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NCT06936280 | RECRUITING | Diabetes Distress

Type 1 Diabetes and Diabetes Distress
Sponsor:

Odense University Hospital

Brief 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.

Condition or disease

Diabetes Distress

Diabetes Mellitus Type 1

Intervention/treatment

ACTnow

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Group-based Psychological Intervention for Emerging Adults With Type 1 Diabetes and Diabetes Distress
Actual Study Start Date : 2025-04-01
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 35 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Type 1 Diabetes and Diabetes Distress

Location Details

NCT06936280

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Denmark,

Esbjerg Hospital

Esbjerg, Denmark,

RECRUITING

Denmark,

Odense University Hospital

Odense, Denmark,

RECRUITING

Denmark,

Sønderborg Hospital

Sønderborg, Denmark,