ACTnow group program for diabetes distress in young adults with type 1 diabetes
Official title: A Group-based Psychological Intervention for Emerging Adults With Type 1 Diabetes and Diabetes Distress
Run by Odense University Hospital · NCT06936280 · Data updated 2026-11-12
This will test whether a group ACT program called ACTnow can lower diabetes distress and improve mental well-being and blood sugar control in 18–35-year-olds with type 1 diabetes and moderate-to-severe diabetes distress.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 35 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 3 sites (Esbjerg and 2 other locations) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | May 31, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | April 9, 2026 |
| Trial ID | NCT06936280 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–35 with type 1 diabetes for at least six months, treated at a diabetes clinic in the Region of Southern Denmark, proficient in Danish, and with a T1-DDS score or subscale score ≥ 2.
✕Probably not a fit
People with active severe psychiatric diagnoses (e.g., psychosis, substance dependence), cognitive impairment, complex problems needing individual therapy, current psychotherapeutic treatment for depression/anxiety, or unstable psychiatric medication are unlikely to benefit from this group intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will randomize eligible participants to either an immediate group-based Acceptance and Commitment Therapy program (ACTnow) or a waitlist control that receives the program after three months. The intervention is delivered by a multidisciplinary team (nurses, psychologists, physicians) and designed to fit into routine diabetes care. Primary outcomes include changes in diabetes distress, with secondary outcomes of psychological well-being and glycemic measures. Initial screening is conducted virtually and participants must be treated at a diabetes clinic in the Region of Southern Denmark.
Why it matters
Potential benefit: If successful, the program could reduce diabetes-related emotional distress and improve psychological well-being and blood glucose control for young adults with type 1 diabetes.
How similar studies have gone: Previous ACT-based and other group psychological interventions for diabetes distress have shown promising but mixed improvements in emotional outcomes, so this approach is plausible but not yet definitive.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Esbjerg Hospital
Esbjerg, Denmark Recruiting -
Odense University Hospital
Odense, Denmark Recruiting -
Sønderborg Hospital
Sønderborg, Denmark Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Predictive CGM with App for people with type 1 or insulin-treated type 2 diabetes
This study tests whether using the Accu-Chek SmartGuide CGM with its Predict App can reduce fear of hypoglycemia and improve related behaviors and confidence in adults with type 1 or insulin-treated type 2 diabetes.
-
Tirzepatide for type 1 diabetes patients who are overweight or obese
This study tests whether tirzepatide can affect stomach emptying in adults with type 1 diabetes and overweight or obesity.
-
GlycoQuest: an AI-powered CGM game for kids with type 1 diabetes and their families
A CGM-linked, AI-adaptive serious game is tested with children 6-17 who have type 1 diabetes and their primary caregivers to see if it helps with glucose control and coping in the first year after diagnosis.
-
Oral insulin vs. subcutaneous insulin in adults with type 1 diabetes
This study tests an oral insulin tablet (SCD0503) against subcutaneous insulin and placebo to see how it behaves in the blood and helps control blood sugar in adults with type 1 diabetes.
-
Genetic risk score and progression to insulin in type 1 diabetes
This study tests whether a genetic risk score can predict which people with type 1 diabetes will need insulin progression over three years.
-
Home-based use of an advanced hybrid closed-loop insulin pump with telemonitoring for adults with type 1 diabetes
This study tests whether starting an advanced hybrid closed-loop insulin pump at home, with online education and telemonitoring, is feasible and safe for adults with type 1 diabetes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.