Condition category
Mental and Behavioural Disorders
Date applied
15/01/2016
Date assigned
07/03/2016
Last edited
07/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Most people are affected by a mental health problem in some form during their lives. It is estimated that as many as 1% of the world’s population suffer from a serious mental disorder, such as schizophrenia. Schizophrenia is a long-term mental health problem that affects how a person thinks, feels and behaves. It involves a wide range of symptoms, including seeing or hearing things that do not exist (hallucinations), having beliefs that do not reflect reality (delusions) and distinct changes in personality or behaviour. These symptoms can be very difficult for patients to deal with, often affecting the way they live their lives and their ability to work. A study in 2007 found that there is a particularly high amount of people suffering from a serious mental disorder like schizophrenia in Jakarta (capital of Indonesia). It was also found that surprisingly few of these people sought treatment in hospital for their condition. Community mental health nursing (CMHN) is a programme set up to try and help people in the community who are at risk of developing a serious mental health problem by working with families to help build up a support network. The aim of this study is to find out whether the CMHN programme is more effective at helping schizophrenia patients to improve their life skills and how well they are able to work.

Who can participate?
Patients between 18 and 55 years old who have been diagnosed with schizophrenia.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group continue to receive standard care for their condition only. Those in the second groups also continue to receive standard care, but are also given weekly cognitive behavioural therapy sessions (a type of talking therapy aiming to change the way a person thinks and behaves) and weekly home visits from community mental health nurses to talk about their symptoms, for 12 weeks. All participants complete questionnaires in order to measure their life skills and work productivity at the start of the study and then again at 12 and 14 weeks.

What are the possible benefits and risks of participating?
Participants who receive the additional therapy may benefit from being able to better cope with their daily lives and being able to work better. There are no risks to participants taking part in the study.

Where is the study run from?
Twenty health centres in Jakarta (Indonesia)

When is the study starting and how long is it expected to run for?
March 2010 to July 2010

Who is funding the study?
Directorate of university research and community service in Indonesia (Indonesia)

Who is the main contact?
Professor Budi Anna Keliat

Trial website

Contact information

Type

Scientific

Primary contact

Prof Budi Anna Keliat

ORCID ID

Contact details

Jl. Pendidikan 3 No 14 RT 001/ RW 01 Babakan Gunung Gede
Bogor
16151
Indonesia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effectiveness of the implementation of Community Mental Health Nursing model to improve life skills and work productivity of patients with mental illness

Acronym

CMHN

Study hypothesis

The implementation of model of community mental health nursing (CMHN) effective in improving life skills and work productivity of patients with mental disorder.

Ethics approval

Nursing Faculty of Indonesia University ethics committee, 24/02/2010, ref: 174/H2.F12.D/HKP.02.04/2010

Study design

Community based randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

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

Condition

Schizophrenia

Intervention

Participants are randomly allocated to one of two groups.

Intervention group: Participants receive treatment via the community mental health model which includes standard therapy and nursing care for schizophrenia. Participants also receive 12 weeks of hour-long cognitive behavioural therapy appointments and weekly home-visits from a trained community nurse so that they can talk about any symptoms they have been experiencing.

Control group: Participants standard therapy and nursing care for schizophrenia only.

Participants are visited by a trained community nurse at 12 and 14 weeks, when their life skills and work productivity are assessed using questionnaires.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Life skills are measured using The Life skill Profile (LSP) at baseline, 12 and 14 weeks.

Secondary outcome measures

Work productivity is measured using the Indonesian version of Work Productivity and Activity Impairment (WPAI) Questionnaire at baseline, 12 and 14 weeks.

Overall trial start date

01/03/2010

Overall trial end date

30/07/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 17 years to 55 years
2. Capacity to provide informed consent
3. Ability to communicate well
4. Diagnosis of schizophrenia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

195

Participant exclusion criteria

Aged below 18 or above 65.

Recruitment start date

01/03/2010

Recruitment end date

09/04/2010

Locations

Countries of recruitment

Indonesia

Trial participating centre

Puskesmas Cipayung
Jakarta Selatan. Jl. Monumen Pancasila Sakti Jakarta Timur
Jakarta
13810
Indonesia

Sponsor information

Organisation

DRPM University of Indonesia

Sponsor details

Jl. Prof. Dr. Bahder Djohan
Kampus UI Depok
West Java
Depok
16424
Indonesia
622178849120
humasfik@ui.ac.id

Sponsor type

University/education

Website

http://fik.ui.ac.id/

Funders

Funder type

Research organisation

Funder name

Directorate of university research and community service in Indonesia (Direktorat riset dan pengabdian masyarakat universitas Indonesia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in the Archives of Neuropsychiatry (Noropsikiyatri Arsivi).

Intention to publish date

30/06/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes