Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04966650 |
| Other study ID # |
NTEC-2021-0379 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2021 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
July 2021 |
| Source |
The University of Hong Kong |
| Contact |
Chan |
| Phone |
98216501 |
| Email |
tiff1004[@]connect.hku.hk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
1. Project title Effectiveness of a Brief Nursing Advice in Promoting the Psychological
Well-Being for University Students with Mild to Moderate Depressive Symptoms: A
Randomized Controlled Trial
2. Investigators Principal Investigator Ms. Tiffany PY CHAN, Doctor of Nursing (Year 3
candidate), School of Nursing, The University of Hong Kong (HKU) Nursing Officer,
University Health Service, The Chinese University of Hong Kong (CUHK)
Co-investigator Dr. William HC LI, Associate Professor, School of Nursing, The
University of Hong Kong (HKU) Dr. Scotty Luk, Director, University Health Service, The
Chinese University of Hong Kong (CUHK)
3. Study site Recruitment of participants will be conducted on campus in CUHK
4. Aims of the project This study aims to assess the effectiveness of a brief nursing
advice in reducing depressive symptoms among university students who presented mild to
moderate depressive symptoms at the University Health Service.
5. Outcomes The primary outcome of this study is the university students' decreasing level
of depressive symptoms.
Description:
University Students with Mild to Moderate Depressive symptoms University students experience
a range of unique psychosocial stressors that increase their risk of major depression that
are substantially higher than those found in the general population (Nahla, et.al., 2013).
The prevalence rates of moderate to extremely severe depression symptom was 69.5% in
Bangladesh (Islam, et.al., 2020), and 57.6% of the students suffered from moderate to
extremely severe depression symptom among final-year medical students in India (Kumar,
et.al.,2019), and a study showed that the prevalence of depression is particularly high among
Australian university students (Farrer, et. al.,2016).
A report from the CHP in Hong Kong showed that the prevalence of mild to moderate, and severe
depressive symptoms in adolescents and children were 51.1%, and 4.2% respectively in 2012
(CHP, 2020). However, a cross-sectional study of Hong Kong showed that a high proportion of
the university students displayed depressive symptoms with 68.5% of them presented mild and
moderate depressive symptoms, and 9% presented moderately severe to severe depressive
symptoms (Lun, et. al., 2018). The result was higher than a similar survey (20.9%) conducted
by the University of Hong Kong 10 years ago (Wong, et. al., 2006). Although almost 3 in every
5 undergraduate students (59.5%) in Hong Kong are likely to experience mild to moderate
depressive symptoms, inadequate attention has been given in primary health care.
Health impact with Mild to Moderate Depressive symptoms Mild depression usually affects our
daily activities and causes detectable symptoms in university students, and it is common but
often remain unrecognized and treated inadequately (Klein, et. al., 2016). If the
investigator can accurately diagnose depression when it is mild, and treating it effectively
at this stage that can prevent the condition from worsening to become moderate or severe. The
majority of suicide cases are linked with mental disorders, and most of them are triggered by
severe depression. Suicide was the second leading cause of death among 15-29 year olds
globally in 2015 (WHO, 2017). In Hong Kong, the number of suicides in the age-group 15 to 24
years increased in subsequent years from 54 in 2014, to 68 in 2015 and 75 in 2016 (DH, 2018).
Insufficient student mental health services within the University Campus In Hong Kong, only 3
out of 8 universities providing health services on campus. At the beginning of school term,
students will be arranged to fill the mental wellness questionnaire from Office of Student
Affairs, and they will be referred to see counselors or consult the doctor in school clinic
if necessary. Only one university provides in-house psychiatric service, the student will be
referred to In-house psychiatric service by OPD doctors. Other universities may refer to
outside psychiatric service, with a long waiting queue for more than 6 months in Hospital
Authority, or to receive private psychiatrist subsidized by university itself. For the
current psychiatric service in one of the universities in Hong Kong, there is a total of 803
attendances (148 students) in 2018/19, with 5.4 visits per student, 79 of students have
depression (53%), 55 students who had suicidal idea, plan or act (37%). A considerable
increase in the demand for psychiatric services followed by an increase number of university
students reported depressive symptoms (64 students in 2017-18 vs 79 students in 2018-19),
consequently increased the waiting time for the consultation. Apart from the existing
psychiatric consultation for those who presented severe depressive symptoms, there is an
imperative need to develop and evaluate effective prevention strategies to help those
university students with mild to moderate depressive symptoms.
Brief nursing advice for University Students with Mild to Moderate Depressive symptoms
Evidence shows that a brief nursing advice is more feasible and cost-effective (Vijay,
G.C.,et. al., 2015), and all very brief interventions for physical activity were acceptable
and low cost. (Pears et. Al., 2015). It can increase physical activity in the short term when
compared with usual care or more intensive interventions. Comparing to other interventions,
such as cognitive behaviour therapy, which probably takes many weeks to implement but with
only short-term effect in reducing depression (Stallman, et al.,2016). All nursing staff are
well trained to provide a brief advice on mental health and thus no extra training is
required. The intervention is suggested to deliver in a single session of no more than 5 min,
that could be delivered in health checks or similar consultations (Vijay, G.C.,et. al.,
2015). Students can receive brief nursing advice at the clinic.
Furthermore, nurses play as an important role in multidisciplinary collaboration in the
University campus, such as Office of Student Affairs, faculty and department. They can refer
their students to university clinic if the student is in needed. All urgent cases can be
arranged to consult in-house psychiatrists within the same day.
If brief nursing advice in the campus can lower the depression symptoms of the university
students, it can align with Department of Health in strengthening the primary health care and
reduce the burden of tertiary healthcare. Due to the convenient location on campus, the
intervention will be more accessible.
Why Physical activity? In general, the counselors or psychiatrists will focus on the
stressors, or signs and symptoms of the university students which cause depression symptoms
in the consultation visit. However, the evidence supporting physical activity as a treatment
for mild-to-moderate depression, which is extensive and relatively uncontested. A precious
study showed that university students who did exercise regularly reported fewer depressive
symptoms than those who did not perform regular exercise (Lun, et. al., 2018). A study
reported that both motivational and volitional elements are important in any intervention to
increase physical activity in people with mild-to-moderate depression (Katarzyna, et. al.,
2018). Physical activity was negatively related to the level of depression by severity among
Undergraduate Students in Malaysia (Wan, et. al., 2020). Students with regular exercise
towards the future experienced fewer depressive symptoms (Lun, et. al., 2018).
Theoretical or conceptual framework of how physical activity can help people reduce the
depressive symptoms Theory-based interventions are more effective in changing behaviour than
interventions that do not use a theoretical approach (Prestwich, A., et. al, 2014), and
Social Cognitive Theory (SCT) is one of the most widely used theories in health behaviour
research. SCT has guided the development of numerous physical activity interventions and its
constructs are strongly associated with physical activity.
Research gap School-based intervention on mental health is found to be insufficient in both
local and global university settings, and rarely discussed or reported in the literature.
Besides, no study describe the theoretical or conceptual framework of brief intervention in
health advice. The investigator hypothesized that brief nursing advice is effective to lower
the severity of depressive symptoms of the university students with mild to moderate
depressive symptoms.
7A. Study design: i. Study design We will conduct a Randomised Control Trial, with two-group
pre-test and repeated post-tests, and a between-subjects design following CONSORT guideline.
PHQ-9 questionnaires (PHQ-9) will be completed by the participants before and after receiving
the intervention. The participants will be assessed their depression symptoms via
questionnaire, followed up their progress of physical activity changes and given a booster
intervention at 2nd month. At 6th month, participants will be assessed their depression
symptoms via questionnaire. For the control group, participants will be given a health
education leaflet and assessed their depression symptoms via questionnaire, followed up their
progress of physical activity changes at 2nd month and 6th month. The researchers strictly
adhere to the declaration of Helsinki.
ii. Settings The setting will be in University Health Service, CUHK campus.
iii. Subjects For the enrolment, all students who visit clinic will be assessed for the
eligibility to join the study. The inclusion criteria include aged 18 aged or above, able to
speak and read in Chinese, had presented mild to moderate depressive symptoms as identified
by a minimum score of 5 on the Patient Health Questionnaire (PHQ-9), and will have at least 1
more year's study period in the university. The investigator will exclude those with actively
suicidal, PHQ score >15-19 moderately severe, 20-27 severe depressive symptoms, or those who
are receiving antidepressant medication or mental health service such as counselling or
psychiatric consultation, or Athletes/ >150 minutes of moderate-intensity aerobic physical
activity throughout the week, or at least 75 minutes of vigorous-intensity physical activity.
For those are excluded in the study, all cases will be referred by medical doctors or
in-house psychiatrists for follow up within the same day.
iv. Procedures
Randomization and allocation concealment Informed consent will be sought from each
participant. The investigator will conduct baseline assessment, and randomization to allocate
the subjects into intervention or control group. All procedure will be implemented in single
room to ensure the privacy and to minimize the possibility of contamination.
Intervention group For the intervention group, participants will receive a 5-mins brief
nursing advice incorporating with Social Cognitive Theory (SCT). The protocol is about the
relationship between exercise and mental health, the advantages of increase physical activity
and regular exercise, and highlight the consequence if not deal with the depressive symptoms.
At the 2nd month, participants will be assessed their depression symptoms via questionnaire,
followed up their progress of physical activity changes and given a booster intervention. At
6th months, subjects will be assessed their depression symptoms and the level of physical
activity changes via questionnaire.
Control Group A wellbeing leaflet from CHP will be provided to each participant. At the 2nd
month, subjects will be assessed their depression symptoms via questionnaire, followed up
their progress of physical activity changes and given another wellbeing leaflets. At 6th
months, subjects will be assessed their depression symptoms the level of physical activity
changes via questionnaire.
After the completion, the subject will be received a $50 cash coupon for the incentive.
v. Data analysis All data will be entered and analyzed by using SPSS for Window, v. 26.
Independent t-test will be used to compare the change in depressive symptoms before and after
intervention between the two groups. The investigator will use the 9-item Patient Health
Questionnaire (PHQ-9) for the measurement tool. It is a valid and reliable tool for assessing
depressive symptoms in Hong Kong general population. It is used to monitor the severity of
depression and response to treatment.
vi. Timeline Research procedure Month/ Year 2021-2022 Aug Sep Oct Nov Dec Jan Feb Mar Apr May
Jun Preparation of questionnaire and recruitment Recruitment and data collection 2nd month
post-intervention evaluation 6th month post-intervention evaluation Data management,
analysis, and report writing
8. Drug investigation: Nil 9. Describe any unusual or discomforting procedures to be used:
Nil. 10. Are there any hazards associated with the investigation? No 11. Direct access to
source data/documents The raw data will be stored in the USB and locked in a safe cabinet by
the Principal Investigator. Only the Investigator will be permitted to access to raw data or
study record. The data will be kept for 3 years after the study completed.
12. Dissemination of study result The research findings will be presented in collective form
in local and international conferences and published in international peer reviewed journals.
13. Consent Eligible participants will be invited to participate in the study by giving a
written consent.
14. Conflict of interest: None 15. Financing and insurance: None
