Effectiveness of a Psychoeducation Program in Patients With Severe Mental Disorder

NCT ID: NCT04272541

Last Updated: 2021-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-20

Study Completion Date

2020-11-20

Brief Summary

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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

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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.

Conditions

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Mental Health Disorder Healthy Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Psychoeducation program

Intervention Type BEHAVIORAL

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

Habitual intervention

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

Group Type ACTIVE_COMPARATOR

Psychopharmacology intervention

Intervention Type DRUG

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

Interventions

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Psychoeducation program

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

Intervention Type BEHAVIORAL

Psychopharmacology intervention

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

Intervention Type DRUG

Other Intervention Names

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Mixed treatment program Standard intervention

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Cognitive impairment
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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José Manuel Pérez Mármol

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José Manuel Pérez Mármol, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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José Manuel Pérez Mármol

Córdoba, , Spain

Site Status

Countries

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Spain

Other Identifiers

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NCT04272541

Identifier Type: -

Identifier Source: org_study_id

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