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Completed

NCT Number: NCT04272541

Effectiveness of a Psychoeducation Program in Patients With Severe Mental Disorder

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.

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Key information

Conditions

Mental Health Disorder Glucose Metabolism Disorders Healthy Lifestyle Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

José Manuel Pérez Mármol

Córdoba, 18007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Cognitive impairment

Treatment and study plan

Psychoeducation program

Behavioral

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

Other names: Mixed treatment program

Psychopharmacology intervention

Drug

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

Other names: Standard intervention

Primary outcomes

  1. weight

    Time frame: Change from Baseline in weight at 3 and 6 months

    This measurement registers weight in Kg

Secondary outcomes

  1. waist circumference

    Time frame: Change from Baseline in waist circumference at 3 and 6 months

    This measurement registers waist circumference in cm

  2. waist-hip ratio

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

    Waist-hip ratio will be calculated

  3. Framingham scale

    Time frame: 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.

  4. Global Assesment of funtioning Scale

    Time frame: 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.

  5. PANNS

    Time frame: Change from Baseline in PANNS at 3 and 6 months

    The Positive and Negative Syndrome Scale for mental disorder

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 17, 2020
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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