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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03000985
Acronym
PSYEDUC
Enrollment
60
Registered
2016-12-22
Start date
2016-04-30
Completion date
2021-12-31
Last updated
2021-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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).

Interventions

BEHAVIORALPsychoeducation

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

Sponsors

Centre Hospitalier Charles Perrens, Bordeaux
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Relapsebaseline (pre-treatment) to six months post-baselineReduction 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

MeasureTime frameDescription
Quality of Lifebaseline (pre-treatment) to six months post-baselineChange from baseline (pre-treatment) to 6 months post-baseline in patient-report of quality of life using the Schizophrenia Caregiver Quality of Life questionnaire.
Burdenbaseline (pre-treatment) to six months post-baselineChange from baseline (pre-treatment) at 6 months post-baseline in family-report of burden using the Zarit Questionnaire.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026