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NCT06405373

Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART

Recruiting
NAAges 30+InterventionalTreatment
University of North Carolina, Chapel Hill
~200 participants
Updated 2025-10-29 on ClinicalTrials.gov
What's tested:ReChargeTakeCharge

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Total Diabetes Distress (T1-DDS Total Score)
Measured over Baseline, Interim (6 weeks), Endpoint (12 weeks)

Conditions

Diabetes type1
Diabetes Mellitus, Type 1
Diabetes, Autoimmune
Diabetes Mellitus
Distress, Emotional

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Anna Kahkoska, MD, PhD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill

Who to contact

Angela Fruik, MPH, RD
[email protected]
919-962-6348
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Total Diabetes Distress (T1-DDS Total Score)Baseline, Interim (6 weeks), Endpoint (12 weeks)

    Self-reported total diabetes distress will be measured using the 28-item Type 1 Diabetes Distress Scale (T1-DDS Total Score). The scale yields an overall distress score that is the average of all responses rated on a 6-point Likert scale for all 28 items (range 1-6). A score \>= 2.0 is considered clinically significant diabetes distress. The primary efficacy outcomes of this study is the change in the T1D-DDS score and the proportion of individuals with a change in the T1D-DDS score at least as large as one minimally clinically important difference (MCID).