Schizophrenia and schizoaffective disorders Mental and Behavioural Disorders Schizophrenia
Conditions
Interventions
Current intervention as of 31/12/2020:
ETAU Control arm
In Pakistan, the usual treatment for patients suffering from psychosis consists of accessing hospital-based psychiatric services with little inv
Sponsors
Khyber Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 13/08/2019: Participant inclusion criteria 1. Have a diagnosis of schizophrenia or schizoaffective disorder based on the International Classification of Disease 10 (ICD-10) criteria assessed using the Mini-International Neuropsychiatric Interview (MINI, Sheehan et al., 1998). 2. Aged between 17-65 years. 3. Do not meet the criteria for remission as defined by the Remission in Schizophrenia Working Group (Andreasen et al., 2005). 4. Have capacity and are able to give informed consent. Previous inclusion criteria: 1. Have a diagnosis of schizophrenia or schizoaffective disorder based on the International Classification of Disease 10 (ICD-10) criteria assessed using the Mini-International Neuropsychiatric Interview (MINI, Sheehan et al., 1998). 2. Aged between 17-45 years. 3. Do not meet the criteria for remission as defined by the Remission in Schizophrenia Working Group (Andreasen et al., 2005). 4. Have capacity and are able to give informed consent.
Exclusion criteria
Exclusion criteria: 1. Have a serious or unstable medical illness. 2. Have a learning disability. 3. Have a severe drug dependence requiring treatment and/or detoxification. 4. Pregnant, trying to get pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Assessment of Functioning Scale (GAF, American Psychiatric Association, 2000) and Medication adherence are measured using a 5-point Likert scale (where 1 always takes medication and 5 is never), adapted from Herz et al. (2000) at baseline, 6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 31/12/2020: 1. Mental state and psychiatric symptoms are measured using the Brief Psychiatric Rating Scale (BPRS)(Overall et al, 1962) at screening, baseline, 6 and 12 months. 2. Caregivers’ burden is measured using the Family Burden Scale (Pai & Kapur, 1981) at baseline, 6 and 12 months. 3. Physical health assessments are measured using the Body Mass Index (BMI) Blood Pressure, waist circumference, PHC health record at baseline. 4. Perceived stigma is measured using the internalized Stigma of Mental Illness (Lysaker et al, 2007) at baseline, 6 and 12 months. 5. Cost of care is measured using the Client Service Receipt Inventory SRI (Chisholm et al, 2000) at baseline, 6 and 12 months. 6. Quality-adjusted life year (QALY) and general Health status are measured using the EuroQoL (EQ5D) (Whynes et al, 2008) which is a standardized instrument for measuring generic health status will be used for computing quality-adjusted life year (QALY) at baseline, 6 and 12 months. 7. Side effects of antipsychotic medication are measured using the Glasgow Antipsychotic Side-effect Scale (GASS) at baseline, 6 and 12 months. 8. Drug use is measured using the Drug Abuse Screening Test-10 (DAST-10 Skinner, 1982) at baseline, 6 and 12 months. 9. Illness severity, improvement and response to treatment is measured using the Clinical Global Impression (CGI Guy, 1976) at baseline, 6 and 12 months. 10. Depression is measured using the Patient Health Questionnaire (PHQ9 Kroenke, 2001) at baseline, 6 and 12 months. 11. Suicide ideation is measured using the Suicide Behaviours Questionnaire-Revised (SBQ-R Osman, 2001) at baseline, 6 and 12 months. _____ Previous secondary outcome measures as of 13/08/2019: 1. Mental state and psychiatric symptoms are measured using the Brief Psychiatric Rating Scale (BPRS)(Overall et al, 1962) at screening, baseline, 6 and 12 months. 2. Caregivers’ burden is measured using the Family Burden Scale (Pai & Kapur, 1981) at ba | — |
Countries
Pakistan, United Kingdom
Contacts
Public ContactMichelle;Saeed Robinson;Farooq
;
Outcome results
None listed