|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
17 October 2016 |
|
Main ID: |
ISRCTN39656144 |
|
Date of registration:
|
04/03/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A web-based psycho-education intervention program for an adult community in Selangor, Malaysia
|
|
Scientific title:
|
A web-based psycho-education intervention program for an adult community in Selangor, Malaysia: study protocol of a randomized controlled trial |
|
Date of first enrolment:
|
28/04/2014 |
|
Target sample size:
|
288 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN39656144 |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel two-arm randomized controlled trial (Treatment)
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Malaysia
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Sherina
Sidik |
|
Address:
|
Department of Psychiatry
Faculty of Medicine & Health Sciences
Universiti Putra Malaysia
UPM Serdang
43400
Selangor
Malaysia |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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
Exclusion criteria: 1. Currently receiving any psychotherapy for diagnosed psychiatric disorders
2. Report suicidal ideation
Age minimum:
Age maximum:
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
Depression and anxiety
Mental and Behavioural Disorders
|
|
Intervention(s)
|
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.
|
|
Primary Outcome(s)
|
|
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(s)
|
|
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.
|
|
Secondary ID(s)
|
|
NMRR-14-698-21864
|
|
Source(s) of Monetary Support
|
|
E-Science MOSTI (Malaysia)
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|