Evaluation of a Psychoeducation Program for Families Caregivers of Schizophrenic Patients : Randomized Study in Two Arms (PSYEDUC)

August 17, 2021 updated by: Centre Hospitalier Charles Perrens, Bordeaux

The involvement of family members is crucial and improves the prognosis of psychiatric patients and reinforces therapeutic adherence and reduces the frequency of relapses. For schizophrenia, the scientific literature clearly shows that it's in the interest of the patient to offer to his family a psychoeducational program.

Therapeutic education programs are now part of the recommendations of good clinical practice and in the French health through the law n ° 2009-879 of July 21, 2009 on the reform of the hospital and relating to patients, health and territories.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objectives We conducted a randomized study in two groups to evaluate the impact of a psychoeducational program for caregivers.

Methods 60 patients with a DSM-V diagnosis of schizophrenia and their families' caregivers are recruited. Families' caregivers are randomly assigned to receive either a 6 session psychoeducation program, or no psychoeducation.

Baseline evaluations:

Patients: symptomatology (PANSS), medication adherence (MARS); Families' Caregivers: Quality of Life (S-CGQoL), Burden (Zarit), knowledge of disease (KAST), therapeutic alliance (4PAS caregivers), depression (CES-D), medication adherence (CRS).

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of schizophrenia, based on ICD-10 (F20 to F29)
  • Receive in-patient treatment at hospital (or medical center linked to Charles Perrens Hospital)
  • Be the caregiver or parent of the patient
  • Patient informed of the diagnosis of his disease

Exclusion Criteria:

  • Mental retardation or other diagnoses that could affect the ability to answer questionnaires, after the acute schizophrenia psychosis is controlled
  • Suicidal ideation
  • Non-comprehension of the French language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Treatment as usual
Experimental: Psychoeducation
6 session of a psychoeducation program with the family. Psychoeducation focuses on explaining schizophrenia as a medical illness, the prognosis, and how the patient and family can increase the likelihood of better outcome.
Behavioral: Psychoeducation
6 session psychoeducation program with the family caregiver of schizophrenics patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse
Time Frame: baseline (pre-treatment) to six months post-baseline
Reduction in the rate of relapse (hospitalization) in patients whose family participated in the psychoeducation group compared to patients without psychoeducation.
baseline (pre-treatment) to six months post-baseline
Medication adherence (caregiver perception)
Time Frame: baseline (pre-treatment) to six months post-baseline.
Change from baseline (pre-treatment) to 6 months post-baseline in caregiver-report of medication adherence using respectively the Compliance Rating Scale.
baseline (pre-treatment) to six months post-baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: baseline (pre-treatment) to six months post-baseline
Change from baseline (pre-treatment) to 6 months post-baseline in patient-report of quality of life using the Schizophrenia Caregiver Quality of Life questionnaire.
baseline (pre-treatment) to six months post-baseline
Burden
Time Frame: baseline (pre-treatment) to six months post-baseline
Change from baseline (pre-treatment) at 6 months post-baseline in family-report of burden using the Zarit Questionnaire.
baseline (pre-treatment) to six months post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Charles Perrens, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 16, 2016

First Submitted That Met QC Criteria

December 20, 2016

First Posted (Estimate)

December 22, 2016

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRIP PSY EDUC 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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