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Clinical Trials/NCT03000985
NCT03000985
Unknown
N/A

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

Centre Hospitalier Charles Perrens, Bordeaux1 site in 1 country60 target enrollmentApril 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Centre Hospitalier Charles Perrens, Bordeaux
Enrollment
60
Locations
1
Primary Endpoint
Relapse
Last Updated
4 years ago

Overview

Brief Summary

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.

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).

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
December 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Hospitalier Charles Perrens, Bordeaux
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Quality of Life(baseline (pre-treatment) to six months post-baseline)
  • Burden(baseline (pre-treatment) to six months post-baseline)

Study Sites (1)

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