Mind Body Program for Vascular Disease

Yale University

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Peripheral Arterial Disease Peripheral Vascular Diseases

Interventions

Problem Solving Therapy and Integrated CareBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Yale New Haven Health Hospital

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Data from ClinicalTrials.gov

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