A Group-based Psychological Intervention for Emerging Adults With Type 1 Diabetes and Diabetes Distress

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Esbjerg Hospital
RECRUITING
Esbjerg
Odense University Hospital
RECRUITING
Odense
Sønderborg Hospital
RECRUITING
Sønderborg
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Intervention at t0
Experimental: wait list control group
Control group for the first 3 months, whereafter the arm will receive the same intervention as arm 1
Related Therapeutic Areas
Sponsors
Leads: Odense University Hospital
Collaborators: Steno Diabetes Center Odense

This content was sourced from clinicaltrials.gov