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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Distress, Psychological; Disorders of Gut-brain Interaction
• Intervention / Treatment: Behavioral: iACTforDGBI intervention; Other: DGBI School

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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))
• Clinically meaningful levels of depressive symptoms or anxiety: score ≥ 7 and ≤ 34 on the Montgomery Åsberg Depression Rating Scale (Svanborg & Åsberg, 1994; (MADRS-S; depressive symptoms), or score ≥ 5 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
• 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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iACTforDGBI intervention; ACT, mindfulness, and compassion-based online intervention	Behavioral: iACTforDGBI intervention; Online ACT, mindfulness, and compassion-based intervention, 8 sessions
Active Comparator: DGBI School; Education on DGBI	Other: DGBI School; Education on DGBI, diet, and psychological factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life (EuroQol 5-Dimension 5-Level, EQ-5D-5L)	Health-related quality of life measured with the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). Five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each with five severity levels, are converted into a single index value using the [Swedish c-TTO value set (Sun et al., 2022) / Swedish experience-based value set (Burström et al., 2020)]. The index is anchored at 1.00 (full health) and 0.00 (a state equivalent to dead), with negative values representing states considered worse than dead; the [Swedish c-TTO value set ranges from -0.31 to 1.00 / Swedish experience-based value set ranges from 0.243 to 0.976]. Higher index values indicate better health-related quality of life (better outcome). The accompanying EQ visual analogue scale ranges from 0 (worst imaginable health) to 100 (best imaginable health), with higher scores indicating better self-rated health.	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)	Health-related quality of life measured with the Assessment of Quality of Life-8 Dimensions (AQoL-8D), a 35-item instrument covering eight dimensions (independent living, happiness, mental health, coping, relationships, self-worth, pain, senses). Item responses are converted into a single utility score using the Australian scoring algorithm, on a scale anchored at 1.00 (full health) and 0.00 (dead); the algorithmic range is 0.09 to 1.00. Higher scores indicate better health-related quality of life (better outcome).	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)	Health care utilisation and productivity losses measured with the Trimbos/iMTA Questionnaire for Costs Associated with Psychiatric Illness (TiC-P). The TiC-P is not scored as a rating scale: reported numbers of health care contacts and days of absenteeism and reduced productivity are multiplied by Swedish unit costs to yield costs in SEK. The minimum is 0 SEK and there is no fixed maximum. Higher values indicate greater resource use and productivity loss (worse outcome).	Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up
Illness-related shame (Chronic Illness-related Shame Scale, CISS)	Illness-related shame measured with the Chronic Illness-related Shame Scale (CISS), a 7-item unidimensional self-report scale. Each item is rated from 0 (never true) to 4 (always true) and items are summed. Total score ranges from 0 to 28. Higher scores indicate greater illness-related shame (worse outcome).	Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up
Psychological flexibility and inflexibility (Multidimensional Psychological Flexibility Inventory, MPFI)	Items are rated on a 6-point scale from 1 (never true) to 6 (always true). Global psychological flexibility and global psychological inflexibility composite scores are each calculated as the mean of their constituent items, giving a score range of 1 to 6 for each composite. Higher psychological flexibility scores indicate greater flexibility (better outcome); higher psychological inflexibility scores indicate greater inflexibility (worse outcome).	Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up
Self-compassion (Self-Compassion Scale-Short Form, SCS-SF)	Self-compassion measured with the Self-Compassion Scale-Short Form (SCS-SF), a 12-item self-report scale. Items are rated from 1 (almost never) to 5 (almost always); negatively worded items are reverse-scored and the total score is the mean of all items, ranging from 1 to 5. Higher scores indicate greater self-compassion (better outcome).	Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up
Treatment credibility and expectancy (Credibility/Expectancy Questionnaire, CEQ)	Treatment credibility and outcome expectancy measured with the Credibility/Expectancy Questionnaire (CEQ), a 6-item self-report measure. The credibility subscale (items 1-3) is rated from 1 (not at all) to 9 (very much) and summed, giving a range of 3 to 27. The expectancy subscale (items 4-6) combines one item rated from 1 to 9 and two items rated from 0% to 100%; these items are standardised and summed, so the subscale has no fixed raw minimum and maximum. Higher scores on both subscales indicate greater perceived treatment credibility and more positive outcome expectancy.	Week 0 (only expectancy sub scale), Week 4 (both subscales)
System usability (System Usability Scale, SUS)	Perceived usability of the online intervention platform measured with the System Usability Scale (SUS), a 10-item self-report scale. Items are rated from 1 (strongly disagree) to 5 (strongly agree); item scores are converted (odd-numbered items: response minus 1; even-numbered items: 5 minus response), summed and multiplied by 2.5. Total score ranges from 0 to 100. Higher scores indicate better perceived usability (better outcome).	Week 8
Negative effects of treatment (Negative Effects Questionnaire, 20-item version, NEQ-20)	Negative effects of treatment measured with the 20-item version of the Negative Effects Questionnaire (NEQ-20). For each item, participants indicate whether the negative effect occurred and, if so, rate its impact from 0 (not at all) to 4 (extremely) and attribute it either to the treatment or to other circumstances. The total score is the sum of the 20 items, ranging from 0 to 80. Higher scores indicate more frequent and more severe negative effects (worse outcome).	Week 8
Global impression of change (Patient Global Impression of Change, PGIC)	Participants' overall impression of change since starting the intervention (Week 0), measured with a single global change item rated on a 7-point scale from 0 (very much worse) to 6 (very much improved)]. A higher score indicates greater perceived improvement (better outcome).	Week 4, Week 8, 3 months follow-up, 6 months follow-up
Awareness of Processes Post-Intervention Scale	Participants' awareness of the therapeutic processes targeted by the intervention, measured with the Awareness of Processes Post-Intervention Scale, a study-specific [N]-item self-report measure. Each item is rated from 1 (not at all true) to 5 (very much true) and items are summed, giving a total score range of 9 to 45. Higher scores indicate greater awareness of the targeted processes.	Week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Life Events Questionnaire	Major life events and self-reported new psychological or physical diagnoses over the preceding 12 months, measured with the Major Life Events Questionnaire, a 28-item checklist. This is not scored as a rating scale; the outcome is the number of events endorsed, ranging from 0 to 28. A higher number indicates more major life events reported. This measure is used to characterise the sample and to identify potential confounders rather than as an efficacy outcome.	Week 0, 6 months follow-up

Collaborators and Investigators

• Sponsor: Örebro University, Sweden

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: September 2, 2026
• First Submitted That Met QC Criteria: September 9, 2026
• First Posted (Actual): September 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 9, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: iACTforDGBI_RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No