Effectiveness of a Psychoeducation Program in Patients With Severe Mental Disorder

NCT04272541 | Completed

• 1 other identifier: NCT04272541
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Disorder; Healthy Lifestyle

Keywords

cardiovascular risk; metabolic syndrome; independency; psychopathology

Outcome Measures

Primary Outcomes (1)

• weight

  This measurement registers weight in Kg

  Change from Baseline in weight at 3 and 6 months

Secondary Outcomes (5)

• waist circumference

  Change from Baseline in waist circumference at 3 and 6 months

• waist-hip ratio

  Change from Baseline in waist-hip ratio at 3 and 6 months

• Framingham scale

  Change from Baseline in Framingham scale at 3 and 6 months

• Global Assesment of funtioning Scale

  Change from Baseline in Global Assesment of funtioning Scale at 3 and 6 months

• PANNS

  Change from Baseline in PANNS at 3 and 6 months

Study Arms (2)

Psychoeducation program

ACTIVE COMPARATOR

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

Habitual intervention

ACTIVE COMPARATOR

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

Drug: Psychopharmacology intervention

Interventions

Psychoeducation program BEHAVIORAL

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

Also known as: Mixed treatment program

Psychoeducation program

Psychopharmacology intervention DRUG

Intervention program consisted of psychopharmacology. This will be executed during 3 months.

Also known as: Standard intervention

Habitual intervention

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cognitive impairment

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

José Manuel Pérez Mármol

Córdoba, 18007, Spain

Location

MeSH Terms

Conditions

Mental Disorders; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• José Manuel Pérez Mármol, PhD

  Department of Physiotherapy. Faculty of Health Sciences, University of Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: February 20, 2020
• Primary Completion: November 20, 2020
• Study Completion: November 20, 2020
• Last Updated: July 7, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)