Anxiety and DepressioniACTforDGBINCT06309004
Development of an Online ACT Intervention for Disorders of Gut-Brain Interaction
An observational study of Anxiety and Depression and Disorders of Gut-brain Interaction, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
The goal of this clinical trial is to develop and test the iACTforDGBI intervention in a sample of Swedish individuals with DGBI (Disorders of Gut-Brain Interaction). The first substudy of this project (Substudy 1) aims to answer the following question: How can the design of iACTforDGBI be tailored to meet the… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety and Depression, Disorders of Gut-brain Interaction
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 23 Sep 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with DGBI: People with clinically meaningful symptom severity of DGBI, and depression and/or anxiety. Healthcare professionals: Physicians, psychologists, nurses, and dietitians working from different regions in Sweden.
Who may be able to join
- Age between 18 and 75 years;
- Exhibiting clinical symptom severity for at 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; 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;
- Access to a device (like a computer, tablet, or smartphone) 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).
- Being a healthcare professional currently working with DGBI patients and/or with ACT-based/digital interventions.
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).
- Healthcare professionals:
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 (Sub-study 1)
The goal of this clinical trial is to develop and test the iACTforDGBI intervention in a sample of Swedish individuals with DGBI (Disorders of Gut-Brain Interaction).
The first substudy of this project (Substudy 1) aims to answer the following question: How can the design of iACTforDGBI be tailored to meet the specific needs of individuals with DGBI and clinically meaningful symptoms of anxiety and depression?
Participants (individuals with symptoms compatible with a DGBI and anxiety and/or depression, and healthcare professionals working with DGBI patients) will be asked to participate in online focus-group interviews and provide information on their views of a preliminary version of the iACTforDGBi intervention.
- Keywords
- DGBI, ACT, Anxiety, Depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults with DGBI | Adults with DGBI, and clinically meaningful symptom levels of anxiety and/or depression | |
| Healthcare professionals | Healthcare professionals (physicians, psychologists, nurses, and dietitians). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Focus group interviews
Focus group interviews
Measured: 60-90 minutes per interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start23 Sep 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and DepressionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University, SahlgrenskaUniversityHospital, Göteborg University
- Responsible party
- Sponsor
- Investigators
- Inês A Trindade, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309004
- Sponsor's protocol ID
- 2023-00741a
- Other IDs
- 2023
- Acronym
- iACTforDGBI
- Status last verified
- Aug 2025
- First submitted
- 7 Mar 2024
- Last updated
- 15 Aug 2025
- 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 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. 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 (Sub-study 1)
- ClinicalTrials.gov ID
- NCT06309004
- Acronym / sponsor ID
- iACTforDGBI / 2023-00741a
- Keywords
- DGBI, ACT, Anxiety, Depression
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Uppsala University, SahlgrenskaUniversityHospital, Göteborg University
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 13 Mar 2024 (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 develop and test the iACTforDGBI intervention in a sample of Swedish individuals with DGBI (Disorders of Gut-Brain Interaction).
The first substudy of this project (Substudy 1) aims to answer the following question: How can the design of iACTforDGBI be tailored to meet the specific needs of individuals with DGBI and clinically meaningful symptoms of anxiety and depression?
Participants (individuals with symptoms compatible with a DGBI and anxiety and/or depression, and healthcare professionals working with DGBI patients) will be asked to participate in online focus-group interviews and provide information on their views of a preliminary version of the iACTforDGBi intervention.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults with DGBI | – | –Adults with DGBI, and clinically meaningful symptom levels of anxiety and/or depression |
| Healthcare professionals | – | –Healthcare professionals (physicians, psychologists, nurses, and dietitians). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with DGBI: People with clinically meaningful symptom severity of DGBI, and depression and/or anxiety. Healthcare professionals: Physicians, psychologists, nurses, and dietitians working from different regions in Sweden.
Key inclusion criteria (7 listed)
- Age between 18 and 75 years;
- Exhibiting clinical symptom severity for at 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; 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 (4 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.
Primary outcome
Focus group interviews
Time frame: 60-90 minutes per interview
Focus group interviews
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- 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 Anxiety and Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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?
An observational study of Anxiety and Depression and Disorders of Gut-brain Interaction, 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 7 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 15 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Focus group interviews (time frame: 60-90 minutes per interview). 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 15 Aug 2025.