Effectiveness of a Psychoeducation Program in Patients With Severe Mental Disorder

Study Overview
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Brief Summary
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Patients with Severe Mental Disorder (SMD) show a life expectancy of 13 to 30 years lower than the general population. Among the factors that determine this expectancy are cardiovascular risk and the metabolic syndrome. The objective of the present study will be to evaluate the effectiveness of a rehabilitative intervention comprinsing a psychopharmacology and psychoeducation program on cardiovascular risk, metabolic syndrome, independency for activities of daily living and psychopathological symptoms.

Detailed Description
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It will be selected sixty patients diagnosed with SMD from a community Mental Health Unit from Spain. It will be implemented a intervention program consisted of psychopharmacology + psychoeducation on healthy living habits during three months. The patients will be evaluated at the beginning, at three months and at six months follow-up for weight, waist circumference, waist-hip ratio, body mass index, cardiovascular risk, independency and psychopathology.

Official Title
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Effectiveness of a Psychoeducation Program on Metabolic Syndrome, Cardiovascular Risk, Independency and Psychopatology in Patients With Severe Mental Illness

Conditions
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Mental Health Disorder, Healthy Lifestyle

Intervention / Treatment
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* Behavioral: Psychoeducation program
* Drug: Psychopharmacology intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 40 years old, A body mass index higher than 30 Psychopathologically stabilized Exclusion Criteria: Cognitive impairment

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Psychoeducation program<br>The intervention program consists of psychopharmacology (standard intervention in mental health services) + individual psychoeducation (individual treatment including learning of Healthy Lifestyle). This program is implemented for three months, allocated in several sessions. | Behavioral: Psychoeducation program<br>* Intervention program consisted of psychopharmacology + psychoeducation. This will be executed during 3 months, distribuited in several sessions.<br>* Other names: Mixed treatment program;|
| Active Comparator: Habitual intervention<br>Intervention program consists of psychopharmacology (standard intervention in mental health services). This program is implemented for three months. | Drug: Psychopharmacology intervention<br>* Intervention program consisted of psychopharmacology. This will be executed during 3 months.<br>* Other names: Standard intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight | This measurement registers weight in Kg | Change from Baseline in weight at 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| waist circumference | This measurement registers waist circumference in cm | Change from Baseline in waist circumference at 3 and 6 months | 
| waist-hip ratio | Waist-hip ratio will be calculated | Change from Baseline in waist-hip ratio at 3 and 6 months | 
| Framingham scale | The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. | Change from Baseline in Framingham scale at 3 and 6 months | 
| Global Assesment of funtioning Scale | This scale evaluates psychological, social, and occupational functioning dimensions on a hypothetical continuum of mental health-illness. | Change from Baseline in Global Assesment of funtioning Scale at 3 and 6 months | 
| PANNS | The Positive and Negative Syndrome Scale for mental disorder | Change from Baseline in PANNS at 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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independency, cardiovascular risk, metabolic syndrome, psychopathology