|

Type 1 Diabetes and Diabetes Distress

RECRUITINGN/ASponsored by Odense University Hospital
Actively Recruiting
PhaseN/A
SponsorOdense University Hospital
Started2025-04-01
Est. completion2026-12-31
Eligibility
Age18 Years – 35 Years
Healthy vol.Accepted

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

Age: 18 Years – 35 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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

Conditions3

DiabetesDiabetes DistressDiabetes Mellitus, Type 1

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.