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Recruiting
NCT05757752
Mind Body Program Vascular
Conditions: Peripheral Arterial Disease, Peripheral Vascular Diseases
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 10
Sponsor: Yale University
Location: United States
Summary
The purpose of the current study is to conduct a proof-of-concept test regarding the delivery of a Mind Body Program for vascular disease, focusing on support for depression, stress, and adherence, as part of patients' chronic disease management for peripheral artery disease (PAD).
Eligibility Criteria
Inclusion Criteria:Rutherford score 1-4 (mild-severe claudication, or ischemic rest pain)Resting ankle-brachial index assessment ≤0.90 or drop in post-exercise ankle pressure ≥20 mmHg or non-compressible ankle-brachial index (≥1.30)
or toe brachial index less than 0.70 in the past yearPositive depression screening result (positive PHQ-9 result ≥10) or high stress screening result (10-item Perceived Stress Scale Score ≥27)Exclusion Criteria:Not speaking either English or SpanishAge ≥18 yearsCurrently incarceratedCurrent alcohol dependency or other substance use disorder (score ≥ 5 on NM-ASSIST)Cognitive impairment (T-MoCA Short <10)Acute suicidal risk (positive screen ASQ Tool)History of psychosis or bipolar disorderPreviously enrolled in the studyUnable to provide written informed consent
Source: ClinicalTrials.gov (NCT05757752). StuddyBuddy aggregates publicly available trial information.