Efficacy of a psychoeducational programme to reduce the burden associated with caring for a patient with schizophrenia or schizoaffective disorder
| ISRCTN | ISRCTN32545295 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32545295 |
| Protocol serial number | PI10/01049 |
| Sponsor | Institute of Psychiatric Research (Spain) |
| Funder | Carlos III Institute of Health [Instituto de Salud Carlos III] (Spain) ref: PI10/ 01049 |
- Submission date
- 02/03/2012
- Registration date
- 15/03/2012
- Last edited
- 08/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Caring for mentally ill patients is stressful and could increase the risk of developing several health problems. A preventative measure such as a psychoeducational intervention could be useful to decrease the burden associated with caregiving. The main aim of this study is to assess the effectiveness of a psychoeducational intervention to caregivers of people diagnosed with schizophrenia.
Who can participate?
Informal caregivers of schizophrenia and schizoaffective patients.
What does the study involve?
Participants are randomly allocated into two groups. One group receives the usual support from the day centres where the patient is being treated. The other group receives the same support plus a psychoeducative intervention of 12 sessions lasting 90-120 minutes. It includes information about the disease and training on different cognitive and behavioral skills. The study runs for 8 months. There are three assessment points at the start of the study and after 4 and 8 months.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Institute of Psychiatric Research (Spain).
When is the study starting and how long is it expected to run for?
March 2012 to October 2012.
Who is funding the study?
Carlos III Institute of Health (Spain).
Who is the main contact?
Dr Manuel Martín Carrasco
iip@fundacion-iip.org
Contact information
Scientific
Maria Josefa Recio Foundation
Institute of Psychiatric Research
Egaña 10
Bilbao
E-48010
Spain
| iip@fundacion-iip.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-arm evaluator-blind multicentre randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Efficacy of a psychoeducative intervention program to prevent or reduce the burden associated with caring for a patient with schizophrenia or schizoaffective disorder: a two arm, evaluator blind, multicentre, randomized controlled trial |
| Study acronym | EDUCA-III |
| Study objectives | 1. The caregivers allocated to the psychoeducative intervention program will present less burden at endpoint (4 months), and at follow up (8 months), than the caregivers allocated to the control condition. 2. The caregivers allocated to the psychoeducative intervention program will present better mental health at endpoint (4 months), and at follow up (8 months), than the caregivers allocated to the control condition. 3. The caregivers allocated to the psychoeducative intervention program will present less anxiety at endpoint (4 months), and at follow up (8 months), than the caregivers allocated to the control condition. 4. The caregivers allocated to the psychoeducative intervention program will present less depression at endpoint (4 months), and at follow up (8 months), than the caregivers allocated to the control condition. 5. The patients whose caregivers have been allocated to the psychoeducative intervention program will present less problems at endpoint (4 months), and at follow up (8 months), than the patients whose caregivers have been allocated to the control condition. 6. The patients whose caregivers have been allocated to the psychoeducative intervention program will present less psychiatric institutionalitation at endpoint (4 months), and at follow up (8 months), than the patients whose caregivers have been allocated to the control condition. |
| Ethics approval(s) | Ethical and Scientific Research Committee of Navarra, Spain, 10/10/2011, ref: Project 74/11 |
| Health condition(s) or problem(s) studied | Burden associated with schizophrenia or schizoaffective disorder caregiving |
| Intervention | Control group: Caregivers allocated to this group received the usual support from the day centre where the patients had a multifaceted/multiprofessional care which aimed at improvement or maintaining as long as possible functional, social, and cognitive abilities. The caregiver received periodical interviews and information about the situation and clinical course of the patient. Intervention group: Caregivers allocated to this group were exposed to the same usual care the control group received plus a psychoeducative intervention program. This intervention was administered in 12 group sessions of 90-120 minutes each and the sessions were administered weekly. The caregiver received standardized information about the clinical course of schizophrenia and training on different cognitive and behavioral skills to increase care abilities, communicative skills, pleasant events, seek support, and relaxation. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Change since baseline to endpoint in the caregiver burden as assessed by the Zarit Burden Interview and the Involvement Evaluation Questionnaire. |
| Key secondary outcome measure(s) |
1. Change since baseline to endpoint in the caregiver mental health as assessed by the General Health Questionnaire, 28 items (GHQ-28) |
| Completion date | 30/10/2012 |
Eligibility
| Participant type(s) | Carer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Males or females with age more than or equal to 18 years, giving care to a familiar person with a diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) -TR criteria 2. The caregiver was not professionally paid for caregiving 3. The familiar diagnosed of schizophrenia or schizoaffective disorder was receiving appropriate care as outpatient in a day centre or ambulatory centre 4. The caregiver spent a minimum of 4 hours/week to attend the patient with schizophrenia or schizoaffective disorder 5. The patient cared for had received a first disease diagnose or had had a first disease episode at least two years before trial recruitment 6. Signed informed consent, for both the patient and the caregiver, to participate in the trial |
| Key exclusion criteria | 1. Caregivers without time to attend the psychoeducative intervention training 2. Caregivers receiving currently or recently (last year), any standardized psychoeducative intervention similar to the one administered in the trial 3. The patient has been hospitalized the last month for a time over 30 days 4. The patient has been diagnosed of mental retardation, dementia or another cognitive disorder 5. The patient lives in a home supervised by professionals |
| Date of first enrolment | 05/03/2012 |
| Date of final enrolment | 30/10/2012 |
Locations
Countries of recruitment
- Spain
Study participating centre
E-48010
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/02/2016: Publication reference added.
