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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3months, and 6months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3months, and 6months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3months, and 6months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Change in Care Satisfaction using COPES Satisfaction with Depression Question
Other outcome measures
Change in Physical activity using Walking Impairment Questionnaire
Change in Physical activity using step count
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.
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,853 Previous Clinical Trials
2,738,551 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not speak English or Spanish.I am 18 years old or older.You have a significant problem with alcohol or other drugs.You have significant problems with memory and thinking.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 are currently at risk of hurting yourself.You have mild to severe leg pain or rest pain due to poor blood flow.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial currently accepting participants?
"Affirmative, clinicaltrials.gov data indicates that recruitment for this experiment is presently ongoing. It was initially published on January 1st 2023 and most recently updated on February 23rd of the same year. This medical trial requires 10 patients from a single site to complete enrollment."
Answered by AI
How many individuals have been admitted into this research project?
"Affirmative. Per the clinicaltrials.gov website, this medical study is recruiting patients and was first published on January 1st 2023 with a most recent update occurring February 23rd 2023. 10 individuals are needed to be enrolled from one location."
Answered by AI
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