Publications by authors named "Lina Braun"

6 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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http://dx.doi.org/10.3389/fpsyt.2021.660534DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8160118PMC
May 2021

Effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): Results of a pragmatic randomized controlled trial.

J Affect Disord 2021 01 15;278:658-671. Epub 2020 Sep 15.

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

Background: Major Depressive Disorder (MDD) has a major impact on public health. Reduction of depression burden in general population is of greatest importance and might be achieved by implementation of depression prevention measures into routine care. We evaluate an online prevention measure as part of a national project aiming to reduce depression in the occupational group of green professions.

Methods: This two-armed pragmatic RCT (n = 360) evaluates the effectiveness of a tailored internet-based intervention (IMI) program compared to enhanced treatment as usual. The IMI program entailed access to one of six guided IMIs each focusing on different symptom areas (depressive mood with optional comorbid diabetes, perceived stress, insomnia, panic and agoraphobia and harmful alcohol consumption). Eligible were entrepreneurs, spouses, family members and pensioners in green professions with adequate insurance status and at least subthreshold depression (PHQ≥5). Primary outcome was depressive symptom severity (QIDS-SR16) at 9-weeks post-treatment (T1). Various secondary outcomes were assessed at T1.

Results: A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033). Categorical analysis indicated a reduced risk of potential MDD with NNTB=28.11. Adherence to the IMI program at T1 was exceptionally low.

Limitations: Results are limited to green professions and representativeness might be restricted by self-selection of participants.

Conclusion: Depression burden in green professions can be reduced by this online prevention measure. Yet, short-term effectiveness is restricted by low adherence rates.

Trial Registration: German Clinical Trial Registration: DRKS00014000. Registered: 09 April 2018.
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http://dx.doi.org/10.1016/j.jad.2020.09.066DOI Listing
January 2021

Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain-related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial.

BMJ Open 2020 09 3;10(9):e034271. Epub 2020 Sep 3.

Clinical Psychology and Psychotherapy, Ulm University, Ulm, Baden-Württemberg, Germany.

Introduction: Chronic pain is highly prevalent, associated with substantial personal and economic burdens, and increased risk for mental disorders. Individuals in green professions (agriculturists, horticulturists, foresters) show increased prevalence of chronic pain and other risk factors for mental disorders. Available healthcare services in rural areas are limited. Acceptance towards face-to-face therapy is low. Internet and mobile-based interventions (IMIs) based on Acceptance and Commitment Therapy (ACT) might be a promising alternative for this population and may enable effective treatment of chronic pain. The present study aims to evaluate the clinical and cost-effectiveness of an ACT-based IMI for chronic pain in green professions in comparison with enhanced treatment as usual (TAU+).

Methods And Analysis: A two-armed pragmatic randomised controlled trial will be conducted. Two hundred eighty-six participants will be randomised and allocated to either an intervention or TAU+ group. Entrepreneurs in green professions, collaborating spouses, family members and pensioners with chronic pain are eligible for inclusion. The intervention group receives an internet-based intervention based on ACT (7 modules, over 7 weeks) guided by a trained e-coach to support adherence (eg, by positive reinforcement). Primary outcome is pain interference (Multidimensional Pain Interference scale; MPI) at 9 weeks post-randomisation. Secondary outcomes are depression severity (Quick Inventory Depressive Symptomology; QIDS-SR16), incidence of major depressive disorder, quality of life (Assessment of Quality of Life; AQoL-8D) and possible side effects associated with the treatment (Inventory for the Assessment of Negative Effects of Psychotherapy; INEP). Psychological flexibility (Chronic Pain Acceptance Questionnaire, Committed Action Questionnaire, Cognitive Fusion Questionnaire) will be evaluated as a potential mediator of the treatment effect. Furthermore, mediation, moderation and health-economic analyses from a societal perspective will be performed. Outcomes will be measured using online self-report questionnaires at baseline, 9-week, 6-month, 12-month, 24-month and 36-month follow-ups.

Ethics And Dissemination: This study was approved by the Ethics Committee of the University of Ulm, Germany (file no. 453/17-FSt/Sta; 22 February 2018). Results will be submitted for publication in peer-reviewed journals and presented at conferences.

Trial Registration Number: German Clinical Trial Registration: DRKS00014619. Registered on 16 April 2018.
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http://dx.doi.org/10.1136/bmjopen-2019-034271DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7473633PMC
September 2020

Implementing internet- and tele-based interventions to prevent mental health disorders in farmers, foresters and gardeners (ImplementIT): study protocol for the multi-level evaluation of a nationwide project.

BMC Psychiatry 2020 08 27;20(1):424. Epub 2020 Aug 27.

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

Background: Farmers are a vulnerable population for developing depression or other mental health disorders due to a variety of risk factors in their work context. Beyond face-to-face resources, preventive internet- and tele-based interventions could extend available treatment options to overcome barriers to care. The German Social Insurance Company for Agriculture, Forestry and Horticulture (SVLFG) implements several guided internet- and mobile-based interventions and personalised tele-based coaching for this specific target group provided by external companies within a nation-wide prevention project for their insured members. The current study aims to evaluate the implementation process and to identify determinants of successful implementation on various individual and organisational levels.

Methods: The current study includes two groups of participants: 1) insured persons with an observable need for prevention services, and 2) staff-participants who are involved in the implementation process. The Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework and the Consolidated Framework for Implementation Research (CFIR) will be used to track and evaluate the implementation process. A mixed-method approach will provide insights on individual and organizational level (e.g. degree of normalization, readiness for change) and helps to identify determinants of successful implementation. In-depth insights on experiences of the participants (e.g. acceptance, satisfaction, barriers and facilitating factors of intervention use) will be yielded through qualitative interviews. Focus groups with field workers provide insights into barriers and facilitators perceived during their consultations. Furthermore, intervention as well as implementation costs will be evaluated. According to the stepwise, national rollout, data collection will occur at baseline and continuously across 24 months.

Discussion: The results will show to what extent the implementation of the internet- and tele-based services as a preventive offer will be accepted by the participants and involved employees and which critical implementation aspects will occur within the process. If the implementation of the internet- and tele-based services succeeds, these services may be feasible in the long-term.

Trial Registration: German Clinical Trial Registration: DRKS00017078 . Registered on 18.04.2019.
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http://dx.doi.org/10.1186/s12888-020-02800-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7450981PMC
August 2020

Clinical and Cost-Effectiveness of Personalized Tele-Based Coaching for Farmers, Foresters and Gardeners to Prevent Depression: Study Protocol of an 18-Month Follow-Up Pragmatic Randomized Controlled Trial (TEC-A).

Front Psychiatry 2020 4;11:125. Epub 2020 Mar 4.

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

Farmers show high levels of depressive symptoms and mental health problems in various studies. This study is part of a nationwide prevention project carried out by a German social insurance company for farmers, foresters, and gardeners (SVLFG) to implement internet- and tele-based services among others to improve mental health in this population. The aim of the present study is to evaluate the (cost-)effectiveness of personalized tele-based coaching for reducing depressive symptom severity and preventing the onset of clinical depression, compared to enhanced treatment as usual. In a two-armed, pragmatic randomized controlled trial ( = 312) with follow-ups at post-treatment (6 months), 12 and 18 months, insured farmers, foresters, and gardeners, collaborating family members and pensioners with elevated depressive symptoms (PHQ-9 ≥ 5) will be randomly allocated to personalized tele-based coaching or enhanced treatment as usual. The coaching is provided by psychologists and consists of up to 34 tele-based sessions for 25-50 min delivered over 6 months. Primary outcome is depressive symptom severity at post-treatment. Secondary outcomes include depression onset, anxiety, stress, and quality of life. A health-economic evaluation will be conducted from a societal perspective. This study is the first pragmatic randomized controlled trial evaluating the (cost-)effectiveness of a nationwide tele-based preventive service for farmers. If proven effective, the implementation of personalized tele-based coaching has the potential to reduce disease burden and health care costs both at an individual and societal level. German Clinical Trial Registration: DRKS00015655.
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http://dx.doi.org/10.3389/fpsyt.2020.00125DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7064472PMC
March 2020

Clinical and cost-effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): study protocol of a 36-month follow-up pragmatic randomized controlled trial.

BMC Psychiatry 2019 09 9;19(1):278. Epub 2019 Sep 9.

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

Background: People in green professions are exposed to a variety of risk factors, which could possibly enhance the development of depression. Amongst possible prevention approaches, internet- and mobile-based interventions (IMIs) have been shown to be effective and scalable. However, little is known about the effectiveness in green professions. The aim of the present study is to examine the (cost-)effectiveness of a tailored IMI program for reducing depressive symptoms and preventing the onset of clinical depression compared to enhanced treatment as usual (TAU+).

Methods: A pragmatic randomized controlled trial (RCT) will be conducted to evaluate a tailored and therapeutically guided preventive IMI program in comparison to TAU+ with follow-ups at post-treatment (9 weeks), 6-, 12-, 24-, and 36-months. Entrepreneurs in green professions, collaborating spouses, family members and pensioners (N = 360) with sufficient insurance status and at least subthreshold depression (PHQ-9 ≥ 5) are eligible for inclusion. Primary outcome is depressive symptom severity (QIDS-SR16). Secondary outcomes include incidence of depression (QIDS-SR16), quality of life (AQoL-8D) and negative treatment effects (INEP). A health-economic evaluation will be conducted from a societal perspective. The IMI program is provided by psychologists of an external service company and consists of six guided IMIs (6-8 modules, duration: 6-8 weeks) targeting different symptoms (depressive mood, depressive mood with comorbid diabetes, perceived stress, insomnia, panic and agoraphobic symptoms or harmful alcohol use). Intervention choice depends on a screening of participants' symptoms and individual preferences. The intervention phase is followed by a 12-months consolidating phase with monthly contact to the e-coach.

Discussion: This is the first pragmatic RCT investigating long-term effectiveness of a tailored guided IMI program for depression prevention in green professions. The present trial builds on a large-scale strategy for depression prevention in green professions. The intended implementation of the IMI program with a nationwide rollout has the potential to reduce overall depression burden and associated health care costs in case of given effectiveness.

Trial Registration: German Clinical Trial Registration: DRKS00014000 . Registered on 09 April 2018.
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http://dx.doi.org/10.1186/s12888-019-2244-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6734248PMC
September 2019
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