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Feasibility and Acceptability of an Online ACT Intervention for Disorders of Gut-Brain Interaction | Clinical Trials | Clareo Health

COMPLETEDNA

Feasibility and Acceptability of an Online ACT Intervention for Disorders of Gut-Brain Interaction

Development, Feasibility, Efficacy, and Cost-effectiveness of an Online ACT Intervention for Disorders of Gut-Brain Interaction (Substudy 2)

NCT06887751•Örebro University, Sweden

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to assess the acceptability, feasibility, and usability of the iACTforDGBI intervention among patients with Disorders of Gut-Brain Interaction (DGBI). The main question it aims to answer are: What are the perceptions of patients with DGBI and healthcare practitioners regarding the acceptability, feasibility, and usability of the iACTforDGBI intervention? Participants will be asked to: Complete the iACTforDGBI intervention prototype, consisting of self-guided online sessions. Participate in online interviews and fill out online questionnaires to evaluate the intervention concerning acceptability, feasibility, usability and preliminary effects.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age between 18 and 75 years
•2. 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))
•3. 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)
•4. Stable medication for psychiatric symptoms including anxiety, depression and sleep problems for at least two months prior to intervention.
•5. Ability to read and write Swedish
•6. 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

•1. Currently undergoing any form of psychological intervention.
•2. Increased risk of suicide (≥4 points on MADRS item 9)
•3. Severe depression (\&amp;gt;34 points on MADRS)

Locations (1)

Örebro University

Örebro, Sweden

Key Dates

Start Date

March 19, 2025

Primary Completion Date

August 30, 2025

Completion Date

August 30, 2025

Last Updated

February 17, 2026

Enrollment

ACTUAL participants

Conditions

DGBIDepression/Anxiety

Interventions

Acceptance and Commitment Therapy (ACT)

BEHAVIORAL

Psychoeducation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Feasibility and Acceptability of an Online ACT Intervention for Disorders of Gut-Brain Interaction

Inclusion Criteria

Exclusion Criteria

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