Depressive SymptomsNCT04966650
Brief Nursing Advice for University Students With Depressive Symptoms
A study testing 5-mins brief nursing advice incorporating with Social Cognitive Theory (SCT) in people with Depressive Symptoms, run by The University of Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- 5-mins brief nursing advice incorporating with Social Cognitive Theory (SCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 30 Jun 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- We 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official 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
- 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
- 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)
- Study site Recruitment of participants will be conducted on campus in CUHK
- 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.
- Outcomes The primary outcome of this study is the university students' decreasing level of depressive symptoms.
Read the detailed 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.
- 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
- 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.
- 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.
- Consent Eligible participants will be invited to participate in the study by giving a written consent.
- Conflict of interest: None 15. Financing and insurance: None
- Conditions
- Depressive Symptoms
- Being tested
- 5-mins brief nursing advice incorporating with Social Cognitive Theory (SCT)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-mins brief nursing advice incorporating with Social Cognitive Theory (SCT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: 5-mins brief nursing advice incorporating with Social Cognitive Theory (SCT) |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
depression symptoms
Change of the level of depression symptoms
Measured: o month, 2nd month, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by The 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, Dr. LI William Ho Cheung, The University of Hong Kong
- Investigators
- Ho Cheung Li, Study director, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966650
- Sponsor's protocol ID
- NTEC-2021-0379
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ibrahim AK, Kelly SJ, Adams CE, Glazebrook C. A systematic review of studies of depression prevalence in university students. J Psychiatr Res. 2013 Mar;47(3):391-400. doi: 10.1016/j.jpsychires.2012.11.015. Epub 2012 Dec 20.
PubMed 23260171
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04966650
- Acronym / sponsor ID
- NTEC-2021-0379
- Conditions
- Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 19 Jul 2021 (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.
- 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
- 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)
- Study site Recruitment of participants will be conducted on campus in CUHK
- 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.
- Outcomes The primary outcome of this study is the university students' decreasing level of depressive symptoms.
Detailed 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.
- 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
- 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.
- 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.
- Consent Eligible participants will be invited to participate in the study by giving a written consent.
- Conflict of interest: None 15. Financing and insurance: None
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: 5-mins brief nursing advice incorporating with Social Cognitive Theory (SCT)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 | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- We 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.
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 |
|---|---|---|
| 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. | Behavioural | Intervention group |
Primary outcome
depression symptoms
Time frame: o month, 2nd month, 6 month
Change of the level of depression symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Background: PubMed 23260171Ibrahim AK, Kelly SJ, Adams CE, Glazebrook C. A systematic review of studies of depression prevalence in university students. J Psychiatr Res. 2013 Mar;47(3):391-400. doi: 10.1016/j.jpsychires.2012.11.015. Epub 2012 Dec 20.
- 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.
Ho Cheung Li study director
The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing 5-mins brief nursing advice incorporating with Social Cognitive Theory (SCT) in people with Depressive Symptoms, run by The University of 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 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 22 Jul 2021. 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 Chan (98216501, tiff1004@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depression symptoms (time frame: o month, 2nd month, 6 month). 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 NCT04966650, which also lists 1 linked publication.
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 22 Jul 2021.