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Search / Trial NCT06887751

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

Launched by ÖREBRO UNIVERSITY, SWEDEN · Mar 13, 2025

Trial Information

Current as of April 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a new online program called iACTforDGBI, designed to help people with Disorders of Gut-Brain Interaction (DGBI), which can include symptoms like stomach pain or bloating, along with feelings of anxiety or depression. The main goal is to find out how acceptable, useful, and easy it is for patients and healthcare providers to use this online tool. Participants will take part in self-guided online sessions and share their thoughts through interviews and questionnaires to help evaluate their experience.

To join the study, you need to be between 18 and 75 years old and have a DGBI diagnosis, along with some level of depression or anxiety. You should also have been on stable medication for these issues for at least two months, be able to read and write in Swedish, and have internet access to use the program. However, if you’re currently receiving psychological treatment or are at risk of suicide, you wouldn’t be eligible to participate. Overall, this trial aims to explore how well this online intervention can support people dealing with both gut and mental health challenges.

Gender

ALL

Eligibility criteria

  • 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)

About örebro University, Sweden

Örebro University, located in Sweden, is a prominent academic institution dedicated to advancing research and education in various fields, including health sciences. The university actively engages in clinical trials to enhance medical knowledge and improve patient outcomes. With a strong focus on interdisciplinary collaboration, Örebro University fosters innovative research initiatives that align with ethical standards and regulatory requirements. Its commitment to excellence in clinical research is supported by a team of experienced researchers and state-of-the-art facilities, making it a key player in the global medical research community.

Locations

örebro, , Sweden

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported