Internet-based Treatment for Depression (IBAT-D)

June 24, 2024 updated by: Chantal Martin Soelch, University of Fribourg

Internet-based Treatment for Depression: a Randomized Controlled Trial Comparing Therapist Support and Peer-support Using an Online Forum.

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Fribourg, Switzerland, 1700
        • Chantal Martin Soelch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Active Comparator: 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.
Device: 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.
Device: 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.
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome
Time Frame: Post-Intervention (+8 weeks +/- 2 weeks)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Objective A
Time Frame: Baseline (0 week) , Mid-intervention (+4 weeks +/- 2 weeks), Post-Intervention (+8 weeks +/- 2 weeks), Follow-up (+20 weeks +/- 2 weeks)

The secondary objective A aims to test the effects of the online program on reward responses for individuals with depressive symptoms. We will assess constructs at Baseline (T0), mid-intervention (4 weeks, T1), post-intervention (8 weeks, T2), and follow-up (3 months after intervention, T3). We will also use a reward task described below. Outcomes associated with the reward task will be evaluated, including anhedonia and reward sensitivity.

Fribourg Reward Task: This task measures reaction times, accuracy, and mood reactions to both monetary and social rewards.

Snaith-Hamilton Pleasure Scale (SHAPS): This scale measures the ability to experience pleasure, covering four areas of hedonic experience: interest/pastimes, social interaction, sensory experience, and food/drink.

Behavioral Inhibition System/Behavioral Activation System (BIS/BAS): This self-reported questionnaire measures activation and inhibition systems, or sensitivity to punishment and reward.
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
Time Frame: Baseline (0 week), Post-Intervention (+8 weeks +/- 2 weeks)

The secondary objectives B and C aim to test the effect of the role of peer-to-peer support with an online forum in addition to an online program (B) and in comparison, between Switzerland and India (C). For this objective, we will assess perceived social support at Baseline (T0) and at post-treatment (T2). This will be evaluated by using:

Perceived Social Support (PSS). The PSS is a self-report questionnaire, which assesses the perception of support from family, friends, and a significant other.
Baseline (0 week), Post-Intervention (+8 weeks +/- 2 weeks)
Additional/Exploratory Outcomes
Time Frame: Post-Intervention (+8 weeks +/- 2 weeks), Follow-up (+20 weeks +/- 2 weeks)
We aim to study treatment effects on comorbid depression symptoms, focusing on anxiety assessed via the Generalized Anxiety Disorder Scale (GAD) for symptoms like nervousness, worry, trouble relaxing, restlessness, irritability, and fear. Additionally, we'll explore how positive outcomes such as self-efficacy (GSES), quality of life (SF-12), and self-esteem (RSE) positively impact depression symptoms. We'll also investigate the influence of stress, trauma, and pain using the Perceived Stress Scale-Short Version (PSS), Somatic Symptom Scale (SSS-8), PTSD Checklist for DSM-5 (PCL-5), and Childhood Trauma Questionnaire-Short Form (CTQ-SF). Lastly, we'll evaluate client satisfaction, usability, and working alliance using the System Usability Scale (SUS) for user experience and satisfaction, and the Client Satisfaction Questionnaire (CSQ) for service satisfaction.
Post-Intervention (+8 weeks +/- 2 weeks), Follow-up (+20 weeks +/- 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Fribourg

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2024

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 28, 2024

Study Record Updates

Last Update Posted (Actual)

June 28, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-D0112

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Deprexis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe