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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06405373
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ReCharge — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
May 8, 2024
Start date
Oct 1, 2024
Status verified
Oct 2025
Primary completion
Sep 15, 2027
Completion
Sep 15, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Angela Fruik, MPH, RD
[email protected]
919-962-6348
Anna Kahkoska, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

Nationwide
Type 1 diabetes trialsEndocrinology trials
By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of North Carolina at Chapel Hill· Chapel Hill, NC

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