Type 1 Diabetes and Diabetes Distress (ACTnow)

Odense University Hospital

Status: Enrolling

Conditions: Diabetes Mellitus Type 1; Diabetes Distress

Treatments: Behavioral: ACTnow

Study type: Interventional

Funder types: Other

Identifiers

NCT06936280

25/13117 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention at t0

Experimental group

Treatment:

Behavioral: ACTnow

wait list control group

Experimental group

Description:

Control group for the first 3 months, whereafter the arm will receive the same intervention as arm 1

Treatment:

Behavioral: ACTnow