Human Investigation Protocol Review

Protocol No:
PROJECT TITLE: Tác động của chương trình hỗ trợ bằng hình thức khai vấn tâm lý theo nhóm (group coaching) đối với sự an lạc và
nỗ lực thực hiện mục tiêu của sinh viên
The impact of group life-coaching on Vietnamese college students' well-being and goal striving

PRINCIPAL INVESTIGATOR: Le Tran Hoang Duy PHONE: 0985191311

E-MAIL ADDRESS: duy.letranhoang@hoasen.edu.vn
CO-INVESTIGATOR(S): PHONE:
Nguyen Hong An 0774876638
Nguyen Thi Ngoc Giau 0989199360
Ha Thi Thanh Huong 0938939445
Le Hoang Mi 0899471830
SUPERVISOR (S): PHONE:
FUNDING SOURCE: Hoa Sen University E-MAIL ADDRESS: vpbgh@hoasen.edu.vn

WILL YOU BE CONDUCTING THIS STUDY AT ANY OFFSITE INSTITUTION(S)?  ☒ YES  ☐NO
IF YES, WHAT IS THE NAME OF THE INSTITUTION(S): Hoa Sen University
The above research project involves as subjects:
TYPE AGE RANGE SOURCE
 ☐Adult Patients (≥18 years)
 ☐Adult Normal Subjects (≥18 years)
 ☐Minor Patients (< 18 years)
 ☐Minor Normal Subjects (<18 years)
 ☐Pregnant Women
☐AIDS Patients
 ☐Drug Users
 ☐Prisoners
 ☐Mentally Retarded
☒Students 18-25 Students at Hoa Sen University
☐Employees
 ☐No Subjects Will Be Enrolled

The project involves the use of:

 ☒ Approved/Investigational Device(s): Form II
 ☐Approved/Investigational Drug(s)/Substance(s): Form III
 ☐ Psychological Tests: Include the test description
 ☐ Surgical Procedures (Biopsy, etc. please explain):  ☐
 ☐ Medical/Dental Procedure (please explain):  ☐
 ☒ Questionnaires  ☐ Interviews
 ☐Discarded Human Tissues/Fluids ☐Use of Fetal and Abortus Tissues
 ☐ Medical/Dental Records Review
 ☐ Video/Audio recordings  ☐ Photographs
 ☐ Blood Samples - Amount per draw:  ☐ Amount total:  ☐
 ☐Other (Please explain):  ☐

Expected duration of entire study: 12 months

Expected duration of study on individual subject: 8 weeks
What services will be the subject’s financial responsibility: No
Amount of costs:
What services will be provided without charge: All EEG Recording and the admission to an 8-week coaching program
Is compensation to subjects planned: ☒ Yes  ☐ No

PART 1: BRIEF OVERVIEW OF RESEARCH PROJECT

1.1 Research Question/Hypothesis
Research objective:
This project aims at developing a life-coaching program for college students and evaluating its impact on their well-being and goal
striving.
Research questions:
What is the impact of participating in a life-coaching program on the students’ well-being and goal striving?
Hypothesis:
1. Compared to the control group, the experimental group reports a statistical meaningful increase in well-being and goal striving
at the end of the coaching program.
2. The impact of the coaching program on well-being and goal striving persists three months after it ends.
3. The impact of participating in the coaching program is shown in participant’s well-being measured by both self-report
questionnaires and EEG signals.
1.2
Academic Validity
1. 1. On the world
The first coaching program in higher education setting was first established at the University of Sydney in 1999 (Grant, 2016).
From 1999 to 2015, the Coaching Psychology Unit (CPU) at the University of Sydney had 150 publications related to this program
(Grant, 2016). These studies show that coaching programs (1) are effective in improving students' well-being and assisting them
to achieve personal goals, (2) can be effective in many difference settings, including educational environment, (3) not only
provide benefits for students but also bring changes in organizational system, (4) have a positive impact not only on helping
achieve student’s career and studying objectives but also positively influence other aspects of their life (Grant, 2016). In addition,
these studies also confirmed the effectiveness of group coaching (Green, Oades, and Grant, 2006). Besides studies in Western
context, recently, this research area has also witnessed new research in Asian educational environments, such as Joh's (2017)
study on a sample of university students in Korea. Studies investigating the effectiveness of coaching programs often use survey
methods to measure the impact of the program on the outcome variables in participants.
References:
Grant, A. M. (2016). What can Sydney tell us about coaching? Research with implications for practice from down under.
Consulting Psychology Journal: Practice and Research, 68(2), 105–117.
Green, L. S., Oades, L. G., & Grant, A. M. (2006). Cognitive-behavioral, solution-focused life coaching: Enhancing goal striving,
well-being, and hope. The Journal of Positive Psychology, 1(3), 142-149.
Joh, S. J. (2017). A Field Experimental Study on the Effects of Coaching on Emotional Intelligence and Communication
Competence. Journal of the Korea Convergence Society, 8(6), 245-253.
The University of Sydney Coaching Psychology Unit. (n.d.). Teaching and research in coaching psychology. Retrieved on 28
June 2020 from https://www.sydney.edu.au/science/our-research/research-areas/psychology/coaching-psychology-unit.html
2. In Vietnam
From our observation, Vietnam has seen the dynamic development of coaching activities in recent years. However, these
activities are usually conducted by non-education organizations such as business enterprises (instead of universities). Research
on coaching in Vietnam has also appeared, although not much, and showed its positive impact on employee’s working
performance (Pham, 2018). However, we did not find any study that assesses the effectiveness of coaching on Vietnamese
university students.
In terms of research methods, there are very few studies in Vietnam using EEG signals to measure changes in psychological
outcomes, even though this method has many outstanding advantages in identify stress of participants (Tsai, 2015; Yamamoto,
Shimada, Koh, Ataka, & Miki, 2014 and can prevent the participant’s bias when answering the questionnaires. The reason for the
limitation of this type of research in Vietnam may lie in the lack of technical means. One of the few recent studies of this type is
the work of Bui Huy Hai and Pham Ngoc Sam (2018) to evaluate the density of emotional arousal epoch based on EEG. Our
research team member, Dr. Ha Thi Thanh Huong, is also working on a project that uses EEG to measure the effectiveness of an
mindfulness-based meditation program on psychological outcomes of participants. However, there are currently no studies in
Vietnam using EEG methods to measure the impact of group coaching on mental health of students. Therefore, our research is
the first work on this topic in Vietnam.
References:
 Bùi Huy Hải và Phạm Ngọc Sâm. (2018). Sử dụng tín hiệu điện não đồ đánh giá độ tập trung của kích thích cảm xúc dựa trên
đánh giá năng lượng và giá trị entropy. Tạp chí khoa học và công nghệ năng lượng (16), 1-7.
Chinh, P. H. (2018). The effect of workplace coaching on employee performance: the case of Tri An factory. Nestlé Vietnam.
Tsai, S. J. (2015). Transcranial focused ultrasound as a possible treatment for major depression. Medical hypotheses, 84(4), 381-
383.
Yamamoto, K., Shimada, H., Koh, H., Ataka, S., & Miki, T. (2014). Serum levels of albumin‐amyloid beta complexes are
decreased in Alzheimer's disease. Geriatrics & gerontology international, 14(3), 716-723.
1.3 Research Methods/ Designs
Students wishing to participate in the research are requested to fill in an application form which includes a screening section. Only
students who fulfil its screening criteria will be admitted to the research. Participants will be randomly assigned to two groups, one
of which is the experimental group (EG) and the other the control group (CG). The two groups will be invited to attend an
information session where they are informed of the study’s information and the nature of life-coaching. Then, the EG will
participate in an eight-week life-coaching program which follows the solution-focused cognitive-behavioural approach, while the
CG enters a waiting period.
We will let the subjects fill in the questionnaires and record their EEG signal, blood pressure and pulse at different times which
are before the coaching program (T1), at the end of the program (T2) and three months after the program (T3, only for the EG).
The questionnaire will be about the participants’ goal striving, positive and negative affects, and life satisfaction. The EEG signal
recording procedure will be used to evaluate how the students’ brain reacts with a stimulated stressful event.
1.4
Statistical Analysis
The design of the research aims at evaluating the impact of a group life-coaching program on participants’ well-being and goal
striving, in which well-being variables are assessed using both self-report and neurological instruments. Data from T1 and T2 will
be analysed to look for between-group differences in outcome variables so that the impact of the coaching program on the EEG is
evaluated. The EEG’s within-group differences in outcome variables across three time points will also be assessed to identify the
effectiveness of life-coaching on participant’s well-being and goal striving over time.
Specifically for the EEG signal, we will select features from Emotive EPOCAlice5. The measured signal will be classified using
machine learning to classify the EEG signal. By doing so, we will be able to see whether attending the coaching program has
correlation with better well-being (e.g., gless brain’s negative reaction to generated stressful events). After that, we will carry out
the correlation test on the coaching program’s effectiveness between well-being results derived from the questionnaires and
measured signals including EEG, Blood Pressure and Pulse.
1.5 Potential Significance/Justification
First of all, the present research’s mixed psychological-neurological method is expected to offer a clearer view of the body-mind
mechanism of the impact of coaching on individuals. Secondly, this study will provide more scientific evidence to coaching
practice for student populations. Finally, the research promises to establish a firm scientific basis for future coaching programs in
Vietnam, especially for the wellbeing and studying-career development of Vietnamese college students.

PART 2: PARTICIPANT RECRUITMENT AND CONSENT

2.1
How many participants will be enrolled in the project?
40-50 students at Hoa Sen University

2.2 Describe who will be selected (inclusive and exclusive criteria)

Inclusive criteria:
Students at Hoa Sen university aging from 18 to 25 (early adulthood) who register to participate the research.

Exclusive criteria:
(1) Those who score high in general mental health problems (as assessed by the questionnaires’ screening survey), (2) are
smokers, (3) left-handers, (4) have vision that is not corrected to normal, (5) are antihistamine, glucocorticoid or asthma
medication users, (7) are exposed to general anesthesia within past one year or (8) have abnormalities in the endocrine system.
These exclusionary criteria are self-affirmed by the prospective participants.
2.3
Provide a detailed description of the method of recruitment.
Online Recruitment
In the post, the contents that we will cover are expected to include: an overview of the research project (topic, timeline, leader,
etc.), proven effectiveness of group coaching to students, benefits or experiences that participants will have when joining the
program and link to the registration form. At the end of the article there will be the contact information of the research manager.
In-Class Recruitment
 In case there's not enough participants when recruiting online, the research team will conduct classroom communication to
students. By randomly selecting 4 to 5 classes taking place at the Nguyen Van Trang or Thanh Thai or Quang Trung campus,
collaborators will be trained to prepare in advance the introduction of the research project to students. The introductory content is
also expected to include a research overview (topic, timeline, leader, etc.), the coaching's proven effectiveness on students and
participants' benefit when they join the program. The researcher will contact the classroom instructor in advance to ask
permission to take 10 minutes before break time so that collaborators can enter the classroom and present about the research.
Then, project the QR code on the slide and ask students feel free to scan and read more about research information (registration
link will also be attached inside).

2.4 Please copy recruitment materials (e.g. letters, advertisements, flyers, verbal or telephone script, etc.)
Additional Files will be Attached with this Form

2.5 Please copy the consent form to be used for this project.
The Consent Form will be Attached along with this Form

PART 3: PROCEDURES AND RISKS

3.1
Describe your Experimental or Clinical Procedure
Implementation plan:

The project includes these steps below:

Stage 1: Subject recruitment and orientation:
- Recruit about 50 suitable subjects, who are students at Hoa Sen University, based on their willingness, cooperation,
clinical record and availability.
- Randomly assign the participants to two groups, one of which is the experimental group (EG, or coachees) and the other
the control group (CG, or waiting-list group).
Stage 2: Data collection and training:
❏ The orientation week:
- Explain to the two groups about the research project and the coaching program
- Encourage the participants to sign in the consent form
- Ask the participants to respond to the self-report questionnaires about their well-being and goal striving for the first time
- Record the participants’ EEG signal.. (blodd pressure? pulse?)
❏ The first to seventh weeks:
- Organise the coaching program for the EG while the CG enter the waiting period
❏ The eighth week:
- After the coaching program, conduct the self-report questionnaires for both groups for the second time.
- Record EEG signal while subject from both groups is responding to digital stress-generating tasks
- Ask subjects from the CG to complete the feedback form. Please note that the questionnaire is used to determine the level
of well-being and goal striving, while the feedback form helps to obtain subjects’ opinion about the experiment as well as this
methodology in order to develop this training more in the near future.
❏ The ninth week:
- Admit the CG to the coaching program while the EG enters the follow-up period.
❏ Three months from the ninth week:
- Ask the EG group to respond to the self-report questionnaires for the third time
- Record EEG signal for subjects from the EG groups while she or he is responding to digital stress-generating tasks.
- Ask the EG to complete the feedback form.
Stage 3: Signal processing & Data analysis:
- Detect and remove the artifacts in the EEG signal.
- Calculate the alpha absolute power before and after the experiment, then divide the latter by the former to get the alpha
absolute power ratio.
 - Compare the difference between blood pressure and pulse before and after the experiment.
- Compare the emotioncognitive scores before and after the experiment.
- Analyse data from the self-report questionnaires to compare in-group and between-group differences in well-being and
goal striving and their changes over time.

3.2
What are the known risks associated with the procedures and your mitigation plan? Also include any risks
associated with the placebo or wash out periods, if applicable.
The application form, together with a screening survey, consists of some questions related to mental health
problems (e.g., DASS-21 and other exclusion criteria) of applicants. Although those questions are not expected to
trigger any serious reactions in applicants, some stress that is related to the applicant's existing problems may occur.
Otherwise, as the admitted participants are expected to be mentally healthy, there is no risk associated with the
procedures afterwards. Our questionnaires of the applicant’s well-being and goal striving questionnaires are
commonly used among research in this area, and so far no risk has been reported. With respect to the EEG
recording procedure, Emotiv EPOC, Headphone, SphygmomanometerAlice 5 is a are sequential commercial grade
and clinical- grade devices which has that have been widely used in the market and also in the IU’s
SchoolDepartment of Biomedical Engineering. There are no risks associated with an EEG No thatrisk has been was
reported till today. The MUSE Headband has no risk reported till today.
3.3
What strategies will be put in place to minimize and/or manage the potential risk(s) to participants and other affected
individuals?
Information of suitable sources of psychological support will be provided at the end of the application form in case that some
applicants feel stressful when replying to our screening survey’s questions.
3.4
Indicate from which sources personal and health information data will be collected.
 - Information of applicants, information of the research participants and their responses to the research questionnaires will be
collected in Google Fforms. InfotmedInformed consent will be given in printed documents.
- Physiological data (EEG, Blood Pressure…) and Questionnaires, Results from CognitiveEmotion Tests.
3.5 How will the confidentiality of participants and their health information be protected?
The survey will be conducted by an online platform called Google Forms. After the survey is completed, the data will be stored on
password protected computers and files that only the named researchers will have access to, then your answers you give to the
survey questions will be removed from the survey servers.

The undersigned accepts responsibility for assuring that with regard to this protocol, all applicable regulations and
policies relative to the protection of the rights and welfare of human subjects are adhered to.

Signature of Principal Investigator 5 January, 2021

Lê Trần Hoàng Duy