Type 1 Diabetes and Diabetes Distress

Not Applicable

Not yet recruiting

• Conditions: Diabetes Distress; Diabetes Mellitus Type 1

• Registration Number: NCT06936280
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-31
• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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
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 HbA1c	from baseline to 3 months	Improved blood glucose control measured by HbA1c. Either reduced or increased HbA1c, depending on the patient

Trial Locations

Locations (3)

Esbjerg Hospital; 🇩🇰 Esbjerg, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Sønderborg Hospital; 🇩🇰 Sønderborg, Denmark