NCT06936280Recruiting
Type 1 Diabetes and Diabetes Distress
A Group-based Psychological Intervention for Emerging Adults With Type 1 Diabetes and Diabetes Distress
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 31 Mar 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 31 May 2027
- Lead sponsor
- Odense University Hospital
- Diseases
- Type 1 diabetes
- NCT number
- NCT06936280
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Apr 2025 to the primary completion date, 31 May 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Not stable medication for anxiety/depression for the past two months or planned change in medication for anxiety/depression during the project period
Other illness
- 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
Other
- Complex challenges best suited to individual treatment
- Current therapeutic treatment for depression, anxiety or stress
Who the study is looking for
- 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
Age in the registry: 18 years to 35 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Esbjerg Hospital Coordinator of this site? Confirm its status | Esbjerg | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
| Sønderborg Hospital Coordinator of this site? Confirm its status | Sønderborg | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.