Ireland
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Active, not recruiting Observational

Development of an Online ACT Intervention for Disorders of Gut-Brain Interaction

NCT06309004 · tracked via the Priya Life Science Sweden tracker
Phase
Observational
Started
2024-09-23
Last updated
2025-08-15

Condition(s) studied

Anxiety and DepressionDisorders of Gut-brain Interaction

Study summary

The goal of this clinical trial is to develop and test the iACTforDGBI intervention in a sample of Swedish individuals with DGBI (Disorders of Gut-Brain Interaction).

The first substudy of this project (Substudy 1) aims to answer the following question: How can the design of iACTforDGBI be tailored to meet the specific needs of individuals with DGBI and clinically meaningful symptoms of anxiety and depression?

Participants (individuals with symptoms compatible with a DGBI and anxiety and/or depression, and healthcare professionals working with DGBI patients) will be asked to participate in online focus-group interviews and provide information on their views of a preliminary version of the iACTforDGBi intervention.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
DGBI participants: Inclusion Criteria: 1. Age between 18 and 75 years; 2. Exhibiting clinical symptom severity for at 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 (MADRS; 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. Access to a device (like a computer, tablet, or smartphone) 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). Healthcare professionals: Inclusion Criteria: a) Being a healthcare professional currently working with DGBI patients and/or with ACT-based/digital interventions.

Primary outcome measure(s)

  • Focus group interviews — 60-90 minutes per interview
    Focus group interviews

Trial sites (1)

FacilityCityRegionStatus
Örebro University Örebro Sweden
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06309004 on ClinicalTrials.gov ↗ ← All trials in Sweden