Actively Recruiting
Type 1 Diabetes and Diabetes Distress
Led by Odense University Hospital · Updated on 2026-04-09
100
Participants Needed
3
Research Sites
112 weeks
Total Duration
On this page
Sponsors
O
Odense University Hospital
Lead Sponsor
S
Steno Diabetes Center Odense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Type 1 Diabetes and Diabetes Distress
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Type 1 diabetes for at least 6 months
- Age between 18 and 35 years
- T1-DDS score of 2 or higher, or T1-DDS subscale score of 2 or higher
- Receiving treatment at a diabetes clinic in the Region of Southern Denmark
- Proficient in Danish language
You will not qualify if you...
- Diagnosed with substance abuse, alcohol abuse, psychosis, schizophrenia, or other psychiatric conditions that may affect participation
- Cognitive disorders such as brain injury
- Facing complex challenges better suited to individual treatment
- Currently receiving therapeutic treatment for depression, anxiety, or stress
- Not on stable medication for anxiety or depression for at least two months or planning medication changes during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Esbjerg Hospital
Esbjerg, Denmark
Actively Recruiting
2
Odense University Hospital
Odense, Denmark
Actively Recruiting
3
Sønderborg Hospital
Sønderborg, Denmark
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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