Effectiveness of a Psychoeducation Program in Patients With Severe Mental Disorder

Not Applicable

Completed

• Conditions: Mental Health Disorder; Healthy Lifestyle
• Interventions: Drug: Psychopharmacology intervention; Behavioral: Psychoeducation program

• Registration Number: NCT04272541
• Lead Sponsor: Universidad de Granada

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-02-13
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-17
• Study Start: 2020-02-20
• Primary Completion: 2020-11-20
• Study Completion: 2020-11-20
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-05
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Over 40 years old,
• A body mass index higher than 30
• Psychopathologically stabilized

Exclusion Criteria

• Cognitive impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Habitual intervention	Psychopharmacology intervention	Intervention program consists of psychopharmacology (standard intervention in mental health services). This program is implemented for three months.
Psychoeducation program	Psychoeducation program	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.

Primary Outcome Measures

Name	Time	Method
weight	Change from Baseline in weight at 3 and 6 months	This measurement registers weight in Kg

Secondary Outcome Measures

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

Trial Locations

Locations (1)

José Manuel Pérez Mármol; 🇪🇸 Córdoba, Spain