Recruiting

Behavioral Approaches

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06405373

Conditions

Diabetes type1

Diabetes Mellitus, Type 1

Diabetes, Autoimmune

Diabetes Mellitus

Distress, Emotional

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

ReCharge

TakeCharge

Study Details

Brief summary:

This study is designed to compare two behavioral approaches to reduce diabetes distress ("the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes") in adults with type 1 diabetes. At the study baseline, participants will be randomized to take part in one of two virtual, group-based interventions (the "Primary" intervention) utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress. After the initial intervention, participants will complete surveys to assess their response to the material. Participants who are determined to be "non-responders" (i.e., the Primary intervention was not effective) will be re-randomized to one of two "Supplementary" interventions, which will include individualized sessions to learn and/or practice strategies related to either the psychological or problem-solving approach.

Conditions

Diabetes type1

Diabetes Mellitus, Type 1

Diabetes, Autoimmune

Diabetes Mellitus

Distress, Emotional

Study ID

NCT06405373

Start date

Oct 1, 2024

Status verified date

Oct, 2025

Completion date

Sep 15, 2027

Anticipated

Primary completion date

Sep 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ReCharge

Participants randomized to ReCharge will participate in an emotions-focused intervention facilitated by a mental health professional.

experimental: TakeCharge

Participants randomized to TakeCharge will participate in a problem-solving focused intervention facilitated by a diabetes care professional.

Interventions

ReCharge

ReCharge is an emotions-focused intervention that utilizes core components of Acceptance and Commitment Therapy (ACT) to address and minimize diabetes distress. This 5-week, group-based, virtual intervention will include a stepwise process to address diabetes distress and provide opportunities to practice new skills. Weekly assignments between the sessions will reinforce class material and give additional practice opportunities. Participants will be expected to interact in each session and will have opportunities to share their experiences and be engaged in discussion with the group and the facilitator.

TakeCharge

TakeCharge is a problem-solving focused intervention that empowers participants to identify and make meaningful changes in their blood glucose management and other diabetes-related behaviors. This 5-week, group-based, virtual intervention will include a stepwise process to analyze data and resolve challenging situations surrounding diabetes management and provide opportunities to practice new skills. Weekly assignments between the sessions will reinforce class material and give additional practice opportunities. Participants will be expected to interact in each session and will have opportunities to share their experiences and be engaged in discussion with the group and the facilitator.

Primary outcome measure

  • Change in Total Diabetes Distress (T1-DDS Total Score) [ Time Frame: Baseline, Interim (6 weeks), Endpoint (12 weeks) ]

Central Contacts and Locations

Central contacts

Angela Fruik, MPH, RD

919-962-6348angela.fruik@unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Angela Fruik, MPH, RD

919-962-6348angela.fruik@unc.edu

Principal Investigator:

Anna Kahkoska, MD, PhD

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Keywords

  • Diabetes
  • Type 1 diabetes
  • Diabetes distress
  • T1D
  • Emotional distress
  • Telehealth
  • SMART design

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2025-10-29.