Clinical Trial

Evaluation of an Online ACT and Compassion-based Intervention for Disorders of Gut-Brain Interaction

Study acronym: iACTforDGBI
Withdrawn
View on ClinicalTrials.gov →
Why the trial 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.
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.
Protocol Amendment History 4 changes
critical Trial status changed: Not Yet Recruiting → Withdrawn 2026-05-09
notable Enrollment reduced: 276 -> 0 participants 2026-05-09
notable Primary completion moved earlier: 2027-12-30 -> 2026-04-30 2026-05-09
minor Completion moved earlier: 2028-12-30 -> 2026-04-30 2026-05-09
Trial Details
NCT Number NCT07521709
Lead Sponsor Örebro University, Sweden
Collaborators: Sahlgrenska University Hospital, Göteborg University, Uppsala University
Conditions DGBI, Depression/Anxiety
Start Date 2026-04-30
Primary Completion 2026-04-30 (estimated)
Study Completion 2026-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-08