Status:
RECRUITING
Feasibility and Acceptability of an Online ACT Intervention for Disorders of Gut-Brain Interaction
Lead Sponsor:
Örebro University, Sweden
Collaborating Sponsors:
Sahlgrenska University Hospital
Göteborg University
Conditions:
DGBI
Depression/Anxiety
Eligibility:
All Genders
18-75 years
Phase:
NA
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 quest...
Eligibility Criteria
Inclusion
- 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 (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)
- 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).
Exclusion
- Currently undergoing any form of psychological intervention.
- Increased risk of suicide (≥4 points on MADRS item 9)
- Severe depression (\>34 points on MADRS)
Key Trial Info
Start Date :
March 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06887751
Start Date
March 19 2025
End Date
August 30 2025
Last Update
April 2 2025
Active Locations (1)
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1
Örebro University
Örebro, Sweden