RecruitingNot ApplicableNCT06936280

Type 1 Diabetes and Diabetes Distress

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


Sponsor

Odense University Hospital

Enrollment

100 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 35 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

Interventions

BEHAVIORALACTnow

The group-based psychological intervention consists of six bi-weekly sessions, each lasting two hours, with 6-10 participants per group, led by a psychologist and nurse. The intervention is based on Acceptance and Commitment Therapy (ACT), an evidence-based approach shown to be effective for chronic diseases, with additional elements from cognitive behavioral therapy and health education. It is manual-based, developed by experienced clinicians at SDCO, and includes tools from an existing diabetes distress intervention (REDUCE). Each session includes a mindfulness exercise, a review of the previous session, a new topic, individual homework assignments, and a conclusion. Participants complete an online questionnaire to track diabetes distress after each session. The group process lasts about 3 months. Preliminary results from a feasibility study showed positive outcomes in recruitment, patient satisfaction, and reduction of diabetes distress (publication in progress).


Locations(3)

Esbjerg Hospital

Esbjerg, Denmark

Odense University Hospital

Odense, Denmark

Sønderborg Hospital

Sønderborg, Denmark

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NCT06936280


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