Internet-based Treatment for Depression

NCT06480474 | Enrolling By Invitation

• 1 other identifier: 2023-D0112
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the present project is to test the efficacy of a validated Internet-based self-help program for depression developed in Germany in the French part of Switzerland. The program has shown to be efficacious in different trials with major depression and depression as a comorbidity of another disorder (e.g., gambling addiction, epilepsy). The objectives of this project are: 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.

Conditions

Depression

Keywords

depression; online intervention; internet-based treatment; online study; peer-support; randomized control trial; India; Switzerland

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  The primary outcome measures are symptoms of depression at post-treatment, that is after 8 weeks. Depressive symptoms will be measured with the Patient Health Questionnaire (PHQ-9) to assess the symptoms of depression.

  Post-Intervention (+8 weeks +/- 2 weeks)

Secondary Outcomes (3)

• Secondary Objective A

  Baseline (0 week) , Mid-intervention (+4 weeks +/- 2 weeks), Post-Intervention (+8 weeks +/- 2 weeks), Follow-up (+20 weeks +/- 2 weeks)

• Secondary Objective B and C

  Baseline (0 week), Post-Intervention (+8 weeks +/- 2 weeks)

• Additional/Exploratory Outcomes

  Post-Intervention (+8 weeks +/- 2 weeks), Follow-up (+20 weeks +/- 2 weeks)

Study Arms (3)

Experimental group

EXPERIMENTAL

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.

Device: Deprexis

Second Experimental group

ACTIVE COMPARATOR

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.

Device: Deprexis; Device: Deprexis with online forum

Control group

NO INTERVENTION

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).

Interventions

Deprexis DEVICE

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.

Experimental group; Second Experimental group

Deprexis with online forum DEVICE

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.

Second Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Read and signed inform consent.
• 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.

You may not qualify if:

• Active suicidal plans (score higher on the suicide item or report suicidal plan in the diagnostic interview)
• 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.

Sponsors & Collaborators

• University of Fribourg: lead
• University of Bern: collaborator
• Indian Institute of Technology: collaborator
• Gaia AG: collaborator
• Haute école d'Ingénierie et d'Architecture de Fribourg: collaborator

Study Sites (1)

Chantal Martin Soelch

Fribourg, 1700, Switzerland

Location

Related Publications (15)

• 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.

  PMID: 18348707 BACKGROUND

• 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.

  PMID: 36424426 BACKGROUND

• 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.

  PMID: 32301648 BACKGROUND

• 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.

  PMID: 18433774 BACKGROUND

• 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.

  PMID: 30610888 BACKGROUND

• 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.

  PMID: 7551619 BACKGROUND

• 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.

  PMID: 20183695 BACKGROUND

• 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.

  PMID: 22060248 BACKGROUND

• 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.

  PMID: 6668417 BACKGROUND

• 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.

  PMID: 29115185 BACKGROUND

• 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.

  PMID: 33471111 BACKGROUND

• 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.

  PMID: 32874927 BACKGROUND

• 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.

  PMID: 19632969 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• Tandon T, Berger T, Meyer B, Khaled OA, Gupta R, Martin-Soelch C. Exploring cross-cultural effectiveness of internet-based depression treatment (IBAT-D) with peer-to-peer support vs. without across WEIRD and non-WEIRD samples: a research protocol for a randomized controlled trial. Trials. 2025 Dec 11;26(1):569. doi: 10.1186/s13063-025-09377-6.

  PMID: 41382119 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: We will use a controlled randomized design with 3 conditions (1. Online program, 2. Online program and online forum, 3. Wait list). Participants will be assessed at 4 time points: before the beginning of the intervention (T0, baseline), at 4 weeks mid-treatment (T1), after the intervention, at 8 weeks (T2), and at the follow-up, that is 3 months post-intervention (T3).

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 28, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

CH (1)