ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes
NCT ID: NCT04933851
Last Updated: 2025-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
250 participants
INTERVENTIONAL
2021-10-25
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ACT1VATE
Participants assigned to the intervention group will be offered a psychological intervention specifically designed to address diabetes-related emotional distress.
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.
DSME/S (usual care)
Participants randomized to the usual care group will be offered standard diabetes self-management education and support (DSME/S).
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Type 1 diabetes
* Glycosylated Hemoglobin (HbA1c) 7.5% - 12.5% in last 90 days
* Screen positive for diabetes distress
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Scripps Whittier Diabetes Institute
OTHER
Responsible Party
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Athena Philis-Tsimikas
Corporate Vice President
Principal Investigators
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Addie Fortmann, PhD
Role: PRINCIPAL_INVESTIGATOR
Scripps Whittier Diabetes Institute
Athena Philis-Tsimikas, MD
Role: PRINCIPAL_INVESTIGATOR
Scripps Whittier Diabetes Institute
Locations
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Scripps Whittier Diabetes Institute
San Diego, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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