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| ID | Type | Description | Link |
|---|---|---|---|
| 25/13117 | Other Identifier | Steno Diabetes Center Odense |
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| Name | Class |
|---|---|
| Steno Diabetes Center Odense | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention at t0 | Experimental |
| |
| wait list control group | Experimental | Control group for the first 3 months, whereafter the arm will receive the same intervention as arm 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACTnow | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in diabetes distress score using T1-DDS | 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. | from baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the T1-DDAS score | 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. | from baseline to 3 months |
| Change in AADQ score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Esbjerg Hospital | Recruiting | Esbjerg | Denmark |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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Using The Acceptance and Action Diabetes Questionnaire (AADQ) to assess change in acceptance of thoughts and feelings about diabetes. 7 point likert scale. |
| from baseline to 3 months |
| Change in GAD-7 score | 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. | from baseline to 3 months |
| Change in HbA1c | Improved blood glucose control measured by HbA1c. Either reduced or increased HbA1c, depending on the patient | from baseline to 3 months |
| Change in PHQ-9 score | Reduced symptoms of depression using the Patient Health Questionnaire (PHQ-9). 4 point likert scale. a score of 20-27 is considered great depression | from baseline to 3 months |
| Odense University Hospital | Recruiting | Odense | Denmark |
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| Sønderborg Hospital | Recruiting | Sønderborg | Denmark |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |