Measures
After recruitment and obtaining written consent from participants, but prior to randomization, baseline assessments will be taken by AH. Baseline assessment includes clinical information from the patient’s clinic record (medical diagnosis and illness duration) and demographic information; age, education level, employment status and marital status.
The primary outcomes for patients and primary caregivers are knowledge about schizophrenia measured by the Knowledge about Schizophrenia Questionnaire (KASQ). Secondary outcomes are schizophrenia symptoms measured by the Positive and Negative Symptom Scale (PANSS) for patients and Family Burden of Care measured by the Family Burden interview Scale (FBIS) and quality of life measured by the Schizophrenic Carers Quality of Life Scale (S-CQoL) for caregivers.
KASQ is a self-reported questionnaire developed by Ascher-Svanum [
25]. It consists of 25 multiple-choice items intended to measure patients’ basic knowledge about schizophrenia and its management, aetiology, prevalence, prognosis, treatment and anti-psychotic medication effects and side effects. KASQ is scored from 0 to 25 with a higher score indicating more knowledge. KASQ has been used with people diagnosed with Schizophrenia and carers worldwide. Studies with subgroups [
25] reported Cronbach’s alpha coefficients of 0.89 and 0.85 and test-retest reliability coefficient over three weeks was 0.83.
The PANSS was developed by Kay [
26]. It assesses positive, negative and general psychopathology schizophrenia symptoms. The scale measures 30 clinical symptoms of schizophrenia, each symptom is scored from 1 indicating absence of psychopathology to 7 indicating severe psychopathology with higher scores indicating a poorer mental health status. The scale has good internal reliability and criterion related validity was examined with Andreasen rating systems. The result indicated that high correlation between two positive scales (r = 0.77, P < .0001) and negative scales (r = 0.77, P < .0001). And GPS from PANSS examined with Clinical Global Impression scale (CGI) and correlation was (r = 0.52, P < .0001) [
27].
The FBIS was developed by Pai and Kapur [
28] and assesses subjective, objective and global burden care of caring for mentally ill relatives at home. The FBIS consists of 24 items and focuses on six domains of caregivers’ burden: family finance, routine, leisure time, physical health, mental health and family interaction. Each item is rated on a three-point Likert scale (0: no burden, 1: moderate burden, 2: severe burden). The participants’ final scores range from 0 to 48; a higher score indicates a higher level of burden. The scale has good reliability and validity (Cronbach’s alpha 0.87; test-retest 0.83) [
29].
The S-CQoL was developed by Richieri [
30] to assess the impact of caring for people diagnosed with Schizophrenia on carers’ quality of life. The S-CQoL consists of 25 items scored from 25 to 125; a higher score indicates a good quality of life. The S-CQoL has seven dimensions: Physical and Psychological Wellbeing (PsPhW), Psychological Burden and Daily Life (PsBDL), Relationships with Spouse (RS), Relationships with Psychiatric Team (RPT), Relationship with Family (RFa), Relationships with friends (RFr) and Material Burden (MB). The Scale has an adequate internal consistency for all dimensions ranging from 0.64 to 0.95 and Cronbach’s alpha is 0.79 to 0.92. External validity examination was shown a significantly correlated S-QoL dimension with all short form-36 dimension scores (SF-36) [
30].
In reviewed literature, there were disparities in the operational definition of relapse. However, the majority of these studies adopted numbers of readmission, or exacerbations in psychotic symptoms of more than 5–10 points measured on the Brief Psychiatric Rating Scale (BPRS) or PANSS, the number of increases in anti-psychotic medication dosage, or medication compliance. For this study, relapse is defined as the number of readmissions measured at baseline three months prior to the study commencing, at end of intervention immediately and three months follow up. Furthermore, relapse with medication means the numbers of increasing current antipsychotic medications prescribed to patients during the same intervals. These data will be obtained from participants’ medical records.
None of these outcomes have been used in an Arabic speaking country so they will be translated from English to Arabic and back translated to English, checked for any discrepancies by independent bilingual translator and original author for each instrument to maintain content validity. Prior to the main study, we will recruit two patients and two carers to test participants’ acceptability and understanding of the scales.
All measures will be assessed at baseline, immediately post-intervention and at 3 month follow-up.
Data analysis
The first stage of the quantitative data analysis will describe participants’ responses to the continuous variables, i.e. KASQ, PANSS, FBIS and S-CQOL scores and patients’ total and mean relapse rates. The next stage of the data analysis will compare KASQ, PANSS, FBIS and S-CQOL scores, and patient relapse rates between the intervention and control arms using independent sample t tests, or non-parametric equivalents if the data are not normally distributed. Effect sizes, 95% confidence intervals (CI), Numbers needed to treat (NNT) and odds ratios will be reported. The third stage of the data analysis will use regression analyses to identify which of the baseline measures are statistically significant predictors of post intervention and follow-up outcomes. The final stage of the data analysis will investigate pre and post intervention differences on all measures within the intervention and control arms using a related t test or non-parametric equivalent if the data are not normally distributed. The level of significance for all analyses will be set at p < 0.05. Analysis will be conducted using the Statistical Package for the Social Sciences (SPSS) version 21.