Pilot of Pragmatic Delivery of Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes (ChargeUp)

University of North Carolina (UNC)

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus; Diabetes type1; Diabetes, Autoimmune; Distress, Emotional

Treatments: Behavioral: TakeCharge; Behavioral: ReCharge

Study type: Interventional

Funder types: Other

Identifiers

NCT06405386

23-2228a

12-22-ACE-18 (Other Grant/Funding Number)

Details and patient eligibility

About

This study is designed to test the feasibility and acceptability of 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. This is a pilot study, which will enroll a small group of participants to enroll and give feedback on their experience.

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.

Full description

The study will test the feasibility and acceptability of two behavioral-based interventions to reduce diabetes distress (DD). The investigators will enroll one cohort (N=15) adults 30 years and older with type 1 diabetes (T1D) and elevated DD from a single clinical site to participate in a 5-week intervention. All interventions and assessments will be delivered in a pragmatic and entirely virtual format.

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.

Enrollment: 12 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

ReCharge

Experimental group

Description:

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

Treatment:

Behavioral: ReCharge

TakeCharge

Experimental group

Description:

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

Treatment:

Behavioral: TakeCharge