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A Group-based Psychological Intervention for Emerging Adults With Type 1 Diabetes and Diabetes Distress
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.
Age
18 - 35 years
Sex
ALL
Healthy Volunteers
No
Esbjerg Hospital
Esbjerg, Denmark
Odense University Hospital
Odense, Denmark
Sønderborg Hospital
Sønderborg, Denmark
Start Date
April 1, 2025
Primary Completion Date
December 31, 2026
Completion Date
December 31, 2026
Last Updated
August 1, 2025
100
ESTIMATED participants
ACTnow
BEHAVIORAL
Lead Sponsor
Odense University Hospital
Collaborators
NCT06887049
NCT06436456
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07325838