Effectiveness of a Psychoeducation Program in Patients With Severe Mental Disorder

Mental Health Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04272541
• Other study ID #: NCT04272541
• Status: Completed
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: November 20, 2020

Study information

• Verified date: July 2021
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• Over 40 years old,

• A body mass index higher than 30

• Psychopathologically stabilized

Exclusion Criteria:

• Cognitive impairment

Related Conditions & MeSH terms

• Healthy Lifestyle
• Mental Disorders
• Mental Health Disorder

Intervention

Behavioral:
• Psychoeducation program
Intervention program consisted of psychopharmacology + psychoeducation. This will be executed during 3 months, distribuited in several sessions.

Drug:
• Psychopharmacology intervention
Intervention program consisted of psychopharmacology. This will be executed during 3 months.

Locations

Country	Name	City	State
Spain	José Manuel Pérez Mármol	Córdoba

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight	This measurement registers weight in Kg	Change from Baseline in weight at 3 and 6 months
Secondary	waist circumference	This measurement registers waist circumference in cm	Change from Baseline in waist circumference at 3 and 6 months
Secondary	waist-hip ratio	Waist-hip ratio will be calculated	Change from Baseline in waist-hip ratio at 3 and 6 months
Secondary	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
Secondary	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
Secondary	PANNS	The Positive and Negative Syndrome Scale for mental disorder	Change from Baseline in PANNS at 3 and 6 months