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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Örebro University

Örebro, Sweden