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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression/Anxiety; DGBI
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy (ACT); Other: Psychoeducation

• Study Type: Interventional
• Enrollment (Actual): 30
• 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. Severe depression (>34 points on MADRS)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Psychoeducation	Other: Psychoeducation; 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 a similar 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. The content of the education course will be based on the IBS school intervention (e.g., Ringström et al., 2009), in particular its online version (Lindfors et al., 2021), developed by members of the current research team. This education intervention was based on the biopsychosocial model of DGBI and was originally developed and tested as a face-to-face group intervention with six 2-h sessions held weekly. IBS school generally aims at increasing disease knowledge in people with IBS and covers a wide spectrum of issues related to IBS, such as disease pathophysiological me
Experimental: Acceptance and Commitment Therapy (ACT)	Behavioral: Acceptance and Commitment Therapy (ACT); The self-guided Online version of Acceptance and Commitment Therapy (iACTforDGBI) intervention will include 8 weekly sessions of around 20 minutes each, and will comprise ACT-consistent informative texts, audio exercises, and videos. The intervention is expected to have the following overall structure: Session 1: Introduction to the intervention and promotion of creative hopelessness, Awareness of bodily sensations, Values clarification Session 2: Committed action, Acceptance, Cognitive defusion Session 3: Self as context, Conclusions Session 4-8: personalised content (in-depth material and tasks based on individual difficulties assessed with diary)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual Interviews	Feasibility and Acceptability of intervention	At post treatment (8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Generalized Anxiety Disorder scale-7 (GAD-7)	Symptoms of general anxiety	At pre and post treatment (0 and 8 weeks), 6-month follow-up (FU1), and 12-month follow-up (FU2) assessments
EQ-5D-5L	Health-related Quality of Life	At pre and post treatment (0 and 8 weeks)
AQoL-8D	Health-related Quality of Life	At pre and post treatment (0 and 8 weeks)
The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)	Healthcare Utilization	At pre and post treatment (0 and 8 weeks)
The Gastrointestinal Symptom Rating Scale (GSRS)	Symptom Severity of DGBI	At pre and post treatment (0 and 8 weeks)
The Chronic Illness Shame Scale (CISS)	Shame of Chronic Illnesses:	At pre and post treatment (0 and 8 weeks)
The Credibility / Expectancy Questionnaire (CEQ)	Treatment Credibility and Expectancy	After session 2 (2 weeks)
The System Usability Scale (SUS)	Intervention Platform Usability	At post treatment (8 weeks)
The Negative Effects Questionnaire (NEQ-20)	Negative Side Effects and Events	At post treatment (8 weeks)
The Intervention Acceptability Scale	Intervention Acceptability	At post treatment (8 weeks)
The Contextual Therapies Process Awareness Scale	Awareness of Processes	At post treatment (8 weeks)
The Patient Health Questionnaire-9 (PHQ-9)	symptoms of depression	At pre and post treatment (0 and 8 weeks)
The Multidimensional Psychological Flexibility Inventory (MPFI)	Psychological flexibility	At pre and post treatment (0 and 8 weeks)
The State Self-Compassion Scale - short Form (SSCS-S)	state self-compassion	At pre and post treatment (0 and 8 weeks)
The Self-Compassion Scale - short Form (SCS-SF)	trait self-compassion	At pre and post treatment (0 and 8 weeks)

Collaborators and Investigators

• Sponsor: Örebro University, Sweden
• Collaborators: Uppsala University; Göteborg University; Sahlgrenska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2025
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: March 6, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 20, 2025

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Acceptance and Commitment Therapy
• Other Study ID Numbers: 2023-00741b

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