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Effectiveness of a Psychoeducation Program in Patients With Severe Mental Disorder

Primary Purpose

Mental Health Disorder, Healthy Lifestyle

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Psychoeducation program
Psychopharmacology intervention
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Health Disorder focused on measuring cardiovascular risk, metabolic syndrome, independency, psychopathology

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Cognitive impairment

Sites / Locations

  • José Manuel Pérez Mármol

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Psychoeducation program

Habitual intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

weight
This measurement registers weight in Kg

Secondary Outcome Measures

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

Full Information

First Posted
February 13, 2020
Last Updated
July 5, 2021
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT04272541
Brief Title
Effectiveness of a Psychoeducation Program in Patients With Severe Mental Disorder
Official Title
Effectiveness of a Psychoeducation Program on Metabolic Syndrome, Cardiovascular Risk, Independency and Psychopatology in Patients With Severe Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
November 20, 2020 (Actual)
Study Completion Date
November 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Disorder, Healthy Lifestyle
Keywords
cardiovascular risk, metabolic syndrome, independency, psychopathology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychoeducation program
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Habitual intervention
Arm Type
Active Comparator
Arm Description
Intervention program consists of psychopharmacology (standard intervention in mental health services). This program is implemented for three months.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation program
Other Intervention Name(s)
Mixed treatment program
Intervention Description
Intervention program consisted of psychopharmacology + psychoeducation. This will be executed during 3 months, distribuited in several sessions.
Intervention Type
Drug
Intervention Name(s)
Psychopharmacology intervention
Other Intervention Name(s)
Standard intervention
Intervention Description
Intervention program consisted of psychopharmacology. This will be executed during 3 months.
Primary Outcome Measure Information:
Title
weight
Description
This measurement registers weight in Kg
Time Frame
Change from Baseline in weight at 3 and 6 months
Secondary Outcome Measure Information:
Title
waist circumference
Description
This measurement registers waist circumference in cm
Time Frame
Change from Baseline in waist circumference at 3 and 6 months
Title
waist-hip ratio
Description
Waist-hip ratio will be calculated
Time Frame
Change from Baseline in waist-hip ratio at 3 and 6 months
Title
Framingham scale
Description
The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual.
Time Frame
Change from Baseline in Framingham scale at 3 and 6 months
Title
Global Assesment of funtioning Scale
Description
This scale evaluates psychological, social, and occupational functioning dimensions on a hypothetical continuum of mental health-illness.
Time Frame
Change from Baseline in Global Assesment of funtioning Scale at 3 and 6 months
Title
PANNS
Description
The Positive and Negative Syndrome Scale for mental disorder
Time Frame
Change from Baseline in PANNS at 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 40 years old, A body mass index higher than 30 Psychopathologically stabilized Exclusion Criteria: Cognitive impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Manuel Pérez Mármol, PhD
Organizational Affiliation
Department of Physiotherapy. Faculty of Health Sciences, University of Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
José Manuel Pérez Mármol
City
Córdoba
ZIP/Postal Code
18007
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of a Psychoeducation Program in Patients With Severe Mental Disorder

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