Efficacy, and Cost-effectiveness of an Online ACT Intervention for Disorders of Gut-Brain Interaction (iACTforDGBI)

NCT07814196 | Not Yet Recruiting Phase 2

• 1 other identifier: iACTforDGBI_RCT
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Test of efficacy and cost-effectiveness of the iACTforDGBI intervention vs an active control group (DGBI School)

Conditions

Disorders of Gut-brain Interaction; Distress, Psychological

Outcome Measures

Primary Outcomes (3)

• Depressive symptoms (Patient Health Questionnaire-9, PHQ-9)

  Depressive symptoms measured with the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report scale. Each item is rated from 0 (not at all) to 3 (nearly every day) and items are summed. Total score ranges from 0 to 27. Higher scores indicate more severe depressive symptoms (worse outcome).

  Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up

• Gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale, GSRS)

  Gastrointestinal symptom severity measured with the Gastrointestinal Symptom Rating Scale (GSRS), a 15-item self-report scale. Each item is rated on a 7-point Likert scale from 1 (no discomfort) to 7 (very severe discomfort), and items are summed. Total score ranges from 15 to 105. Higher scores indicate more severe gastrointestinal symptoms (worse outcome).

  Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up

• Anxiety symptoms (Generalized Anxiety Disorder 7-item scale, GAD-7)

  Anxiety symptoms measured with the Generalized Anxiety Disorder 7-item scale (GAD-7). Each of the 7 items is rated from 0 (not at all) to 3 (nearly every day) and items are summed. Total score ranges from 0 to 21. Higher scores indicate more severe anxiety symptoms (worse outcome).

  Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up

Secondary Outcomes (11)

• Health-related quality of life (EuroQol 5-Dimension 5-Level, EQ-5D-5L)

  Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up

• Health-related quality of life (Assessment of Quality of Life-8 Dimensions, AQoL-8D)

  Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up

• Health care use and productivity costs (Trimbos/iMTA Questionnaire for Costs Associated with Psychiatric Illness, TiC-P)

  Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up

• Illness-related shame (Chronic Illness-related Shame Scale, CISS)

  Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up

• Psychological flexibility and inflexibility (Multidimensional Psychological Flexibility Inventory, MPFI)

  Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up

Other Outcomes (1)

• Major Life Events Questionnaire

  Week 0, 6 months follow-up

Study Arms (2)

iACTforDGBI intervention

EXPERIMENTAL

ACT, mindfulness, and compassion-based online intervention

Behavioral: iACTforDGBI intervention

DGBI School

ACTIVE COMPARATOR

Education on DGBI

Other: DGBI School

Interventions

iACTforDGBI intervention BEHAVIORAL

Online ACT, mindfulness, and compassion-based intervention, 8 sessions

iACTforDGBI intervention

DGBI School OTHER

Education on DGBI, diet, and psychological factors

DGBI School

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years
• 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))
• 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
• 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).

You may not qualify if:

• Currently undergoing any form of psychological intervention.
• Increased risk of suicide (≥4 points on MADRS item 9).
• Ongoing or previously diagnosed severe psychiatric disorder, such as schizophrenia spectrum disorders or bipolar disorder.

Sponsors & Collaborators

• Örebro University, Sweden: lead

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 10, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share