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

Örebro University, Sweden

Status: Active, not recruiting

Conditions: Disorders of Gut-brain Interaction; Anxiety and Depression

Study type: Observational

Funder types: Other

Identifiers

NCT06309004

2023-00741a

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

DGBI participants:

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 and/or with ACT-based/digital interventions.

Trial design

15 participants in 2 patient groups

Adults with DGBI

Description:

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

Healthcare professionals

Description:

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