ISRCTN ISRCTN12360747
DOI https://doi.org/10.1186/ISRCTN12360747
Secondary identifying numbers N/A
Submission date
15/01/2016
Registration date
07/03/2016
Last edited
07/03/2016
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
Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Budi Anna Keliat
Scientific

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

Study information

Study designCommunity based randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleThe effectiveness of the implementation of Community Mental Health Nursing model to improve life skills and work productivity of patients with mental illness
Study acronymCMHN
Study objectivesThe implementation of model of community mental health nursing (CMHN) effective in improving life skills and work productivity of patients with mental disorder.
Ethics approval(s)Nursing Faculty of Indonesia University ethics committee, 24/02/2010, ref: 174/H2.F12.D/HKP.02.04/2010
Health condition(s) or problem(s) studiedSchizophrenia
InterventionParticipants 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 typeMixed
Primary outcome measureLife skills are measured using The Life skill Profile (LSP) at baseline, 12 and 14 weeks.
Secondary outcome measuresWork productivity is measured using the Indonesian version of Work Productivity and Activity Impairment (WPAI) Questionnaire at baseline, 12 and 14 weeks.
Overall study start date01/03/2010
Completion date30/07/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants195
Key inclusion criteria1. Aged between 17 years to 55 years
2. Capacity to provide informed consent
3. Ability to communicate well
4. Diagnosis of schizophrenia
Key exclusion criteriaAged below 18 or above 65.
Date of first enrolment01/03/2010
Date of final enrolment09/04/2010

Locations

Countries of recruitment

  • Indonesia

Study participating centre

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

Sponsor information

DRPM University of Indonesia
University/education

Jl. Prof. Dr. Bahder Djohan, Kampus UI Depok, West Java
Depok
16424
Indonesia

Phone 622178849120
Email humasfik@ui.ac.id
Website http://fik.ui.ac.id/
ROR logo "ROR" https://ror.org/0116zj450

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date30/06/2016
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in the Archives of Neuropsychiatry (Noropsikiyatri Arsivi).
IPD sharing plan