Type 1 Diabetes and Diabetes Distress
A Group-based Psychological Intervention for Emerging Adults With Type 1 Diabetes and Diabetes Distress
Odense University Hospital
100 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria5
- 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
Interventions
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).
Locations(3)
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NCT06936280