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

Development, Feasibility, Efficacy, and Cost-effectiveness of an Online ACT Intervention for Disorders of Gut-Brain Interaction (Sub-study 1)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06309004

Acronym

iACTforDGBI

Enrollment

Registered

2024-03-13

Start date

2024-09-23

Completion date

2025-09-30

Last updated

2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety and Depression, Disorders of Gut-brain Interaction

Keywords

DGBI, ACT, Anxiety, Depression

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
Focus group interviews	60-90 minutes per interview	Focus group interviews

Countries

Sweden

Outcome results