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Type 1 Diabetes and Diabetes Distress

Type 1 Diabetes and Diabetes Distress

Recruiting
18-35 years
All
Phase N/A

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Overview

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

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

Study details
    Diabetes Distress
    Diabetes Mellitus Type 1

NCT06936280

Odense University Hospital

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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