Clinical trial NCT06936280: Type 1 Diabetes and Diabetes Distress
Official title: A Group-based Psychological Intervention for Emerging Adults With Type 1 Diabetes and Diabetes Distress
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Distress
Diabetes Mellitus Type 1
Keywords: RCT study
type 1 diabetes
diabetes distress
ACTnow
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Center Odense
First posted: 2025-04-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in diabetes distress score using T1-DDS
timeFrame: from baseline to 3 months
Secondary outcomes:
measure: Change in the T1-DDAS score
timeFrame: from baseline to 3 months
measure: Change in AADQ score
timeFrame: from baseline to 3 months
measure: Change in GAD-7 score
timeFrame: from baseline to 3 months
measure: Change in HbA1c
timeFrame: from baseline to 3 months
measure: Change in PHQ-9 score
timeFrame: from baseline to 3 months
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Esbjerg Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Sønderborg
country: Denmark
facility: Sønderborg Hospital
Study officials:
References: