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

Not Applicable

• Conditions: Psychiatric Hospitalization; Educational Problems; Family Relations; Relapse; Medication Adherence; Psychiatric Disorder; Schizophrenia; Mental Disorder
• Interventions: Behavioral: Psychoeducation

• Registration Number: NCT03000985
• Lead Sponsor: Centre Hospitalier Charles Perrens, Bordeaux

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).

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-12-16
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-22
• Primary Completion: 2020-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-18
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychoeducation	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.

Primary Outcome Measures

Name	Time	Method
Relapse	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)	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 Outcome Measures

Name	Time	Method
Quality of Life	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.
Burden	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.

Trial Locations

Locations (1)

Centre Hospitalier Charles PERRENS; 🇫🇷 Bordeaux, France