Addressing emotional distress to improve outcomes in adults with type 1 diabetes: Protocol for ACT1VATE randomized controlled trial.
Contemp Clin Trials
; 146: 107687, 2024 Sep 13.
Article
en En
| MEDLINE
| ID: mdl-39265782
ABSTRACT
BACKGROUND:
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.METHODS:
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.DISCUSSION:
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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Colección:
01-internacional
Base de datos:
MEDLINE
Idioma:
En
Revista:
Contemp Clin Trials
Asunto de la revista:
MEDICINA
/
TERAPEUTICA
Año:
2024
Tipo del documento:
Article
Pais de publicación:
Estados Unidos