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

Study Overview
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Brief Summary
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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
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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).

Conditions
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Schizophrenia, Mental Disorder, Educational Problems, Family Relations, Relapse, Medication Adherence, Psychiatric Disorder, Psychiatric Hospitalization

Intervention / Treatment
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* Behavioral: Psychoeducation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychoeducation<br>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<br>* 6 session psychoeducation program with the family caregiver of schizophrenics patients.<br>|
| No Intervention: Control<br>Treatment as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse | 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) | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relapse, schizophrenia, psychoeducation program, family caregiver, medication adherence, burden