Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ReCharge, TakeCharge.
- Who it may be relevant to
- Registry conditions: Diabetes type1, Diabetes Mellitus, Type 1, Diabetes, Autoimmune, Diabetes Mellitus. Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Behavioral 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 - Behavioral 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 practi
Primary outcome measures
- Change in Total Diabetes Distress (T1-DDS Total Score) [Time frame: Baseline, Interim (6 weeks), Endpoint (12 weeks)]
Secondary outcome measures (12)
- Change in Core Diabetes Distress (T1-DDAS Core Score) [Time frame: Baseline, Interim (6 weeks), Endpoint (12 weeks)]
- Change in Sources of Diabetes Distress (T1-DDS Subscale Scores) [Time frame: Baseline, Interim (6 weeks), Endpoint (12 weeks)]
- Change in Perceived Stress [Time frame: Baseline, Interim (6 weeks), Endpoint (12 weeks)]
- Change in Diabetes Quality of Life [Time frame: Baseline, Interim (6 weeks), Endpoint (12 weeks)]
- Change in Perceived Confidence in Diabetes [Time frame: Baseline, Interim (6 weeks), Endpoint (12 weeks)]
- Change in Diabetes Specific Self-Compassion [Time frame: Baseline, Interim (6 weeks), Endpoint (12 weeks)]
- Change in Hypoglycemic Attitudes and Behaviors [Time frame: Baseline, Interim (6 weeks), Endpoint (12 weeks)]
- Change in Hemoglobin A1c (HbA1c) [Time frame: Baseline, Endpoint (12 weeks)]
- Change in Percent of Time in Range (TIR) [Time frame: Baseline, Endpoint (12 weeks)]
- Change in Percent of Time Below Range (TBR) [Time frame: Baseline, Endpoint (12 weeks)]
- Change in Percent of Time Above Range (TAR) [Time frame: Baseline, Endpoint (12 weeks)]
- Glycemic Variability [Time frame: Baseline, Endpoint (12 weeks)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of North Carolina at Chapel Hill — Chapel Hill
Identifiers
NCT: NCT06405373 · 23-2228b · 12-22-ACE-18