NCT04933851

ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Scripps Whittier Diabetes Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 7.5% - 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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-25
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2021-06-22
• Last updated: 2025-07-04

Locations

1 site across 1 country: United States