Actively Recruiting

Phase Not Applicable
Age: 18Years - 35Years
All Genders
NCT06936280

Type 1 Diabetes and Diabetes Distress

Led by Odense University Hospital · Updated on 2026-04-09

100

Participants Needed

3

Research Sites

112 weeks

Total Duration

On this page

Sponsors

O

Odense University Hospital

Lead Sponsor

S

Steno Diabetes Center Odense

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Type 1 Diabetes and Diabetes Distress

Who Can Participate

Age: 18Years - 35Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Type 1 diabetes for at least 6 months
  • Age between 18 and 35 years
  • T1-DDS score of 2 or higher, or T1-DDS subscale score of 2 or higher
  • Receiving treatment at a diabetes clinic in the Region of Southern Denmark
  • Proficient in Danish language
Not Eligible

You will not qualify if you...

  • Diagnosed with substance abuse, alcohol abuse, psychosis, schizophrenia, or other psychiatric conditions that may affect participation
  • Cognitive disorders such as brain injury
  • Facing complex challenges better suited to individual treatment
  • Currently receiving therapeutic treatment for depression, anxiety, or stress
  • Not on stable medication for anxiety or depression for at least two months or planning medication changes during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Esbjerg Hospital

Esbjerg, Denmark

Actively Recruiting

2

Odense University Hospital

Odense, Denmark

Actively Recruiting

3

Sønderborg Hospital

Sønderborg, Denmark

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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