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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a Mind-Body Program designed to help individuals with peripheral artery disease (PAD) manage their condition more effectively. The program focuses on improving mood and managing stress through problem-solving therapy and integrated care. Those who have experienced leg pain while walking or at rest and have felt depressed or very stressed may find this program beneficial. Participants will work with a therapist, either in-person or online, over several weeks to learn new techniques for managing their health. As an unphased trial, this study provides participants the opportunity to explore innovative strategies for enhancing well-being and managing PAD symptoms.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Mind-Body Program is safe for managing vascular disease?

Research shows that Problem Solving Therapy, part of the Mind-Body Program for Vascular Disease, is generally safe. Studies have found that this therapy can help manage stress and depression, often linked to vascular problems. It focuses on teaching problem-solving skills, which can improve mood and health management.

This therapy does not involve medications, so it avoids typical medication side effects. Instead, it uses talk therapy to help people manage stress more effectively. Reports have not indicated any serious negative effects with this treatment. The approach is well-tolerated, making it a safe option for managing mood and stress in individuals with peripheral artery disease (PAD). ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mind-Body Program for Vascular Disease because it offers a fresh approach to managing vascular conditions by focusing on mental health and problem-solving skills. Unlike standard treatments that primarily address physical symptoms, this program emphasizes improving mood and reducing distress, which can significantly enhance overall disease management. The program's delivery through both in-person and telehealth sessions makes it accessible and flexible, catering to participants' varied needs and lifestyles. This holistic approach could lead to better long-term management of vascular disease by empowering patients with strategies to cope with their condition more effectively.

What evidence suggests that this Mind Body Program is effective for managing vascular disease?

Research has shown that Problem Solving Therapy, which participants in this trial will receive, effectively manages symptoms of depression and stress. One study found that this therapy helps people address mood issues and improve their overall mental health. In this trial, participants will also experience integrated care, which combines mental health care with medical treatment to help patients adhere to their treatment plans. This approach benefits those with long-term conditions like peripheral artery disease (PAD). Overall, these methods aim to improve both mental well-being and physical health. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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

You have significant problems with memory and thinking.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5579718/

A Problem-Solving Intervention for Cardiovascular Disease ... This paper describes a study protocol to evaluate a problem-solving intervention that aims to help patients at risk for developing cardiovascular disease.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2780951

Assessment of Studies of Quality Improvement Strategies ... This systematic and scoping review assesses evidence on the effectiveness and implementation of quality improvement strategies to improve ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2943727/

Problem Solving Therapy for Subthreshold Depression in ... One recent trial, bythis research group, has provided data on the feasibility, acceptability and effectiveness of the treatment known as Problem Solving Therapy ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001178

Association Between Mental Health Burden, Clinical ... Other effective approaches for both depression management and cardiovascular outcomes are exercise-based interventions, which have been shown ...

5. sp2.upenn.edu sp2.upenn.edu/wp-content/uploads/2014/07/cmha2.pdf

Problem-Solving Therapy for Subthreshold Depression in ... One recent trial, by this research group, has provided data on the feasibility, acceptability, and effective- ness of the treatment known as problem-solving.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05757752

NCT05757752 | Mind Body Program for Vascular Disease The intervention, will consist of problem solving therapy techniques to promote PAD self-management behaviors and depression/distress management. What is the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10514776/

Integrating Psychosocial Care in the Management ... We present a call to action to expand PAD care by integrating psychosocial care in the management of patients with vascular disease.

8. ahajournals.org ahajournals.org/doi/pdf/10.1161/CIR.0000000000001178

Circulation Cognitive behavioral therapy/problem solving therapy in collaborative care settings. Medications: SSRIs and TCAs, but caution for adverse ...

9. mdpi.com mdpi.com/2076-328X/14/6/446

Effectiveness of Problem-Solving Therapy in Improving ... However, the results of four RCTs demonstrated no effect of PST on patient functioning. The quality of evidence for the outcomes ranged from very low to high.

10. clinicaltrials.gov clinicaltrials.gov/study/NCT05757752?term=AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(%22Peripheral%20Vascular%20Diseases%22))&rank=10

NCT05757752 | Mind Body Program for Vascular Disease The intervention, will consist of problem solving therapy techniques to promote PAD self-management behaviors and depression/distress management. What is the ...