Type 1 Diabetes and Diabetes Distress

NCT06936280 | Recruiting

• 1 other identifier: 25/13117
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Distress; Diabetes Mellitus Type 1

Keywords

RCT study; type 1 diabetes; diabetes distress; ACTnow

Outcome Measures

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.

  from baseline to 3 months

Secondary Outcomes (5)

• Change in the T1-DDAS score

  from baseline to 3 months

• Change in AADQ score

  from baseline to 3 months

• Change in GAD-7 score

  from baseline to 3 months

• Change in HbA1c

  from baseline to 3 months

• Change in PHQ-9 score

  from baseline to 3 months

Study Arms (2)

Intervention at t0

EXPERIMENTAL

Behavioral: ACTnow

wait list control group

EXPERIMENTAL

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

Behavioral: ACTnow

Interventions

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).

Intervention at t0; wait list control group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead
• Steno Diabetes Center Odense: collaborator

Study Sites (3)

Esbjerg Hospital

Esbjerg, Denmark

RECRUITING

Odense University Hospital

Odense, Denmark

RECRUITING

Sønderborg Hospital

Sønderborg, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 20, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 9, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)