Mind Body Program for Vascular Disease

NCT05757752 | Withdrawn

• 1 other identifier: 2000034225
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Change in PAD-Specific Health Status on the Peripheral Artery Questionnaire (PAQ)

  The PAQ Summary Score is a 20-item, validated, self-report instrument quantifying patients' disease specific health status. The measure is comprised of 6 domains including physical limitations, symptoms, symptom stability, social functioning, treatment satisfaction, and quality of life. Total scores range from 0 to 100, with higher scores indicate better functioning. Change will be determined using comparisons between baseline and 6 months.

  Baseline and 6months.

• Change in Depressive Symptoms assessed by Symptom Checklist-20 (SCL-20)

  Patient depressive symptoms will be measured using the SCL-20. The SCL-20 is a 20-item, validated, self-report instrument assessing depressive symptom intensity. Total scores range from 0 to 80, with higher score indicating higher depressive symptom intensity. Change will be determined using comparisons between baseline, 3 months and 6 months.

  Baseline, 3months, and 6months.

• Change in Depressive Symptoms assessed by Patient Health Questionnaire (PHQ-9)

  Patient depressive symptoms will be measured using the 9-item PHQ-9. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety. Change will be determined by whether sufficient improvement is demonstrated between initial screening, baseline, 3 months, and 6 months. Sufficient improvement is defined as a 30% improvement if the prior depression score was between 5-10, or a 50% improvement if the score was greater than 20.

  initial screening, baseline, 3months, and 6months

• Change in Stress Symptoms assessed using Perceived Stress Scale (PSS-10)

  Patient distress levels will be measured using the 10-item PSS-10. The PSS-10 is a 10-item, validated, self-report, questionnaire used to assess perceived control and confidence in managing stressful situations over the past month. Scores range from 0 to 40, with higher scores indicated higher levels of perceived stress. Change will be determined by whether sufficient improvement is demonstrated between initial screening up to 6 months. Sufficient improvement is defined as moving from a high stress (score 27-40 on PSS-10) to a moderate stress (score 14-26).

  initial screening, baseline, 3months, and 6months.

Secondary Outcomes (1)

• Change in Care Satisfaction using COPES Satisfaction with Depression Question

  baseline and 6months

Other Outcomes (2)

• Change in Physical activity using step count

  baseline, 3months, and 6months

• Change in Physical activity using Walking Impairment Questionnaire

  baseline, 3months, and 6months

Study Arms (1)

Intervention

OTHER

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.

Behavioral: Problem Solving Therapy and Integrated Care

Interventions

Problem Solving Therapy and Integrated Care BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Health Hospital

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 7, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)