Clinical trial NCT06309004: Development of an Online ACT Intervention for Disorders of Gut-Brain Interaction
Official title: Development, Feasibility, Efficacy, and Cost-effectiveness of an Online ACT Intervention for Disorders of Gut-Brain Interaction (Sub-study 1)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Clinically Meaningful Symptoms Levels of Symptoms of DGBI and Depression and/or Anxiety
Keywords: DGBI
ACT
Anxiety
Depression
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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:

ACT therapists, health psychologists, physicians, nurses, and dietitians working with people with DGBI, from different regions in Sweden.

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 in DGBI) will be asked to: a) Evaluate a preliminary version of the iACTforDGBI intervention, consisting of self-guided online sessions. b) Participate in online focus-group interviews and provide information on their views of a preliminary version of the iACTforDGBi intervention


Eligibility 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.

Primary outcomes:
measure: Focus group interviews
timeFrame: One week after access to the preliminary intervention platform
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: