Condition category
Mental and Behavioural Disorders
Date applied
02/09/2014
Date assigned
04/03/2015
Last edited
23/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We are conducting a study to determine the effectiveness and applicability of a web-based psycho-education intervention program for an adult community in Selangor, Malaysia. The aim of our study is to determine whether the web-based psycho-education program (self-
management) is effective in reducing depression and anxiety symptoms, as well as to increase the participants’ knowledge on mental health.

Who can participate?
Participants who have participated in the first phase of this study and who are still living in Selangor.

What does the study involve?
Participants will be invited to participate in the study by trained research assistants and will be briefed about the study. Upon consenting to participate in the study, the participants will complete an online assessment and then will be randomly allocated to either the intervention or the control group. Participants in the intervention group will be requested to complete four sessions of a web-based intervention program within 4 weeks. After the participants in the intervention group complete all the sessions, the participants in the control group are offered the same program. Participants in both groups will be followed-up at weeks 5 and 12.

What are the possible benefits and risk of participating?
The benefits of participating in the study are the participants will be able to know their current mental health status and increase their knowledge on mental health, and this possibly may help to reduce the symptoms of depression and anxiety. There could be a minimal risk in this study, such as eye strain while reading the information in the website.

Where is the study run from?
The web-based psycho-education program ‘Program Komuniti Sihat’ (Wellness Community Programme) will be conducted in Selangor, Malaysia in collaboration with Universiti Putra Malaysia.

When is the study starting and how long is it expected to run for?
The study is expected to start in early August 2014 and the follow-up assessments are expected to be completed at the end of October 2014.

Who is funding the study?
The study is funded by the Ministry of Science, Technology and Innovation under the E-Science fund by the government of Malaysia.

Who is the main contact?
Professor Dr Sherina Mohd Sidik
sherina@upm.edu.my

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sherina Sidik

ORCID ID

Contact details

Department of Psychiatry
Faculty of Medicine & Health Sciences
Universiti Putra Malaysia
UPM Serdang
Selangor
43400
Malaysia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NMRR-14-698-21864

Study information

Scientific title

A web-based psycho-education intervention program for an adult community in Selangor, Malaysia: study protocol of a randomized controlled trial

Acronym

N/A

Study hypothesis

It is hypothesized that the symptoms of depression and anxiety will reduce in the intervention group as compared to the control group. Knowledge of the participants is also expected to increase after the intervention. The null hypothesis is there is no significant difference between the intervention and control groups, in terms of reduction of depression and anxiety symptoms and increase in the knowledge on mental health.

Ethics approval

University Putra Malaysia, 14/08/2013, ref. UPM/TNCPI/RMC/1.4.18.1

Study design

Parallel two-arm randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Depression and anxiety

Intervention

The study will involve an estimated of 288 participants, who have previously participated in the first phase of this study (A cross-sectional study on contributing factors of depression and anxiety among adults in Selangor, Malaysia). Participants in the intervention group will be invited to participate in the 4 weeks of web-based psycho-education program. The intervention program consists of 4 sessions, with each session accessed on each week. Participants in both groups will be followed-up at week 5 and week 12.

The control group in the study is a wait-list control group. After the participants in the intervention group complete all the sessions of the psycho-education program, the participants in the control group are offered the same program thereafter.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Change in depressive and anxiety symptoms. This is defined by a change in the sum score on the Patient Health Questionnaire 9 (PHQ-9) and Generalized Anxiety Disorder 7 (GAD-7) between the baseline and follow-up assessments at week 5 and 12.

Secondary outcome measures

Change in the mental health literacy score. This is defined by a change in the total score on the mental health literacy questionnaire between the baseline and follow-up assessments at week 5 and 12.

Overall trial start date

01/03/2013

Overall trial end date

30/11/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants who have participated in the first phase of this study and who are still living
in Selangor
2. Having access to computer and internet connection
3. Are internet-literate

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

288 participants (144 participants each for the intervention and control group)

Participant exclusion criteria

1. Currently receiving any psychotherapy for diagnosed psychiatric disorders
2. Report suicidal ideation

Recruitment start date

28/04/2014

Recruitment end date

14/08/2014

Locations

Countries of recruitment

Malaysia

Trial participating centre

Universiti Putra Malaysia
Selangor
43400
Malaysia

Sponsor information

Organisation

Universiti Putra Malaysia (Malaysia)

Sponsor details

c/o Sherina Mohd Sidik
Department of Psychiatry
Faculty of Medicine & Health Sciences
Universiti Putra Malaysia
UPM Serdang
Selangor
43400
Malaysia

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

E-Science MOSTI (Malaysia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27329333

Publication citations

Additional files

Editorial Notes

23/06/2016: Publication reference added.