Clinical trial NCT06405373: Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART
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: RECRUITING
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: 200
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The study will compare the effectiveness of an emotions-focused approach with a problem-solving based approach to reduce diabetes distress (DD). The investigators will enroll N=200 adults 30 years and older with type 1 diabetes (T1D) and elevated DD from a single clinical site to participate in a 12-week study. All interventions and assessments will be delivered in a pragmatic and entirely virtual format. The investigators will utilize a precision medicine trial design (Sequential Multiple Assignment Randomized Trial; SMART) to compare two evidence-based, virtual group interventions to reduce DD in adults with T1D (primary aim). The secondary aims of the study are to estimate next best steps for participants who do not respond to group-based interventions, and to estimate optimal treatments or sequences of treatments for different individuals based on their individual characteristics, including response to prior treatment.

The study includes an initial 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. Participants will complete a series of assessments to determine their response to the Primary Intervention. Participants who did not respond to the Primary Intervention will be re-randomized to participate in one of two Supplementary Interventions over a 5-week period, where they will have three virtual, individualized sessions for exposure and practice with either the ReCharge or TakeCharge curriculum.

The investigators will evaluate the Reach, Effectiveness, Adoption, Implementation, and Maintenance of all phases of the study. By collecting both quantitative data and key qualitative feedback from providers and participants, the investigators will be able to assess and improve the pragmatic design of these evidence-based interventions for routine integration into healthcare settings. Completion of primary and secondary aims will inform a future program which saves resources and expands the availability of guidelines-oriented care to all patients with T1D.

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, Interim (6 weeks), Endpoint (12 weeks)
Secondary outcomes:
measure: Change in Core Diabetes Distress (T1-DDAS Core Score)
timeFrame: Baseline, Interim (6 weeks), Endpoint (12 weeks)
measure: Change in Sources of Diabetes Distress (T1-DDS Subscale Scores)
timeFrame: Baseline, Interim (6 weeks), Endpoint (12 weeks)
measure: Change in Perceived Stress
timeFrame: Baseline, Interim (6 weeks), Endpoint (12 weeks)
measure: Change in Diabetes Quality of Life
timeFrame: Baseline, Interim (6 weeks), Endpoint (12 weeks)
measure: Change in Perceived Confidence in Diabetes
timeFrame: Baseline, Interim (6 weeks), Endpoint (12 weeks)
measure: Change in Diabetes Specific Self-Compassion
timeFrame: Baseline, Interim (6 weeks), Endpoint (12 weeks)
measure: Change in Hypoglycemic Attitudes and Behaviors
timeFrame: Baseline, Interim (6 weeks), Endpoint (12 weeks)
measure: Change in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Endpoint (12 weeks)
measure: Change in Percent of Time in Range (TIR)
timeFrame: Baseline, Endpoint (12 weeks)
measure: Change in Percent of Time Below Range (TBR)
timeFrame: Baseline, Endpoint (12 weeks)
measure: Change in Percent of Time Above Range (TAR)
timeFrame: Baseline, Endpoint (12 weeks)
measure: Glycemic Variability
timeFrame: Baseline, Endpoint (12 weeks)
Other outcomes:
measure: Intervention Satisfaction
timeFrame: Interim (6 weeks) and Endpoint (12 weeks)
measure: Perceived Effectiveness of the Intervention
timeFrame: Interim (6 weeks) and Endpoint (12 weeks)
measure: Long-term Change in Total Diabetes Distress (T1-DDS Total Score)
timeFrame: 24 and 36 weeks
measure: Long-term Change in Core Diabetes Distress (T1-DDAS Core Score)
timeFrame: 24 and 36 weeks
measure: Long-term Change in Sources of Diabetes Distress (T1-DDS Subscale Scores)
timeFrame: 24 and 36 weeks
measure: Long-term Change in Hemoglobin A1c (HbA1c)
timeFrame: 24 and 36 weeks
measure: Long-term Change in Percent of Time in Range (TIR)
timeFrame: 24 and 36 weeks
measure: Long-term Change in Percent of Time Below Range (TBR)
timeFrame: 24 and 36 weeks
measure: Long-term Change in Percent of Time Above Range (TAR)
timeFrame: 24 and 36 weeks
measure: Long-term Glycemic Variability
timeFrame: 24 and 36 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: