CClinicalTrials.gg
Status unknownNCT03000985PSYEDUCUpdated Aug 18, 2021

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

An interventional study of Psychoeducation in Schizophrenia, Mental Disorder and Educational Problems, sponsored by Centre Hospitalier Charles Perrens, Bordeaux. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-18.

Sponsored by Centre Hospitalier Charles Perrens, Bordeaux · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

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

Keywords

  • schizophrenia
  • psychoeducation program
  • family caregiver
  • relapse
  • medication adherence
  • burden
03

In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 3,374 interventional studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

Centre Hospitalier Charles Perrens, Bordeaux is the lead sponsor of 19 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Psychoeducation

  • No intervention
    Control

    Treatment as usual

Interventions

  • BehavioralPsychoeducation

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

06

What researchers measure

Primary outcomes

  1. Relapse

    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

  2. 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.

    Time frame: baseline (pre-treatment) to six months post-baseline.

Secondary outcomes

  1. 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.

    Time frame: baseline (pre-treatment) to six months post-baseline

  2. Burden

    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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 21830849 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03000985
Lead sponsor
Centre Hospitalier Charles Perrens, Bordeaux
Responsible party
Sponsor
First posted
Dec 22, 2016
Start date
Apr 2016
Primary completion
Dec 2020
Completion
Dec 2021 (estimated)
Last update
Aug 18, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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