Clinical trial NCT06480474: Internet-based Treatment for Depression
Official title: Internet-based Treatment for Depression: a Randomized Controlled Trial Comparing Therapist Support and Peer-support Using an Online Forum.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression
Keywords: depression
online intervention
internet-based treatment
online study
peer-support
randomized control trial
India
Switzerland
Lead sponsor: University of Fribourg
Sponsor class: OTHER
Collaborators: name: University of Bern
name: Indian Institute of Technology
name: Gaia AG
name: Haute école d'Ingénierie et d'Architecture de Fribourg
First posted: 2024-06-28
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

Detailed description: Depression is one of the most frequent mental disorders that affect society and individuals psychologically and financially. The text revision of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) defines characterized depression as a minimum of 2 weeks of low mood or loss of interest in daily activities, accompanied by vegetative, motor, and cognitive symptoms. Depressed individuals may also have suicidal thoughts or tendencies. However, not everyone receives adequate care and there is a treatment gap. The causes of the treatment gap are diverse and include the difficulty in accessing treatment, the lack of mental health specialists in a region or a country, the fear of stigmatization, cultural beliefs about mental health, etc.. Technologies such as Internet-based self-help interventions are promising to reduce the burden of depression and to address the treatment gap. Several meta-analyses found that these interventions are effective in reducing depression. Internet-based self-help interventions are easily available, can be utilized regardless of time and location, and can be provided to a large population simultaneously. Although Switzerland has a well-developed mental health care, the treatment gap for depression in Switzerland is estimated to be 51% and depression represents a strong societal burden. The main aim of this study will be to examine the efficacy of a web-based self-help intervention for depression in the French-speaking part of Switzerland, in a randomized clinical trial.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Primary Outcome
timeFrame: Post-Intervention (+8 weeks +/- 2 weeks)
Secondary outcomes:
measure: Secondary Objective A
timeFrame: Baseline (0 week) , Mid-intervention (+4 weeks +/- 2 weeks), Post-Intervention (+8 weeks +/- 2 weeks), Follow-up (+20 weeks +/- 2 weeks)
measure: Secondary Objective B and C
timeFrame: Baseline (0 week), Post-Intervention (+8 weeks +/- 2 weeks)
measure: Additional/Exploratory Outcomes
timeFrame: Post-Intervention (+8 weeks +/- 2 weeks), Follow-up (+20 weeks +/- 2 weeks)
Other outcomes:
Locations:
city: Fribourg
country: Switzerland
facility: Chantal Martin Soelch
Study officials:
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