Internet-based Treatment for Depression (IBAT-D)

University of Fribourg

Status: Invitation-only

Conditions: Depression

Treatments: Device: Deprexis; Device: Deprexis with online forum

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06480474

2023-D0112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

Experimental group

Experimental group

Description:

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.

Treatment:

Device: Deprexis

Second Experimental group

Active Comparator group

Description:

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.

Treatment:

Device: Deprexis with online forum

Device: Deprexis

Control group

No Intervention group

Description:

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).