A Mixed Method Pilot Study for Patients With Mild Cognitive Impairment and Insomnia.

The 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

This study is proposed to address the research gap identified by the investigation team. The investigators 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. The investigators 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 Cognitive behavioral therapy for insomnia (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.

The proposed study will have two aims: i) to evaluate the effects of an empowerment-based CBT-I on sleep pattern, sleep quality, cognitive function and HRQoL in MCI persons; and ii) to examine whether the effects of the empowerment-based CBT-I on cognitive function and HRQoL, if any, are mediated through improved sleep. 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 single-blinded parallel-group waitlist RCT study to investigate the effects of the 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 waitlist control group will receive usual care during the study period and then will receive the CBT-I upon completion of the study evaluation. To minimize biases, another research assistant (RA2) who is blinded to the group allocation will be responsible for collecting post-test data. A total of 30 subjects will be recruited to participate in the initial phase of pilot study to explore the feasibility and acceptability of the methods and procedures to be used on a subsequent full-scale RCT. The RA2 will also invite all participants in this pilot phase to complete a satisfaction survey upon completion of the intervention. All of the participants in the intervention group will be invited to take part in a semi-structured qualitative interview to gather in-depth comments about the feasibility and acceptability of the empowerment-based CBT-T intervention. The collected information will be used to optimize the procedures and process of the main study. To reduce contamination of the control group, the intervention sessions will be delivered in a private room of the study sites. The participants in the intervention group will be advised not to share the content with other members in the centers. Nonetheless, the active ingredients of the intervention are the intensive interactions between the intervener and the participants, which is less likely to be replicated and disclosed by the participants. Study Interventions 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. 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.51 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. The content of the CBT-I components complies with the recommendations for managing chronic insomnia by major international sleep associations. A five-step empowerment approach 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, 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 individualized one-to-one face-to-face meetings (7th and 9th week) and telephone calls (three bi-weekly calls on 8th, 10th and 12th week) upon the completion of all the group-based sessions. A personal 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 individualized face-to-face sessions and 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 The control group will not receive any structured cognitive training or sleep promoting interventions during the study period. The participants in the control group will continue to participate in the social activities offered by the elderly community centers. They have access to the newspapers, board games and computer facility in the centers. Upon completion of collecting all evaluation data for both groups at the three different time points, the empowerment-based CBT-I will be offered to participants in the control group.

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.

The control group will not receive any structured cognitive training or sleep promoting interventions during the study period. The participants in the control group will continue to participate in the social activities offered by the elderly community centers. They have access to the newspapers, board games and computer facility in the centers. Upon completion of collecting all evaluation data for both groups at the three different time points, the empowerment-based CBT-I will be offered to participants in the control group.

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.

Changes from Baseline in Sleep on the 19 item The Pittsburgh Sleep Quality (PSQI) Index at the 12th week and 3 months

The Chinese PSQI is a validated, self-reported instrument for assessing sleep disturbance over the month. A 3-point Likert scale is used to each item (0=no difficulty; to 3 =severe difficulty). Possible total score ranging from 0-21. MCI persons with global score>5 will be eligible for inclusion.

Change from Baseline Chinese PSQI at the 12th week (after the intervention) and 3 months (follow up)]

Changes from Baseline in Insomnia Severity on the 7-item The Chinese version of the Insomnia Severity Index (ISI-C)at the 12th week and 3 months

The ISI-C is a validated, self-reported instrument for assessing the perceived insomnia severity, consequences of insomnia and the degree of distress related to insomnia. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), Possible a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

to record the frequency of body movement, will be used to objectively assess sleep patterns automatically.

Change from Baseline the frequency of body movement at the 12th week (after the intervention) and 3 months (follow up)]

to record the intensity of body movement, will be used to objectively assess sleep patterns automatically.

Change from Baseline the intensity of body movement at the 12th week (after the intervention) and 3 months (follow up)]

To record the sleep parameters include total sleep time (TST), sleep latency (SL), wake after sleep onset (WASO) and the ratio of total sleep time (TST) to sleep efficiency (SE) of sleep, will be used to objectively assess sleep patterns automatically.

Change from Baseline sleep parameters at the 12th week (after the intervention) and 3 months (follow up)]

Changes from the Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)

The ADAS-Cog is a validated instrument for assessing language, memory in order to detect the subtle cognitive changes. The standard ADAS-cog includes the following 11 items, with a possible Total scoring range of 0 - 70. The ADAS score is based on the number of errors made in each item. A score of 70 represents the most severe impairment and 0 represents the least impairment.

The HKLLT is a validated instrument for assessing complex attention, executive function and task switching. Participants were required to learn a list of 16 Chinese words through three learning trials. After 10 and 30 min delay, they were asked to recall as many words as possible. The total number of recalled words after a delay was used to reflect verbal memory ability. A low score on Trial 1, with normal performance on Trial 3 and total learning, is considered to reflect problems in auditory attention spam, but intact learning ability. Poor scores on all three learning trials provide evidence for acquisition problems in learning and memory. The T-score range from <20 to >/= 65. The score of >=65 represents superior and <20 represents the severely impaired.

CCT is a validated instrument for assessing complex attention, executive function and task switching. Time taken to complete each part of the CTT is recorded in seconds and is compared to normative data. Qualitative aspects of the performance that may be indicative of brain dysfunction (e.g. near misses, prompts required, sequencing errors for color and number) are also recorded. The CTT manual reports that it takes 3-8 minutes to complete the CTT. A task is discontinued if the client takes longer than 240 seconds to complete it. Performance time <60 seconds on the CTT was found to predict passing the on-road evaluation, whereas >60 seconds was predictive of failing

SF-12 is a validated instrument for assessing the general health of people, both physical and mental well-being. A mental component score and a physical component score are reported as Z-scores (different compared to the population average, 12 are both 50 points). The standard deviation is 10 points, so each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.

Inclusion Criteria: aged >=50 years living in the community Independence in daily living as evaluated through the clinical interview Presence of cognitive complaints, defined as >= 3 complaints on the Memory Inventory for Chinese Abnormal objective cognitive performance defined as <-1.5 standard deviations from age Education-matched normal persons on the Montreal Cognitive Assessment Hong Kong Version (HK-MoCA) Persons with poor sleep quality that can be assessed by the Pittsburgh Sleep Quality Index, with a global PSQI score of >5 Exclusion Criteria: Persons with confirmed dementia Persons with known psychiatric conditions Persons with impaired communication Persons with sleep disorders with an organic cause (e.g., sleep apnea, or restless legs syndrome) or due to a medical problem (e.g., pain) Persons with the use of hypnotics and other medications known to affect sleep (e.g., steroids, anxiolytics)

Li PWC, Yu DSF, Wong CWY. An empowerment-based cognitive behavioural therapy for persons with mild cognitive impairment and insomnia: Protocol for a mixed-method pilot study. J Adv Nurs. 2021 Apr;77(4):2054-2063. doi: 10.1111/jan.14740. Epub 2021 Jan 13.