N/A
Completed N=287
Life Goals Collaborative Care to Improve Health Outcomes in Mental Disorders
Source: ClinicalTrials.gov NCT01487668 ↗Enrolled (actual)
287
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: Physical Health-related Quality of Life — 34.00; 33.61 units on a scale
Summary
Persons with serious mental illness (SMI) are at increased risk of cardiovascular disease (CVD). The goals of this study are to test a treatment, Life Goals Collaborative Care to help promote health behavior change and improve mental health and physical health-related quality of life, as well as to get feedback from patients and providers on what is needed to help better coordinate the physical and mental health care of these patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physical Health-related Quality of Life |
34.00; 33.61 | — |
| SECONDARY Improved Mental Health-related Quality of Life |
36.36; 38.13 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of serious mental illness (schizophrenia, bipolar disorder, other psychosis, major depressive disorder, or other recurrent depression or affective disorder)
- Have at least one of the following risk factors for CVD (cardiovascular disease):
- Body mass index (BMI) >28 or waist circumference of >35 (women) or >40 (men) inches OR
- Self-reported diagnosis of hypertension ("high blood pressure"), dyslipidemia ("high cholesterol") or diabetes or high blood sugar OR
- Documentation in the medical record of a diagnosis of or treatment for hypertension (defined as documented diagnosis or blood pressure of >140/90 on 2 occasions or prescription for an antihypertensive medication), dyslipidemia (documented diagnosis or LDL>160 or prescription for a lipid-lowering medication) or diabetes mellitus (documented diagnosis or HbA1C >7% or current prescription for oral hypoglycemic therapy)
Exclusion Criteria
- Have unresolved substance intoxication or withdrawal, such as appearing to be intoxicated (e.g., incoherent, slurred speech), or experiencing withdrawal symptoms from substance abuse at the time of enrollment.
- Are unwilling or unable to provide informed consent or comply with study requirements at the time of enrollment (e.g., unable to complete forms or attend sessions due to substantial functional limitations).
- Active suicidal ideation at time of enrollment (focused interventions are more appropriate for this group)
Data sourced from ClinicalTrials.gov (NCT01487668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.