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

NCT ID: NCT03000985

Last Updated: 2021-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2021-12-31

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Psychoeducation

Intervention Type BEHAVIORAL

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

Control

Treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psychoeducation

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Charles Perrens, Bordeaux

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Charles PERRENS

Bordeaux, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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David MISDRAHI, M.D

Role: primary

003356563449

Arnaud TESSIER, M.Sc

Role: backup

003356563449

References

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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.

Reference Type BACKGROUND
PMID: 21830849 (View on PubMed)

Tessier A, Roger K, Gregoire A, Desnavailles P, Misdrahi D. Family psychoeducation to improve outcome in caregivers and patients with schizophrenia: a randomized clinical trial. Front Psychiatry. 2023 Jun 23;14:1171661. doi: 10.3389/fpsyt.2023.1171661. eCollection 2023.

Reference Type DERIVED
PMID: 37426102 (View on PubMed)

Other Identifiers

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PHRIP PSY EDUC 2013

Identifier Type: -

Identifier Source: org_study_id

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