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

Not yet recruiting

• Conditions: Clinically Meaningful Symptoms Levels of Symptoms of DGBI and Depression and/or Anxiety

• Registration Number: NCT06309004
• Lead Sponsor: Örebro University, Sweden

Brief 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 in DGBI) will be asked to: a) Evaluate a preliminary version of the iACTforDGBI intervention, consisting of self-guided online sessions. b) Participate in online focus-group interviews and provide information on their views of a preliminary version of the iACTforDGBi intervention

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Study First Posted: 2024-03-13
• Last Update Posted: 2024-03-13
• Study Start: 2024-05-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Focus group interviews	One week after access to the preliminary intervention platform	Focus group interviews