ClinicalTrials.gov identifier: NCT02261272.
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http://dx.doi.org/10.1016/j.invent.2018.02.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6096334PMC
June 2018

Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia.

Sleep Med 2018 07 20;47:77-85. Epub 2017 Dec 20.

Department of Psychiatry and Neurobehavioral Sciences, Center for Behavioral Health and Technology, University of Virginia School of Medicine, USA.

Objective: The aim of this study was to investigate in a randomized clinical trial the role of sleep-related cognitive variables in the long-term efficacy of an online, fully automated cognitive behavioral therapy intervention for insomnia (CBT-I) (Sleep Healthy Using the Internet [SHUTi]).

Method: Three hundred and three participants (M = 43.3 years; SD = 11.6) were randomly assigned to SHUTi or an online patient education condition and assessed at baseline, postintervention (nine weeks after baseline), and six and 12 months after the intervention period. Cognitive variables were self-reported internal and chance sleep locus of control, dysfunctional beliefs and attitudes about sleep (DBAS), sleep specific self-efficacy, and insomnia knowledge. Primary outcomes were self-reported online ratings of insomnia severity (Insomnia Severity Index), and sleep onset latency and wake after sleep onset from online sleep diaries, collected 12 months after the intervention period.

Results: Those who received SHUTi had, at postassessment, higher levels of insomnia knowledge (95% confidence interval [CI] = 0.10-0.16) and internal sleep locus of control (95% CI = 0.04-0.55) as well as lower DBAS (95% CI = 1.52-2.39) and sleep locus of control attributed to chance (95% CI = 0.15-0.71). Insomnia knowledge, chance sleep locus of control, and DBAS mediated the relationship between condition and at least one 12-month postassessment sleep outcome. Within the SHUTi condition, changes in each cognitive variable (with the exception of internal sleep locus of control) predicted improvement in at least one sleep outcome one year later.

Conclusion: Online CBT-I may reduce the enormous public health burden of insomnia by changing underlying cognitive variables that lead to long-term changes in sleep outcomes.
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http://dx.doi.org/10.1016/j.sleep.2017.11.1140DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5993570PMC
July 2018

Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial.

J Natl Cancer Inst 2018 08;110(8):880-887

Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, Charlottesville, VA.

Background: Insomnia is two to three times more prevalent in cancer survivors than in the general population, where it is estimated to be 10% to 20%. Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended treatment for chronic insomnia, but meeting survivor needs remains a challenge. Internet-delivered CBT-I (iCBT-I) has been shown efficacious in otherwise healthy adults. We tested the efficacy of iCBT-I in breast cancer survivors with clinically significant sleep disturbance.

Methods: Women from a national sample of Danish breast cancer survivors who experienced clinically significant sleep disturbance were randomly allocated to iCBT-I or waitlist control (55:45). The fully automated iCBT-I program consisted of six cores. Online measures of insomnia severity, sleep quality, and fatigue were collected at baseline, postintervention (nine weeks), and follow-up (15 weeks). Online sleep diaries were completed over two-week periods pre- and postintervention. Intention-to-treat analyses (time × group interactions) were conducted with mixed linear models and corrected for multiple outcomes. All statistical tests were two-sided.

Results: A total of 255 women were randomly allocated to iCBT-I (n = 133) or waitlist control (n = 122). Statistically significant (P ≤ .02) time × group interactions were found for all sleep-related outcomes from pre- to postintervention. Effect sizes (Cohen's d) ranged from 0.33 (95% confidence interval [CI] = 0.06 to 0.61) for wake after sleep onset to 1.17 (95% CI = 0.87 to 1.47) for insomnia severity. Improvements were maintained for outcomes measured at follow-up (d = 0.66-1.10).

Conclusions: iCBT-I appears to be effective in breast cancer survivors, with additional benefit in terms of reduced fatigue. This low-cost treatment could be incorporated in cancer rehabilitation programs.
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http://dx.doi.org/10.1093/jnci/djx293DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6093474PMC
August 2018

Web-Delivered Cognitive Behavioral Therapy for Distressed Cancer Patients: Randomized Controlled Trial.

J Med Internet Res 2018 01 31;20(1):e42. Epub 2018 Jan 31.

Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia.

Background: Web-based interventions present a potentially cost-effective approach to supporting self-management for cancer patients; however, further evidence for acceptability and effectiveness is needed.

Objective: The goal of our research was to assess the effectiveness of an individualized Web-based cognitive behavioral therapy (CBT) intervention on improving psychological and quality of life outcomes in cancer patients with elevated psychological distress.

Methods: A total of 163 distressed cancer patients (111 female, 68.1%) were recruited through the Queensland Cancer Registry and the Cancer Council Queensland Cancer Helpline and randomly assigned to either a Web-based tailored CBT intervention (CancerCope) (79/163) or a static patient education website (84/163). At baseline and 8-week follow-up we assessed primary outcomes of psychological and cancer-specific distress and unmet psychological supportive care needs and secondary outcomes of positive adjustment and quality of life.

Results: Intention-to-treat analyses showed no evidence of a statistically significant intervention effect on primary or secondary outcomes. However, per-protocol analyses found a greater decrease for the CancerCope group in psychological distress (P=.04), cancer-specific distress (P=.02), and unmet psychological care needs (P=.03) from baseline to 8 weeks compared with the patient education group. Younger patients were more likely to complete the CancerCope intervention.

Conclusions: This online CBT intervention was associated with greater decreases in distress for those patients who more closely adhered to the program. Given the low costs and high accessibility of this intervention approach, even if only effective for subgroups of patients, the potential impact may be substantial.

Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12613001026718; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364768&isReview=true (Archived by WebCite at http://www.webcitation.org/6uPvpcovl).
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http://dx.doi.org/10.2196/jmir.8850DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5812983PMC
January 2018

Convergence of online daily diaries and timeline followback among women at risk for alcohol exposed pregnancy.

J Subst Abuse Treat 2017 11 16;82:7-11. Epub 2017 Aug 16.

Department of Psychiatry and Neurobehavioral Sciences, Center for Behavioral Health and Technology, University of Virginia School of Medicine, 560 Ray C. Hunt Drive, Charlottesville, VA 22903, United States.

Researchers and clinicians interested in assessing drinking and unprotected sex in evaluating risk for alcohol-exposed pregnancy (AEP) have limited options. The current investigation examined the degree to which data collected from online prospectively collected daily diaries (Diaries) converged with data from interviewer-administered retrospective timeline follow back (TLFB), the standard in AEP intervention studies. 71 women (M=27.7, SD=6.2) at risk for AEP were recruited via online advertising and were randomly assigned to an online patient education condition or a tailored, online internet intervention to reduce AEP risk. All participants were administered both Diaries and TLFB at baseline and 6months after intervention. Key outcomes were variables of drinking rates and unprotected sex that combined to indicate risk for AEP. Zero-order and intra-class correlations (ICC) between Diaries and TLFB were strong for each outcome. Examination of ICC confidence intervals indicated that condition assignment did not have a significant impact on the degree of convergence between Diaries and TLFB. With the exception of proportion of days drinking and proportion of days with unprotected sex at baseline, none of the paired t-tests reached significance. Examination of descriptive statistics revealed that 63% of participants reported problem alcohol use and unprotected sex in both the 10-day Diaries and 90-day TLFB at baseline, with 70% agreement at post 6-month follow up. Findings indicate overall strong agreement between TLFB and Diaries in detecting alcohol use and unprotected sex in women at risk for AEP, and each method has benefits and challenges that should be weighed carefully by researchers and treatment providers.
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http://dx.doi.org/10.1016/j.jsat.2017.08.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5659835PMC
November 2017