Clinical trial NCT06405386: Pilot of Pragmatic Delivery of Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes
Official title: Fusing Rapid-cycle Testing and Adaptive Trial Designs: A Scientific Pipeline to Translate and Individualize Evidence-based Psychosocial and Behavioral Interventions in Routine Type 1 Diabetes Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2024-05-08
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Total Diabetes Distress (T1-DDS Total Score)
timeFrame: Baseline, Endpoint (6 weeks)
Secondary outcomes:
measure: Change in Core Diabetes Distress (T1-DDAS Core Score)
timeFrame: Baseline, Endpoint (6 weeks)
measure: Change in Sources of Diabetes Distress (T1-DDS Subscale Scores)
timeFrame: Baseline, Endpoint (6 weeks)
measure: Change in Perceived Stress
timeFrame: Baseline, Endpoint (6 weeks)
measure: Change in Diabetes Quality of Life
timeFrame: Baseline, Endpoint (6 weeks)
measure: Change in Perceived Confidence in Diabetes
timeFrame: Baseline, Endpoint (6 weeks)
measure: Change in Diabetes Specific Self-Compassion
timeFrame: Baseline, Endpoint (6 weeks)
measure: Change in Hypoglycemic Attitudes and Behaviors
timeFrame: Baseline, Endpoint (6 weeks)
measure: Change in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Endpoint (6 weeks)
measure: Change in Percent of Time in Range (TIR)
timeFrame: Baseline, Endpoint (6 weeks)
measure: Change in Percent of Time Below Range (TBR)
timeFrame: Baseline, Endpoint (6 weeks)
measure: Change in Percent of Time Above Range (TAR)
timeFrame: Baseline, Endpoint (6 weeks)
measure: Glycemic Variability
timeFrame: Baseline, Endpoint (6 weeks)
Other outcomes:
measure: Intervention Satisfaction
timeFrame: Endpoint (6 weeks)
measure: Perceived Effectiveness of the Intervention
timeFrame: Endpoint (6 weeks)
measure: Long-term Change in Total Diabetes Distress (T1-DDS Total Score)
timeFrame: 12 weeks
measure: Long-term Change in Core Diabetes Distress (T1-DDAS Core Score)
timeFrame: 12 weeks
measure: Long-term Change in Sources of Diabetes Distress (T1-DDS Subscale Scores)
timeFrame: 12 weeks
measure: Long-term Change in Hemoglobin A1c (HbA1c)
timeFrame: 12 weeks
measure: Long-term Change in Percent of Time in Range (TIR)
timeFrame: 12 weeks
measure: Long-term Change in Percent of Time Below Range (TBR)
timeFrame: 12 weeks
measure: Long-term Change in Percent of Time Above Range (TAR)
timeFrame: 12 weeks
measure: Long-term Change in Glycemic Variability
timeFrame: 12 weeks
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Anna Kahkoska, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: