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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04272541

Enrollment

Registered

2020-02-17

Start date

2020-02-20

Completion date

2020-11-20

Last updated

2021-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Lifestyle, Mental Health Disorder

Keywords

cardiovascular risk, metabolic syndrome, independency, psychopathology

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.

Interventions

BEHAVIORALPsychoeducation program

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

DRUGPsychopharmacology intervention

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 90 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Cognitive impairment

Design outcomes

Primary

Measure	Time frame	Description
weight	Change from Baseline in weight at 3 and 6 months	This measurement registers weight in Kg

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026