Internet-based Mindfulness-based Training (iMBT) for People With Depression: Investigation of Its Efficacy and Mechanism of Change
Phase: NA
Conditions: Mindfulness, Depression
Sponsor: Chinese University of Hong Kong

 
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Title: Internet-based Mindfulness-based Training (iMBT) for People with Depression: Investigation of its 
efficacy and mechanism of change 
Document date: 24-09-2021 
 
 

 
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THE CHINESE UNIVERSITY OF HONG KONG 
Survey and Behavioural Research Ethics 
Application Form 
 
NOTE: This Form is to be completed by researchers whose 
research studies involve survey or observation on human subjects. 
Please read the Guidelines for Survey and Behavioural Research 
Ethics carefully before completing this Form. Once the Form is 
completed, please submit together with all relevant documents to 
the Survey and Behavioural Research Ethics Faculty Sub-
committee (c/o Faculty Office concerned). With all the necessary 
information and documents received, the processing time of each 
application is approximately 6 to 8 weeks from the time of 
application. 
 
[For SBREC Use Only] 
Reference No. 
: 
 
Date of 
Received 
: 
 
Type of Review 
: 
☐ 
Expedited 
 
 
☐ 
Full 
 
Part A: Basic Information 
Project Title 
Internet-based Mindfulness-based Training (iMBT) for People with Depression: Investigation of its 
efficacy and mechanism of change  
 
Name of Grant Applied /Being Applied  
(if applicable) 
Grant Ref. No. / Account No.  
(if applicable) 
 
 
Name of Principal Investigator 
(Please underline the surname)(in full) 
Department / Unit 
(in full) 
Winnie W.S. Mak 
Psychology 
Tel. No. 
E-mail Address 
39436577 
wwsmak@cuhk.edu.hk 
For 
students 
Name of Supervisor / Course 
Instructor 
Programme and Year of Study 
Student ID 
 
 
 
Certification of Ethics Training Test(s) 
For details, please visit the Research Ethics Training Website (https://www.research-ethics.cuhk.edu.hk/web/)  
 
 
 
E-Cert ID 
 
E-Cert End Date  
1. Survey and Behavioural Research Ethics  
B106610 
 
27/01/2022 
 
2. Publication Ethics 
B106610 
 
27/01/2022 
 
 
Part B: Summary of Research Proposal (maximum 150 words) 
Summarize, in layperson’s language, the objective(s) and significance of the research. 

 
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Major depressive disorder is a significant public health concern, and internet-based psychotherapy is a 
promising therapeutic approach. With growing evidence that mindfulness-based interventions are 
efficacious in treating depression, this research seeks to examine whether internet-based mindfulness-
based therapy (iMBT) is similarly effective. The aims of this study are:  
(1) to evaluate the efficacy of iMBT in treating adults with depression as compared to usual care, and  
(2) to investigate the mechanisms of iMBT with various statistical tools.  
 
If validated, this research can provide support for the clinical utility of iMBT as a stand-alone mental 
health intervention for people who are clinically depressed. This study will advance our understanding 
of the causal pathways between mindfulness-based intervention and depression and guide future 
research, theoretical developments and clinical practice. This effort increases our repertoire of treatment 
offerings for people with depression.  
 
 
 
Part C: Particulars of Research 
 
Human participants  
 
Age range (Check all that apply) 
☐ 0-17  
☒ 18-59  
☒ 60+  
Specification of the inclusion and exclusion criteria of the study (if any) 
For inclusion, participants must be (1) over 18, (2) have access to computer and mobile phone (since this 
is an internet-based therapy), and must (3) score >9 on PHQ9, (4) have ability to read and type Chinese.  
Exclusion criteria includes (1) self-reported presence of psychosis or bipolar disorder, post-traumatic 
stress disorder, drug or alcohol dependence, current use of antipsychotic medications, (2) self-reported 
frequent suicidal ideation (more than half of the days in the past two weeks), (3) completion of an online 
mental health program/research for depression in the past 3 months  
 
 
1. 
Does the study use only publicly available data? 
☐ Yes 
☒ No 
 
 
 
 
2. 
Does the study involve only survey or observation of public 
officials? 
☐ Yes 
☒ No 
 
 
 
 
If you have checked “Yes” to any of the above questions, you can skip Question 3 and go 
straight to Question 4 to apply for an expedited review. 
 
 
 
 
3. 
Checklist to determine whether a full review is needed: 
 
 
 
(a) 
Does the study involve participants who are unable to give 
informed consent (e.g. children, individuals with intellectual 
disabilities or cognitive impairments)? 
 
(If Yes, please elaborate how consent can be obtained in Question 4.) 
☐ Yes 
☒ No 
 
 
 
 
 
 
(b) 
Will deception of participants be necessary prior to or during 
the study? (If Yes, please attach a debriefing form.) 
☐ Yes 
☒ No 
 
 
 
 
 
 
(c) 
Details on participant remuneration: 
 
 
 
 
(i) 
Will participants receive inducements or rewards (other 
than reasonable expenses and compensation for time) 
before, during, or after participation? 
 
☒ Yes 
☐ No 
 
 
 
If Yes, please specify the form of remuneration e.g. cash, course credit, gift certificate. For cash 
and gift, state the amount; for course credit, state its percentage of the final grade: 
 
 
 
Participants can get a maximum of $200 (either cash or gift certificate) to compensate 
for time used to complete the assessments.  
 
 
 
 
 
 
 
 
(ii) Will the payment be prorated for partial participation? 
☐ Yes 
☒ No 

 
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(d) 
Does the study involve sensitive aspects of the participant’s 
own behaviour such as illegal conduct, illicit drug use, 
suicidality, and sexual conduct? (If Yes, please provide details in 
Question 4.) 
☐ Yes 
☒ No 
 
 
 
 
 
 
(e) 
If the observations on the participants are disclosed, will it 
reasonably place the participant at risk of criminal or civil 
liability or be damaging to the participant’s financial standing, 
employability, or reputation? 
 
☐ Yes 
☒ No 
 
 
If Yes, please provide details below: 
 
 
 
 
 
 
 
 
 
(f) 
Does the study/experiment induce undue psychological stress? 
 
☐ Yes 
☒ No 
 
 
If Yes, please provide details below: 
 
 
 
 
 
 
 
 
 
(g) 
Is pain or more than mild discomfort likely to result from 
participating the study? 
 
☐ Yes 
☒ No 
 
 
If Yes, please provide details below: 
 
 
 
 
 
 
 
 
 
(h) 
Does the study involve prolonged and repetitive testing? 
 
☒ Yes 
☐ No 
 
 
If Yes, please provide details below: 
 
 
Participants will be expected to complete an Internet-based mindfulness-based training 
delivered over a 6-week period via an internet e-learning mental health platform.  
Participants will be assessed at four different time points:  
(1) before intervention (T0), (2) 2,4 weeks since the commencement of group (T1,2), (3) 6 
weeks after (i.e., when the intervention ends) (T3), (4) at 3-month follow-up(T4).  
 
 
 
 
 
 
 
(i) 
Will the participants be identified? 
 
☐ Yes 
☒ No 
 
 
If Yes, please provide details below: 
 
 
 
 
 
 
If you have checked “Yes” to any of the above items, you must go through a full review. Please 
attach a detailed research proposal. 
 
4. 
Summary of Research Procedures (maximum 300 words) 
Describe what the participants will do, where the research activities will take place, the total 
number of sessions the participants need to participate and their total time commitment. 
Besides, please attach the instruments (e.g. questionnaire, focus group discussion guide, 
interview guide, etc.) that will be used in data collection. If the instruments are not yet 
available, please provide a detailed description of them. 

 
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Participants who have provided consent and passed an online screening (based on the above-
mentioned inclusion and exclusion criteria) will engage in a 6-week IMBT, consisting of 6 modules 
with 4 sections each. It is expected that participants will complete one module per week, each module 
lasting around 1 hour while participants are encouraged to practice for 15 minutes a day.  
The control group will be advised to seek assistance from their usual healthcare provider when 
needed.  
Both treatment group and control group will be assessed at four different time points:  
before intervention (T0), (2) 2,4 weeks since the commencement of group (T1,2), (3) 6 weeks after 
(i.e., when the intervention ends) (T3), (4) at 3-month follow-up(T4).  
Initial screening will utilise the PHQ9. Once participants have been recruited, online assessments will 
be conducted via Qualtrics at each of the aforementioned timepoints. The assessments will include:  
- 
Patient Health Questionnaire (PHQ9)  
- 
Five Facets Mindfulness Questionnaire – Short form (FFMQ-SF)  
- 
Warwick Edinburgh Mental Wellbeing Scale  
- 
Credibility and Expectancy Questionnaire (CEQ)  
- 
Difficulties in Emotional Regulation Scale (DERS)  
- 
Nonattachment scale 
- 
Stillness scale  
- 
Equanimity scale  
- 
Peace of mind scale   
 
 
5. 
Will consent form be used? 
 
☒ Yes 
☐ No 
 
If No, please provide reason(s) below: 
 
 
 
 
 
 
 
 
 
(a) 
Type of consent (Check all that apply)(Please attach a copy of consent form.) 
 
 
 
☒ 
Formal Consent  
 
 
 
 
 
☒ 
Informed consent  
(for participants able to give legal valid informed consent and not belonging to any 
vulnerable groups) 
 
☐ 
 
Parent/guardian consent  
(for participants under 18 years old or those belonging to a vulnerable group) 
 
☐ 
Assent form  
(for participants not competent to give legal valid informed consent) 
 
☐ 
Passive informed consent  
(for surveys to be conducted through the schools or other authorities) 
 
 
 
 
 
 
 
 
☐ 
Informal Consent 
 
 
 
 
 
Please provide justifications: 
 
 
 
 
 
 
 
 
6. 
Confidentiality of data 
 
 
 
(a) 
Collection of auditory and visual data (Check all that apply)  
 
 
 
 
 
☐ Audiotapes 
☐ Still photos 
 
 
 
 
☐ Videotapes 
☒ Not applicable 
 
 
 
 
 
 
 
 
 
(b) 
Does the study involve multi-phase data collection? 
 
☒ Yes 
☐ No 

 
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If Yes, please explain the tracking and coding system(s): 
 
 
Participants will be identified by a unique ID to match their data across time.  
 
 
 
 
 
 
(c) 
Does the study involve collecting data through an Internet 
survey platform? 
 
☒ Yes 
☐ No 
 
 
If Yes, please address the confidentiality of data collected via e-mail, Web interfaces, and other 
networked information: 
 
 
Yes, Qualtrics will be used, participants again identified by their respective unique IDs.  
 
 
 
 
 
 
(d) 
Will any individually identifiable information, including images 
of participants, be published, shared, or disseminated? 
 
☐ Yes 
☒ No 
 
 
If Yes, please elaborate how the explicit consent or assent for such publication/share/dissemination can 
be obtained from participants: 
 
 
 
 
 
 
 
 
7. 
Data Security 
Describe how and where data will be kept to protect participant’s confidentiality. 
 
  
     
 
 

 
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Appendix 1 – Grant Application 
 
THE CHINESE UNIVERSITY OF HONG KONG 
Social Science Panel 
 
Direct Grant for Research 2019-20 
Application Form 
 
 
1. 
Investigator(s) Information 
[Please attach a CV (within two A4 pages) for the Principal Investigator and each Co-Investigator (if any).] 
 
 
 
 
Name 
Department / Unit 
a) Principal Investigator 
Winnie W. S. Mak 
Psychology 
b) Co-Investigator(s) 
Larry Auyeung 
Psychology 
 
 
 
 
2. 
Plan to develop this proposal into RGC General Research Fund (GRF) / Early Career Scheme (ECS) 
proposal within two years : 
 
 
 
 
Yes  
(for applied amount up to HK$100,000) 
 
☐No  
(for applied amount up to HK$50,000) (Please skip part 4a) 
 
 
3. 
Project Title 
 
 
 
Internet-based Mindfulness-based Training (iMBT) for People with Depression: Investigation of its efficacy and 
mechanism of change 
 
 
4. 
Project Objectives and Long-term Significance (A maximum of one A4 page) 
 
Please state the purpose of the proposed investigation, identify the key issues and problems being addressed and the possible outcome of 
the research project, its relevance, significance and value. 
 
 
 
Project Objectives 
Major depressive disorder is a significant public health concern due to its high prevalence, high 
disease burden, and common comorbidity. One promising approach to enhance the accessibility and 
serviceability of psychotherapy is to complement the existing health system through evidence-based self-
management programs delivered via the Internet. Despite the growing evidence of the efficacy of 
mindfulness-based interventions in the treatment of an array of physical health and mental health 
conditions, research into the efficacy of Internet-based mindfulness programs and its therapeutic 
mechanism on the treatment of common mental disorders is relatively scarce. Through the development of 
Internet-based mindfulness-based training (iMBT) and close examination of its mechanisms, detailed 
refinement in the program development can be made to maximize its effectiveness for specific 
populations. 
 
With reference to the current research and service gap, our aims of this study are:  
(1) to evaluate the efficacy of iMBT in treating adults with depression as compared to usual care, and  
(2) to investigate the mechanisms of iMBT using latent growth curve modelling 
We expect that the newly developed iMBT will have favorable effect on depressive symptoms, 
mindfulness, difficulties in emotion regulation, and positive mental well-being among adults with 
depression. 
 
Application 
no
: 
 
 
 
(For Office Use Only) 
 

 
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Long-term Significance 
Practically, given the popularity of mindfulness and wide-spread adoption of e-therapy, this research 
can provide support for the clinical utility of iMBT as a stand-alone mental health intervention for people 
who are clinically depressed. Theoretically, this study will advance our understanding of the causal 
pathways between mindfulness-based intervention and depression and guide future research, theoretical 
developments and clinical practice. This effort increases our repertoire of treatment offerings for people 
with depression. Especially, in light of the long waiting time in the public mental health services, the 
expansion of evidence-based online interventions provide an effective and efficient way for individuals 
with varied mental health needs to obtain the interventions the need. By systematically testing iMBT as 
possible treatment of choice for people with depression, we add to the offerings of Internet-based 
interventions as expand the use of iMBT to not only for mental health promotion and mental illness 
prevention, but also treatment for depression. 
In addition to establishing its effectiveness in the treatment of depression, by dismantling the process by 
which iMBT lead to changes in individuals’ approach to life and subsequent improvement in their mental 
well-being, we can further deliberate how to adapt iMBT to increase awareness and maximize gains. This 
proposal is one of the series of attempts in my research lab that aims to build a wide repertoire of online 
programs and services with the aims to improve public mental health. The building of a versatile iMBT 
portal in this application through Learning Management System would allow our team to continue to 
conduct research on online interventions with the aims to develop personalized public mental health. 
 
 
 
How will this proposal be developed into RGC General Research Fund (GRF) / Early Career Scheme 
(ECS) proposal? (A maximum of one A4 page) 
 
 
 
If iMBT is showed to be effective in the treatment of people with depression, our next step is to 
conduct a non-inferiority trial comparing iMBT with Internet-based cognitive behavioral therapy 
(iCBT) in the treatment of common mental disorders. The reason for this progression being iCBT is a 
well-established intervention for the treatment of depression and anxiety. A recent meta-analytic review 
showed that iCBT was as effective as its face-to-face counterpart for clinical practice in treating 
depression16. If iMBT is demonstrated to be as effective as iCBT in the non-inferiority trial, we have 
the potential to increase our repertoire of mental health services and approaches to the general public 
for the treatment of common mental disorders. So far, no study has compared these two streams of 
intervention approaches, especially online interventions. Moreover, with this step, we will be in greater 
position to identify moderators that help us determine which interventions are suitable for whom under 
what kind of circumstances. This question is essential in the development of personalized mental health 
care.  
 
In subsequent grant proposal, we aim to further dissect and unpack the active ingredients in iMBT and 
iCBT that allows us to make more precise prediction for individuals’ outcomes. With more data being 
collected, we also aim to leverage machine learning and big data analytics to observe patterns that 
allow us to refine our approaches for based on individuals’ psychosocial profiles. Under 
implementation science, our aim is to understand how best to implement different online and low-
intensity approaches by investigating on usage patterns, adherence factors, specific features of each 
program, and match between person’s preferences with program’s offerings.  
 
 
5. 
Background of Research (A maximum of three A4 pages, including references.) 
 
Summary of related work already done by you and other researchers, and outline of previous and alternative approaches to the 
issue: 
 
 

 
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1.1 Internet delivered Intervention for Depression 
Major depressive disorder (MDD) is a significant and common public health concern due to its high 
prevalence, high disease burden, and common comorbidity 1–3. While evidence-based psychological treatments 
are available, most of those affected by depression do not have access to these treatments or seek help5. Several 
reasons such as long waiting time of mental health service, barriers in access to care, and reluctance to seek 
help due to stigma are contributing to this situation6. One promising approach to enhance the accessibility and 
serviceability of psychotherapy is to complement the existing system using evidence-based self-management 
programs delivered via the Internet. Different forms of psychotherapy, could potentially be transferable to 
Internet-based interventions, especially when guided by coaches9 who provide online guidance, encouragement, 
and therapeutic activities 10,11. The initiatives of translating and scaling up mental health service via the Internet 
echo with the National Institute for Health and Care Excellence guidelines (NICE) for managing depression 12. 
The guideline recommended low-intensity Internet-based interventions as first line treatment prior to more 
complex higher-tier services. Internet-based interventions for major depression has not only been shown to be 
efficacious 13, but also cost-effective and able to generate societal savings14,15. Notably, a recent meta-analytic 
review revealed that Internet-based cognitive behavioral therapy (iCBT) was as effective as its face-to-face 
counterpart for clinical practice in treating depression16. Given the high accessibility and low recurring costs of 
Internet-based interventions for depression, these interventions are suggested to have a huge potential for public 
mental health impact. 
 
1.2 Mindfulness-based Training as an Internet delivered Intervention for People with Depression 
In addition to iCBT, Internet-based mindfulness-based training (iMBT) has also gained evidence in 
improving mental well-being and reducing psychological distress. Mindfulness is defined “paying attention in a 
particular way: on purpose, in the present moment, and nonjudgmentally” 17,18. In the context of understanding 
the beneficial effect of mindfulness on depression, it is theorized that mindfulness training reduced depression 
through encouraging individuals to notice experiences regardless of its valence labelled, and to approach those 
experiences with gentleness, curiosity and interest without suppressing, judging, or pushing these experiences 
away 19. In turn, repetitive negative thinking, which involves cognitive over-engagement in attempt to control 
unpleasant inner experiences, would be attenuated by the facilitation of individuals’ processing of their affective 
experiences17,20. Moreover, through observing that different experiences come and go over time, mindfulness 
practitioners come to know the impermanent and transitory nature of the inner experience and realize that it is 
not always necessary to react.  
A recent meta-analysis that included 209 studies with 12,145 participants concluded that mindfulness-
based intervention is an effective treatment for various psychological problems, and is especially effective for 
reducing depression, anxiety and stress21. Evidence of online mindfulness-based intervention has demonstrated 
its effectiveness among community samples and subclinical populations with elevated depressive symtoms23,24. 
In addition, iMBT may be more acceptable than intervention using the traditional cognitive behavioral 
approach. As reported in a recent study, intervention with mindfulness element was chosen as the first option of 
intervention by over 80% of people with depression/anxiety. Moreover, nearly half of the participants in a study 
reported preference of online formats for mindfulness interventions over group/individual formats28.  
Given its acceptability and preference by individuals with mental health needs and its promising effects in 
reducing depressive and anxiety symptoms, another critical question lies in examining how MBT works so that 
further refinement of such approach can be made based on its theoretical roots and mechanism of change. The 
precise mechanisms underlying the effect of mindfulness have received recent theoretical attention19,29,30. 
Despite not having abundant studies, recent meta-analysis of mediation studies with 12 RCTs identified 
consistent evidence for the change in mindfulness as a mechanism underlying MBIs31. However, simply 
identifying mindfulness as the mechanism of change in MBT is too crude and intuitive. Further unpacking the 
effects of mindfulness is necessary to understand the process through which individuals experience changes. 
One possibility is to examine specific effect of each facet in mindfulness (i.e., observe, describe, act with 
awareness, non-react and non-judgement). Correlational study suggested that different facets of mindfulness 
have differential relationships with various psychological variables 32. Although most facets of mindfulness are 
frequently found to be associated with reduced psychological distress, the “observe” facets is often uncorrelated 
or even positively correlated with mood symptoms 33. In accord with the Acceptance and Monitor theory19, a 
recent study showed high observing skills was correlated with higher depressive symptoms with low 
acceptance. Yet, high observing skills in combination with high acceptance correlated with increased adaptive 
cognitive processing tendencies 34. Consequently, it is important to examine relationships between change of 
mindfulness and that of psychological symptoms at the facet level to provide a more fine-grained perspective 
on the contribution of mindfulness. This could also facilitate refinement of iMBT.  
 

 
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1.3 Aims and hypotheses 
 
The research goals of this randomized controlled trial are to determine the feasibility and the mechanism 
of change of iMBT that has been developed using the Acceptance Checklist for Clinical Effectiveness Pilot 
Trials (ACCEPT) framework35.  
 
The primary research question is as follows: 
‣ 
What is the effectiveness of the iMBT in relation to improvements on depressive symptoms among people 
with clinical depression, relative to a usual care control after the intervention and in 3-month follow-up?  
Secondary questions include the following:  
‣ 
Which facet(s) of mindfulness (i.e., observe, describe, act with awareness, non-react and non-judgement) 
improved during the intervention? 
‣ 
How does the growth trajectory of different facets of mindfulness relate to the improvement of well-being 
and reduction of ill-being?  
 
We hypothesize that: 
H1 Participants in iMBT group will have greater reduction in depressive symptoms and increase in all facets 
of mindfulness and mental well-being, than the usual care group at post-intervention, and 3-month follow-
up. 
H2  Using latent growth analysis, the intraindividual growth trajectory of the monitor and acceptance facets of 
mindfulness would mediate the effect of iMBT on the intraindividual changes in depressive symptoms. 
H3  Using multi-group analysis, in accord with Acceptance and Monitor theory, the relationship between the 
growth trajectory of monitor facets of mindfulness and the growth trajectory of depressive symptoms will 
be moderated by the level of acceptance. People with greater acceptance of inner experience will benefit 
more from the change of monitor facets of mindfulness in iMBT. 
 
References 
1.  
FerrariAJ, SomervilleAJ, BaxterAJ, et al. Global variation in the prevalence and incidence of major 
depressive disorder: A systematic review of the epidemiological literature. Psychol Med. 2013. 
doi:10.1017/S0033291712001511 
2.  
LiuQ, HeH, YangJ, FengX, ZhaoF, LyuJ. Changes in the global burden of depression from 1990 to 
2017: Findings from the Global Burden of Disease study. J Psychiatr Res. 2019. 
doi:10.1016/j.jpsychires.2019.08.002 
3.  
PatelV, ChisholmD, ParikhR, et al. Addressing the burden of mental, neurological, and substance use 
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6736(15)00390-6 
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RussTC, StamatakisE, HamerM, StarrJM, KivimäkiM, BattyGD. Association between psychological 
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5.  
KazdinAE. Addressing the treatment gap: A key challenge for extending evidence-based psychosocial 
interventions. Behav Res Ther. 2017. doi:10.1016/j.brat.2016.06.004 
6.  
MagaardJL, SeeralanT, SchulzH, BrüttAL. Factors associated with help-seeking behaviour among 
individuals with major depression: A systematic review. PLoS One. 2017. 
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7.  
AnderssonG, TitovN. Advantages and limitations of Internet-based interventions for common mental 
disorders. World Psychiatry. 2014. doi:10.1002/wps.20083 
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FairburnCG, PatelV. The impact of digital technology on psychological treatments and their 
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AnderssonG, CarlbringP, LindeforsN. History and Current Status of ICBT. In: Guided Internet-Based 
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JohanssonR, AnderssonG. Internet-based psychological treatments for depression. Expert Rev 
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AnderssonG, TopoocoN, HavikO, NordgreenT. Internet-supported versus face-to-face cognitive 
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Kabat-ZinnJ. Mindfulness-based interventions in context: Past, present, and future. Clin Psychol Sci 
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KhouryB, LecomteT, FortinG, et al. Mindfulness-based therapy: A comprehensive meta-analysis. Clin 
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HofmannSG, SawyerAT, WittAA, OhD. The Effect of Mindfulness-Based Therapy on Anxiety and 
Depression: A Meta-Analytic Review. J Consult Clin Psychol. 2010. doi:10.1037/a0018555 
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BarthJ, MunderT, GergerH, et al. Comparative Efficacy of Seven Psychotherapeutic Interventions for 
Patients with Depression: A Network Meta-Analysis. PLoS Med. 2013. 
doi:10.1371/journal.pmed.1001454 
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WahbehH, SvalinaMN, OkenBS. Group, One-on-One, or Internet? Preferences for Mindfulness 
Meditation Delivery Format and their Predictors. Open Med J. 2014. 
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29.  
GarlandEL, GaylordSA, FredricksonBL. Positive Reappraisal Mediates the Stress-Reductive Effects of 
Mindfulness: An Upward Spiral Process. Mindfulness (N Y). 2011. doi:10.1007/s12671-011-0043-8 
30.  
TeperR, InzlichtM. Meditation, mindfulness and executive control: The importance of emotional 
acceptance and brain-based performance monitoring. Soc Cogn Affect Neurosci. 2013. 
doi:10.1093/scan/nss045 
31.  
GuJ, StraussC, BondR, CavanaghK. How do mindfulness-based cognitive therapy and mindfulness-
based stress reduction improve mental health and wellbeing? A systematic review and meta-analysis of 
mediation studies. Clin Psychol Rev. 2015. doi:10.1016/j.cpr.2015.01.006 
32.  
CashM, WhittinghamK. What Facets of Mindfulness Contribute to Psychological Well-being and 
Depressive, Anxious, and Stress-related Symptomatology? Mindfulness (N Y). 2010. 
doi:10.1007/s12671-010-0023-4 
33.  
RudkinE, MedvedevON, SiegertRJ. The Five-Facet Mindfulness Questionnaire: Why the Observing 
Subscale Does Not Predict Psychological Symptoms. Mindfulness (N Y). 2018. doi:10.1007/s12671-017-
0766-2 
34.  
DesrosiersA, VineV, CurtissJ, KlemanskiDH. Observing nonreactively: A conditional process model 
linking mindfulness facets, cognitive emotion regulation strategies, and depression and anxiety 
symptoms. J Affect Disord. 2014. doi:10.1016/j.jad.2014.04.024 
35.  
CharlesworthG, BurnellK, HoeJ, OrrellM, RussellI. Acceptance checklist for clinical effectiveness pilot 
trials: A systematic approach. BMC Med Res Methodol. 2013. doi:10.1186/1471-2288-13-78 
 

 
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6. 
Research Plan and Methodology (A maximum of three A4 pages, including key references.) 
 
 
 
2 Research Plan and Methodology 
2.1 Trial design, Procedure and Study Flow 
A two-armed parallel RCT following CONSORT statement1 will be conducted to examine the efficacy of 
an Internet-based mindfulness-based training (iMBT) to a treatment-as-usual control group (TAU). Intervention 
(iMBT) will be delivered over a 6-week period via an internet e-learning mental health platform.  
All participants who are interested to join this research will be provided with an electronic informed 
consent form, and online screening. The online screening included a self-assessment of depressive symptoms 
using PHQ-9 as well as items that assessed the inclusion and exclusion criteria.  
Participants will be included if they are: (1) aged over 18, (2) have access to computer and mobile phone, 
(3) scored > 9 on PHQ-9, administered via telephone by trained interviewers, and (4) have ability to read and 
type Chinese. Exclusion criteria includes (1) self-reported presence of psychosis or bipolar disorder, post-
traumatic stress disorder, drug or alcohol dependence, current use of antipsychotic medications, (2) self-
reported frequent suicidal ideation (more than half of the days in the past two weeks), (3) completion of an 
online mental health program/research for depression in the past 3 months. 
Any excluded applicants will receive contact information on community mental health services. 
Following telephone assessment, eligible participants will be randomized to either iMBT or TAU by block 
randomization with block number of 6 with allocation ratio of 1:1. 
Participants will be assessed at the following time points: (1) before intervention (T0), (2) 2,4 weeks since 
the commencement of group (T1,2), (3) 6 weeks after (i.e., when the intervention ends) (T3), (4) at 3-month 
follow-up(T4). Participants in the TAU will have the assessment according to specific times as the iMBT group 
(i.e. weeks since commencement of group) (see Figure 1).  
 
 
Figure 1 CONSORT flow diagram 
 
2.2 Intervention 
2.2.1 Internet-delivered Mindfulness Based Training (iMBT) 
The iMBT developed for this study will be adapted from our team’s previous study3 and the manual of 
mindfulness based cognitive therapy4. To suit a public mental health approach and to increase program 
attractiveness and adherence, the program is designed to be brief in nature while strive to preserve all the 
essential elements in the original manual and program, for example, participants will be asked to practice 
meditations for 15 minutes a day instead of the original 45 minutes a day, and each module is shortened to 
approximately 1 hour instead of the original 2.5 hours. 
The core focus of iMBT will be on educating participants to adopt a new way of being and relating to their 
thoughts and feelings, and altering specific cognitions is not emphasized. This iMBT is comprised of six weekly 
modules on education about mindfulness, guidance on using mindfulness skills to manage symptoms, guided 
meditations (e.g., mindful breathing, mindful eating, mindful walking, body scan, acceptance, choiceless 
awareness and disengaging from thoughts exercise), and guidance on using informal mindfulness skills in day-
to-day life.  
Readings, audio and graphics are included to explain the concept of mindfulness and overcome common 
difficulties associated with mindfulness practice. Furthermore, participants are encouraged to practice daily 
mindfulness exercises using the downloadable audio built within the learning platform. Participants will reflect 
on their experiences by keeping a personal log. An online coach, who will be a trained undergraduate student in 

 
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psychology, will give weekly written feedback based on this log through a secured e-mail system, guiding the 
participants through the program with personal feedback, encouragement and support. 
2.2.2 Treatment-as-usual control group (TAU) 
The TAU group will be advised to seek assistance from their usual healthcare provider when needed. 
2.3 Power Calculation and Sample Size 
Based on past research5, we expected a small to medium (f = 0.11) difference between the iMBT and the 
TAU control group. Thus, using G ∗ Power software (version 3.1.9.2), a sample size of 116 will be needed to 
detect superiority of the intervention groups over the TAU control group with 80% power. 
2.4 Analytical procedure 
2.4.1 Efficacy analyses of iMBT on Depressive symptoms, Mindfulness, and Mental Well-being 
Significance testing of baseline group equivalence will be conducted using Analysis of variance (ANOVA) 
and chi square test if the variables consisted of nominal data.  
To investigate the efficacy of iMBT, intention-to-treat (ITT) linear mixed models using restricted 
maximum likelihood (REML) estimation will be conducted for each outcome measure.  
Fixed factors of time, group, and time*group will be entered in each model. Within-group effect size will 
be computed for pre(T0)-to-post(T3), and pre(T0) to follow-up(T4) changes on each outcome measures, and 
between-group effect sizes (Hedge’s g) will be computed at post(T3) and follow-up(T4). Reliable change scores 
were calculated 6 between pre(T0)and post(T3)-intervention, as well as between pre(T0)and follow-up(T4) for 
the PHQ-9, to determine rates of clinically reliable improvement and deterioration. All analyses will be 
performed in SPSS version 24. 
2.4.2 Mechanism of the iMBT: Parallel process growth modelling 
To investigate which facet(s) of mindfulness mediate(s) the therapeutic effect of iMBT, parallel process 
growth modelling will be used. Structural equation modelling (AMOS, version 26.0) will be used to compute 
the latent growth curve models 7,8. Latent growth curve modelling is a longitudinal analysis that analyzes 
growth over a period of time. Each growth curve has a latent baseline (the intercept) and a growth rate over 
time (the slope). LGM here will be used to characterize the overall trajectories of change (slope) of all five 
facets in mindfulness. How changes in each facets of mindfulness covaries between conditions, and the extent 
to which changes in each facets of mindfulness (putative mediators) mediates the effects of iMBT on changes in 
mental health outcomes will be analyzed. Quadratic growth factors will be added to the models to better 
estimate the trajectory shape when necessary.  
To assess the existence of a mediating indirect effect from intervention allocation to the mental health 
outcome via the putative mediators, we will combine the growth model for the metal health outcome and the 
growth model for each putative mediators model into a combined parallel process growth model (see Fig 2). We 
will test the product of (a) the effect of treatment allocation on the growth of the mediator and (b) the effect of 
growth on the mediator on the growth rate on the outcome. The ab-product’s confidence intervals will be 
estimated based on bootstrapping of 1000 samples9. 
 
Figure 2. Parallel process growth model to assess statistical mediation over slopes. Rectangles denote observed variables and ellipses 
denote for latent variables. PMR = putative mediator (i.e. five facets in mindfulness which include observe, describe, act with awareness, 
non-react and non-judgement) MHO= mental health outcome (i.e. depressive symptoms, well-being, and difficulties in emotion 
regulation) T0,T1,T2 and T3 = Assessment at week 0,2,4 and 6. Bolded arrows highlighted the path of primary interest, which include 
the path from treatment allocation, (a)to growth in the putative mediator, to growth in the mental health outcome (i.e., the ab-product). 

 
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The adequacy of the models will be examined the following goodness of fit indices: comparative fit index 
(CFI), Tucker and Lewis index (TLI), and incremental fit index (IFI), which indicate a good adjustment to 
empirical data when around 0.95, and the standardized root mean squared residual (SRMR), which indicates a 
good adjustment when <0.08 10. 
2.5 Feasibility 
 
Given that our laboratory has already developed the prototype of the iMBT, it is anticipated that this trial 
will be completed within a 2-year period, with approximately 70% of participants retained. This is in line with 
similar e-psychotherapy studies where one meta-analysis reported an average of 23% dropout. 
 
References 
1.  
SchulzKF, AltmanDC, MoherD. CONSORT 2010 Statement: Updated guidelines for reporting parallel 
group randomised trials. Ital J Public Health. 2010. doi:10.4178/epih/e2014029 
2.  
SheehanDV., LecrubierY, SheehanKH, et al. The Mini-International Neuropsychiatric Interview 
(M.I.N.I.): The development and validation of a structured diagnostic psychiatric interview for DSM-IV 
and ICD-10. In: Journal of Clinical Psychiatry. ; 1998. 
3.  
MakWWS, TongACY, YipSYC, et al. Efficacy and moderation of mobile app–Based programs for 
mindfulness-Based training, self-Compassion training, and cognitive behavioral psychoeducation on 
mental health: Randomized controlled noninferiority trial. J Med Internet Res. 2018. 
doi:10.2196/mental.8597 
4.  
StoneAB. Mindfulness-Based Cognitive Therapy for Depression: A New Approach to Preventing 
Relapse. Psychiatr Serv. 2005. doi:10.1176/appi.ps.56.9.1165 
5.  
SpijkermanMPJ, PotsWTM, BohlmeijerET. Effectiveness of online mindfulness-based interventions in 
improving mental health: A review and meta-analysis of randomised controlled trials. Clin Psychol Rev. 
2016. doi:10.1016/j.cpr.2016.03.009 
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JacobsonNS, TruaxP. Clinical Significance: A Statistical Approach to Defining Meaningful Change in 
Psychotherapy Research. J Consult Clin Psychol. 1991. doi:10.1037/0022-006X.59.1.12 
7.  
ByrneBM. Structural Equation Modeling with AMOS: Basic Concepts, Applications, and Programming, 
Second Edition.; 2013. doi:10.4324/9780203805534 
8.  
DuncanTE. An Introduction to Latent Variable Growth Curve Modeling.; 2013. 
doi:10.4324/9780203879962 
9.  
MacKinnonDP, LockwoodCM, WilliamsJ. Confidence limits for the indirect effect: Distribution of the 
product and resampling methods. Multivariate Behav Res. 2004. doi:10.1207/s15327906mbr3901_4 
10.  
HuLT, BentlerPM. Cutoff criteria for fit indexes in covariance structure analysis: Conventional criteria 
versus new alternatives. Struct Equ Model. 1999. doi:10.1080/10705519909540118 
 
 
 
7. 
Working Schedule 
 
 
 
 
 
 
 
 
 
a) 
Start Date: 
June 30, 2020 
(DD/MM/YYYY) 
b) 
End Date: 
June 29, 2022 
(DD/MM/YYYY) 
c) 
Duration (in months): 
24 months 
 
 
 
  
 
 
 
 
 
 
Winnie W. S. Mak 
 
 
Signature of Principal Investigator 
 
Name of Principal Investigator 
 
 
Psychology 
 
February 27, 2020 
 
Department / Unit 
 
Date 
- End -