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

Primary Purpose

Schizophrenia, Mental Disorder, Educational Problems

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Psychoeducation

About this trial

This is an interventional supportive care trial for Schizophrenia focused on measuring schizophrenia, psychoeducation program, family caregiver, relapse, medication adherence, burden

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier Charles PERRENSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Psychoeducation

Control

Arm Description

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.

Treatment as usual

Outcomes

Primary Outcome Measures

Relapse

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)

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

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.

Burden

Change from baseline (pre-treatment) at 6 months post-baseline in family-report of burden using the Zarit Questionnaire.

Full Information

NCT ID

NCT03000985

First Posted

December 16, 2016

Last Updated

August 17, 2021

Sponsor

Centre Hospitalier Charles Perrens, Bordeaux

1. Study Identification

Unique Protocol Identification Number

NCT03000985

Brief Title

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

Acronym

PSYEDUC

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 2016 (undefined)

Primary Completion Date

December 2020 (Actual)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Charles Perrens, Bordeaux

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

schizophrenia, psychoeducation program, family caregiver, relapse, medication adherence, burden

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Psychoeducation

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

Treatment as usual

Intervention Type

Behavioral

Intervention Name(s)

Psychoeducation

Intervention Description

6 session psychoeducation program with the family caregiver of schizophrenics patients.

Primary Outcome Measure Information:

Title

Relapse

Description

Reduction in the rate of relapse (hospitalization) in patients whose family participated in the psychoeducation group compared to patients without psychoeducation.

Time Frame

baseline (pre-treatment) to six months post-baseline

Title

Medication adherence (caregiver perception)

Description

Change from baseline (pre-treatment) to 6 months post-baseline in caregiver-report of medication adherence using respectively the Compliance Rating Scale.

Time Frame

baseline (pre-treatment) to six months post-baseline.

Secondary Outcome Measure Information:

Title

Quality of Life

Description

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.

Time Frame

baseline (pre-treatment) to six months post-baseline

Title

Burden

Description

Change from baseline (pre-treatment) at 6 months post-baseline in family-report of burden using the Zarit Questionnaire.

Time Frame

baseline (pre-treatment) to six months post-baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Centre Hospitalier Charles PERRENS

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David MISDRAHI, M.D

Phone

003356563449

dmisdrahi@ch-perrens.fr

First Name & Middle Initial & Last Name & Degree

Arnaud TESSIER, M.Sc

Phone

003356563449

atessier@ch-perrens.fr

12. IPD Sharing Statement

Citations:

PubMed Identifier

21830849

Citation

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.

Results Reference

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

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