Evaluation of an Online ACT and Compassion-based Intervention for Disorders of Gut-Brain Interaction (NCT07521709) | Clinical Trial Compass
WithdrawnNot Applicable
Evaluation of an Online ACT and Compassion-based Intervention for Disorders of Gut-Brain Interaction
Stopped: Study halted before recruitment started due to data integrity issues from the previous pilot studies. Decision made by PI, with support from the host institution.
Sweden0Started 2026-04-30
Plain-language summary
The goal of this clinical trial is to assess the efficacy and cost-effectiveness of the iACTforDGBI intervention among adults with Disorders of Gut-Brain Interaction (DGBI) and psychological distress. The main questions it aims to answer are: What is the efficacy of iACTforDGBI vs DGBI School? What is the cost-effectiveness of iACTforDGBI vs DGBI School? Who are the responders of each intervention? What are the moderators and mechanisms of change of the interventions? Participants will be asked to: Complete one of the two interventions (to which they will be randomly allocated to). Both interventions are 8-session online programs, delivered via an interactive platform and tailored for Swedish-speaking adults with symptoms compatible with a DGBI and psychological distress. Both interventions are theory-based and expected to be beneficial. Participants will be asked to fill out online questionnaires for screening of study eligibility, and baseline, post-treatment and follow-up outcome measures to evaluate the intervention. A subsample will also be interviewed post treatment.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age between 18 and 75 years
✓. Meeting clinical symptom levels for least one DGBI diagnosis (assessed with the Rome IV Diagnostic Questionnaire for Functional Gastrointestinal Disorders in Adults (Palsson et al., 2016))
✓. Clinically meaningful levels of depressive symptoms or anxiety: score ≥ 13 on the Montgomery Åsberg Depression Rating Scale (Svanborg \& Åsberg, 1994; (MADRS-S; depressive symptoms), or score ≥ 10 on the Generalized Anxiety Disorder scale-7 (GAD-7; anxiety symptoms; Spitzer et al., 2006)
✓. Stable medication for psychiatric symptoms including anxiety, depression and sleep problems for at least two months prior to intervention.
✓. Ability to read and write Swedish
✓. Have access to a device (like computer, tablet or smartphone with) with access to the internet and that can be used to attend video conferences and preview the intervention platform (i.e., have a microphone and speakers or headphones).
Exclusion criteria
✕. Currently undergoing any form of psychological intervention.