Clinical trial NCT06887751: Feasibility and Acceptability 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 (Substudy 2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: DGBI
Depression/Anxiety
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
name: Göteborg University
name: Uppsala University
First posted: 2025-03-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pilot study (feasibility including acceptability) in which we intend to see how the prototype intervention and overall workload (including measurements) is perceived by the participants.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the acceptability, feasibility, and usability of the iACTforDGBI intervention among patients with Disorders of Gut-Brain Interaction (DGBI). The main question it aims to answer are:

What are the perceptions of patients with DGBI and healthcare practitioners regarding the acceptability, feasibility, and usability of the iACTforDGBI intervention?

Participants will be asked to:

Complete the iACTforDGBI intervention prototype, consisting of self-guided online sessions.

Participate in online interviews and fill out online questionnaires to evaluate the intervention concerning acceptability, feasibility, usability and preliminary effects.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 75 years
2. Meeting clinical symptom levels for 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 (Svanborg \&amp; Åsberg, 1994; (MADRS-S; 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. Have access to a device (like computer, tablet or smartphone with) 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 (\&amp;amp;gt;34 points on MADRS)

Primary outcomes:
measure: Individual Interviews
timeFrame: At post treatment (8 weeks)
Secondary outcomes:
measure: The Generalized Anxiety Disorder scale-7 (GAD-7)
timeFrame: At pre and post treatment (0 and 8 weeks), 6-month follow-up (FU1), and 12-month follow-up (FU2) assessments
measure: EQ-5D-5L
timeFrame: At pre and post treatment (0 and 8 weeks)
measure: AQoL-8D
timeFrame: At pre and post treatment (0 and 8 weeks)
measure: The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
timeFrame: At pre and post treatment (0 and 8 weeks)
measure: The Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: At pre and post treatment (0 and 8 weeks)
measure: The Chronic Illness Shame Scale (CISS)
timeFrame: At pre and post treatment (0 and 8 weeks)
measure: The Credibility / Expectancy Questionnaire (CEQ)
timeFrame: After session 2 (2 weeks)
measure: The System Usability Scale (SUS)
timeFrame: At post treatment (8 weeks)
measure: The Negative Effects Questionnaire (NEQ-20)
timeFrame: At post treatment (8 weeks)
measure: The Intervention Acceptability Scale
timeFrame: At post treatment (8 weeks)
measure: The Contextual Therapies Process Awareness Scale
timeFrame: At post treatment (8 weeks)
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: At pre and post treatment (0 and 8 weeks)
measure: The Multidimensional Psychological Flexibility Inventory (MPFI)
timeFrame: At pre and post treatment (0 and 8 weeks)
measure: The State Self-Compassion Scale - short Form (SSCS-S)
timeFrame: At pre and post treatment (0 and 8 weeks)
measure: The Self-Compassion Scale - short Form (SCS-SF)
timeFrame: At pre and post treatment (0 and 8 weeks)
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University
Study officials:
References: