Efficacy of a psychoeducational programme to reduce the burden associated with caring for a patient with schizophrenia or schizoaffective disorder

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN32545295

Enrollment

200

Registered

2012-03-15

Start date

2012-03-05

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burden associated with schizophrenia or schizoaffective disorder caregiving Mental and Behavioural Disorders Problems related to certain psychosocial circumstances

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change since baseline to endpoint in the caregiver burden as assessed by the Zarit Burden Interview and the Involvement Evaluation Questionnaire.	—

Secondary

Measure	Time frame
1. Change since baseline to endpoint in the caregiver mental health as assessed by the General Health Questionnaire, 28 items (GHQ-28) 2. Change since baseline to endpoint in the caregiver anxiety as assessed by the State-Trait Anxiety Inventory (STAI) 3. Change since baseline to endpoint in the caregiver depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D) 4. Change since baseline to endpoint in the patient?s problems as assessed by the Health of the Nation Outcome Scales. (HONOS) 5. Number of institutionalizations since baseline	—

Measure

Time frame

1. Change since baseline to endpoint in the caregiver mental health as assessed by the General Health Questionnaire, 28 items (GHQ-28) 2. Change since baseline to endpoint in the caregiver anxiety as assessed by the State-Trait Anxiety Inventory (STAI) 3. Change since baseline to endpoint in the caregiver depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D) 4. Change since baseline to endpoint in the patient?s problems as assessed by the Health of the Nation Outcome Scales. (HONOS) 5. Number of institutionalizations since baseline

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026