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NCT Number: NCT06936280

Type 1 Diabetes and Diabetes Distress

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.

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Key information

Conditions

Diabetes Distress Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus Type 1 Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Esbjerg Hospital, Esbjerg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Change in diabetes distress score using T1-DDS

    Time frame: 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 outcomes

  1. Change in the T1-DDAS score

    Time frame: 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.

  2. Change in AADQ score

    Time frame: 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.

  3. Change in GAD-7 score

    Time frame: 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.

  4. Change in HbA1c

    Time frame: from baseline to 3 months

    Improved blood glucose control measured by HbA1c. Either reduced or increased HbA1c, depending on the patient

  5. Change in PHQ-9 score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Steno Diabetes Center Odense

Registry information

Official study title

A Group-based Psychological Intervention for Emerging Adults With Type 1 Diabetes and Diabetes Distress

Acronym: ACTnow

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 20, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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