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NOT YET RECRUITING
NCT07521709
NA

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

Sponsor: Örebro University, Sweden

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

276

Start Date

2026-05-15

Completion Date

2028-12-30

Last Updated

2026-04-13

Healthy Volunteers

No

Interventions

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.

Locations (1)

Örebro University

Örebro, Sweden