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

NCT06405386 | Completed

• 2 other identifiers: 23-2228a12-22-ACE-18
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Total Diabetes Distress (T1-DDS Total Score)

  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).

  Baseline, Endpoint (6 weeks)

Secondary Outcomes (12)

• Change in Core Diabetes Distress (T1-DDAS Core Score)

  Baseline, Endpoint (6 weeks)

• Change in Sources of Diabetes Distress (T1-DDS Subscale Scores)

  Baseline, Endpoint (6 weeks)

• Change in Perceived Stress

  Baseline, Endpoint (6 weeks)

• Change in Diabetes Quality of Life

  Baseline, Endpoint (6 weeks)

• Change in Perceived Confidence in Diabetes

  Baseline, Endpoint (6 weeks)

Other Outcomes (10)

• Intervention Satisfaction

  Endpoint (6 weeks)

• Perceived Effectiveness of the Intervention

  Endpoint (6 weeks)

• Long-term Change in Total Diabetes Distress (T1-DDS Total Score)

  12 weeks

Study Arms (2)

ReCharge

EXPERIMENTAL

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

Behavioral: ReCharge

TakeCharge

EXPERIMENTAL

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

Behavioral: TakeCharge

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.

ReCharge

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.

TakeCharge

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• American Diabetes Association: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Anna Kahkoska, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 8, 2024
• Study Start: July 22, 2024
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 6 and continuing for 18 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)