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

NCT07175402 | Completed

• 1 other identifier: 2023-00751d
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

DGBI; Depression/Anxiety

Outcome Measures

Primary Outcomes (1)

• Individual interviews

  Feasibility and acceptability of intervention

  At post treatment (8 weeks)

Secondary Outcomes (15)

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

  At pre and post treatment (0 and 8 weeks).

• EQ-5D-5L

  At pre and post treatment (0 and 8 weeks)

• AQoL-8D

  At pre and post treatment (0 and 8 weeks)

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

  At pre and post treatment (0 and 8 weeks)

• The Gastrointestinal Symptom Rating Scale (GSRS)

  At pre and post treatment (0 and 8 weeks)

Study Arms (2)

Acceptance and Commitment Therapy (ACT)

EXPERIMENTAL

Acceptance and Commitment Therapy (ACT)

Behavioral: Acceptance and Commitment Therapy (ACT)

Education on DGBI, psychoeducation

ACTIVE COMPARATOR

Education on DGBI, psychoeducation

Other: Psychoeducation

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

The 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 0: Individual videoconference meeting, introduction. Session 1: Creative hopelessness and mindfulness. Session 2: The body, acceptance, and values. Session 3: Compassion. Session 4: Cognitive defusion and committed action. Session 5-7: Personalised content (in-depth material and tasks based on individual difficulties assessed with diary). Session 8: Summary of intervention.

Acceptance and Commitment Therapy (ACT)

Psychoeducation 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 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. Session 0: Individual session, introduction. Session 1-8: The content 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.

Education on DGBI, psychoeducation

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 (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)
• Severe depression (≥34 points on MADRS)

Sponsors & Collaborators

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

Study Sites (1)

Örebro University

Örebro, Sweden

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Principal Investigator, other investigators
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a second (beta) pilot study (feasibility including acceptability) in which the investigators intend to see how the intervention and overall workload (including measurements) is perceived by the participants.

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: September 8, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

SE (1)