Type 1 Diabetes and Diabetes Distress
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ACTnow.
- Who it may be relevant to
- Registry conditions: Diabetes Distress, Diabetes Mellitus Type 1. Basic parameters: 18 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Group-based Psychological Intervention for Emerging Adults With Type 1 Diabetes and Diabetes Distress
Overview
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.
Interventions
- Behavioral ACTnow
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 diabet
Primary outcome measures
- Change in diabetes distress score using T1-DDS [Time frame: from baseline to 3 months]
Secondary outcome measures (5)
- Change in the T1-DDAS score [Time frame: from baseline to 3 months]
- Change in AADQ score [Time frame: from baseline to 3 months]
- Change in GAD-7 score [Time frame: from baseline to 3 months]
- Change in HbA1c [Time frame: from baseline to 3 months]
- Change in PHQ-9 score [Time frame: from baseline to 3 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 3 centers
- Esbjerg Hospital — Esbjerg
- Odense University Hospital — Odense
- Sønderborg Hospital — Sønderborg
Identifiers
NCT: NCT06936280 · 25/13117 · 25/13117