Publications by authors named "Natalie Bauereiss"

8 Publications

  • Page 1 of 1

Clinical and Cost-Effectiveness of PSYCHOnlineTHERAPY: Study Protocol of a Multicenter Blended Outpatient Psychotherapy Cluster Randomized Controlled Trial for Patients With Depressive and Anxiety Disorders.

Front Psychiatry 2021 14;12:660534. Epub 2021 May 14.

Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University of Erlangen-Nuremberg, Erlangen, Germany.

Internet- and mobile-based interventions (IMIs) and their integration into routine psychotherapy (i.e., blended therapy) can offer a means of complementing psychotherapy in a flexible and resource optimized way. The present study will evaluate the non-inferiority, cost-effectiveness, and safety of two versions of integrated blended psychotherapy for depression and anxiety compared to standard cognitive behavioral therapy (CBT). A three-armed multicenter cluster-randomized controlled non-inferiority trial will be conducted comparing two implementations of blended psychotherapy (PSYCHOnlineTHERAPY) compared to CBT. Seventy-five outpatient psychotherapists with a CBT-license will be randomized in a 1:1:1 ratio. Each of them is asked to include 12 patients on average with depressive or anxiety disorders resulting in a total sample size of = 900. All patients receive up to a maximum of 16 psychotherapy sessions, either as routine CBT or alternating with Online self-help sessions (fix: 8/8; flex: 0-16). Assessments will be conducted at patient study inclusion (pre-treatment) and 6, 12, 18, and 24 weeks and 12 months post-inclusion. The primary outcome is depression and anxiety severity at 18 weeks post-inclusion (post-treatment) using the Patient Health Questionnaire Anxiety and Depression Scale. Secondary outcomes are depression and anxiety remission, treatment response, health-related quality of life, patient satisfaction, working alliance, psychotherapy adherence, and patient safety. Additionally, several potential moderators and mediators including patient characteristics and attitudes toward the interventions will be examined, complemented by ecological day-to-day digital behavior variables via passive smartphone sensing as part of an integrated smart-sensing sub-study. Data-analysis will be performed on an intention-to-treat basis with additional per-protocol analyses. In addition, cost-effectiveness and cost-utility analyses will be conducted from a societal and a public health care perspective. Additionally, qualitative interviews on acceptance, feasibility, and optimization potential will be conducted and analyzed. PSYCHOnlineTHERAPY will provide evidence on blended psychotherapy in one of the largest ever conducted psychotherapy trials. If shown to be non-inferior and cost-effective, PSYCHOnlineTHERAPY has the potential to innovate psychotherapy in the near future by extending the ways of conducting psychotherapy. The rigorous health care services approach will facilitate a timely implementation of blended psychotherapy into standard care. The trial is registered in the German Clinical Trials Register (DRKS00023973; date of registration: December 28th 2020).
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May 2021

Feasibility of a Software agent providing a brief Intervention for Self-help to Uplift psychological wellbeing ("SISU"). A single-group pretest-posttest trial investigating the potential of SISU to act as therapeutic agent.

Internet Interv 2021 Apr 24;24:100377. Epub 2021 Feb 24.

Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Lise Meitner Straße 16, 89081 Ulm, Germany.

Background: Software agents are computer-programs that conduct conversations with a human. The present study evaluates the feasibility of the software agent "SISU" aiming to uplift psychological wellbeing. Methods: Within a one-group pretest-posttest trial,  = 30 German-speaking participants were recruited. Assessments took place before (t1), during (t2) and after (t3) the intervention. The ability of SISU to guide participants through the intervention, acceptability, and negative effects were investigated. Data analyses are based on intention-to-treat principles. Linear mixed models will be used to investigate short-term changes over time in mood, depression, anxiety.

Intervention: The intervention consists of two sessions. Each session comprises writing tasks on autobiographical negative life events and an Acceptance- and Commitment Therapy-based exercise respectively. Participants interact with the software agent on two consecutive days for about 30 min each.

Results: All participants completed all sessions within two days. User experience was positive, with all subscales of the user experience questionnaire (UEQ) M > 0.8. Participants experienced their writings as highly self-relevant and personal. However, 57% of the participants reported at least one negative effect attributed to the intervention. Results on linear mixed models indicate an increase in anxiety over time (β = 1.33,  = .001). Qualitative User Feedback revealed that the best thing about SISU was its innovativeness (13%) and anonymity (13%). As worst thing about SISU participants indicated that the conversational style of SISU often felt unnatural (73%).

Conclusion: SISU successfully guided participants through the two-day intervention. Moreover, SISU has the potential to enter the inner world of participants. However, intervention contents have the potential to evoke negative effects in individuals. Expectable short-term symptom deterioration due to writing about negative autobiographical life events could not be prevented by acceptance and commitment therapy-based exercises. Hence, results suggest a revision of intervention contents as well as of the conversational style of SISU. The good adherence rate indicates the useful and acceptable format of SISU as a mental health chatbot. Overall, little is known about the effectiveness of software agents in the context of psychological wellbeing. Results of the present trial underline that the innovative technology bears the potential of SISU to act as therapeutic agent but should not be used with its current intervention content.

Trial-registration: The Trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Studies Register (DRKS): DRKS00014933 (date of registration: 20.06.2018). Link:
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April 2021

Lessons learned from an attempted randomized-controlled feasibility trial on "WIDeCAD" - An internet-based depression treatment for people living with coronary artery disease (CAD).

Internet Interv 2021 Apr 24;24:100375. Epub 2021 Feb 24.

Department of Clinical Psychology and Psychotherapy, University Ulm, Ulm, Germany.

Despite the high prevalence of comorbid depression in people living with coronary artery disease (CAD), uptake of psychological treatment is generally low. This study was designed to investigate the feasibility of an internet-based cognitive-behavioral (iCBT) depression intervention for people with CAD and depressive symptoms.

Methods: People with CAD and depressive symptoms (PHQ-9 ≥ 5) were randomly assigned to the eight modules comprising iCBT ( = 18), or waitlist-control ( = 16). Measures were taken at baseline (t1) and at post-treatment (eight weeks after randomization, t2). Feasibility-related outcomes were recruitment strategy, study attrition, intervention dropout, satisfaction, negative effects as well as the potential of the intervention to affect likely outcomes in a future full-scale trial (depression, anxiety, quality of life, fear of progression). Data analyses were based on intention-to-treat principles. Linear regression models were used to detect between group differences. Linear Mixed Models were used to model potential changes over time.

Results: This trial was terminated prior to a-priori defined sample size has been reached given low recruitment success as well as high intervention dropout (88%) and study attrition (23%). On average, participants in the intervention group completed  = 2.78 ( = 3.23) modules. Participants in the waitlist control group barely started one module ( = 0.82,  = 1.81). The satisfaction with the intervention was low ( = 20.6,  = 0.88). Participants reported no negative effects attributed to the iCBT. Differences between groups with regard to depression, anxiety, fear of progression and quality of life remained non-significant ( > 0.05).

Conclusion: This trial failed to recruit a sufficient number of participants. Future work should explore potential pitfalls with regards to the reach and persuasiveness of internet interventions for people living with CAD. The study gives important indications for future studies with regard to the need for new ideas to reach and treat people with CAD and depression.
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April 2021

Study protocol of a randomised controlled trial on SISU, a software agent providing a brief self-help intervention for adults with low psychological well-being.

BMJ Open 2021 02 8;11(2):e041573. Epub 2021 Feb 8.

Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.

Introduction: Only a minority of people living with mental health problems are getting professional help. As digitalisation moves on, the possibility of providing internet/mobile-based interventions (IMIs) arises. One type of IMIs are fully automated conversational software agents (chatbots). Software agents are computer programs that can hold conversations with a human by mimicking a human conversational style. Software agents could deliver low-threshold and cost-effective interventions aiming at promoting psychological well-being in a large number of individuals. The aim of this trial is to evaluate the clinical effectiveness and acceptance of the brief software agent-based IMI SISU in comparison with a waitlist control group.

Methods And Analysis: Within a two-group randomised controlled trial, a total of 120 adult participants living with low well-being (Well-being Scale/WHO-5) will be recruited in Germany, Austria and Switzerland. SISU is based on therapeutic writing and acceptance and commitment therapy-based principles. The brief intervention consists of three modules. Participants work through the intervention on 3 consecutive days. Assessment takes place before (t1), during (t2) and after (t3) the interaction with SISU, as well as 4 weeks after randomisation (t4). Primary outcome is psychological well-being (WHO-5). Secondary outcomes are emotional well-being (Flourishing Scale), psychological flexibility (Acceptance and Action Questionnaire-II), quality of life (Assessment of Quality of Life -8D), satisfaction with the intervention (Client Satisfaction Questionnaire-8) and side effects (Inventory for the assessment of negative effectsof psychotherapy). Examined mediators and moderators are sociodemographic variables, personality (Big Five Inventory-10), emotion regulation (Emotion Regulation Questionnaire), alexithymia (Toronto Alexithymia Scale-20), centrality of events (Centrality of Events Scale), treatment expectancies (Credibility Expectancy Questionnaire) and technology alliance (Inventory of Technology Alliance-Online Therapy). Data analysis will be based on intention-to-treat principles. SISU guides participants through a 3-day intervention.

Ethics And Dissemination: This trial has been approved by the ethics committee of the Ulm University (No. 448/18, 18.02.2019). Results will be submitted for publication in a peer-reviewed journal and presented at conferences.

Trial Registration: The trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Trials Register (DRKS): DRKS00016799 (date of registration: 25 April 2019). In case of important protocol modifications, trial registration will be updated. This is protocol version number 1.
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February 2021

Validation of the Mobile Application Rating Scale (MARS).

PLoS One 2020 2;15(11):e0241480. Epub 2020 Nov 2.

Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University Ulm, Ulm, Germany.

Background: Mobile health apps (MHA) have the potential to improve health care. The commercial MHA market is rapidly growing, but the content and quality of available MHA are unknown. Instruments for the assessment of the quality and content of MHA are highly needed. The Mobile Application Rating Scale (MARS) is one of the most widely used tools to evaluate the quality of MHA. Only few validation studies investigated its metric quality. No study has evaluated the construct validity and concurrent validity.

Objective: This study evaluates the construct validity, concurrent validity, reliability, and objectivity, of the MARS.

Methods: Data was pooled from 15 international app quality reviews to evaluate the metric properties of the MARS. The MARS measures app quality across four dimensions: engagement, functionality, aesthetics and information quality. Construct validity was evaluated by assessing related competing confirmatory models by confirmatory factor analysis (CFA). Non-centrality (RMSEA), incremental (CFI, TLI) and residual (SRMR) fit indices were used to evaluate the goodness of fit. As a measure of concurrent validity, the correlations to another quality assessment tool (ENLIGHT) were investigated. Reliability was determined using Omega. Objectivity was assessed by intra-class correlation.

Results: In total, MARS ratings from 1,299 MHA covering 15 different health domains were included. Confirmatory factor analysis confirmed a bifactor model with a general factor and a factor for each dimension (RMSEA = 0.074, TLI = 0.922, CFI = 0.940, SRMR = 0.059). Reliability was good to excellent (Omega 0.79 to 0.93). Objectivity was high (ICC = 0.82). MARS correlated with ENLIGHT (ps<.05).

Conclusion: The metric evaluation of the MARS demonstrated its suitability for the quality assessment. As such, the MARS could be used to make the quality of MHA transparent to health care stakeholders and patients. Future studies could extend the present findings by investigating the re-test reliability and predictive validity of the MARS.
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December 2020

PartnerCARE-a psycho-oncological online intervention for partners of patients with cancer: study protocol for a randomised controlled feasibility trial.

BMJ Open 2020 10 5;10(10):e035599. Epub 2020 Oct 5.

Department of Psychosomatic Medicine and Psychotherapy, University Ulm Medical Center, Ulm, Germany.

Introduction: Cancer burdens not only the patient but also the partner to a comparable extent. Partners of patients with cancer are highly involved in the caring process and therefore often experience distress and report a low quality of life. Interventions for supporting partners are scarce. Existing ones are rarely used by partners because they are often time-consuming per se and offer only limited flexibility with regard to schedule and location. The online intervention PartnerCARE has been developed on the basis of caregiver needs and consists of six consecutive sessions and four optional sessions, which are all guided by an e-coach. The study aims to evaluate feasibility and acceptance of the online intervention PartnerCARE and the related trial process. In addition, first insights of the putative efficacy of PartnerCARE should be gained.

Methods And Analysis: A two-arm parallel-group randomised controlled trial will be conducted to compare the PartnerCARE online intervention with a waitlist control group. The study aims to recruit in total n=60 partners of patients with any type of cancer across different access paths (eg, university medical centres, support groups, social media). Congruent with feasibility study objectives, the primary outcome comprises recruitment process, study procedure, acceptance and satisfaction with the intervention (Client Satisfaction Questionnaire adapted to Internet-based interventions), possible negative effects (Inventory of Negative Effects in Psychotherapy) and dropout rates. Secondary outcomes include quality of life, distress, depression, anxiety, caregiver burden, fear of progression, social support, self-efficacy, coping and loneliness. Online measurements will be performed by self-assessment at three time points (baseline/pre-randomisation, 2 months and 4 months after randomisation). Data analyses will be based on intention-to-treat principle.

Ethics And Dissemination: Ethics approval has been granted by the Ethics Committee of the University of Ulm (No 390/18). Results from this study will be disseminated to relevant healthcare communities, in peer-reviewed journals and at scientific and clinical conferences.

Trial Registration Number: DRKS00017019.
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October 2020

Internet- Based Interventions in Chronic Somatic Disease.

Dtsch Arztebl Int 2018 11;115(40):659-665

Institute of Psychology and Education, Department of Clinical Psychology and Psychotherapy, Universityof Ulm, Ulm, Germany; Department for Psychology, Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany; Department of Medical Psychology, VU University Medical Center and Academic Medical Center, Amsterdam, Netherlands; Department of Behavioural Sciences and Learning, Linköpings University, Linköping and Departmentof Clinical Neuroscience, Karolinska Institut, Stockholm, Sweden.

Background: Clinical guidelines recommend psychosocial care as an integral part of medical treatment, but access is often limited. Technology-based approaches provide an attractive opportunity to optimize health outcomes and quality of life in people with chronic somatic diseases e.g. by means of Internet- and mobile-based interventions (IMIs). The present article provides an overview on the basics of IMIs, applications and their evidence base for people living with chronic somatic diseases.

Methods: We conducted a selective literature search in the PubMed and Cochrane databases. Reviews which included randomized controlled trials investigating psychological IMIs were discussed pertaining to their relevance for the population described.

Results: IMIs lead to a change in unfavorable behavior connected to chronic somatic diseases. IMIs can foster protective factors like balanced physical activity or risk factors like smoking or alcohol consumption. However, studies reveal small effect sizes of d=0.25 for physical activity and an averaged effect size of d=0.20 for smoking and alcohol consumption. Additionally, IMIs can be used for the (co-)treatment of chronic somatic diseases, for instance to increase disease-specific selfefficacy in patients with diabetes (d=0.23). Studies included in meta-analyses are often highly heterogenous and are investigated in research contexts with limited health care services relevance.

Conclusion: IMIs are potentially effective when aiming at lifestyle changes and supporting medical treatment in people with chronic somatic diseases. However, results are still heterogenous and the evidence base is limited regarding specific settings, compounding the discussion of possible ways of implementing IMIs into our healthcare systems.
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November 2018

Effects of existential interventions on spiritual, psychological, and physical well-being in adult patients with cancer: Systematic review and meta-analysis of randomized controlled trials.

Psychooncology 2018 11 2;27(11):2531-2545. Epub 2018 Aug 2.

Department of Clinical Psychology and Psychotherapy, Ulm University, Germany.

Objectives: To synthesize the evidence of existential interventions in adult patients with cancer.

Methods: Embase, MEDLINE, CENTRAL, CINAHL, PsycINFO, PSYNDEX, and the WHO ICTRP were searched up until 26 January 2018. Eligibility criteria for studies were (1) adult patients with cancer, (2) evaluation of existential interventions, (3) compared with active/non-active control, (4) assessing relevant spiritual, psychological, or physical outcomes, and (5) conducted as randomized controlled trials. Standardized mean differences (Hedges' g) were calculated, and meta-analyses were conducted using random effects models. Effects were aggregated within four time horizons (post-treatment; ≤3 months; ≤6 months; >6 months). Heterogeneity was assessed by forest plots and I . Risk of bias was assessed using the Cochrane Risk of Bias Tool. This review has been registered with Prospero (CRD42016042895).

Results: A total of 3461 records were identified, of which 30 unique studies (3511 participants) were included in the review and 24 studies were included in meta-analyses. Existential interventions showed significant effects on existential well-being (g = 0.52; CI[0.13; 0.91; k = 10; I  = 85%) and quality of life (g = 0.21; CI[0.01; 0.42]; k = 17; I  = 75%) at post-treatment, on hope at post-treatment (g = 0.43; CI[0.12; 0.74]; k = 12; I  = 86%) and after 6 months (g = 0.25; CI[0.02; 0.48]; k = 3; I  = 0%) and on self-efficacy at post-treatment (g = 0.50; CI[0.09; 0.90]; k = 2; I  = 0%). No significant effects were found on the remaining outcomes and time points. Significant moderator effects were found for professional background of therapists, intervention concept, number of sessions, and setting.

Conclusions: This systematic review and meta-analysis provides evidence that adult patients with cancer across all stages and types benefit from existential interventions. Future research should strive towards a higher standardization in particular with respect to outcome assessments.
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November 2018