Internet-based Treatment for Depression
NCT Number: NCT06480474
Acronym: IBAT-D
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression
Interventions: DEVICE: Deprexis|DEVICE: Deprexis with online forum
Sponsor: University of Fribourg
Collaborators: University of Bern|Indian Institute of Technology|Gaia AG|Haute école d'Ingénierie et d'Architecture de Fribourg
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-30
Completion Date: 2026-05-30
Locations: Chantal Martin Soelch, Fribourg, 1700, Switzerland

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.

Primary Outcome Measures: 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 Outcome Measures: Secondary Objective A, 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, 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, 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)