An interventional study of Lifestyle Medicine in Insomnia, sponsored by Chinese University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-11.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
This study will examine the effects of a self-help smartphone-based multi-component lifestyle medicine intervention (LM) for alleviating insomnia symptoms in a Chinese population. Since a range of lifestyle factors are related to the pathogenesis and progression of insomnia, modifying different lifestyle factors simultaneously, such as diet, exercise, stress, and sleep which are empirically supported by previous reviews, may be effective to reduce insomnia symptoms (Reid et al., 2010; Vedaa et al., 2016). Traditional Chinese nutritional values will be integrated into the smartphone application to increase the acceptability towards the intervention. A prevalence study suggested that self-help interventions are preferred due to the potential stigmatization related to mental health interventions and the high cost of mental health services in Hong Kong (Lee, Tsang, \& Kwok, 2007). Nonetheless, to date, only limited self-help interventions that target lifestyle medicine for sleep-related problems are available. Through this study, we aimed to promote evidence-based patient care and improve help-seeking behaviors and access to evidence-based lifestyle interventions for insomnia.
This study will be a randomized controlled trial on the effects of a self-help smartphone-based multi-component lifestyle medicine intervention for reducing insomnia symptoms in the Chinese population. Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). Assuming an alpha error of 5%, a beta error rate of 20%, and a between-group effect size of 0.77 for the Insomnia Severity Scale (Ip et al., 2020), the final sample is 28 for both groups. With an estimation of 20% withdrawal, 70 eligible participants will be randomly assigned to either the smartphone-based multi-component lifestyle medicine intervention (LM group) or the waitlist control group (WL group) in a ratio of 1:1.
1,855 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 593 are open to participants now.
This study's planned enrollment of 70 is close to the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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Exclusion Criteria:
Lifestyle intervention with components including exercise, diet, stress management, and sleep management
Behavioral: Lifestyle Medicine
Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment
Lifestyle intervention with components including exercise, diet, stress management, and sleep management
Change in the Insomnia Severity Index (ISI)
ISI is a 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.
Time frame: Baseline, immediately post-intervention, and 1-month post-intervention
Change in the Hospital Anxiety and Depression Scale (HADS)
The HADS, a self-reporting questionnaire used for assessing the level of depressive and anxiety symptoms over the past week on a 4-point scale. The HADS consists of two parts: an anxiety subscale (HADS-A) and a depression subscale (HADS-D), both of which have seven items.
Time frame: Baseline, immediately post-intervention, and 1-month post-intervention
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
SF-6D is a preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.
Time frame: Baseline, immediately post-intervention, and 1-month post-intervention
Change in the Health-Promoting Lifestyle Profile (HPLP II)
The 52-item HPLPII is composed of a total scale and six subscales to measure behaviors in the theorized dimensions of health-promoting lifestyle: spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility, and stress management.
Time frame: Baseline, immediately post-intervention, and 1-month post-intervention
Change in the Sheehan Disability Scale (SDS)
SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life.
Time frame: Baseline, immediately post-intervention, and 1-month post-intervention
Change in the Credibility-Expectancy Questionnaire (CEQ)
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
Time frame: Baseline, immediately post-intervention, and 1-month post-intervention
Change in the Pittsburgh sleep quality index (PSQI)
Participants' subjective sleep disturbance over the past month will be assessed using PSQI. PSQI consists of 19 self-rating items that can be categorized into seven components, including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored on a 4-point Likert scale (0-3). The sum of the seven components results in a global score of 21. A high score indicates worse sleep quality.
Time frame: Baseline, immediately post-intervention, and 1-month post-intervention
Change in the Consensus Sleep Diary (CSD-M)
The standardized sleep diary records sleep time, wake time, perceived sleeping quality, use of hypnotics, etc. on a daily basis. Variables derived from the sleep diary include sleep onset latency (SOL), wake after sleep onset (WASO), total wake time (TWT), total sleep time (TST), sleep efficiency (SE), etc.
Time frame: Baseline, immediately post-intervention, and 1-month post-intervention
Self-developed survey
The self-developed survey will collect information including demographic information (e.g., age, gender, level of education, working industry, relationship status, and location of residence), substance use, body mass index (BMI), rest-activity pattern, and social rhythms, etc.
Time frame: Baseline
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Chinese University of Hong Kong