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

NCT06309004 | Active Not Recruiting

• 1 other identifier: 2023-00741a
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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 with DGBI patients) will be asked to participate in online focus-group interviews and provide information on their views of a preliminary version of the iACTforDGBi intervention.

Conditions

Anxiety and Depression; Disorders of Gut-brain Interaction

Keywords

DGBI; ACT; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• Focus group interviews

  Focus group interviews

  60-90 minutes per interview

Study Arms (2)

Adults with DGBI

Adults with DGBI, and clinically meaningful symptom levels of anxiety and/or depression

Healthcare professionals

Healthcare professionals (physicians, psychologists, nurses, and dietitians).

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with DGBI: People with clinically meaningful symptom severity of DGBI, and depression and/or anxiety. Healthcare professionals: Physicians, psychologists, nurses, and dietitians working from different regions in Sweden.

You may qualify if:

• Age between 18 and 75 years;
• 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));
• 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);
• 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;
• 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).

You may not qualify if:

• Currently undergoing any form of psychological intervention;
• Increased risk of suicide (≥4 points on MADRS item 9);
• Severe depression (≥34 points on MADRS).
• Healthcare professionals:
• a) Being a healthcare professional currently working with DGBI patients and/or with ACT-based/digital interventions.

Sponsors & Collaborators

• Örebro University, Sweden: lead
• Uppsala University: collaborator
• SahlgrenskaUniversityHospital: collaborator
• Göteborg University: collaborator

Study Sites (1)

Örebro University

Örebro, Sweden

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Inês A Trindade, PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 13, 2024
• Study Start: September 23, 2024
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

SE (1)