Type 1 Diabetes and Diabetes Distress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorOdense University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ACTnow
BehavioralThe 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).
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Intervention at t0Experimental treatment 1 intervention
Group B: wait list control groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
from baseline to 3 monthsSecondary outcomes
1
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.
Time frame
from baseline to 3 months2
Change in AADQ score
Using The Acceptance and Action Diabetes Questionnaire (AADQ) to assess change in acceptance of thoughts and feelings about diabetes. 7 point likert scale.
Time frame
from baseline to 3 months3
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.
Time frame
from baseline to 3 months4
Change in HbA1c
Improved blood glucose control measured by HbA1c. Either reduced or increased HbA1c, depending on the patient
Time frame
from baseline to 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Odense University Hospital
Lead sponsor
Steno Diabetes Center Odense
Collaborator
Source ClinicalTrials.gov