Type 1 Diabetes and Diabetes Distress

Recruiting now · Not applicable

Conditions studied: Diabetes Distress, Diabetes Mellitus Type 1

In brief

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.

Key facts

Study ID

NCT06936280

Run by

Odense University Hospital

People needed

100

Starts

2025-04-01

Expected to finish

2027-05-31

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Esbjerg Hospital — Esbjerg, Denmark (enrolling)
• Odense University Hospital — Odense, Denmark (enrolling)
• Sønderborg Hospital — Sønderborg, Denmark (enrolling)

Full record on ClinicalTrials.gov

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