Online intervention for gut-brain disorders
Development, Feasibility, Efficacy, and Cost-effectiveness of an Online ACT Intervention for Disorders of Gut-Brain Interaction (Substudy 2)
This study is testing an online therapy program for people with gut-brain disorders to see how well it works and how users feel about it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Örebro University, Sweden Academic / other |
| Locations | 1 site (Örebro) |
| Trial ID | NCT06887751 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the acceptability, feasibility, and usability of an online Acceptance and Commitment Therapy (ACT) intervention designed for patients with Disorders of Gut-Brain Interaction (DGBI). Participants will engage with the iACTforDGBI intervention through self-guided online sessions and provide feedback via online interviews and questionnaires. The study aims to gather insights from both patients and healthcare practitioners regarding their experiences with the intervention.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with a diagnosis of DGBI and clinically significant levels of depression or anxiety.
Not a fit: Patients who are not proficient in Swedish or do not have access to the necessary technology may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a novel and accessible treatment option for patients suffering from DGBI and associated mental health issues.
How similar studies have performed: Other studies have shown promise in using online interventions for mental health and gut-brain disorders, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Örebro
- Örebro University — Örebro, Sweden (Recruiting)
Study contacts
- Study coordinator: Inês A Trindade, Phd
- Email: ines.trindade@oru.se
- Phone: +4619302264
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.