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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Depression/Anxiety; DGBI
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy with explicit self-compassion training; Other: Education

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden
    • Örebro University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. Ongoing or previously diagnosed severe psychiatric disorder, such as schizophrenia spectrum disorders or bipolar disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acceptance and Commitment Therapy with explicit self-compassion training	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.
Active Comparator: Education about DGBI and distress; Education	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
EuroQol 5-Dimension 5-Level (EQ-5D-5L), EQ Vas 0-100, higher = better health-related quality of life	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)	Health-related Quality of Life, Utility score -0.04 - 1.00, higher = better quality of life	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)	Healthcare Utilization, no single fixed min/max, higher = worse/more costly outcome	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)	Shame of Chronic Illnesses, total score 0-28, higher = worse shame related to chronic illness	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)	Treatment Credibility and Expectancy, total score 3-27 each, higher = better treatment credibility/expectancy	T0 (week 0, only expectancy sub scale), Tmid (week 4, both subscales)
The System Usability Scale (SUS)	Intervention Platform Usability, total score 0-100, higher = better usability	T1 (week 8)
The Negative Effects Questionnaire (NEQ-20)	Negative Side Effects and Events, total score 0-80, higher = worse negative effects	T1 (week 8)
Global Impression of Change Scale	Impression of change, a single global change item, higher = worse	Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
Awareness of Processes Post-Intervention Scale	Awareness of Processes, higher = more awareness	T1 (week 8)
The Multidimensional Psychological Flexibility Inventory (MPFI)	Psychological flexibility, composites scored as means, higher = worse for inflexibility	T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
Self-Compassion Scale	Self-compassion, higher = better self-compassion	T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
Insomnia Severity Index	Insomnia symptoms, total score 0-28, higher = worse insomnia severity	T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
Major Life Events	Past 12 months. Questions about psychological/physical diagnoses, usually more events/greater burden = worse stress exposure	T0 (week 0), T3 (6 month follow-up)

Collaborators and Investigators

• Sponsor: Örebro University, Sweden
• Collaborators: Uppsala University; Göteborg University; Sahlgrenska University Hospital
• Investigators: Principal Investigator: Inês A Trindade, Phd, Örebro University, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2026
• Primary Completion (Actual): April 30, 2026
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: 2023-00751e

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This question is under investigation. Some of our data contain sensitive information on health, and the main priority is participants integrity which need to be balanced against basic scientific principles on scrutiny. However, any personal data that can be shared without compromising participants integrity to a reasonable degree will be shared upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No