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

September 9, 2026 updated by: Ines Trindade, Örebro University, Sweden
Test of efficacy and cost-effectiveness of the iACTforDGBI intervention vs an active control group (DGBI School)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Depressive symptoms (Patient Health Questionnaire-9, PHQ-9)
Time Frame: Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up
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)
Time Frame: Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up
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)
Time Frame: Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health-related quality of life (EuroQol 5-Dimension 5-Level, EQ-5D-5L)
Time Frame: Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up
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)
Time Frame: Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up
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)
Time Frame: Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up
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)
Time Frame: Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up
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)
Time Frame: Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up
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)
Time Frame: Week 0, Week 4, Week 8, 3 months follow-up, 6 months follow-up
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)
Time Frame: Week 0 (only expectancy sub scale), Week 4 (both subscales)
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)
Time Frame: Week 8
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)
Time Frame: Week 8
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)
Time Frame: Week 4, Week 8, 3 months follow-up, 6 months follow-up
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
Time Frame: Week 8
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major Life Events Questionnaire
Time Frame: Week 0, 6 months follow-up
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Örebro University, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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