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

Schizophrenia Clinical Trial

— PSYEDUC  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03000985
• Other study ID #: PHRIP PSY EDUC 2013
• Status: Recruiting
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2021

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Charles Perrens, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Educational Problems
• Family Relations
• Medication Adherence
• Mental Disorder
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder
• Psychiatric Hospitalization
• Recurrence
• Relapse
• Schizophrenia

Intervention

Behavioral:
• Psychoeducation
6 session psychoeducation program with the family caregiver of schizophrenics patients.

Locations

Country	Name	City	State
France	Centre Hospitalier Charles PERRENS	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Charles Perrens, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (1)

Misdrahi D, Petit M, Blanc O, Bayle F, Llorca PM. The influence of therapeutic alliance and insight on medication adherence in schizophrenia. Nord J Psychiatry. 2012 Feb;66(1):49-54. doi: 10.3109/08039488.2011.598556. Epub 2011 Aug 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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