Diabetes DistressACTnowNCT06936280
Type 1 Diabetes and Diabetes Distress
A study testing ACTnow in people with Diabetes Distress and Diabetes Mellitus Type 1, run by Odense University Hospital at 3 sites in Denmark.
Trial summary
The goal of this clinical trial is to reduce diabetes distress in emerging adults (18-35 years) with type 1 diabetes and moderate-to-severe diabetes distress. The expectation is that a group-based psychological intervention (ACTnow) will not only reduce diabetes distress but also improve psychological well-being and… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Diabetes Distress, Diabetes Mellitus Type 1
- What is being tested?
- ACTnow
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Apr 2025to 31 May 2027
- Phase
- Interventional
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 diabetes for at least 6 months
- Age between 18 and 35
- T1-DDS score ≥ 2, or T1-DDS subscale score ≥ 2
- Treated in a diabetes clinic in the Region of Southern Denmark
- Proficient in Danish
Who cannot join
- Psychiatric diagnosis: diagnosed with substance abuse, alcohol abuse, psychosis, schizophrenia or any other psychiatric diagnosis that may compromise participation in the intervention
- Cognitive disorders such as brain injury
- Complex challenges best suited to individual treatment
- Current therapeutic treatment for depression, anxiety or stress
- Not stable medication for anxiety/depression for the past two months or planned change in medication for anxiety/depression during the project period
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Esbjerg Hospital
Esbjerg
Claus Bogh Juhl, +45 79183120, claus.bogh.juhl@rsyd.dk
- Recruiting
Odense University Hospital
Odense
Claus Bogh Juhl, +45 79183120, claus.bogh.juhk@rsyd.dk
- Recruiting
Sønderborg Hospital
Sønderborg
Frans Brandt Kristensen, +45 79973010, FBK@rsyd.dk
About this study
Official title: A Group-based Psychological Intervention for Emerging Adults With Type 1 Diabetes and Diabetes Distress
The goal of this clinical trial is to reduce diabetes distress in emerging adults (18-35 years) with type 1 diabetes and moderate-to-severe diabetes distress.
The expectation is that a group-based psychological intervention (ACTnow) will not only reduce diabetes distress but also improve psychological well-being and glycemic outcomes.
Read more
The intervention involves a multidisciplinary team, including nurses, psychologists, and physicians, and is designed in a format that can easily be integrated into future standard care.
The main research questions are:
- Does a group-based psychological intervention reduce diabetes distress?
- Does a group-based psychological intervention improve psychological well-being and glycemic outcomes?
Researchers will compare the group-based psychological intervention (arm 1) with a waitlist control group, which will receive the intervention after three months (arm 2).
Participants will first attend a virtual screening interview with a psychologist or nurse to identify if they are eligible to participate in the study. After randomization, the intervention group receives six bi-weekly sessions, each lasting two hours, led by a psychologist and nurse. Each session includes a mindfulness exercise, a review of the previous session, a new topic, individual homework assignments, and a conclusion.
- Conditions
- Diabetes Distress, Diabetes Mellitus Type 1
- Being tested
- ACTnow
- Keywords
- RCT study, type 1 diabetes, diabetes distress, ACTnow
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTnowBehavioural
The group-based psychological intervention consists of six bi-weekly sessions, each lasting two hours, with 6-10 participants per group, led by a psychologist and nurse.
The intervention is based on Acceptance and Commitment Therapy (ACT), an evidence-based approach shown to be effective for chronic diseases, with additional elements from cognitive behavioral therapy and health education. It is manual-based, developed by experienced clinicians at SDCO, and includes tools from an existing diabetes distress intervention (REDUCE).
Each session includes a mindfulness exercise, a review of the previous session, a new topic, individual homework assignments, and a conclusion. Participants complete an online questionnaire to track diabetes distress after each session. The group process lasts about 3 months. Preliminary results from a feasibility study showed positive outcomes in recruitment, patient satisfaction, and reduction of diabetes distress (publication in progress).
| Study group | Role | What they receive |
|---|---|---|
| Intervention at t0 | Experimental | Not described Receives: Behavioral: ACTnow |
| wait list control group | Experimental | Control group for the first 3 months, whereafter the arm will receive the same intervention as arm 1 Receives: Behavioral: ACTnow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diabetes distress score using T1-DDS
The primary outcome, is a reduction in the degree of diabetes distress measured using the Type 1 Diabetes Distress Scale (T1-DDS). The scale uses a 6 point likert-scale. The combined DDS score is divided by 28 to give a number between 1 and 6. A score between 2,00-2,99 is defined as moderate diabetes distress, and a score above 3,00 is defined as high diabetes distress.
Measured: from baseline to 3 months
Secondary outcomes (5)
Change in the T1-DDAS score
Using the Type 1-Diabetes Distress Assessment System to assess change in concerns related to diabetes technology. 5 point likert scale. A score above 2,00 is consideret moderat concerns.
Measured: from baseline to 3 months
Change in AADQ score
Using The Acceptance and Action Diabetes Questionnaire (AADQ) to assess change in acceptance of thoughts and feelings about diabetes. 7 point likert scale.
Measured: from baseline to 3 months
Change in GAD-7 score
Using the Generalized Anxiety Disorder Assessment (GAD-7) to assess change in symptoms of anxiety. Using a 4 point likert scale. A score between 15-21 is consideret great anxiety.
Measured: from baseline to 3 months
Change in HbA1c
Improved blood glucose control measured by HbA1c. Either reduced or increased HbA1c, depending on the patient
Measured: from baseline to 3 months
Change in PHQ-9 score
Reduced symptoms of depression using the Patient Health Questionnaire (PHQ-9). 4 point likert scale. a score of 20-27 is considered great depression
Measured: from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Apr 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes DistressStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Waiting list design. Randomization to either a control group or intervention group. The intervention group will receive the intervention at T0 whereas the control group will wait 3 months before receiving the intervention.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Odense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936280
- Sponsor's protocol ID
- 25/13117
- Other IDs
- 25/13117
- Acronym
- ACTnow
- Status last verified
- Jul 2025
- First submitted
- 31 Mar 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Group-based Psychological Intervention for Emerging Adults With Type 1 Diabetes and Diabetes Distress
- ClinicalTrials.gov ID
- NCT06936280
- Acronym / sponsor ID
- ACTnow / 25/13117
- Conditions
- Diabetes Distress, Diabetes Mellitus Type 1
- Keywords
- RCT study, type 1 diabetes, diabetes distress, ACTnow
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Odense
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 20 Apr 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 reduce diabetes distress in emerging adults (18-35 years) with type 1 diabetes and moderate-to-severe diabetes distress.
The expectation is that a group-based psychological intervention (ACTnow) will not only reduce diabetes distress but also improve psychological well-being and glycemic outcomes.
The intervention involves a multidisciplinary team, including nurses, psychologists, and physicians, and is designed in a format that can easily be integrated into future standard care.
The main research questions are:
- Does a group-based psychological intervention reduce diabetes distress?
- Does a group-based psychological intervention improve psychological well-being and glycemic outcomes?
Researchers will compare the group-based psychological intervention (arm 1) with a waitlist control group, which will receive the intervention after three months (arm 2).
Participants will first attend a virtual screening interview with a psychologist or nurse to identify if they are eligible to participate in the study. After randomization, the intervention group receives six bi-weekly sessions, each lasting two hours, led by a psychologist and nurse. Each session includes a mindfulness exercise, a review of the previous session, a new topic, individual homework assignments, and a conclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Waiting list design. Randomization to either a control group or intervention group. The intervention group will receive the intervention at T0 whereas the control group will wait 3 months before receiving the intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention at t0 | Experimental | Behavioral: ACTnow |
| wait list control group | Experimental | Behavioral: ACTnowControl group for the first 3 months, whereafter the arm will receive the same intervention as arm 1 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Type 1 diabetes for at least 6 months
- Age between 18 and 35
- T1-DDS score ≥ 2, or T1-DDS subscale score ≥ 2
- Treated in a diabetes clinic in the Region of Southern Denmark
- Proficient in Danish
Key exclusion criteria (5 listed)
- Psychiatric diagnosis: diagnosed with substance abuse, alcohol abuse, psychosis, schizophrenia or any other psychiatric diagnosis that may compromise participation in the intervention
- Cognitive disorders such as brain injury
- Complex challenges best suited to individual treatment
- Current therapeutic treatment for depression, anxiety or stress
- Not stable medication for anxiety/depression for the past two months or planned change in medication for anxiety/depression during the project period
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 |
|---|---|---|
| ACTnowThe group-based psychological intervention consists of six bi-weekly sessions, each lasting two hours, with 6-10 participants per group, led by a psychologist and nurse. The intervention is based on Acceptance and Commitment Therapy (ACT), an evidence-based approach shown to be effective for chronic diseases, with additional elements from cognitive behavioral therapy and health education. It is manual-based, developed by experienced clinicians at SDCO, and includes tools from an existing diabetes distress intervention (REDUCE). Each session includes a mindfulness exercise, a review of the previous session, a new topic, individual homework assignments, and a conclusion. Participants complete an online questionnaire to track diabetes distress after each session. The group process lasts about 3 months. Preliminary results from a feasibility study showed positive outcomes in recruitment, patient satisfaction, and reduction of diabetes distress (publication in progress). | Behavioural | Intervention at t0, wait list control group |
Primary outcome
Change in diabetes distress score using T1-DDS
Time frame: from baseline to 3 months
The primary outcome, is a reduction in the degree of diabetes distress measured using the Type 1 Diabetes Distress Scale (T1-DDS). The scale uses a 6 point likert-scale. The combined DDS score is divided by 28 to give a number between 1 and 6. A score between 2,00-2,99 is defined as moderate diabetes distress, and a score above 3,00 is defined as high diabetes distress.
5 secondary outcomes
Change in the T1-DDAS score
Time frame: from baseline to 3 months
Change in AADQ score
Time frame: from baseline to 3 months
Change in GAD-7 score
Time frame: from baseline to 3 months
Change in HbA1c
Time frame: from baseline to 3 months
Change in PHQ-9 score
Time frame: from baseline to 3 months
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 9 Apr 2026.
- Individual participant dataSharing planned: No
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Remotely Delivered Mindfulness-Based Diabetes Education
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Digital Health Literacy and Diabetes Management in Type 2 Diabetes
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTnow in people with Diabetes Distress and Diabetes Mellitus Type 1, run by Odense University Hospital at 3 sites in Denmark.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diabetes distress score using T1-DDS (time frame: from baseline to 3 months). 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 9 Apr 2026.