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

NCT ID: NCT06309004

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-23
• Study Completion Date: 2025-09-30

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Adults with DGBI

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

No interventions assigned to this group

Healthcare professionals

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

No interventions assigned to this group

Eligibility Criteria

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).

a) Being a healthcare professional currently working with DGBI patients and/or with ACT-based/digital interventions.

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:

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uppsala University

OTHER

Sponsor Role: collaborator

SahlgrenskaUniversityHospital

UNKNOWN

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: collaborator

Örebro University, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Inês A Trindade, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

Örebro University

Örebro, , Sweden

Countries

Sweden

Other Identifiers

2023-00741a

Identifier Type: -

Identifier Source: org_study_id