Condition category
Mental and Behavioural Disorders
Date applied
27/11/2013
Date assigned
16/12/2013
Last edited
27/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Patrick Callaghan

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

PEP

Study hypothesis

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

1. Jordanian Ministry of Health Ethics Committee, 10/08/2012
2. University of Nottingham Medical Ethical Committee, 23/07/2012

Study design

Placebo-controlled single-blind randomized controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/09/2012

Overall trial end date

01/05/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

144

Participant 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

Recruitment start date

01/09/2012

Recruitment end date

01/05/2013

Locations

Countries of recruitment

Jordan

Trial participating centre

University of Nottingham
Nottingham
NG7 2HA
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Queens Medical Centre
Nottingham
NG7 2HA
United Kingdom

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Other

Funder name

Islamic Development Bank (Saudi Arabia)

Alternative name(s)

IDB

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Saudi Arabia

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24450608
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25885432

Publication citations

  1. Protocol

    Hasan AA, Callaghan P, Lymn JS, Evaluation of the impact of a psycho-educational intervention on knowledge levels and psychological outcomes for people diagnosed with Schizophrenia and their caregivers in Jordan: a randomized controlled trial., BMC Psychiatry, 2014, 14, 17, doi: 10.1186/1471-244X-14-17.

  2. Results

    Hasan AA, Callaghan P, Lymn JS, Evaluation of the impact of a psycho-educational intervention for people diagnosed with schizophrenia and their primary caregivers in Jordan: a randomized controlled trial, BMC Psychiatry, 2015 , 15, 72, doi: 10.1186/s12888-015-0444-7.

Additional files

Editorial Notes