Mind Body Program for Vascular Disease

NCT ID: NCT05757752

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-12-31

Brief 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).

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: OTHER

Problem Solving Therapy and Integrated Care

Intervention Type: BEHAVIORAL

The intervention, will consist of problem solving therapy techniques to promote PAD self-management behaviors and depression/distress management.

Interventions

Problem Solving Therapy and Integrated Care

The intervention, will consist of problem solving therapy techniques to promote PAD self-management behaviors and depression/distress management.

Intervention Type: BEHAVIORAL

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yale New Haven Health Hospital

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

2000034225

Identifier Type: -

Identifier Source: org_study_id