Mental Health IssueNCT05528640
Interventional Study of Mental Health Literacy Educational Program for General Hospital Nurses
A study testing Mental Health Literacy Program in people with Mental Health Issue, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Mental health literacy is a concept that encompasses knowledge of mental health, mental illnesses, and their management; mental illness-related attitudes/ stigma; and help-seeking efficacy. It impacted care provision by affecting healthcare professionals' ability to recognize, manage and prevent mental illnesses. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Mental Health Literacy Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2022to 21 Apr 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Full-time registered nurse (general) or enrolled nurse (general)
- Take care for adult patients in emergency departments or medical ward
Who cannot join
- Does not understand Chinese and English
- Unable to access or use the internet.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Chinese University of Hong Kong
Hong Kong, 852
Cheng Ho Yu, PhD, 3943 6230, hycheng@cuhk.edu.hk
About this study
Official title: The Effectiveness of an Educational Program on the Mental Health Literacy of Nurses Working in General Hospitals: a Controlled Trial
Mental health literacy is a concept that encompasses knowledge of mental health, mental illnesses, and their management; mental illness-related attitudes/ stigma; and help-seeking efficacy. It impacted care provision by affecting healthcare professionals' ability to recognize, manage and prevent mental illnesses. It was found that physical-mental comorbidity (co-occurrence of physical and mental illnesses) imposed a burden on patients and the healthcare system. However, the referral rate to psychiatric consultation-liaison in general hospitals was low could be attributed to the suboptimal level of mental health literacy of general hospital healthcare professionals. Nurses are the major healthcare workforce in general hospitals for the initial identification of mental illness, help doctors to deal with patients' conditions, and make a contribution to positive patient outcomes in general hospitals. Therefore, there is an urgent need to improve the mental health literacy of nurses working in general hospitals.
An education program had been developed guided by the concept of mental health literacy, and self-efficacy theory. This study aims to examine the effect of an educational program on improving the mental health literacy of general hospital nurses, in terms of knowledge of mental health, mental illnesses, and their treatment; attitude or stigma about mental illnesses; and help-seeking efficacy. It also measures the interventional effect on perceived competency in caring for patients with mental illness and work stress among general hospital nurses, as well as patient satisfaction with nursing care in general hospitals.
Read the detailed description
This study is a prospective 2-arm parallel controlled trial. The study sites will be conducted in the emergency departments and medical wards of two similar regional general hospitals. It is estimated using GPower that a sample size of 64 participants per group is adequate to detect an effect size of 0.5 on the primary outcomes at a post-intervention time point with 80% power at a 5% level of significance. Participants will be assigned to either an intervention group or a control group. Participants in the intervention group will receive a Mental Health Literacy Program consisting of six 30-minutes online educational sessions and one 60-minutes face-to-face session. No active intervention will be given to the control group. Outcome measures will be measured by the Mental Health Literacy Scale, the Behavioral Health Care Competency survey, the Workplace Stress Scale, and Hospital Patient Satisfaction Survey at baseline, immediately after intervention, and one-month after intervention.
- Conditions
- Mental Health Issue
- Being tested
- Mental Health Literacy Program
- Keywords
- Education, Mental health literacy, Nurses, General hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health Literacy ProgramOther
Six educational sessions will be delivered on a private YouTube channel which consists of information about mental health literacy (knowledge about priority mental illnesses, attitude/ stigma related to mental illnesses, and help-seeking efficacy). There will be six-weeks unrestricted access period. Afterwards, the round-up session which consists of problem-based learning and group sharing will be delivered in person. Two vignettes based on the clinical scenarios will be given for discussion. Furthermore, participants are encouraged to share their opinion on mental health literacy, strategies for dealing with difficulties of caring for patients with mental illnesses in general hospitals, way to promote mental health literacy of healthcare professionals in general hospitals
| Study group | Role | What they receive |
|---|---|---|
| Mental Health Literacy Educational Program | Experimental | An educational program consisting of six 30-minutes online educational sessions and one 60-minutes face-to-face session. Receives: Other: Mental Health Literacy Program |
| Control Group | No intervention | No active intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in level of mental health literacy
The level of participant's mental health literacy will be evaluated using The Mental Health Literacy Scale developed by Connor \& Casey (2015). This questionnaire comprised 35 items which consisted of the ability to recognize disorders (8 questions), knowledge of where to seek information (4 questions), knowledge of risk factors and causes (2 questions), knowledge of self-treatment (2 questions), knowledge of professional help available (3 questions), attitudes that promote recognition or appropriate help-seeking behavior (16 questions) (O'Connor \& Casey, 2015). Questions with a 4-point scale are rated "1" was very unlikely/unhelpful, "4" was very likely/helpful and for a 5-point scale that "1" strongly disagreed/definitely unwilling, "5" strongly agreed/definitely willing. The higher the total score indicates a higher level of mental health literacy.
Measured: Baseline, immediately after intervention, one month after intervention
Secondary outcomes (3)
Change from baseline in perceived competency in caring for patients with mental illnesses
The Behavioral Health Care Competency survey will be used to assess the perceived competency in caring for patients with mental illnesses. It consists of 23-items to assess the participants' perception of their competency in assessment, intervention, recognition of the need for referral, and dealing with resources issues (Rutledge et al., 2013; Rutledge et al., 2012). Questions with a 5-point Likert-type scale with responses 1= "Strongly disagree" to 5=" Strongly agree" The higher the total score, the higher respondent's perceived competency in caring for patients with mental illnesses.
Measured: Baseline, immediately after intervention, one month after intervention
Change from baseline in level of work stress
The Workplace Stress Scale developed by the Marlin Company will be used to assess participants' work stress levels. This scale consists of eight items that describe the perception of the respondent toward his or her work. Questions with a 5-point scale are rated "1' was never, and "5" was very often. The higher the total score indicates a higher level of work stress. A total score of 15 or lower interpreted as stress is not much of an issue, whilst 31-40 was indicative of a potentially dangerous stress level that may need to seek professional assistance.
Measured: Baseline, immediately after intervention, one month after intervention
Change from baseline in patient satisfaction with nursing care
Hospital Patient Satisfaction Survey will be used to assess the patient satisfaction with nursing care in general hospitals. There are eight questions on the scale to measure patient satisfaction with nursing care during the hospitalization with a 4-point Likert scale (from "0"=never to "4"=always).
Measured: Baseline, immediately after intervention, one month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start1 Sep 2022 (estimated)
- Primary completion18 Jan 2023 (estimated)
- Study completion21 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective 2-arm parallel controlled trial.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHEUNG, Janice, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528640
- Sponsor's protocol ID
- 1155149877
- Status last verified
- Sep 2022
- First submitted
- 1 Jun 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Educational Program on the Mental Health Literacy of Nurses Working in General Hospitals: a Controlled Trial
- ClinicalTrials.gov ID
- NCT05528640
- Acronym / sponsor ID
- 1155149877
- Conditions
- Mental Health Issue
- Keywords
- Education, Mental health literacy, Nurses, General hospital
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 18 Jan 2023 (estimated)
- Study completion
- 21 Apr 2023 (estimated)
- First posted
- 6 Sep 2022 (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.
Mental health literacy is a concept that encompasses knowledge of mental health, mental illnesses, and their management; mental illness-related attitudes/ stigma; and help-seeking efficacy. It impacted care provision by affecting healthcare professionals' ability to recognize, manage and prevent mental illnesses. It was found that physical-mental comorbidity (co-occurrence of physical and mental illnesses) imposed a burden on patients and the healthcare system. However, the referral rate to psychiatric consultation-liaison in general hospitals was low could be attributed to the suboptimal level of mental health literacy of general hospital healthcare professionals. Nurses are the major healthcare workforce in general hospitals for the initial identification of mental illness, help doctors to deal with patients' conditions, and make a contribution to positive patient outcomes in general hospitals. Therefore, there is an urgent need to improve the mental health literacy of nurses working in general hospitals.
An education program had been developed guided by the concept of mental health literacy, and self-efficacy theory. This study aims to examine the effect of an educational program on improving the mental health literacy of general hospital nurses, in terms of knowledge of mental health, mental illnesses, and their treatment; attitude or stigma about mental illnesses; and help-seeking efficacy. It also measures the interventional effect on perceived competency in caring for patients with mental illness and work stress among general hospital nurses, as well as patient satisfaction with nursing care in general hospitals.
Detailed description
This study is a prospective 2-arm parallel controlled trial. The study sites will be conducted in the emergency departments and medical wards of two similar regional general hospitals. It is estimated using GPower that a sample size of 64 participants per group is adequate to detect an effect size of 0.5 on the primary outcomes at a post-intervention time point with 80% power at a 5% level of significance. Participants will be assigned to either an intervention group or a control group. Participants in the intervention group will receive a Mental Health Literacy Program consisting of six 30-minutes online educational sessions and one 60-minutes face-to-face session. No active intervention will be given to the control group. Outcome measures will be measured by the Mental Health Literacy Scale, the Behavioral Health Care Competency survey, the Workplace Stress Scale, and Hospital Patient Satisfaction Survey at baseline, immediately after intervention, and one-month after intervention.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a prospective 2-arm parallel controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Mental Health Literacy Educational Program | Experimental | Other: Mental Health Literacy ProgramAn educational program consisting of six 30-minutes online educational sessions and one 60-minutes face-to-face session. |
| Control Group | No intervention | –No active intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Full-time registered nurse (general) or enrolled nurse (general)
- Take care for adult patients in emergency departments or medical ward
Key exclusion criteria (2 listed)
- Does not understand Chinese and English
- Unable to access or use the internet.
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 |
|---|---|---|
| Mental Health Literacy ProgramSix educational sessions will be delivered on a private YouTube channel which consists of information about mental health literacy (knowledge about priority mental illnesses, attitude/ stigma related to mental illnesses, and help-seeking efficacy). There will be six-weeks unrestricted access period. Afterwards, the round-up session which consists of problem-based learning and group sharing will be delivered in person. Two vignettes based on the clinical scenarios will be given for discussion. Furthermore, participants are encouraged to share their opinion on mental health literacy, strategies for dealing with difficulties of caring for patients with mental illnesses in general hospitals, way to promote mental health literacy of healthcare professionals in general hospitals | Other | Mental Health Literacy Educational Program |
Primary outcome
Change from baseline in level of mental health literacy
Time frame: Baseline, immediately after intervention, one month after intervention
The level of participant's mental health literacy will be evaluated using The Mental Health Literacy Scale developed by Connor \& Casey (2015). This questionnaire comprised 35 items which consisted of the ability to recognize disorders (8 questions), knowledge of where to seek information (4 questions), knowledge of risk factors and causes (2 questions), knowledge of self-treatment (2 questions), knowledge of professional help available (3 questions), attitudes that promote recognition or appropriate help-seeking behavior (16 questions) (O'Connor \& Casey, 2015). Questions with a 4-point scale are rated "1" was very unlikely/unhelpful, "4" was very likely/helpful and for a 5-point scale that "1" strongly disagreed/definitely unwilling, "5" strongly agreed/definitely willing. The higher the total score indicates a higher level of mental health literacy.
3 secondary outcomes
Change from baseline in perceived competency in caring for patients with mental illnesses
Time frame: Baseline, immediately after intervention, one month after intervention
Change from baseline in level of work stress
Time frame: Baseline, immediately after intervention, one month after intervention
Change from baseline in patient satisfaction with nursing care
Time frame: Baseline, immediately after intervention, one month after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Mental Health Issue
Active, not recruiting
Chicago Parent Program for Foster and Kinship Caregivers
Behavior Problem, Parenting
Active, not recruiting
Tailoring CPP for the Foster Care Setting
Behavior Problem
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Active, not recruiting
Supporting Health in Veterans With Heart Failure
Heart Failure
Not yet recruiting
Hybrid Pilot of Personalized Parent-Child Interaction Therapy
Disruptive Behaviors
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Health Literacy Program in people with Mental Health Issue, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 2 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 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Cheung Janice (+852 59287861, 1155149877@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in level of mental health literacy (time frame: Baseline, immediately after intervention, one month after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2022.