NCT07521709

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

Efficacy and Cost Effectiveness of an Online ACT Intervention for Disorders of Gut-Brain Interaction: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: Örebro University, Sweden · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• DGBI
• Depression/Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	Acceptance and Commitment Therapy with explicit self-compassion training	The self-guided Online version of Acceptance and Commitment Therapy with explicit self-compassion components (iACTforDGBI) intervention will include 8 weekly sessions of around 20-30 minutes each, and will comprise ACT-consistent informative texts, audio exercises, and videos.
OTHER	Education	Participants in the active control group will be asked to complete 8 weekly 20-minute sessions of an online course for education on DGBIs. This course will be delivered through the same platform than the one delivering the online ACT for DGBI intervention, via the same website. The intervention platform will have similar designs and structure, and will be developed by the same web development company. This intervention is based on the IBS school program (e.g., Ringström et al., 2009), in particular its online version (Lindfors et al., 2021), developed by members of the current research team.

Timeline

• Start date: 2026-05-15
• Primary completion: 2027-12-30
• Completion: 2028-12-30
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Sweden