Mental Health LiteracyNCT04266119
Online HOPE Intervention on Mental Health Literacy Among Youths in Singapore: An RCT Protocol
A study testing Online HOPE intervention in people with Mental Health Literacy and Depression Literacy, run by National University of Singapore.
Trial summary
The author developed the HOPE intervention based on a systematic review (Tay, Tay, \& Klainin-Yobas, 2018). The overall aim of the study is to test the effectiveness of the online HOPE intervention in enhancing mental health literacy, depression literacy, psychological well-being and in reducing stress among youths… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Literacy, Depression Literacy, Psychological Well-being
- What is being tested?
- Online HOPE intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- : a) students of a particular University in Singapore, b) aged between 18 to 24 years old, c) had internet access and d) could read, write and understand the English language.
Who cannot join
- Exclusion criteria were reading or hearing disabilities. This was because the online HOPE intervention consists of written words and videos that require visual and auditory abilities, respectively.
Trial locations and contacts
No sites are listed yet.
About this study
The author developed the HOPE intervention based on a systematic review (Tay, Tay, \& Klainin-Yobas, 2018). The overall aim of the study is to test the effectiveness of the online HOPE intervention in enhancing mental health literacy, depression literacy, psychological well-being and in reducing stress among youths aged 18 - 24 living in Singapore.
Read the detailed description
The study will be a two-group, parallel randomized control trial (RCT), with a pre-test, post-test and repeated, control group design.
he overall aim of the study is to test the effectiveness of the online HOPE intervention in enhancing mental health literacy, on depression literacy, psychological well-being and in reducing stress among youths aged 18 - 24 living in Singapore.
- Conditions
- Mental Health Literacy, Depression Literacy, Psychological Well-being, Stress, Psychological
- Being tested
- Online HOPE intervention
- Medical subject headings
- Psychological Well-Being, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online HOPE interventionBehavioural
Online HOPE intervention to increase mental health literacy
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The HOPE intervention can be accessed through web. It consists of two sessions per week, with a total of four sessions. In this study, participants will be sent weekly weblinks for access to each session. Each session take about ten minutes to complete. Each session consist of pre-post multiple-choice and/or open-end question, video(s) and mental health information. The first session is about depression. The second session is about positive psychology and consists of relevant exercises such as gratitude, affect-based and strength-based exercises. The third session describes anxiety disorder. The last session describes relaxation techniques and self-management of unhelpful thoughts.
Each session consists of quizzes, video(s), and graphical / written information Receives: Behavioral: Online HOPE intervention |
| Control | Active comparator | The group will receive a control website intervention that consists of several graphical inspirational quotes. Examples of the quotes are, 'Today is full of possible' and 'You can do anything'. Receives: Behavioral: Online HOPE intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Literacy
using D-Lit. The scale consists of 22 items that are scored 'true', 'false' or 'don't know'. Greater scores equate greater depression MHL.
Measured: Change from baseline depression literacy to post intervention (up to 1 month), and follow up at 2 months
Anxiety literacy
A-Lit. The scale consists of 22 items that are scored 'true', 'false' or 'don't know'. Greater scores equate greater anxiety MHL.
Measured: Change from baseline depression literacy to post intervention (up to 1 month), and follow up at 2 months
Mental health literacy
depression vignette (shortened)
Measured: Change from baseline depression literacy to post intervention (up to 1 month), and follow up at 2 months
Secondary outcomes (2)
Psychological well-being
Ryff's Psychological Well-Being Scale. PWB can be measured by the 18-items psychological well-being scale that measures the six dimensions of PWB (Ryff, 1989). The scale ranges from 1 (strongly disagree) to 7 (strongly agree). Scores ranged from 18 to 123, with greater points indicating greater PWB.
Measured: Change from baseline depression literacy to post intervention (up to 1 month), and follow up at 2 months
Stress
Perceived Stress Scale. The 10-question perceived stress scale (PSS) consists of five response categories: never (0), almost never (1), sometimes (2), fairly often (3), and very often (4). Total scores range from 0 to 56, with higher scores indicating higher stress.
Measured: Change from baseline depression literacy to post intervention (up to 1 month), and follow up at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study startFeb 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health LiteracyStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Piyanee KLAININ-YOBAS, Associate Professor from National University of Singapore, Yong Shian Shawn GOH, Assistant Professor from National University of Singapore
- Responsible party
- Principal investigator, Tay Jing Ling, National University of Singapore
- Investigators
- Jing Ling Tay, MN, Principal investigator, Singapore University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266119
- Sponsor's protocol ID
- S-19-251
- Other IDs
- NYF/Jul19/01
- Status last verified
- Feb 2020
- First submitted
- 6 Feb 2020
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tay JL. Online HOPE intervention on help-seeking attitudes and intentions among young adults in Singapore: A randomized controlled trial and process evaluation. Arch Psychiatr Nurs. 2022 Dec;41:286-294. doi: 10.1016/j.apnu.2022.09.008. Epub 2022 Sep 17.
PubMed 36428062Tay JL, Goh YSS, Sim K, Klainin-Yobas P. Impact of the HOPE Intervention on Mental Health Literacy, Psychological Well-Being and Stress Levels amongst University Undergraduates: A Randomised Controlled Trial. Int J Environ Res Public Health. 2022 Aug 8;19(15):9772. doi: 10.3390/ijerph19159772.
PubMed 35955126
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online HOPE Intervention on Mental Health Literacy Among Youths in Singapore: An RCT Protocol
- ClinicalTrials.gov ID
- NCT04266119
- Acronym / sponsor ID
- S-19-251
- Conditions
- Mental Health Literacy, Depression Literacy, Psychological Well-being, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Piyanee KLAININ-YOBAS, Associate Professor from National University of Singapore, Yong Shian Shawn GOH, Assistant Professor from National University of Singapore
- Study start
- Feb 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The author developed the HOPE intervention based on a systematic review (Tay, Tay, \& Klainin-Yobas, 2018). The overall aim of the study is to test the effectiveness of the online HOPE intervention in enhancing mental health literacy, depression literacy, psychological well-being and in reducing stress among youths aged 18 - 24 living in Singapore.
Detailed description
The study will be a two-group, parallel randomized control trial (RCT), with a pre-test, post-test and repeated, control group design.
he overall aim of the study is to test the effectiveness of the online HOPE intervention in enhancing mental health literacy, on depression literacy, psychological well-being and in reducing stress among youths aged 18 - 24 living in Singapore.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Online HOPE interventionThe HOPE intervention can be accessed through web. It consists of two sessions per week, with a total of four sessions. In this study, participants will be sent weekly weblinks for access to each session. Each session take about ten minutes to complete. Each session consist of pre-post multiple-choice and/or open-end question, video(s) and mental health information. The first session is about depression. The second session is about positive psychology and consists of relevant exercises such as gratitude, affect-based and strength-based exercises. The third session describes anxiety disorder. The last session describes relaxation techniques and self-management of unhelpful thoughts. Each session consists of quizzes, video(s), and graphical / written information |
| Control | Active comparator | Behavioral: Online HOPE interventionThe group will receive a control website intervention that consists of several graphical inspirational quotes. Examples of the quotes are, 'Today is full of possible' and 'You can do anything'. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- : a) students of a particular University in Singapore, b) aged between 18 to 24 years old, c) had internet access and d) could read, write and understand the English language.
Key exclusion criteria (1 listed)
- Exclusion criteria were reading or hearing disabilities. This was because the online HOPE intervention consists of written words and videos that require visual and auditory abilities, respectively.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online HOPE interventionOnline HOPE intervention to increase mental health literacy | Behavioural | Control, Intervention |
Primary outcome
Depression Literacy
Time frame: Change from baseline depression literacy to post intervention (up to 1 month), and follow up at 2 months
using D-Lit. The scale consists of 22 items that are scored 'true', 'false' or 'don't know'. Greater scores equate greater depression MHL.
Anxiety literacy
Time frame: Change from baseline depression literacy to post intervention (up to 1 month), and follow up at 2 months
A-Lit. The scale consists of 22 items that are scored 'true', 'false' or 'don't know'. Greater scores equate greater anxiety MHL.
Mental health literacy
Time frame: Change from baseline depression literacy to post intervention (up to 1 month), and follow up at 2 months
depression vignette (shortened)
2 secondary outcomes
Psychological well-being
Time frame: Change from baseline depression literacy to post intervention (up to 1 month), and follow up at 2 months
Stress
Time frame: Change from baseline depression literacy to post intervention (up to 1 month), and follow up at 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Derived from this study: PubMed 36428062Tay JL. Online HOPE intervention on help-seeking attitudes and intentions among young adults in Singapore: A randomized controlled trial and process evaluation. Arch Psychiatr Nurs. 2022 Dec;41:286-294. doi: 10.1016/j.apnu.2022.09.008. Epub 2022 Sep 17.
- Derived from this study: PubMed 35955126Tay JL, Goh YSS, Sim K, Klainin-Yobas P. Impact of the HOPE Intervention on Mental Health Literacy, Psychological Well-Being and Stress Levels amongst University Undergraduates: A Randomised Controlled Trial. Int J Environ Res Public Health. 2022 Aug 8;19(15):9772. doi: 10.3390/ijerph19159772.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Ling Tay, MN principal investigator
Singapore University of Singapore
Questions about this trial
What is this clinical trial studying?
A study testing Online HOPE intervention in people with Mental Health Literacy and Depression Literacy, run by National University of Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Ling Tay, MN (93847905, e0223169@u.nus.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Literacy (time frame: Change from baseline depression literacy to post intervention (up to 1 month), and follow up at 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04266119, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.