Mind-Body Program for Vascular Disease

Overseen By Kim Smolderen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Substance use, Cognitive impairment, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6-8 weeks

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

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.

Inclusion Criteria

Your ankle and toe blood pressure measurements show signs of poor blood flow in the past year.

You have been diagnosed with depression or have very high stress levels.

You have mild to severe leg pain or rest pain due to poor blood flow.

Exclusion Criteria

Previously enrolled in the study

Unable to provide written informed consent

Currently incarcerated

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Mind Body Program for Vascular Disease, working with a study interventionist weekly for 6-8 week cycles

6-8 weeks

Weekly visits (in-person or via telehealth)

Follow-up

Participants are monitored for changes in stress, physical activity, and depressive symptoms

6 months

Assessments at baseline, 3 months, and 6 months

Treatment Details

Interventions

• Problem Solving Therapy and Integrated Care

Trial Overview 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.

Participant Groups

Group I: Intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+