Behavioral approaches to reduce diabetes distress in adults with type 1 diabetes
Fusing Rapid-cycle Testing and Adaptive Trial Designs: A Scientific Pipeline to Translate and Individualize Evidence-based Psychosocial and Behavioral Interventions in Routine Type 1 Diabetes Care
This study tests two different group programs to see if they can help adults with type 1 diabetes feel less stressed about managing their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06405373 on ClinicalTrials.gov |
What this trial studies
This study compares two behavioral interventions aimed at reducing diabetes distress in adults with type 1 diabetes. Participants will be randomly assigned to either an emotions-focused or a problem-solving approach delivered in a virtual group format. After the initial intervention, those who do not respond will receive individualized sessions based on their needs. The study aims to evaluate the effectiveness of these approaches over a 12-week period and to identify optimal treatment strategies for individuals based on their responses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 years and older with type 1 diabetes or latent autoimmune diabetes in adults experiencing elevated diabetes distress.
Not a fit: Patients who are unable to participate in virtual sessions or have major medical or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the emotional well-being and management of diabetes for patients with type 1 diabetes.
How similar studies have performed: Other studies have shown promise in using behavioral interventions to address diabetes distress, indicating that this approach is both relevant and potentially effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults 30 years and older * Type 1 diabetes OR latent autoimmune diabetes in adults (LADA) clinically managed as type 1 diabetes * Elevated diabetes distress, defined as a score \>= 2.0 on the T1-DDAS core scale * English speaking Exclusion Criteria: * Does not receive diabetes care at UNC Endocrinology at Eastowne * Cannot commit to the pre-scheduled weekly, virtual sessions * Diagnosis of any major medical or psychiatric condition that would preclude participation * Diagnosis of dementia or other conditions that affect memory or information retention, such as cognitive impairment * Visual or auditory impairment that would interfere with participation in a group intervention * Receiving inpatient psychiatric treatment or history of a suicide attempt within the past 12 months at the time of enrollment
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Anna Kahkoska, MD, PhD — University of North Carolina, Chapel Hill
- Study coordinator: Angela Fruik, MPH, RD
- Email: angela.fruik@unc.edu
- Phone: 919-962-6348
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.