Effectiveness of a Psychoeducation Program in Patients With Severe Mental Disorder

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

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.

Study Overview

• Status: Completed
• Conditions: Mental Health Disorder; Healthy Lifestyle
• Intervention / Treatment: Behavioral: Psychoeducation program; Drug: Psychopharmacology intervention

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Córdoba, Spain, 18007
    • José Manuel Pérez Mármol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Cognitive impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Psychoeducation program; Intervention program consisted of psychopharmacology + psychoeducation. This will be executed during 3 months, distribuited in several sessions.; Other Names: Mixed treatment program
Active Comparator: Habitual intervention; Intervention program consists of psychopharmacology (standard intervention in mental health services). This program is implemented for three months.	Drug: Psychopharmacology intervention; Intervention program consisted of psychopharmacology. This will be executed during 3 months.; Other Names: Standard intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: José Manuel Pérez Mármol, PhD, Department of Physiotherapy. Faculty of Health Sciences, University of Granada

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Actual): November 20, 2020
• Study Completion (Actual): November 20, 2020

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 5, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: cardiovascular risk; metabolic syndrome; psychopathology; independency
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: NCT04272541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No