SchizophreniaPSYEDUCNCT03000985
Evaluation of a Psychoeducation Program for Families Caregivers of Schizophrenic Patients : Randomized Study in Two Arms
A study testing Psychoeducation in people with Schizophrenia and Mental Disorder, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Mental Disorder, Educational Problems
- What is being tested?
- Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Charles PERRENS
Bordeaux, 33076
David MISDRAHI, M.D, 003356563449, dmisdrahi@ch-perrens.fr
Arnaud TESSIER, M.Sc, 003356563449, atessier@ch-perrens.fr
About this study
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).
- Conditions
- Schizophrenia, Mental Disorder, Educational Problems, Family Relations, Relapse, Medication Adherence
- Being tested
- Psychoeducation
- Keywords
- schizophrenia, psychoeducation program, family caregiver, relapse, medication adherence, burden
- Medical subject headings
- Schizophrenia, Mental Disorders, Recurrence, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
6 session psychoeducation program with the family caregiver of schizophrenics patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Psychoeducation |
| Control | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse
Reduction in the rate of relapse (hospitalization) in patients whose family participated in the psychoeducation group compared to patients without psychoeducation.
Measured: 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.
Measured: baseline (pre-treatment) to six months post-baseline.
Secondary outcomes (2)
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.
Measured: baseline (pre-treatment) to six months post-baseline
Burden
Change from baseline (pre-treatment) at 6 months post-baseline in family-report of burden using the Zarit Questionnaire.
Measured: baseline (pre-treatment) to six months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2020
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Charles Perrens, Bordeaux
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000985
- Sponsor's protocol ID
- PHRIP PSY EDUC 2013
- Acronym
- PSYEDUC
- Status last verified
- Aug 2021
- First submitted
- 16 Dec 2016
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
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 21830849Tessier 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.
PubMed 37426102
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Psychoeducation Program for Families Caregivers of Schizophrenic Patients : Randomized Study in Two Arms
- ClinicalTrials.gov ID
- NCT03000985
- Acronym / sponsor ID
- PSYEDUC / PHRIP PSY EDUC 2013
- Conditions
- Schizophrenia, Mental Disorder, Educational Problems, Family Relations, Relapse, Medication Adherence
- Keywords
- schizophrenia, psychoeducation program, family caregiver, relapse, medication adherence, burden
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Charles Perrens, BordeauxOther government
- Study start
- Apr 2016
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 22 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation | Experimental | Behavioral: Psychoeducation6 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. |
| Control | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducation6 session psychoeducation program with the family caregiver of schizophrenics patients. | Behavioural | Psychoeducation |
Primary outcome
Relapse
Time frame: baseline (pre-treatment) to six months post-baseline
Reduction in the rate of relapse (hospitalization) in patients whose family participated in the psychoeducation group compared to patients without psychoeducation.
Medication adherence (caregiver perception)
Time frame: 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.
2 secondary outcomes
Quality of Life
Time frame: baseline (pre-treatment) to six months post-baseline
Burden
Time frame: baseline (pre-treatment) to six months post-baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Background: PubMed 21830849Misdrahi 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.
- Derived from this study: PubMed 37426102Tessier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation in people with Schizophrenia and Mental Disorder, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse (time frame: baseline (pre-treatment) to six months post-baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03000985, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.