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

Summary

Participation Requirements

Description

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 th...

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.

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