Pilot of Pragmatic Delivery of Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes
NCT ID: NCT06405386
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2024-07-22
2024-10-15
Brief Summary
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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 intervention, participants will attend focus groups and fill out anonymous qualitative surveys to give feedback on their experience. Results of the pilot will inform and improve an upcoming research study of the same design.
Detailed Description
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The investigators will compare two evidence-based, virtual group interventions to reduce DD in adults with T1D. The study includes a randomization to one of two 5-week Primary Interventions: "ReCharge", an Acceptance and Commitment Therapy (ACT)-focused approach that will help to reduce the emotional burden of diabetes management; or "TakeCharge", a problem-solving focused approach that will equip participants with new skills to manage type 1 diabetes.
After the 5-week intervention period, participants will provide final outcome data and feedback on their experience using surveys and focus groups. Quantitative and quantitative results will be used to improve the intervention prior to rollout of a longer-term trial of the same design. Long-term data will be collected at 12-weeks post enrollment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ReCharge
Participants randomized to ReCharge will participate in an emotions-focused intervention facilitated by a mental health professional.
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
Participants randomized to TakeCharge will participate in a problem-solving focused intervention facilitated by a diabetes care professional.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
ALL
No
Sponsors
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American Diabetes Association
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Anna Kahkoska, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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12-22-ACE-18
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
23-2228a
Identifier Type: -
Identifier Source: org_study_id