DGBIiACTforDGBINCT07521709

Evaluation of an Online ACT and Compassion-based Intervention for Disorders of Gut-Brain Interaction

A study testing Acceptance and Commitment Therapy with explicit self-compassion training and Education in people with DGBI and Depression/Anxiety, run by Örebro University, Sweden at 1 site in Sweden.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: DGBI, Depression/Anxiety
What is being tested?: Acceptance and Commitment Therapy with explicit self-compassion training and Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteSweden
Study dates: 30 Apr 2026to 30 Apr 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 ≥ 13 on the Montgomery Åsberg Depression Rating Scale (Svanborg \& Åsberg, 1994; (MADRS-S; depressive symptoms), or score ≥ 10 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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Örebro University
Örebro

Other trials in Sweden

About this study

Official title: Efficacy and Cost Effectiveness of an Online ACT Intervention for Disorders of Gut-Brain Interaction: A Randomized Controlled Trial

The goal of this clinical trial is to assess the efficacy and cost-effectiveness of the iACTforDGBI intervention among adults with Disorders of Gut-Brain Interaction (DGBI) and psychological distress. The main questions it aims to answer are: What is the efficacy of iACTforDGBI vs DGBI School? What is the cost-effectiveness of iACTforDGBI vs DGBI School? Who are the responders of each intervention? What are the moderators and mechanisms of change of the interventions? Participants will be asked to: Complete one of the two interventions (to which they will be randomly allocated to). Both interventions are 8-session online programs, delivered via an interactive platform and tailored for Swedish-speaking adults with symptoms compatible with a DGBI and psychological distress. Both interventions are theory-based and expected to be beneficial. Participants will be asked to fill out online questionnaires for screening of study eligibility, and baseline, post-treatment and follow-up outcome measures to evaluate the intervention. A subsample will also be interviewed post treatment.

Conditions: DGBI, Depression/Anxiety
Being tested: Acceptance and Commitment Therapy with explicit self-compassion training, Education
Medical subject headings: Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acceptance and Commitment Therapy with explicit self-compassion trainingBehavioural
The self-guided Online version of Acceptance and Commitment Therapy with explicit self-compassion components (iACTforDGBI) intervention will include 8 weekly sessions of around 20-30 minutes each, and will comprise ACT-consistent informative texts, audio exercises, and videos.
EducationOther
Participants in the active control group will be asked to complete 8 weekly 20-minute sessions of an online course for education on DGBIs. This course will be delivered through the same platform than the one delivering the online ACT for DGBI intervention, via the same website. The intervention platform will have similar designs and structure, and will be developed by the same web development company. This intervention is based on the IBS school program (e.g., Ringström et al., 2009), in particular its online version (Lindfors et al., 2021), developed by members of the current research team.

Study groups in NCT07521709
Study group	Role	What they receive
Acceptance and Commitment Therapy with explicit self-compassion training	Experimental	Acceptance and Commitment Therapy with explicit self-compassion training Receives: Behavioral: Acceptance and Commitment Therapy with explicit self-compassion training
Education about DGBI and distress	Active comparator	Education Receives: Other: Education

What is being measured

The primary outcome is the main question the study is designed to answer.

The Gastrointestinal Symptom Rating Scale (GSRS)
Symptom Severity of DGBI, minimum 15, maximum 105, higher = worse gastrointestinal symptoms
Measured: T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up). T3 (6 month follow-up), T4 (12 month follow-up)
The Generalized Anxiety Disorder scale-7 (GAD-7)
Symptoms of general anxiety, total score 0-21, higher = worse anxiety symptoms
Measured: T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
The Patient Health Questionnaire-9 (PHQ-9)
symptoms of depression, total score 0-27, higher = worse depressive symptoms
Measured: T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)

Secondary outcomes (13)

EuroQol 5-Dimension 5-Level (EQ-5D-5L), EQ Vas 0-100, higher = better health-related quality of life
Health-related Quality of Life
Measured: T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
Assessment of Quality of Life - 8 dimensions (AQoL-8D)
Health-related Quality of Life, Utility score -0.04 - 1.00, higher = better quality of life
Measured: T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Healthcare Utilization, no single fixed min/max, higher = worse/more costly outcome
Measured: T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
The Chronic Illness Shame Scale (CISS)
Shame of Chronic Illnesses, total score 0-28, higher = worse shame related to chronic illness
Measured: T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
The Credibility / Expectancy Questionnaire (CEQ)
Treatment Credibility and Expectancy, total score 3-27 each, higher = better treatment credibility/expectancy
Measured: T0 (week 0, only expectancy sub scale), Tmid (week 4, both subscales)
The System Usability Scale (SUS)
Intervention Platform Usability, total score 0-100, higher = better usability
Measured: T1 (week 8)
The Negative Effects Questionnaire (NEQ-20)
Negative Side Effects and Events, total score 0-80, higher = worse negative effects
Measured: T1 (week 8)
Global Impression of Change Scale
Impression of change, a single global change item, higher = worse
Measured: Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
Awareness of Processes Post-Intervention Scale
Awareness of Processes, higher = more awareness
Measured: T1 (week 8)
The Multidimensional Psychological Flexibility Inventory (MPFI)
Psychological flexibility, composites scored as means, higher = worse for inflexibility
Measured: T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
Self-Compassion Scale
Self-compassion, higher = better self-compassion
Measured: T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
Insomnia Severity Index
Insomnia symptoms, total score 0-28, higher = worse insomnia severity
Measured: T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
Major Life Events
Past 12 months. Questions about psychological/physical diagnoses, usually more events/greater burden = worse stress exposure
Measured: T0 (week 0), T3 (6 month follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 202630 Apr 2026

First posted13 Apr 2026
Study start30 Apr 2026
Primary completion30 Apr 2026
Study completion30 Apr 2026

Why it stopped: Study halted before recruitment started due to data integrity issues from the previous pilot studies. Decision made by PI, with support from the host institution.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DGBIStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a randomized controlled trial in which we intend to compare the efficacy and cost-effectiveness of the iACTforDGBI intervention compared to the active control group (DGBI School).
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07521709
Sponsor's protocol ID: 2023-00751e
Other IDs: 2023
Acronym: iACTforDGBI
Status last verified: May 2026
First submitted: 27 Mar 2026
Last updated: 8 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: This question is under investigation. Some of our data contain sensitive information on health, and the main priority is participants integrity which need to be balanced against basic scientific principles on scrutiny. However, any personal data that can be shared without compromising participants integrity to a reasonable degree will be shared upon reasonable request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All DGBI trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Cost Effectiveness of an Online ACT Intervention for Disorders of Gut-Brain Interaction: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07521709
Acronym / sponsor ID: iACTforDGBI / 2023-00751e
Conditions: DGBI, Depression/Anxiety
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Study halted before recruitment started due to data integrity issues from the previous pilot studies. Decision made by PI, with support from the host institution.
Enrolment: 0 participants (actual)
Lead sponsor: Örebro University, SwedenUniversity, hospital or other
Collaborators: Sahlgrenska University Hospital, Göteborg University, Uppsala University
Study start: 30 Apr 2026 (actual)
Primary completion: 30 Apr 2026 (actual)
Study completion: 30 Apr 2026 (actual)
First posted: 13 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: This is a randomized controlled trial in which we intend to compare the efficacy and cost-effectiveness of the iACTforDGBI intervention compared to the active control group (DGBI School).

Arm	Type	Receives
Acceptance and Commitment Therapy with explicit self-compassion training	Experimental	Behavioral: Acceptance and Commitment Therapy with explicit self-compassion trainingAcceptance and Commitment Therapy with explicit self-compassion training
Education about DGBI and distress	Active comparator	Other: EducationEducation

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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 ≥ 13 on the Montgomery Åsberg Depression Rating Scale (Svanborg \& Åsberg, 1994; (MADRS-S; depressive symptoms), or score ≥ 10 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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Acceptance and Commitment Therapy with explicit self-compassion trainingThe self-guided Online version of Acceptance and Commitment Therapy with explicit self-compassion components (iACTforDGBI) intervention will include 8 weekly sessions of around 20-30 minutes each, and will comprise ACT-consistent informative texts, audio exercises, and videos.	Behavioural	Acceptance and Commitment Therapy with explicit self-compassion training
EducationParticipants in the active control group will be asked to complete 8 weekly 20-minute sessions of an online course for education on DGBIs. This course will be delivered through the same platform than the one delivering the online ACT for DGBI intervention, via the same website. The intervention platform will have similar designs and structure, and will be developed by the same web development company. This intervention is based on the IBS school program (e.g., Ringström et al., 2009), in particular its online version (Lindfors et al., 2021), developed by members of the current research team.	Other	Education about DGBI and distress

Primary outcome

The Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up). T3 (6 month follow-up), T4 (12 month follow-up)
Symptom Severity of DGBI, minimum 15, maximum 105, higher = worse gastrointestinal symptoms
The Generalized Anxiety Disorder scale-7 (GAD-7)
Time frame: T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
Symptoms of general anxiety, total score 0-21, higher = worse anxiety symptoms
The Patient Health Questionnaire-9 (PHQ-9)
Time frame: T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
symptoms of depression, total score 0-27, higher = worse depressive symptoms

13 secondary outcomes

EuroQol 5-Dimension 5-Level (EQ-5D-5L), EQ Vas 0-100, higher = better health-related quality of life
Time frame: T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
Assessment of Quality of Life - 8 dimensions (AQoL-8D)
Time frame: T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Time frame: T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
The Chronic Illness Shame Scale (CISS)
Time frame: T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
The Credibility / Expectancy Questionnaire (CEQ)
Time frame: T0 (week 0, only expectancy sub scale), Tmid (week 4, both subscales)
The System Usability Scale (SUS)
Time frame: T1 (week 8)
The Negative Effects Questionnaire (NEQ-20)
Time frame: T1 (week 8)
Global Impression of Change Scale
Time frame: Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
Awareness of Processes Post-Intervention Scale
Time frame: T1 (week 8)
The Multidimensional Psychological Flexibility Inventory (MPFI)
Time frame: T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
Self-Compassion Scale
Time frame: T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
Insomnia Severity Index
Time frame: T0 (week 0), T1 (week 8), T2 (3 month follow-up), T3 (6 month follow-up), T4 (12 month follow-up)
Major Life Events
Time frame: T0 (week 0), T3 (6 month follow-up)

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
Individual participant dataSharing planned: Undecided. This question is under investigation. Some of our data contain sensitive information on health, and the main priority is participants integrity which need to be balanced against basic scientific principles on scrutiny. However, any personal data that can be shared without compromising participants integrity to a reasonable degree will be shared upon reasonable request.

Related trials for DGBI

Recruiting
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Not yet recruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Inês A Trindade, Phd principal investigator

Örebro University, Sweden

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Gastrointestinal Symptom Rating Scale (GSRS) (time frame: T0 (week 0), Tmid (week 4), T1 (week 8), T2 (3 month follow-up). T3 (6 month follow-up), T4 (12 month follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07521709.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.