Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
NA
240 participants
INTERVENTIONAL
2024-05-30
2026-05-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Primary Objective: To test the effects of the self-help web-based program on depressive symptoms in French-speaking individuals in Switzerland.
Secondary Objective A: To test the effects of the online program on reward responses for individuals with depressive symptoms.
Secondary Objectives B and C: To test the effects of the role of peer-to-peer support using an online forum in addition to an online program (B) and comparison between Switzerland and India (C).
This project can inform clinicians about what they can offer as a treatment to individuals, either in combination with psychotherapy or when there is no quick or direct access to a psychotherapist. The study promises to have a direct practical significance for people suffering from depression.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Moreover, anhedonia is a core symptom of depression. It is defined as a loss of pleasure or a lack of reactivity when faced with pleasurable stimuli . Hedonic capacity decreases with depression, such as a reduced reactivity to pleasant cues or diminished reward responsiveness . Reward processes are shown to induce positive or pleasurable experiences . Specifically, there might be a strong association between the presence of anhedonia in depressed patients and dysfunction of the reward system . One secondary objective (A) of this project is to examine reward responses and sensitivity in individuals with depressive symptoms and more specifically, the effect of an online intervention for depression on reward responses. Finally, whereas the effect of therapist support (in the form of guidance during the treatment) in internet-based self-help programs is well investigated, the role of peer support within internet-based self-help has not yet been fully understood. There is evidence suggesting that patients' mutual exchange via integrated discussion forums can increase the efficacy of Internet-based treatments and could help to overcome adherence issues of Internet-based self-help programs. Further secondary objectives (B and C) of this study are to investigate the effects of the role of peer-to-peer support using an online forum in addition to an online program and comparison between Switzerland and India.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental group
The first experimental group will have access to an online self-help program for depression. The program Deprexis® is a self-help, web-based intervention that proposed various modules to face depression. They will have access to the program for 8 weeks. They are asked to complete the modules as many times as they wish and to use to program at least 30 minutes, 1 or 2 times a week. They will be assessed at baseline (T0), mid-intervention (4-weeks, T1), post-intervention (8-weeks, T2) and for the follow-up (3 months post intervention, T3). They will be asked to complete online questionnaires.
Deprexis
The internet-based self-help program used in this study, Deprexis, contains 10 modules ( based on different psychotherapeutic approaches, consistent with a cognitive-behavioral perspective) and accessible at any time via regular internet browsers on laptops, computers, tablets, or smartphones through a secure website. Participants can repeat all modules as often as they wish after completing the full sequence once.
Second Experimental group
The second experimental group will have access to both the online program as well as an online forum in which they will be divided into a group of 10 and they will be requested to ask, respond, and share their experiences with other participants. They will have access to the program and to the online forum for 8 weeks. They are asked to complete the modules as many times as they wish and to use to program at least 30 minutes, 1 or 2 times a week. They will be assessed at baseline (T0), mid-intervention (4-weeks, T1), post-intervention (8-weeks, T2) and for the follow-up (3 months post intervention, T3). They will be asked to complete online questionnaires.
Deprexis
The internet-based self-help program used in this study, Deprexis, contains 10 modules ( based on different psychotherapeutic approaches, consistent with a cognitive-behavioral perspective) and accessible at any time via regular internet browsers on laptops, computers, tablets, or smartphones through a secure website. Participants can repeat all modules as often as they wish after completing the full sequence once.
Deprexis with online forum
Those in this group will have access to deprexis ( same as the first group) as well as an online forum built for the study. This forum will feature a general discussion page where participants can ask and answer questions, and they will be divided into groups of 10 to share experiences if they wish. Additionally, there will be subforums related to specific modules of the program. Participants can share their experiences and ask questions related to the modules. A moderator will regularly check to ensure no personal or sensitive information is disclosed and will ask questions weekly to encourage contributions to the forum.
Control group
The control intervention is a wait list control group that will, after the 8 weeks of treatment, have access to the online self-help program and will complete questionnaires (the same as the two experimental groups), reward task at baseline, at 8-weeks and at the follow-up (3 months post-intervention).
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Deprexis
The internet-based self-help program used in this study, Deprexis, contains 10 modules ( based on different psychotherapeutic approaches, consistent with a cognitive-behavioral perspective) and accessible at any time via regular internet browsers on laptops, computers, tablets, or smartphones through a secure website. Participants can repeat all modules as often as they wish after completing the full sequence once.
Deprexis with online forum
Those in this group will have access to deprexis ( same as the first group) as well as an online forum built for the study. This forum will feature a general discussion page where participants can ask and answer questions, and they will be divided into groups of 10 to share experiences if they wish. Additionally, there will be subforums related to specific modules of the program. Participants can share their experiences and ask questions related to the modules. A moderator will regularly check to ensure no personal or sensitive information is disclosed and will ask questions weekly to encourage contributions to the forum.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Older than 18 years old
* Have access to a computer or laptop or tablet with an internet connection.
* Sufficient French language skills
* Fulfil the criteria of characterised depression according to the M.I.N.I diagnostic interview.
* Provide emergency contact before intervention.
Exclusion Criteria
* Have a history of psychotic disorder or bipolar disorder.
* Have changed their dosage of prescribed medication for anxiety or depression in the last month before the study.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Bern
OTHER
Indian Institute of Technology
UNKNOWN
Gaia AG
INDUSTRY
Haute école d'Ingénierie et d'Architecture de Fribourg
UNKNOWN
University of Fribourg
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Chantal Martin Soelch
Prof. Dr.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chantal Martin Soelch
Fribourg, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kessler RC, Wang PS. The descriptive epidemiology of commonly occurring mental disorders in the United States. Annu Rev Public Health. 2008;29:115-29. doi: 10.1146/annurev.publhealth.29.020907.090847.
Tandon T, Piccolo M, Ledermann K, Gupta R, Morina N, Martin-Soelch C. Relationship between behavioral and mood responses to monetary rewards in a sample of Indian students with and without reported pain. Sci Rep. 2022 Nov 24;12(1):20242. doi: 10.1038/s41598-022-24821-2.
Tanner JA, Davies PE, Overall CC, Grima D, Nam J, Dechairo BM. Cost-effectiveness of combinatorial pharmacogenomic testing for depression from the Canadian public payer perspective. Pharmacogenomics. 2020 Jun;21(8):521-531. doi: 10.2217/pgs-2020-0012. Epub 2020 Apr 17.
Pizzagalli DA, Iosifescu D, Hallett LA, Ratner KG, Fava M. Reduced hedonic capacity in major depressive disorder: evidence from a probabilistic reward task. J Psychiatr Res. 2008 Nov;43(1):76-87. doi: 10.1016/j.jpsychires.2008.03.001. Epub 2008 Apr 22.
Rojas LM, Bahamon M, Wagstaff R, Ferre I, Perrino T, Estrada Y, St George SM, Pantin H, Prado G. Evidence-based prevention programs targeting youth mental and behavioral health in primary care: A systematic review. Prev Med. 2019 Mar;120:85-99. doi: 10.1016/j.ypmed.2018.12.009. Epub 2019 Jan 2.
Snaith RP, Hamilton M, Morley S, Humayan A, Hargreaves D, Trigwell P. A scale for the assessment of hedonic tone the Snaith-Hamilton Pleasure Scale. Br J Psychiatry. 1995 Jul;167(1):99-103. doi: 10.1192/bjp.167.1.99.
Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009;38(4):196-205. doi: 10.1080/16506070903318960.
Berger T, Hammerli K, Gubser N, Andersson G, Caspar F. Internet-based treatment of depression: a randomized controlled trial comparing guided with unguided self-help. Cogn Behav Ther. 2011;40(4):251-66. doi: 10.1080/16506073.2011.616531.
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
Cuijpers P, Cristea IA, Karyotaki E, Reijnders M, Hollon SD. Component studies of psychological treatments of adult depression: A systematic review and meta-analysis. Psychother Res. 2019 Jan;29(1):15-29. doi: 10.1080/10503307.2017.1395922. Epub 2017 Nov 7.
Karyotaki E, Efthimiou O, Miguel C, Bermpohl FMG, Furukawa TA, Cuijpers P; Individual Patient Data Meta-Analyses for Depression (IPDMA-DE) Collaboration; Riper H, Patel V, Mira A, Gemmil AW, Yeung AS, Lange A, Williams AD, Mackinnon A, Geraedts A, van Straten A, Meyer B, Bjorkelund C, Knaevelsrud C, Beevers CG, Botella C, Strunk DR, Mohr DC, Ebert DD, Kessler D, Richards D, Littlewood E, Forsell E, Feng F, Wang F, Andersson G, Hadjistavropoulos H, Christensen H, Ezawa ID, Choi I, Rosso IM, Klein JP, Shumake J, Garcia-Campayo J, Milgrom J, Smith J, Montero-Marin J, Newby JM, Breton-Lopez J, Schneider J, Vernmark K, Bucker L, Sheeber LB, Warmerdam L, Farrer L, Heinrich M, Huibers MJH, Kivi M, Kraepelien M, Forand NR, Pugh N, Lindefors N, Lintvedt O, Zagorscak P, Carlbring P, Phillips R, Johansson R, Kessler RC, Brabyn S, Perini S, Rauch SL, Gilbody S, Moritz S, Berger T, Pop V, Kaldo V, Spek V, Forsell Y. Internet-Based Cognitive Behavioral Therapy for Depression: A Systematic Review and Individual Patient Data Network Meta-analysis. JAMA Psychiatry. 2021 Apr 1;78(4):361-371. doi: 10.1001/jamapsychiatry.2020.4364.
Klein JP, Barthel B, Berger T, Moritz S. Feasibility, effectiveness and safety of the self-management intervention deprexis in routine medical care: Results of an uncontrolled observational study. Internet Interv. 2020 Dec;22:100341. doi: 10.1016/j.invent.2020.100341. Epub 2020 Aug 27.
Meyer B, Berger T, Caspar F, Beevers CG, Andersson G, Weiss M. Effectiveness of a novel integrative online treatment for depression (Deprexis): randomized controlled trial. J Med Internet Res. 2009 May 11;11(2):e15. doi: 10.2196/jmir.1151.
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-D0112
Identifier Type: -
Identifier Source: org_study_id