Evaluation of the impact of a PsychoEducational intervention on knowledge levels and Psychological outcomes for schizophrenic patients and their carers in Jordan

ISRCTN	ISRCTN78084871
DOI	https://doi.org/10.1186/ISRCTN78084871
Protocol serial number	N/A
Sponsor	University of Nottingham (UK)
Funder	Islamic Development Bank (Saudi Arabia)

Submission date: 27/11/2013
Registration date: 16/12/2013
Last edited: 27/10/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Schizophrenia is one of the most serious forms of mental illness among people being treated in psychiatric clinics in developing and developed countries, and can be chronic , recurrent, disabling and debilitating (affecting the ability to carry on with regular activities). The aims of this study are to examine the effectiveness of delivering a psychoeducational intervention, in booklet form, on schizophrenia knowledge of patients and caregivers, positive and negative schizophrenia symptoms, relapse rate of patients, burden of care, and quality of life of caregivers.

Who can participate?
The study aims to recruit about 144 men and women living with schizophrenia or schizoaffective disorder and their primary caregivers, age > 18 years from outpatient clinics in four mental health clinics in Jordan.

What does the study involve?
At baseline (before the start of the intervention), participants were invited to sign a consent form and complete baseline measures (knowledge level, schizophrenia symptoms and relapse rate). Baseline measures for carers are knowledge level, burden of care and quality of life. Participants were randomly allocated to one of two groups: participants in the intervention arm of the study received a psychoeducation booklet each fortnight plus treatment as usual in the clinic for 12 weeks. On the other hand, participants in control group received treatment as usual in the outpatient clinic for 12 weeks. The outcomes were again measured at the end of the treatment and at three months follow-up.

What are the possible benefits and risks of participating?
Potential benefits from this study include increasing patients' knowledge about schizophrenia, improved positive and negative symptoms associated with schizophrenia and reduced relapse rate. Potential benefits to caregivers are improved quality of life, enhanced knowledge level and reduced burden of care.

Where is the study run from?
In the four major outpatient clinics for mental health in Jordan.

When is the study starting and how long is it expected to run for?
Recruitment started at the end of 2012. Participants were enrolled on the study for a period of 6 months.

Who is funding the study?
Islamic Development Bank (Saudi Arabia).

Who is the main contact?
Professor Patrick Callaghan
Dr Joanne Lymn, Joanne.Lymn@nottingham.ac.uk
Mr Abd Alhadi Hasan, ntxah3@nottingham.ac.uk

Contact information

Dr Patrick Callaghan
Scientific

University of Nottingham
A Floor
Queens Medical Centre
Nottingham
NG7 2HA
United Kingdom

Study information

Primary study design	Interventional
Study design	Placebo-controlled single-blind randomized controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluation of the impact of a PsychoEducational intervention on knowledge levels and Psychological outcomes for people diagnosed with schizophrenia and their carers in Jordan: A randomized controlled trial and process evaluation
Study acronym	PEP
Study objectives	Patients who receive psychoeducation will show equal or greater knowledge of schizophrenia, improved psychotic symptoms and lower relapse rates at post-intervention and follow-up than patients who receive treatment as usual (TAU). Carers who receive psychoeducation will show equal or greater knowledge of schizophrenia, lower burden of care and improved quality of life post-intervention and follow-up than carers who receive TAU.
Ethics approval(s)	1. Jordanian Ministry of Health Ethics Committee, 10/08/2012 2. University of Nottingham Medical Ethical Committee, 23/07/2012
Health condition(s) or problem(s) studied	Schizophrenia
Intervention	Intervention: treatment as usual + psychoeducational intervention Based on Atkinson and Coia model. It consists of six booklets each fortnight covering essential topics to patients and carers: 1. General information about schizophrenia 2. Anti-psychotic medication effects and side effects 3. Relapse signs 4. Problem solving 5. Coping with Illness Control: Treatment as usual for 12 weeks. Patients and carers will be followed up at baseline, end of treatment and three months follow-up.
Intervention type	Other
Primary outcome measure(s)	1. Patients' primary outcome is knowledge level about schizophrenia measured by knowledge about schizophrenia questionnaires (KASQ) 2. Carers' primary outcome is knowledge level about schizophrenia measured by knowledge about schizophrenia questionnaires (KASQ) All outcomes measured at baseline, end of treatment and three months follow up.
Key secondary outcome measure(s)	Patient: 1. Schizophrenia symptoms are measured by the positive and negative syndrome scale (PANSS) 2. Relapse with hospitalization is measured by the number of mental hospital re-admissions 3. Relapse with medication is calculated by the number of anti-psychotic drug dosage increases Caregivers: 1. Burden of care is measured by Family Burden Interview Schedule (FBIS) 2. Quality of life is measured by Schizophrenia-Caregiver Quality of Life (S-CQoL) All outcomes measured at baseline, end of treatment and three months follow up.
Completion date	01/05/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	144
Key inclusion criteria	Patients: 1. Diagnosed with schizophrenia or schizoaffective disorder based on the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) 2. Able to read Arabic or English language 3. Written consent 5. Aged 18 or over, either sex Caregivers: 1. Primary caregivers - caregivers who mostly involved in patients' care 2. Able to read Arabic or English language 3. Written consent 5. Aged 18 or over, either sex
Key exclusion criteria	Patients: 1. Any learning disability 2. Presence of known organic mental disorder 3. Had a history of substance abuse or current substance abuse 4. Living alone without caregivers or attended any psychosocial intervention previously Caregivers: Involved in caring for more than one patient with mental disorder
Date of first enrolment	01/09/2012
Date of final enrolment	01/05/2013

Locations

Countries of recruitment

United Kingdom
England
Jordan

Study participating centre

University of Nottingham

Nottingham
NG7 2HA
United Kingdom

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	08/04/2015		Yes	No
Protocol article	protocol	22/01/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes