ACTnow group program for diabetes distress in young adults with type 1 diabetes
A Group-based Psychological Intervention for Emerging Adults With Type 1 Diabetes and Diabetes Distress
NA · Odense University Hospital · NCT06936280
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Odense University Hospital (other) |
| Locations | 3 sites (Esbjerg and 2 other locations) |
| Trial ID | NCT06936280 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Esbjerg and 2 other locations
- Esbjerg Hospital — Esbjerg, Denmark (RECRUITING)
- Odense University Hospital — Odense, Denmark (RECRUITING)
- Sønderborg Hospital — Sønderborg, Denmark (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Distress, Diabetes Mellitus Type 1, RCT study, type 1 diabetes, diabetes distress, ACTnow