NCT03000985

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

4.7 years

First QC Date

December 16, 2016

Last Update Submit

August 17, 2021

Conditions

SchizophreniaMental DisorderEducational ProblemsFamily RelationsRelapseMedication AdherencePsychiatric DisorderPsychiatric Hospitalization

Keywords

schizophreniapsychoeducation programfamily caregiverrelapsemedication adherenceburden

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Quality of Life

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

  • Burden

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

Study Arms (2)

Psychoeducation

EXPERIMENTAL

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

Control

NO INTERVENTION

Treatment as usual

Interventions

PsychoeducationBEHAVIORAL

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

Psychoeducation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Charles PERRENS

Bordeaux, 33076, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 21830849BACKGROUND

  • 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.

    PMID: 37426102DERIVED

MeSH Terms

Conditions

SchizophreniaMental DisordersRecurrenceMedication Adherence

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2016

First Posted

December 22, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

August 18, 2021

Record last verified: 2021-08

Locations

FR(1)