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Talking it out: new group therapy aims to ease diabetes distress in young adults

NCT ID NCT06936280

Symptom relief Sponsor: Odense University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a group-based psychological program called ACTnow for emerging adults (ages 18-35) with type 1 diabetes who feel overwhelmed by their condition. The program includes six bi-weekly sessions led by a psychologist and nurse, focusing on mindfulness and acceptance strategies. Researchers will compare the group therapy to a waitlist to see if it reduces diabetes distress and improves blood sugar levels and overall well-being.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
group-based psychological intervention (ACTnow) based on Acceptance and Commitment Therapy
What this could lead to
If it works, this could provide an effective, scalable way to reduce diabetes distress and improve quality of life for young adults with type 1 diabetes.
What could go wrong
This is a relatively small trial (100 participants) and the control group will receive the intervention later, so long-term benefits are unclear. The intervention is behavioral, so results depend on participant engagement and may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 35 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes distress Diabetes mellitus, type 1

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Esbjerg Hospital

    RECRUITING

    Esbjerg, Denmark

  • Odense University Hospital

    RECRUITING

    Odense, Denmark

  • Sønderborg Hospital

    RECRUITING

    Sønderborg, Denmark

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