Diabetes Distress, Diabetes Mellitus Type 1
Conditions
Keywords
RCT study, type 1 diabetes, diabetes distress, ACTnow
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.
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).
Sponsors
Odense University Hospital
Steno Diabetes Center Odense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Waiting list design. Randomization to either a control group or intervention group. The intervention group will receive the intervention at T0 whereas the control group will wait 3 months before receiving the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in diabetes distress score using T1-DDS | from baseline to 3 months | The primary outcome, is a reduction in the degree of diabetes distress measured using the Type 1 Diabetes Distress Scale (T1-DDS). The scale uses a 6 point likert-scale. The combined DDS score is divided by 28 to give a number between 1 and 6. A score between 2,00-2,99 is defined as moderate diabetes distress, and a score above 3,00 is defined as high diabetes distress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the T1-DDAS score | from baseline to 3 months | Using the Type 1-Diabetes Distress Assessment System to assess change in concerns related to diabetes technology. 5 point likert scale. A score above 2,00 is consideret moderat concerns. |
| Change in AADQ score | from baseline to 3 months | Using The Acceptance and Action Diabetes Questionnaire (AADQ) to assess change in acceptance of thoughts and feelings about diabetes. 7 point likert scale. |
| Change in GAD-7 score | from baseline to 3 months | Using the Generalized Anxiety Disorder Assessment (GAD-7) to assess change in symptoms of anxiety. Using a 4 point likert scale. A score between 15-21 is consideret great anxiety. |
| Change in HbA1c | from baseline to 3 months | Improved blood glucose control measured by HbA1c. Either reduced or increased HbA1c, depending on the patient |
| Change in PHQ-9 score | from baseline to 3 months | Reduced symptoms of depression using the Patient Health Questionnaire (PHQ-9). 4 point likert scale. a score of 20-27 is considered great depression |
Countries
Denmark
Outcome results
None listed