Mind Body Program Vascular

Mind Body Program for Vascular Disease Proof-of-Concept Study

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).

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease; Peripheral Vascular Diseases
• Intervention / Treatment: Behavioral: Problem Solving Therapy and Integrated Care

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kim Smolderen, PhD; Phone Number: 203-737-7673; Email: kim.smolderen@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Yale New Haven Health Hospital
      • Contact: Kim Smolderen, PhD; Email: kim.smolderen@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Care Satisfaction using COPES Satisfaction with Depression Question	Patient satisfaction with the care they receive participating in the Mind Body Program for Vascular Disease will be measures using the single item COPES Satisfaction with Depression Question. This item asks patients to rate the quality of professional care they have received for their symptoms of distress or depression over the last 2 months. Scores range from 1 (Excellent) to 5 (Poor), with higher scores indicating worse satisfaction. Patients who did not receive care for distress or depression symptoms have the option to indicate this as their response. Change will be determined using comparisons between baseline and 6 months.	baseline and 6months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical activity using step count	Physical activity levels will be measured as 7-day averaging of step counts by Garmin Vivofit activity trackers. Sedentary behavior is defined as <7000 steps per day and being physically active is defined as ≥7000 steps per day. The investigators will consider a clinically meaningful treatment signal that >50% of patients will display active behavior (7-day average of ≥7000 steps/day) at 6 months.	baseline, 3months, and 6months
Change in Physical activity using Walking Impairment Questionnaire	The Walking Impairment Questionnaire is a 19-item, validated, self-report measure of the degree of difficulty participants experience related to walking distance and speed, as well as symptoms they experience while walking (e.g., stiffness, pain, aches). Scores range from 0-100 with lower scores indicating lower performance. Change will be determined using comparisons between baseline up to 6 months.	baseline, 3months, and 6months

Collaborators and Investigators

• Sponsor: Yale University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 2000034225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No