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OpenTrials
Active, Not Recruiting

NCT Number: NCT06309004

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Örebro University

Örebro, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

DGBI participants:

Inclusion criteria

  • 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).

Exclusion criteria

  • 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:

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Focus group interviews

    Time frame: 60-90 minutes per interview

    Focus group interviews

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

  • Göteborg University
  • SahlgrenskaUniversityHospital
  • Uppsala University

Registry information

Official study title

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

Acronym: iACTforDGBI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2024
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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