Mind Body Program for Vascular Disease

Yale University

Status: Withdrawn

Conditions: Peripheral Vascular Diseases; Peripheral Arterial Disease

Treatments: Behavioral: Problem Solving Therapy and Integrated Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05757752

2000034225

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 year
• Positive 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 Spanish
• Age ≥18 years
• Currently incarcerated
• Current 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 disorder
• Previously enrolled in the study
• Unable to provide written informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Intervention

Other group

Description:

Participants meeting eligibility criteria will participate in the Mind Body Program for Vascular Disease, working in-person or via telehealth with a study interventionist for an hour weekly in 6-8 week cycles learning problem-solving techniques targeting mood/distress and enhancing disease management strategies. Participants will be assessed at baseline, 3-months, and 6-months.

Treatment:

Behavioral: Problem Solving Therapy and Integrated Care