Clinical trial NCT03000985: Evaluation of a Psychoeducation Program for Families Caregivers of Schizophrenic Patients : Randomized Study in Two Arms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Mental Disorder
Educational Problems
Family Relations
Relapse
Medication Adherence
Psychiatric Disorder
Psychiatric Hospitalization
Keywords: schizophrenia
psychoeducation program
family caregiver
relapse
medication adherence
burden
Lead sponsor: Centre Hospitalier Charles Perrens, Bordeaux
Sponsor class: OTHER_GOV
First posted: 2016-12-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Relapse
timeFrame: baseline (pre-treatment) to six months post-baseline
measure: Medication adherence (caregiver perception)
timeFrame: baseline (pre-treatment) to six months post-baseline.
Secondary outcomes:
measure: Quality of Life
timeFrame: baseline (pre-treatment) to six months post-baseline
measure: Burden
timeFrame: baseline (pre-treatment) to six months post-baseline
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Charles PERRENS
Study officials:
References:
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.