ArticleContemporary clinical trials2024
Addressing emotional distress to improve outcomes in adults with type 1 diabetes: Protocol for ACT1VATE randomized controlled trial.
Article in Contemporary clinical trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04933851 (ACT1VATE), which is not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes
Who cites it
1 citing paper in PubMed.
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Authors and funding
9 authors.
Funding
Abstract
backgroundDiabetes 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.
methodsThis 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 registrationNCT04933851 (https://clinicaltrials.gov/ct2/show/NCT04933851). CLINICAL TRIAL: Clinicaltrials.govNCT04933851https://clinicaltrials.gov/study/NCT04933851.
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