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

Not Applicable

Recruiting

• Conditions: DGBI; Depression/Anxiety

• Registration Number: NCT06887751
• Lead Sponsor: Örebro University, Sweden

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-13
• Study Start: 2025-03-19
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Individual Interviews	At post treatment (8 weeks)	Feasibility and Acceptability of intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Örebro University; 🇸🇪 Örebro, Sweden