Back to resultsMind Body Program Vascular
Primary Purpose
Peripheral Arterial Disease, Peripheral Vascular Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem Solving Therapy and Integrated Care
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
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
Sites / Locations
- Yale New Haven Health HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention
Arm 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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05757752
Brief Title
Mind Body Program Vascular
Official Title
Mind Body Program for Vascular Disease Proof-of-Concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Peripheral Vascular Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving Therapy and Integrated Care
Intervention Description
The intervention, will consist of problem solving therapy techniques to promote PAD self-management behaviors and depression/distress management.
Primary Outcome Measure Information:
Title
Change in PAD-Specific Health Status on the Peripheral Artery Questionnaire (PAQ)
Description
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.
Time Frame
Baseline and 6months.
Title
Change in Depressive Symptoms assessed by Symptom Checklist-20 (SCL-20)
Description
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.
Time Frame
Baseline, 3months, and 6months.
Title
Change in Depressive Symptoms assessed by Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
initial screening, baseline, 3months, and 6months
Title
Change in Stress Symptoms assessed using Perceived Stress Scale (PSS-10)
Description
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).
Time Frame
initial screening, baseline, 3months, and 6months.
Secondary Outcome Measure Information:
Title
Change in Care Satisfaction using COPES Satisfaction with Depression Question
Description
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.
Time Frame
baseline and 6months
Other Pre-specified Outcome Measures:
Title
Change in Physical activity using step count
Description
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.
Time Frame
baseline, 3months, and 6months
Title
Change in Physical activity using Walking Impairment Questionnaire
Description
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.
Time Frame
baseline, 3months, and 6months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kim Smolderen, PhD
Phone
203-737-7673
Email
kim.smolderen@yale.edu
Facility Information:
Facility Name
Yale New Haven Health Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Smolderen, PhD
Email
kim.smolderen@yale.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mind Body Program Vascular
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