Mind Body Program Vascular

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05757752
• Other study ID #: 2000034225
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: Kim Smolderen, PhD
• Phone: 203-737-7673
• Email: kim.smolderen[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Yale New Haven Health Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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.
Primary	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.
Primary	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
Primary	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	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