Intervention for Persistent Mental Illness

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Persistent Mental Illness+1 MoreCardiac Rehabilitation Program - Behavioral
Eligibility
30 - 59
All Sexes
What conditions do you have?
Select

Study Summary

The goal of this prospective, randomized trial is to explore the link between cardiovascular disease and mortality in individuals with severe and persistent mental illness (SPMI). The main question it aims to answer is: Is a primary prevention cardiac rehabilitation intervention feasible and effective at reducing cardiovascular risk in people with a primary psychotic disorder or bipolar disorder?" Participants will undergo a multi-component primary prevention intervention program. Researchers will compare with a control group to see if cardiovascular risk reduction is attained.

Eligible Conditions
  • Persistent Mental Illness
  • Cardiovascular Prevention

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 9 months

9 months
30-year Cardiovascular risk
Efficacy outcome
PRIMROSE BMI risk score
PRIMROSE Lipid risk score
Quality of life

Trial Safety

Trial Design

2 Treatment Groups

Control
1 of 2
Intervention
1 of 2

Active Control

Experimental Treatment

46 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention · No Placebo Group · N/A

Intervention
Behavioral
Experimental Group · 1 Intervention: Cardiac Rehabilitation Program · Intervention Types: Behavioral
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cardiac Rehabilitation Program
2017
N/A
~110

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 9 months

Who is running the clinical trial?

Lady Davis InstituteLead Sponsor
39 Previous Clinical Trials
4,772 Total Patients Enrolled
Jewish General HospitalOTHER
134 Previous Clinical Trials
319,560 Total Patients Enrolled
Michael J GoldfarbPrincipal InvestigatorLady Davis Institute

Eligibility Criteria

Age 30 - 59 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between 30 and 59 years of age.
You have been diagnosed with a mental health condition such as schizophrenia, schizoaffective disorder, or bipolar I disorder.
You are engaging in two or more heart-related risk behaviors/conditions, such as smoking, obesity, hypertension, diabetes mellitus, metabolic syndrome, dyslipidemia and obstructive sleep apnea.
Your Framingham cardiovascular risk score is 10% or higher (intermediate risk).
You are prepared to engage in a cardiac rehabilitation program.