The Feasibility and Preliminary Effects of an Empowerment-based Cognitive Behavioural Therapy for Insomnia on Sleep, Cognitive Function and Health--related Quality of Life in Persons With Mild Cognitive Impairment
Phase: NA
Conditions: Mild Cognitive Impairment, Insomnia
Sponsor: The University of Hong Kong

Study Proposal (version3,19 Oct 2020) 
Page 1 of 8 
The University of Hong Kong 
School of Nursing 
 
Study Proposal 
 
Study Title: The feasibility and preliminary effects of an empowerment-based cognitive behavioural therapy 
for insomnia on sleep, cognitive function and health-related quality of life in persons with mild cognitive 
impairment: A mixed-method pilot study  
 
Background 
 
The detrimental impacts of cognitive impairment 
Dementia is an irreversible devastating neurodegenerative disorder characterized by memory loss, cognitive 
deterioration, functional impairment and behavioral changes. Alzheimer’s disease is the most common type, 
accounting for 60-80% of late-life dementia.[16, 17] Dementia imposes not only significant physical and 
psychological burdens on the sufferers and their families but also enormous service demands on health and 
social care systems. Because dementia is an incurable and progressive debilitating chronic condition, it is 
imperative to develop effective means by which to mitigate disease burden at the pre-dementia stage. Mild 
cognitive impairment (MCI) represents the reversible, intermediate clinical state between normal age-related 
cognitive decline and dementia, but it does not fulfill the diagnostic criteria for dementia.[3, 18] It is a highly 
prevalent condition, particularly among the geriatric population. A meta-analysis including 34 epidemiologic 
studies reported the prevalence of MCI ranged from 8.4% for people aged 65-69 years to 25.2% for those 
aged 80-84 years.[20] Solid epidemiological evidence suggests that MCI persons are prone to progress to 
dementia, most often Alzheimer’s disease, at a rate of 10 to 15% per year.[18] These data highlight the 
urgent need to identify effective and safe strategies to halt or even reverse the progression of cognitive 
impairment in MCI persons. 
 
Insomnia in MCI persons 
At present, no pharmacological treatment has proved to be effective in reversing cognitive impairment in 
MCI persons. Instead, modification of risk factors remains the primary strategy to reshape the cognitive 
trajectory in these persons. Empirical evidence has linked several lifestyle and vascular risk factors to an 
increased risk of cognitive decline in MCI and Alzheimer’s disease.[22] Accordingly, research evidence is 
accumulating to support the empirical effects of risk modification interventions in improving the cognitive 
health of MCI persons, such as engagement in physical, social and cognitive activities.[23-25] Indeed, 
growing evidence is emerging to suggest insomnia as a new risk factor to be associated with cognitive 
decline and conversion from MCI to dementia.[5] Insomnia symptoms, including difficulty in falling asleep, 
waking up during the night and early morning awakening, are highly prevalent among MCI persons but have 
received the least attention. 27] Epidemiological evidence also suggests that poor sleep is associated with an 
increased risk of converting from MCI to dementia.[30] 
 
 
The underlying mechanisms linking sleep to cognition 
General and condition-specific mechanisms underlie the connection between sleep and cognition. Generally, 
sleep serves a restorative function in the brain to maintain normal cognitive function. In particular, slow-
wave sleep (i.e., deep sleep) is essential for memory consolidation, a crucial process that stabilizes and fully 
integrates memory traces into long-term memory. Studies have documented that changing the sleep 
architecture by reducing the time in slow-wave sleep result in memory loss.[6, 31] Specifically, the 
underlying mechanisms linking sleep and cognition are related to the deposition of amyloid-β in the brain, 
the hallmark histopathological change in Alzheimer’s disease. APoor sleep increases the level of amyloid-β 
release over time and augments amyloid-β deposition,[8] thus entailing an increased chance of amyloid 
plaque accumulation and subsequently contributing to early cognitive decline and conversion to dementia 
through the disruption of hippocampus-dependent memory.[9] The aforementioned vicious cycle between 
disturbed sleep and amyloid-β pathology underscores the potential cognitive benefits of interventions to 
improve sleep among MCI persons. 
 

Study Proposal (version3,19 Oct 2020) 
Page 2 of 8 
Sleep promotion in MCI persons: an unaddressed issue 
Pharmacotherapy remains the most common sleep aid modality for managing insomnia in adults. However, 
hypnotic drugs are typically not suggested for long-term use in an older population because of the increased 
risk for adverse effects, drug-drug interactions, dependence, tolerance and the lack of empirical evidence to 
support their long-term efficacy in this population.[33] Their common side effect of reducing cognitive 
performance further compromises their use among the MCI population.[34] Thus, the use of non-
pharmacological approaches should be a priority to promote better sleep in this clinical population. Among 
such strategies, cognitive-behavioral therapy for insomnia (CBT-I) has received the best recognition in the 
literature.[11, 35] 
CBT-I is a multi-component approach that combines various cognitive and behavioral strategies including 
sleep restriction, stimulus control, cognitive therapy, sleep hygiene and relaxation strategies. The underlying 
assumption of this non-pharmacological treatment is based on Spielman’s 3P Model of Insomnia, which 
delineates the roles of predisposing, precipitating and perpetuating factors in hampering effective sleep 
function.[36] CBT-I comprehensively tackles these factors that maintain insomnia over time through the 
following five key intervention components: 
 
1. 
Stimulus control: a set of behaviors aimed at strengthening the association between the bedroom and 
other environmental cues with rapid sleep onset. 
2. 
Sleep restriction: a technique to consolidate sleep by limiting the time spent in bed to the actual time 
of sleeping. An initial sleep deprivation is induced to increase sleep efficacy and is followed by a gradual 
prolongation of the sleeping time. 
3. 
Sleep hygiene: teaching lifestyle habits that are more conducive to sleeping and avoiding sleep-
incompatible behaviors. 
4. 
Relaxation training: a technique used to induce a complete state of physical and mental relaxation 
and hence reduce cognitive, emotional and physiological arousal that is non-conducive to sleeping. 
5. 
Cognitive restructuring: a technique to alter faulty beliefs and attitudes that often serve to exacerbate 
insomnia and replace them with more adaptive substitutes. 
 
The sleep-promoting effects of CBT-I have been widely examined in clinical trials.[12] Because it addresses 
a variety of perpetuating factors of insomnia, CBT-I was found to be more effective than a single-component 
approach in tackling insomnia.[11] As such, the international guideline from the American College of 
Physicians has recommended the wide application of CBT-I to manage chronic insomnia in general 
adults.[11] Despite such strong recognition of the sleep-promoting effects of CBT-I, its application in people 
with MCI is minimal. The compromised cognitive ability of this group and, thereby, the resulting challenges 
in their active engagement may explain such limited application. 
 
 
Engaging MCI persons in an active learning process: an empowerment approach 
The empowerment approach has recently emerged as a novel, effective paradigm for health promotion and 
education. This person-centered collaborative approach optimizes learning by promoting patient 
participation during the educational process.[39] The essence of the empowerment model equips the 
therapist with a step-by-step approach to support the participants in understanding the rationale for 
behavioral changes; a goal-setting process to help them to stay focused and increase their motivation and 
autonomy;[14] and a subsequent process to assist the participants in developing an action plan as a roadmap 
to guide progressive goal attainment. The step of action planning also helps the participants to translate 
abstract knowledge and beliefs into concrete actions.[14] To the best of our knowledge, such an 
empowerment-based approach has never been used to compensate for the cognitive impairment in MCI 
persons that precludes the uptake of CBT-I content. Given the strong relationship between sleep and 
cognitive impairment, and the inadequacy of current empirical evidence on sleep-promoting interventions 
for MCI persons, we hypothesize that a multi-component CBT-I intervention featuring an empowerment-
based approach would improve the sleep and cognitive function in this highly vulnerable group. 
 
 
Work done by us 

Study Proposal (version3,19 Oct 2020) 
Page 3 of 8 
This study is proposed to address the research gap identified by the investigation team. We are currently 
conducting a randomized controlled trial (RCT) to examine the effects of a new volunteer-supported model 
to improve cognitive function in MCI persons through the promotion of an active lifestyle. We noticed that 
sleep problems are highly prevalent among this vulnerable group, and their motivation is low. As such, this 
team of investigators, which has a strong research track record and expertise in delivering psychosocial 
interventions, care of persons with MCI and dementia and chronic disease management using the 
empowerment-based educational model, developed an evidenced-based CBT-I intervention featuring the 
empowerment approach to improve sleep quality and cognition in persons with MCI. The PI and the Co-I 
(D. Yu) have successfully used the empowerment model to promote self-care among patients with heart 
failure. Indeed, the co-investigators have extensive research and clinical experience in working with people 
with MCI and dementia. The Co-I (D. Yu), a nursing academician specializing in gerontology, has 
established an online CBT-based website (Sweet Dream) to fight against insomnia in the older population in 
Hong Kong and has tested the effects of an activity-based intervention for older people with sleep 
complaints. Another Co-I (A. Wong) is a psychologist with substantial research experience working with 
people with MCI and dementia. This study proposes to address a neglected area in the literature and to test 
the effects of an empowerment-based CBT-I for MCI persons on their sleep and cognition. 
 
Research plan and methodology 
The proposed study will have two aims:i) to determine the feasibility of an empowerment-based CBT-I in 
MCI persons; and ii) to examine the preliminary effects of the empowerment-based CBT-I on sleep, 
cognitive outcomes and HRQoL in persons with MCI. Sleep pattern in terms of time to initiate sleep (sleep 
latency, SL), number and duration of awakenings after sleep onset (WASO), ratio of total sleep time (TST) 
to the time spent in bed (sleep efficiency, SE) and sleep quality will be the primary outcomes, and cognitive 
function and HRQoL will be the secondary outcomes. 
 
Study design 
This will be a mixed-method study with a single-blinded parallel-group randomized controlled trial (RCT) 
and a qualitative study to determine the feasibility and preliminary effects of the empowerment-based CBT-I 
on sleep, cognitive outcomes and HRQoL in persons with MCI. The study implementation protocol is 
outlined in Figure 1. A research assistant (RA1) will recruit eligible participants from the elderly community 
centers operated by two non-governmental organizations in Hong Kong. After collecting the baseline data 
(T0), RA1 will randomly assign participants into the intervention group and control group with block 
randomization to ensure even distribution of participants in the two study groups over the study period. A 
computer-generated random sequence will be used to determine the block size (6, 8 and 10) and respective 
study group allocation in a 1:1 ratio. To ensure allocation concealment, the group allocation will be 
determined according to the random sequence codes placed in sealed opaque envelopes. Participants in the 
intervention group will receive the empowerment-based CBT-I, whereas the control group will receive usual 
care. To minimize biases, another research assistant (RA2) who is blinded to the group allocation will be 
responsible for collecting post-test data immediately (T1) and 3 months (T2) post-intervention for both 
groups. A total of 10 participants, with 3-4 participants from each intervention group, will be invited to take 
part in a qualitative interview to obtain more in-depth comments about the feasibility and acceptability of the 
intervention. 
 
 
Study participants 
Adults will be eligible to join the study if they are aged ≥50 years, living in the community, with MCI 
defined by the following criteria: i) presence of significant cognitive complaints, defined as ≥3 complaints 
on the Memory Inventory for Chinese;[44] ii) abnormal objective cognitive performance defined as < -1.5 
standard deviations from age- and education-matched normal persons on the Montreal Cognitive Assessment 
Hong Kong version (HK-MoCA);[45] and iii) independence in daily living as evaluated through the clinical 
interview. Participants are required to have poor sleep quality that can be assessed by the Pittsburgh Sleep 
Quality Index (PSQI).[46] The PSQI consists of 19 items evaluating seven domains of subjective sleep 
quality in the preceding month. Each subscale is weighted equally on a 0 to 3 scale. A global score is 
obtained by summing the scores of the subscales, with a higher score indicating worse sleep quality. MCI 
persons with a global PSQI score of >5 will be eligible for inclusion.  Persons with confirmed dementia, 

Study Proposal (version3,19 Oct 2020) 
Page 4 of 8 
with known psychiatric conditions, impaired communication, sleep disorders with an organic cause (e.g., 
sleep apnea, or restless legs syndrome) or due to a medical problem (e.g., pain) and those using hypnotics 
and other medications known to affect sleep (e.g., steroids, anxiolytics) will be excluded. A total of 60 
participants (i.e., 30/study arm) will be recruited for this pilot RCT. The findings of this pilot will provide 
information for estimating the effect size, which will inform the sample size for a subsequent full-scale RCT.   
 
Intervention group: Empowerment-based CBT-I for MCI 
Participants in the intervention group will participate in a 12-week empowerment-based CBT-I comprising 
face-to-face sessions supplemented with telephone follow-ups. In total, six face-to-face sessions (90 
minutes/session) will be conducted in a small group format with 6–8 participants in a group and two 30-
minute individual sessions will be scheduled over eight weeks, with the individual sessions arranged in the 
4th and 7th week, and this is then followed by two bi-weekly telephone follow-ups. The face-to-face delivery 
modality is adopted to meet the challenges of mildly impaired cognition faced by MCI persons, whereas the 
small group format was chosen in accordance with the literature suggesting it has efficacy comparable with 
the individual format.[50] The group format is more cost-effective, and it can facilitate peer modeling and 
learning. The face-to-face sessions will cover the following core areas in CBT-I: i) sleep education, ii) sleep 
hygiene and relaxation, iii) sleep restriction, iv) stimulus control and v) cognitive therapy. The first five 
sessions will cover these core areas, and a booster session will then follow to summarize the key components 
of CBT-I and equip the participants with relapse-prevention strategies when sleeping problems recur (Table 
1). The content of the CBT-I components complies with the recommendations for managing chronic 
insomnia by major international sleep associations.[11, 51]  
A five-step empowerment approach (Figure 2) will be adopted to implement each face-to-face session to 
facilitate goal attainment and behavioral maintenance. At the beginning of each session, RA1 will encourage 
the participants to discuss their usual practice or beliefs about sleep or insomnia related to the core area of 
that week. The RA1 will make use of various therapeutic communication and counseling skills during the 
process, which are outlined in Figure 2. Moreover, supportive, non-judgmental and empathetic attitudes will 
be used to build a rapport with the participants. The RA1 will then deliver a structured educational session 
about the topic area. The rationales and explicit methods of how to carry out the suggested behaviors will be 
stated. The content will emphasize assisting participants to understand the linkage between their usual 
practice (behaviors/thoughts) and the consequences to sleep disruption. The RA1 will then facilitate the 
participants to identify the discrepancies between their usual practice/dysfunctional beliefs and the 
recommended best practice for sleep improvement/beliefs that favor better sleep. Easy-to-understand comic 
stories will be incorporated to illustrate the more abstract concepts about dysfunctional beliefs related to 
insomnia (for the session on cognitive therapy) and bed-sleep association (for the session on stimulus 
control). The RA1 will also highlight the possible consequences of these discrepancies on brain health. The 
RA1 will then assist participants to set self-directed goals related to these areas. During this process, the 
RA1 will work collaboratively with the participants and ensure that the goals are achievable yet challenging. 
The RA1 will also work with the participants to develop an action plan for achieving the goals set during 
each session. After action-planning, a subsequent interactive skill-building session will ensure that 
participants acquire the skills required to perform specific behaviors. A scenario-based approach will be 
adopted to train the participants on how to maintain the recommended behaviors. The RA1 will make use of 
group dynamics by encouraging the discussion among the peers of successful actions, feelings, concerns and 
perceived barriers to goal achievement. Various memory compensatory strategies will be used to reinforce 
the educational content, such as memory aids (e.g., memory notebooks, calendars and to-do lists) and 
mnemonic strategies. Each subsequent session will begin with a discussion of progress in goal attainment 
and challenges and barriers encountered while implementing the action plan set during the preceding week. 
The RA1 will also review the key messages delivered in previous sessions. 
The RA1 will provide continuous support through telephone calls (two bi-weekly calls) upon the completion 
of all face-to-face sessions. A telephone record containing the participants’ demographic and clinical profile, 
endorsed dysfunctional beliefs and attitudes about sleep, self-directed goals and action plans will be created 
to facilitate the telephone support. The RA1 will monitor participants’ adherence to the recommended 
behaviors and goal attainment progress, identify barriers in real-life settings and provide methods of 
resolving them. The advice and counseling given will be documented to guide subsequent telephone calls. 
 
Control group: Usual care 

Study Proposal (version3,19 Oct 2020) 
Page 5 of 8 
The control group will receive the standard care provided by the elder community centers. The participants 
in the control group are required to consent not to participate in any structured cognitive training activities 
provided by the centers during the study period.  
Fidelity monitoring of the study intervention 
A step-by-step standard manual with sample dialogue will be developed to guide the RA1 in delivering the 
intervention. Moreover, the PI will randomly select two groups in the intervention arm for fidelity 
monitoring and checking. The face-to-face sessions will be videotaped, and the telephone calls will be 
audiotaped after obtaining the participants’ consent. A performance checklist will be developed and used for 
fidelity checking. Two postdoctoral fellows will be invited to review the videos and complete the checklist. 
In addition, the attendance of the participants will be recorded. All of these data will be used to interpret the 
study findings. 
 
Outcome measures 
 
Sleep assessment. Three measures were chosen to evaluate sleep pattern and quality by both subjective and 
objective means according to the recommendations suggested by the international expert consensus.[52] The 
19-item Chinese version of the PSQI will be used to assess subjective sleep quality.[53] It is reliable 
(Cronbach’s alpha = 0.83) and has shown good test-retest reliability and discriminant validity.[53] The 
Chinese version of the Insomnia Severity Index (ISI-C) (7-item)[54] will be used to assess the perceived 
insomnia severity, consequences of insomnia and the degree of distress related to insomnia. A five-point 
Likert scale is used, with higher values indicating higher levels of perceived severity of insomnia, more 
severe consequences of insomnia and a greater degree of distress associated with insomnia. The ISI-C has 
good internal consistency (Cronbach’s alpha = 0.81), construct and discriminant validity.[54] An Actiwatch, 
which contains an accelerometer to record the frequency and intensity of body movement, will be used to 
objectively assess sleep patterns. The parameters of sleep pattern include TST, SL, WASO and the ratio of 
TST to SE. Participants will be instructed to wear the Actiwatch on their non-dominant wrist during sleep for 
a consecutive seven-day period.  
 
Cognitive assessments. To detect subtle cognitive changes, a battery of cognitive assessments will be used to 
evaluate various domains of cognition, including the Cantonese version of the Alzheimer’s Disease 
Assessment Scale–Cognitive subscale (ADAS-Cog)[55] for global cognition, the digit span-forward and 
backward test for attention and working memory, the Hong Kong List Learning Test for episodic memory, 
and the Color Trails Test for complex attention, executive function and task switching. 
 
HRQoL. The Chinese Hong Kong version of the Short Form Health Survey (SF-12) will be used to measure 
HRQoL.[56] It consists of 12 items to form two summary scores to reflect people’s physical and mental 
well-being, with higher scores indicating better HRQoL. Its psychometric properties are satisfactory with 
evidence of good reliability, content and construct validity.[56]  
 
Data analysis 
Statistical analysis of the outcome comparisons will be performed on the basis of the intention-to-treat 
principle. Variables with skewed data will be transformed appropriately before being subjected to analysis. 
Baseline characteristics between the two study arms will be compared by t-test, chi-square or Fisher’s tests, 
as appropriate. Repeated measure ANOVA will be used to determine the effects of the intervention by 
comparing differential between group changes across the 3 time-points. All statistical analyses will be 
performed using IBM SPSS 25.0. All statistical tests will be two-sided, and a p-value of less than 0.05 will 
be considered statistically significant. All statistical analyses will be performed using SAS release 9.4 (SAS 
Institute, Cary, NC). All statistical tests involved will be two-sided with the level of significance set at 0.05. 
 
Ethical Consideration: 
This study followed the Declaration of Helsinki on medical protocol and ethics. Ethics approval will be 
obtained from the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong 
Kong West Cluster. Patients are voluntary participants in the study. A written informed consent, which will 
include the research title, purpose, explanation of the research, and the procedures of the study, will be 
obtained from each eligible participant. Risks and benefits are also explained clearly to the participants. 

Study Proposal (version3,19 Oct 2020) 
Page 6 of 8 
Participants have the right to withdraw from the study at any time. They will be protected from discomfort 
and harm during the study. Further, anonymity and confidentiality of the participants will be strictly 
protected. Their decision of participating in the study will not affect the quality of present or future care they 
receive in the hospital. 
 
References: 
1. 
Prince M, Guerchet M, Prina M. The epidemiology and impact of dementia: current state and future 
trends. WHO Thematic Briefing. World Health Organization, 2015. 
2. 
Prince M, Wimo A, Guerchet M, Ali G, Wu Y, Prina M. World Alzheimer Report 2015. The global 
impact of dementia. An analysis of prevalence, incidence, cost & trends. Alzheimer ’s Disease International. 
2015. [cited 2018 Oct 1] Available from: https://www.alz.co.uk/research/WorldAlzheimerReport2015.pdf  
4. 
Petersen RC, Smith GE, Waring SC, Ivnik RJ, Tangalos EG, Kokmen E. Mild cognitive impairment: 
clinical characterization and outcome. Arch Neurol 1999; 56(3):303-8. 
5. 
Yaffe K, Falvey CM, Hoang T. Connections between sleep and cognition in older adults. The Lancet 
Neurology. 2014; 13(10):1017-28. 
6. 
Stickgold R. Sleep-dependent memory consolidation. Nature. 2005; 437(7063):1272. 
8. 
Kang JE, Lim MM, Bateman RJ, Lee JJ, Smyth LP, Cirrito JR, Fujiki N, Nishino S, Holtzman DM. 
Amyloid-β dynamics are regulated by orexin and the sleep-wake cycle. Science  2009; 326(5955):1005-7. 
9. 
Westerberg CE, Mander BA, Florczak SM, Weintraub S, Mesulam MM, Zee PC, Paller KA. 
Concurrent impairments in sleep and memory in amnestic mild cognitive impairment. J Int Neuropsychol 
Soc 2012; 18(3):490-500. 
10. 
de Almondes KM, Costa MV, Malloy-Diniz LF, Diniz BS. Insomnia and risk of dementia in older 
adults: systematic review and meta-analysis. J Psychiatr Res 2016; 77:109-15. 
11. 
Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD. Management of chronic insomnia 
disorder in adults: a clinical practice guideline from the American College of Physicians. Ann Intern Med 
2016;165(2):125-33. 
12. 
Brasure M, Fuchs E, MacDonald R, Nelson VA, Koffel E, Olson CM, Khawaja IS, Diem S, Carlyle 
M, Wilt TJ, Ouellette J, Butler M, Kane RL. Psychological and behavioral interventions for managing 
insomnia disorder: an evidence report for a clinical practice guideline by the American College of 
Physicians. Ann Intern Med 2016; 165(2):113-24. 
14. 
Feste C, Anderson RM. Empowerment: from philosophy to practice. Patient Educ Couns 1995; 
26(1):139-44. 
15. 
World Health Organization. Dementia: a public health priority. 2012. [cited 2018 Oct 1]. Available 
from: https://www.who.int/mental_health/publications/dementia_report_2012/en/  
16. 
World Health Organization. Global action plan on the public health response to dementia 2017–
2025. 2017. [cited 2018 Oct 1]. Available from 
http://www.who.int/mental_health/neurology/dementia/action_plan_2017_2025/en/  
17. 
Alzheimer’s Association. 2018 Alzheimer's disease facts and figures. Alzheimers Dement 2018; 
14(3):367-429. 
18. 
Petersen RC, Caracciolo B, Brayne C, Gauthier S, Jelic V, Fratiglioni L. Mild cognitive impairment: 
a concept in evolution. J Intern Med 2014; 275(3):214-28. 
20. 
Petersen RC, Lopez O, Armstrong MJ, Getchius TSD, Ganguli M, Gloss D, Gronseth GS, Marson 
D, Pringsheim T, Day GS, Sager M, Stevens J, Rae-Grant A. Practice guideline update summary: Mild 
cognitive impairment: Report of the Guideline Development, Dissemination, and Implementation 
Subcommittee of the American Academy of Neurology. Neurology 2018; 90(3):126-135. 
21. 
Tang LN, Lau ML, Chan CC, Tam YY, Yung CY, Li HS, Yeung PY. A study of the progression to 
dementia according to subtypes of mild cognitive impairment in Hong Kong elders. Alzheimers Dement 
2016; 12(7):P1064-5. 
22. 
Norton S, Matthews FE, Barnes DE, Yaffe K, Brayne C. Potential for primary prevention of 
Alzheimer's disease: an analysis of population-based data. The Lancet Neurology 2014; 13(8):788-94. 
23. 
Reijnders J, van Heugten C, van Boxtel M. Cognitive interventions in healthy older adults and 
people with mild cognitive impairment: a systematic review. Ageing Res Rev 2013; 12(1):263-75. 
24. 
Gates N, Singh MAF, Sachdev PS, Valenzuela M. The effect of exercise training on cognitive 
function in older adults with mild cognitive impairment: a meta-analysis of randomized controlled trials. Am 
J Geriatr Psychiatry 2013; 21(11):1086-97. 

Study Proposal (version3,19 Oct 2020) 
Page 7 of 8 
25. 
Hughes TF, Flatt JD, Fu B, Chang CCH, Ganguli M. Engagement in social activities and 
progression from mild to severe cognitive impairment: the MYHAT study. Int Psychogeriatr 2013; 
25(4):587-95. 
30. 
Tranah GJ, Blackwell T, Stone KL, Ancoli-Israel S, Paudel ML, Ensrud KE, Cauley JA, Redline S, 
Hillier TA, Cummings SR, Yaffe K; SOF Research Group. Circadian activity rhythms and risk of incident 
dementia and mild cognitive impairment in older women. Ann Neurol 2011; 70(5):722-32. 
31. 
Diekelmann S, Born J. The memory function of sleep. Nat Rev Neurosci 2010; 11(2):114. 
33. 
Schroeck JL, Ford J, Conway EL, Kurtzhalts KE, Gee ME, Vollmer KA, Mergenhagen KA. Review 
of safety and efficacy of sleep medicines in older adults. Clin Ther 2016; 38(11):2340-72. 
34. 
Vermeeren A, Coenen AM. Effects of the use of hypnotics on cognition. Prog Brain Res 2011; 
190:89-103. 
35. 
Morin CM, Bootzin RR, Buysse DJ, Edinger JD, Espie CA, Lichstein KL. Psychological and 
behavioral treatment of insomnia: update of the recent evidence (1998–2004). Sleep 2006; 29(11):1398-414. 
36. 
Spielman AJ, Caruso LS, Glovinsky PB. A behavioral perspective on insomnia treatment. Psychiatr 
Clin 1987; 10(4):541-553. 
41. 
Newman S, Steed L, Mulligan K. Self-management interventions for chronic illness. Lancet 2004; 
364(9444):1523-37. 
42. 
Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in 
primary care. JAMA 2002; 288(19):2469-75. 
43. 
Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM. Self-management education for adults with 
type 2 diabetes. Diabetes Care 2002; 25(7):1159-71. 
44. 
Lam LC, Lui VW, Tam CW, Chiu HF. Subjective memory complaints in Chinese subjects with mild 
cognitive impairment and early Alzheimer's disease. Int J Geriatr Psychiatry 2005; 20(9):876-82. 
45. 
Wong A, Law LS, Liu W, Wang Z, Lo ES, Lau A, Wong LK, Mok VC. Montreal cognitive 
assessment: one cutoff never fits all. Stroke 2015; 46(12):3547-50. 
46. 
Buysse DJ, Reynolds III CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality 
Index: a new instrument for psychiatric practice and research. Psychiatry Res 1989;28(2):193-213. 
47. 
Irwin MR, Cole JC, Nicassio PM. Comparative meta-analysis of behavioral interventions for 
insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age. Health Psychol 2006; 
25(1):3. 
48. 
Trauer JM, Qian MY, Doyle JS, Rajaratnam SM, Cunnington D. Cognitive behavioral therapy for 
chronic insomnia: a systematic review and meta-analysis. Ann Intern Med 2015; 163(3):191-204. 
49. 
Loehlin JC. Latent variable models: An introduction to factor, path, and structural equation analysis: 
Psychology Press; 2004. 
50. 
Koffel EA, Koffel JB, Gehrman PR. A meta-analysis of group cognitive behavioral therapy for 
insomnia. Sleep Med Rev 2015; 19:6-16. 
51. 
American Academy of Sleep Medicine. Practice parameters for the psychological and behavioral 
treatment of insomnia: an update. An American Academy of Sleep Medicine report. Sleep 2006; 
29(11):1415-9. 
52. 
Buysse DJ, Ancoli-Israel S, Edinger JD, Lichstein KL, Morin CM. Recommendations for a standard 
research assessment of insomnia. Sleep 2006; 29(9):1155-73. 
53. 
Tsai PS, Wang SY, Wang MY, Su CT, Yang TT, Huang CJ, Fang SC. Psychometric evaluation of 
the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) in primary insomnia and control subjects. 
Qual Life Res 2005; 14(8):1943-52. 
54. 
Yu DS. Insomnia Severity Index: psychometric properties with Chinese community‐dwelling older 
people. J Adv Nurs 2010; 66(10):2350-9. 
55. 
Chu L, Chiu K, Hui S, Yu G, Tsui W, Lee P. The reliability and validity of the Alzheimer's Disease 
Assessment Scale Cognitive Subscale (ADAS-Cog) among the elderly Chinese in Hong Kong. Ann Acad 
Med Singapore 2000; 29(4):474-85. 
56. 
Lam CL, Eileen Y, Gandek B. Is the standard SF-12 health survey valid and equivalent for a 
Chinese population? Qual Life Res 2005;14(2):539-47. 
57. 
Baron RM, Kenny DA. The moderator–mediator variable distinction in social psychological 
research: Conceptual, strategic, and statistical considerations. J Pers Soc Psychol 1986; 51(6):1173. 
58. 
Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in 
randomized clinical trials. Arch Gen Psychiatry 2002; 59(10):877-83. 

Study Proposal (version3,19 Oct 2020) 
Page 8 of 8