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

NCT07521709 | Withdrawn DMC

• 1 other identifier: 2023-00751e
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• The Gastrointestinal Symptom Rating Scale (GSRS)

  Symptom Severity of DGBI, minimum 15, maximum 105, higher = worse gastrointestinal symptoms

  T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up). T3 (6 month follow-up), T4 (12 month follow-up)

• The Generalized Anxiety Disorder scale-7 (GAD-7)

  Symptoms of general anxiety, total score 0-21, higher = worse anxiety symptoms

  T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)

• The Patient Health Questionnaire-9 (PHQ-9)

  symptoms of depression, total score 0-27, higher = worse depressive symptoms

  T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)

Secondary Outcomes (13)

• EuroQol 5-Dimension 5-Level (EQ-5D-5L), EQ Vas 0-100, higher = better health-related quality of life

  T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)

• Assessment of Quality of Life - 8 dimensions (AQoL-8D)

  T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)

• The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)

  T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)

• The Chronic Illness Shame Scale (CISS)

  T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)

• The Credibility / Expectancy Questionnaire (CEQ)

  T0 (week 0, only expectancy sub scale), Tmid (week 4, both subscales)

Study Arms (2)

Acceptance and Commitment Therapy with explicit self-compassion training

EXPERIMENTAL

Acceptance and Commitment Therapy with explicit self-compassion training

Behavioral: Acceptance and Commitment Therapy with explicit self-compassion training

Education about DGBI and distress

ACTIVE COMPARATOR

Education

Other: Education

Interventions

Acceptance and Commitment Therapy with explicit self-compassion training BEHAVIORAL

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.

Acceptance and Commitment Therapy with explicit self-compassion training

Education OTHER

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.

Education about DGBI and distress

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Currently undergoing any form of psychological intervention.
• Increased risk of suicide (≥4 points on MADRS item 9).
• Ongoing or previously diagnosed severe psychiatric disorder, such as schizophrenia spectrum disorders or bipolar disorder.

Sponsors & Collaborators

• Örebro University, Sweden: lead
• Sahlgrenska University Hospital: collaborator
• Göteborg University: collaborator
• Uppsala University: collaborator

Study Sites (1)

Örebro University

Örebro, Sweden

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Inês A Trindade, Phd

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Researcher responsible for randomization and allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized controlled trial in which we intend to compare the efficacy and cost-effectiveness of the iACTforDGBI intervention compared to the active control group (DGBI School).

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 13, 2026
• Study Start: April 30, 2026
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

SE (1)