Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT06309004
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 and/or with ACT-based/digital interventions.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06309004
Study Brief:
Protocol Section:
NCT06309004