ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes
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: ACT1VATE, DSME/S.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes. Basic parameters: from 18 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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Overview
This research will compare a psychological intervention ("ACT1VATE") versus diabetes self-management education and support (DSME/S; usual care) in improving clinical, behavioral, psychosocial, process, and cost outcomes among adults with poorly controlled type 1 diabetes (T1D) who are experiencing significant diabetes-related emotional distress and poor glycemic control in a real world, healthcare environment.
Detailed description
This randomized controlled trial will compare a telemedicine psychological intervention specifically designed to address diabetes distress ("ACT1VATE") versus traditional diabetes self-management education and support (DSME/S; usual care) in improving glycemic control among N=250 adults with type 1 diabetes (T1D), glycosylated hemoglobin (HbA1c) between 7.0% - 12.5% in the last 90 days, and significant diabetes distress. Capitalizing on existing and real-world processes, the electronic health record (EHR) will be used to identify eligible patients and examine primary outcomes. Participants randomized to the usual care group will be offered standard, 1:1 DSME/S delivered by a Certified Diabetes Care and Education Specialist via telemedicine format. Participants randomized to the ACT1VATE group will be offered 5 group-therapy telemedicine sessions delivered by a Behavioral Health Provider who is an integrated member of the diabetes care team. ACT1VATE is grounded in Acceptance and Commitment Therapy (ACT), which has been delivered effectively in clinics via brief format; implemented via phone and other modalities; and adapted for a wide range of chronic conditions. The primary clinical outcome, HbA1c, assessed as part of quarterly standard-of-care medical visits will be extracted from the EHR over 12 months. Changes in patient-reported behavioral (diabetes self-care) and psychosocial (emotional well-being, quality of life) outcomes will be evaluated via online surveys at baseline, month 6, and month 12. A thorough process evaluation will be conducted to establish reach, acceptability/feasibility, adoption/maintenance, and fidelity of the intervention and will integrate patient and provider perspectives. Cost-effectiveness will also be examined from the health system perspective. By maximizing integration with routine medical care for T1D in a real world, healthcare environment, results will be highly generalizable and hold great potential to inform the future of care for adults living with T1D.
Interventions
- Behavioral ACT1VATE
ACT1VATE, informed by Acceptance and Commitment Therapy (ACT), will consist of five, 90-minute group-based telemedicine therapy sessions delivered by a Behavioral Health Provider. - Behavioral DSME/S
Diabetes self-management education and support (DSME/S) will be delivered by a Certified Diabetes Care and Education Specialist via one-on-one telemedicine format.
Primary outcome measures
- Glycosylated Hemoglobin (HbA1c) [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months]
- Diabetes Distress Scale [Time frame: Baseline, 6 months, 12 months]
Secondary outcome measures (8)
- Summary of Diabetes Self-Care Activities Survey [Time frame: Baseline, 6 months, 12 months]
- Generalized Anxiety Disorder Assessment [Time frame: Baseline, 6 months, 12 months]
- Patient Health Questionnaire-8 [Time frame: Baseline, 6 months, 12 months]
- Perceived Stress Scale [Time frame: Baseline, 6 months, 12 months]
- The WHO Well-Being Index [Time frame: Baseline, 6 months, 12 months]
- Hypoglycemic Attitudes and Behaviors Scale [Time frame: Baseline, 6 months, 12 months]
- Revised Diabetes Knowledge Test [Time frame: Baseline, 6 months, 12 months]
- Diabetes Support and Isolation Questionnaire [Time frame: Baseline, 6 months, 12 months]
Eligibility criteria
Inclusion criteria
- Spanish or English-speaking
- Type 1 diabetes
- Glycosylated Hemoglobin (HbA1c) 7.0% - 12.5% in last 90 days
- Screen positive for diabetes distress
Exclusion criteria
- Severe medical or psychological conditions that would interfere with participation based on the opinion of a provider
- Plans to move out of the San Diego area in the next 12 months
- Lack of technology capability required to complete online surveys and telemedicine visit
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
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Scripps Whittier Diabetes Institute — San Diego
Publications
- Soriano EC, Fortmann AL, Guzman SJ, Sandoval H, Spierling Bagsic SR, Bastian A, Antrim M, Chichmarenko M, Philis-Tsimikas A. Addressing emotional distress to improve outcomes in adults with type 1 diabetes: Protocol for ACT1VATE randomized controlled trial. Contemp Clin Trials. 2024 Nov;146:107687. doi: 10.1016/j.cct.2024.107687. Epub 2024 Sep 13. PMID 39265782
Identifiers
NCT: NCT04933851 · 1R01DK127491 · R01DK127491