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Mind-Body Program for Vascular Disease

N/A

Recruiting

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Not speaking either English or Spanish

Age ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3months, and 6months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a mind-body program can help people with vascular disease manage their depression, stress and medication adherence.

Who is the study for?

This trial is for adults with mild to severe claudication or ischemic rest pain due to vascular diseases like PAD. Participants must have certain diagnostic scores indicating reduced blood flow in limbs, and show signs of depression or high stress. Exclusions include non-English/Spanish speakers, incarcerated individuals, substance abuse issues, cognitive impairment, acute suicidal risk, psychosis/bipolar history, prior study enrollment or inability to consent.

What is being tested?

The study tests a Mind Body Program aimed at supporting patients with vascular disease by addressing depression and stress as part of chronic disease management for PAD. It involves Problem Solving Therapy and Integrated Care approaches designed to improve overall health outcomes.

What are the potential side effects?

Since the interventions are psychological therapies rather than medications, traditional side effects are not expected. However, participants may experience emotional discomfort when discussing personal issues during therapy sessions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not speak English or Spanish.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3months, and 6months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3months, and 6months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3months, and 6months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+1 more

Secondary study objectives

Change in Care Satisfaction using COPES Satisfaction with Depression Question

Other study objectives

Change in Physical activity using Walking Impairment Questionnaire

Change in Physical activity using step count

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 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.

0 / 2Eligibility criteria met