Journal article
Addressing emotional distress to improve outcomes in adults with type 1 diabetes: Protocol for ACT1VATE randomized controlled trial
Contemporary clinical trials, v 146, 107687
01 Nov 2024
PMID: 39265782
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Diabetes distress (DD) is a prevalent concern among people with type 1 diabetes (T1D) and is linked to poor clinical outcomes. Instead of targeting the elimination of DD, we propose a novel approach that empowers individuals with strategies to manage their diabetes effectively in the context of DD: Acceptance and Commitment Therapy (ACT). The purpose of this in-progress trial is to compare an ACT group intervention (ACT1VATE) with usual care in improving HbA1c, DD, quality of life, and cost-effectiveness in adults with T1D.
This is a two-arm, parallel group, randomized controlled superiority trial enrolling N = 250 adults with T1D, elevated HbA1c, and significant DD in a real-world community-based health system. Participants are randomized to receive ACT1VATE (a five-week ACT group telehealth intervention) or diabetes self-management education and support (usual care as the first-line recommended intervention for DD). The trial will examine comparative effectiveness in improving HbA1c, DD, quality of life, and cost-effectiveness over 12 months.
We predict that ACT1VATE will be superior given its (1) specific focus on DD, without any expectation that difficult diabetes-related thoughts and emotions must (or can) be completely eliminated; and (2) purposeful linkage of diabetes self-care behaviors to an individual’s deeply held values, thus eliciting intrinsic, patient-centric motivation for meaningful and lasting health behavior changes. This trial will provide a valuable test of real-world effectiveness, drive sustainability and scalability, and inform the future of chronic disease care.
Trial registration: NCT04933851 (https://clinicaltrials.gov/ct2/show/NCT04933851).
Clinical Trial: Clinicaltrials.govNCT04933851https://clinicaltrials.gov/study/NCT04933851
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Details
- Title
- Addressing emotional distress to improve outcomes in adults with type 1 diabetes: Protocol for ACT1VATE randomized controlled trial
- Creators
- Emily C. Soriano - Scripps Whittier Diabetes InstituteAddie L. Fortmann - Scripps Whittier Diabetes InstituteSusan J. Guzman - NanoImaging ServicesHaley Sandoval - Scripps Whittier Diabetes InstituteSamantha R. Spierling Bagsic - Scripps Whittier Diabetes InstituteAlessandra Bastian - Scripps Whittier Diabetes InstituteMcKayla Antrim - Drexel UniversityMariya Chichmarenko - Scripps Whittier Diabetes InstituteAthena Philis-Tsimikas - Scripps Whittier Diabetes Institute
- Publication Details
- Contemporary clinical trials, v 146, 107687
- Publisher
- Elsevier
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- College of Medicine
- Web of Science ID
- WOS:001317522000001
- Scopus ID
- 2-s2.0-85203827085
- Other Identifier
- 991022202524404721
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- Web of Science research areas
- Medicine, Research & Experimental
- Pharmacology & Pharmacy