DGBIiACTforDGBINCT07175402
Feasibility and Acceptability of an Online ACT Intervention for Disorders of Gut-Brain Interaction - Beta Trial
A study testing Acceptance and Commitment Therapy (ACT) and Psychoeducation in people with DGBI and Depression/Anxiety, run by Örebro University, Sweden at 1 site in Sweden.
Trial 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). Read more about this study
- 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 (ACT) and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSweden
- Study dates
- 8 Sep 2025to 31 Dec 2025
- 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 (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)
- Severe depression (≥34 points on MADRS)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development, Feasibility, Efficacy, and Cost-effectiveness of an Online ACT Intervention for Disorders of Gut-Brain Interaction (Beta Trial)
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.
- Conditions
- DGBI, Depression/Anxiety
- Being tested
- Acceptance and Commitment Therapy (ACT), Psychoeducation
- 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 (ACT)Behavioural
The Online version of Acceptance and Commitment Therapy (iACTforDGBI) intervention will include 8 weekly sessions of around 20 minutes each, and will comprise ACT-consistent informative texts, audio exercises, and videos. The intervention is expected to have the following overall structure: Session 0: Individual videoconference meeting, introduction. Session 1: Creative hopelessness and mindfulness. Session 2: The body, acceptance, and values. Session 3: Compassion. Session 4: Cognitive defusion and committed action. Session 5-7: Personalised content (in-depth material and tasks based on individual difficulties assessed with diary). Session 8: Summary of intervention.
PsychoeducationOther
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 a similar 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. Session 0: Individual session, introduction. Session 1-8: The content will be based on the IBS school intervention (e.g., Ringström et al., 2009), in particular its online version (Lindfors et al., 2021), developed by members of the current research team. This education intervention was based on the biopsychosocial model of DGBI and was originally developed and tested as a face-to-face group intervention with six 2-h sessions held weekly. IBS school generally aims at increasing disease knowledge in people with IBS and covers a wide spectrum of issues related to IBS.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Experimental | Acceptance and Commitment Therapy (ACT) Receives: Behavioral: Acceptance and Commitment Therapy (ACT) |
| Education on DGBI, psychoeducation | Active comparator | Education on DGBI, psychoeducation Receives: Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual interviews
Feasibility and acceptability of intervention
Measured: At post treatment (8 weeks)
Secondary outcomes (15)
The Generalized Anxiety Disorder scale-7 (GAD-7)
Symptoms of general anxiety, min-max: 0-21, higher scores: more symptoms of general anxiety.
Measured: At pre and post treatment (0 and 8 weeks).
EQ-5D-5L
Health-related Quality of Life, min-max 0-1 (index value), higher scores: better health-related quality of life
Measured: At pre and post treatment (0 and 8 weeks)
AQoL-8D
Health-related Quality of Life, min-max -0.04-1.00, higher scores: better health-related quality of life.
Measured: At pre and post treatment (0 and 8 weeks)
The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Healthcare Utilization, no fixed range (reports number of contacts, costs etc.), higher scores: greater healthcare utilization/higher costs.
Measured: At pre and post treatment (0 and 8 weeks)
The Gastrointestinal Symptom Rating Scale (GSRS)
Symptom Severity of DGBI, min-max 19-133, higher scores: more severe gastrointestinal symptoms.
Measured: At pre and post treatment (0 and 8 weeks)
The Chronic Illness Shame Scale (CISS)
Shame of Chronic Illnesses, min-max 0-28, higher scores: greater shame related to chronic illness.
Measured: At pre and post treatment (0 and 8 weeks)
The Credibility/Expectancy Questionnaire (CEQ)
Treatment Credibility and Expectancy, min-max 0-27 credibility, 0-9 expectancy, higher scores: higher treatment credibility/expectancy.
Measured: After session 2 (2 weeks)
The System Usability Scale (SUS), min-max 0-100, higher scores: greater perceived usability.
Intervention Platform Usability
Measured: At post treatment (8 weeks)
The Negative Effects Questionnaire (NEQ-20), min-max 0-80 (depending on number of endorsed negative effects), higher scores: more negative effects/adverse events.
Negative side effects and events
Measured: At post treatment (8 weeks)
The Intervention Acceptability Scale
Intervention Acceptability, min-max 1-5 per item, higher scores: greater intervention acceptability.
Measured: At post treatment (8 weeks)
The Contextual Therapies Process Awareness Scale
Awareness of Processes, min-max 1-5 per item, higher scores: greater process awareness.
Measured: At post treatment (8 weeks)
The Patient Health Questionnaire-9 (PHQ-9)
Symptoms of depression, min-max 0-27, higher scores: more depressive symptoms.
Measured: At pre and post treatment (0 and 8 weeks)
The Multidimensional Psychological Flexibility Inventory (MPFI)
Psychological flexibility, min-max 1-6 per item, higher scores: indicate more rigidity/avoidance on negative sub scales
Measured: At pre and post treatment (0 and 8 weeks)
The State Self-Compassion Scale - short form (SSCS-S)
State self-compassion, min-max 6-30, higher scores: greater state self-compassion.
Measured: At pre and post treatment (0 and 8 weeks)
The Self-Compassion Scale - short form (SCS-SF)
Trait self-compassion, min-max 12-60, higher scores: greater trait self-compassion.
Measured: At pre and post treatment (0 and 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start8 Sep 2025
- Primary completion30 Nov 2025
- Study completion31 Dec 2025
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 second (beta) pilot study (feasibility including acceptability) in which the investigators intend to see how the intervention and overall workload (including measurements) is perceived by the participants.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Göteborg University, Uppsala University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175402
- Sponsor's protocol ID
- 2023-00751d
- Other IDs
- 2023
- Acronym
- iACTforDGBI
- Status last verified
- Feb 2026
- First submitted
- 9 Sep 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This question is under investigation. Some of the 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Feasibility, Efficacy, and Cost-effectiveness of an Online ACT Intervention for Disorders of Gut-Brain Interaction (Beta Trial)
- ClinicalTrials.gov ID
- NCT07175402
- Acronym / sponsor ID
- iACTforDGBI / 2023-00751d
- Conditions
- DGBI, Depression/Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Göteborg University, Uppsala University
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 16 Sep 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a second (beta) pilot study (feasibility including acceptability) in which the investigators intend to see how the intervention and overall workload (including measurements) is perceived by the participants.
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT)Acceptance and Commitment Therapy (ACT) |
| Education on DGBI, psychoeducation | Active comparator | Other: PsychoeducationEducation on DGBI, psychoeducation |
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 (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)
- Severe depression (≥34 points on MADRS)
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 (ACT)The Online version of Acceptance and Commitment Therapy (iACTforDGBI) intervention will include 8 weekly sessions of around 20 minutes each, and will comprise ACT-consistent informative texts, audio exercises, and videos. The intervention is expected to have the following overall structure: Session 0: Individual videoconference meeting, introduction. Session 1: Creative hopelessness and mindfulness. Session 2: The body, acceptance, and values. Session 3: Compassion. Session 4: Cognitive defusion and committed action. Session 5-7: Personalised content (in-depth material and tasks based on individual difficulties assessed with diary). Session 8: Summary of intervention. | Behavioural | Acceptance and Commitment Therapy (ACT) |
| PsychoeducationParticipants 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 a similar 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. Session 0: Individual session, introduction. Session 1-8: The content will be based on the IBS school intervention (e.g., Ringström et al., 2009), in particular its online version (Lindfors et al., 2021), developed by members of the current research team. This education intervention was based on the biopsychosocial model of DGBI and was originally developed and tested as a face-to-face group intervention with six 2-h sessions held weekly. IBS school generally aims at increasing disease knowledge in people with IBS and covers a wide spectrum of issues related to IBS. | Other | Education on DGBI, psychoeducation |
Primary outcome
Individual interviews
Time frame: At post treatment (8 weeks)
Feasibility and acceptability of intervention
15 secondary outcomes
The Generalized Anxiety Disorder scale-7 (GAD-7)
Time frame: At pre and post treatment (0 and 8 weeks).
EQ-5D-5L
Time frame: At pre and post treatment (0 and 8 weeks)
AQoL-8D
Time frame: At pre and post treatment (0 and 8 weeks)
The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Time frame: At pre and post treatment (0 and 8 weeks)
The Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: At pre and post treatment (0 and 8 weeks)
The Chronic Illness Shame Scale (CISS)
Time frame: At pre and post treatment (0 and 8 weeks)
The Credibility/Expectancy Questionnaire (CEQ)
Time frame: After session 2 (2 weeks)
The System Usability Scale (SUS), min-max 0-100, higher scores: greater perceived usability.
Time frame: At post treatment (8 weeks)
The Negative Effects Questionnaire (NEQ-20), min-max 0-80 (depending on number of endorsed negative effects), higher scores: more negative effects/adverse events.
Time frame: At post treatment (8 weeks)
The Intervention Acceptability Scale
Time frame: At post treatment (8 weeks)
The Contextual Therapies Process Awareness Scale
Time frame: At post treatment (8 weeks)
The Patient Health Questionnaire-9 (PHQ-9)
Time frame: At pre and post treatment (0 and 8 weeks)
The Multidimensional Psychological Flexibility Inventory (MPFI)
Time frame: At pre and post treatment (0 and 8 weeks)
The State Self-Compassion Scale - short form (SSCS-S)
Time frame: At pre and post treatment (0 and 8 weeks)
The Self-Compassion Scale - short form (SCS-SF)
Time frame: At pre and post treatment (0 and 8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided. This question is under investigation. Some of the 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT) and Psychoeducation in people with DGBI and Depression/Anxiety, run by Örebro University, Sweden at 1 site in Sweden.
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: finished, as of the sponsor's last update on 17 Feb 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Individual interviews (time frame: At post treatment (8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.