Back to resultsSelf-help Lifestyle Medicine for Insomnia
Primary Purpose
Insomnia
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Lifestyle Medicine
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Lifestyle Medicine, Self-help
Eligibility Criteria
Inclusion Criteria:
- Hong Kong residents
- Aged ≥ 18 years
- Have an Insomnia Severity Index (ISI) score ≥10, indicating at least sub threshold level of insomnia symptoms are present
- Able to read Chinese and type in Chinese or English
- Have an Internet-enabled mobile device (iOS or Android operating system)
- Are willing to provide informed consent and comply with the trial protocol
Exclusion Criteria:
- Current involvement in psychotherapy or unstable medication for sleep, depression, and/or anxiety
- Beck Depression Inventory (BDI-II) Item 9 score of at least 2 indicating a current moderate suicidal risk that requires active crisis management (referral information to professional services will be provided to those with serious suicidal risk)
- Are having unsafe conditions and are not recommended for exercise or a change in diet by physicians
- Having major psychiatric, medical, or neurocognitive disorders that make participation infeasible or interfere with the adherence to the lifestyle modification
- Other untreated sleep disorders, including narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) based on the cut-off scores (≥ 7 on narcolepsy; ≥ 15 on OSA; ≥ 7 on RLS/PLMD) of individual sections in SLEEP-50
- Shift work, pregnancy, work, family, or other commitments that interfere with regular night-time sleep patterns
- Hospitalization
Sites / Locations
- The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lifestyle Medicine Group
Waitlist Control Group
Arm Description
Lifestyle intervention with components including exercise, diet, stress management, and sleep management
Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Change in the Credibility-Expectancy Questionnaire (CEQ)
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
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.
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.
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.
Full Information
NCT ID
NCT04703283
First Posted
January 7, 2021
Last Updated
January 7, 2021
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04703283
Brief Title
Self-help Lifestyle Medicine for Insomnia
Official Title
Effect of a Self-help Smartphone-based Lifestyle Intervention in Reducing Insomnia Symptoms: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Lifestyle Medicine, Self-help
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Medicine Group
Arm Type
Experimental
Arm Description
Lifestyle intervention with components including exercise, diet, stress management, and sleep management
Arm Title
Waitlist Control Group
Arm Type
No Intervention
Arm Description
Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Medicine
Intervention Description
Lifestyle intervention with components including exercise, diet, stress management, and sleep management
Primary Outcome Measure Information:
Title
Change in the Insomnia Severity Index (ISI)
Description
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
Secondary Outcome Measure Information:
Title
Change in the Hospital Anxiety and Depression Scale (HADS)
Description
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
Title
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
Description
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
Title
Change in the Health-Promoting Lifestyle Profile (HPLP II)
Description
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
Title
Change in the Sheehan Disability Scale (SDS)
Description
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
Title
Change in the Credibility-Expectancy Questionnaire (CEQ)
Description
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
Title
Change in the Pittsburgh sleep quality index (PSQI)
Description
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
Title
Change in the Consensus Sleep Diary (CSD-M)
Description
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
Title
Self-developed survey
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Hong Kong residents
Aged ≥ 18 years
Have an Insomnia Severity Index (ISI) score ≥10, indicating at least sub threshold level of insomnia symptoms are present
Able to read Chinese and type in Chinese or English
Have an Internet-enabled mobile device (iOS or Android operating system)
Are willing to provide informed consent and comply with the trial protocol
Exclusion Criteria:
Current involvement in psychotherapy or unstable medication for sleep, depression, and/or anxiety
Beck Depression Inventory (BDI-II) Item 9 score of at least 2 indicating a current moderate suicidal risk that requires active crisis management (referral information to professional services will be provided to those with serious suicidal risk)
Are having unsafe conditions and are not recommended for exercise or a change in diet by physicians
Having major psychiatric, medical, or neurocognitive disorders that make participation infeasible or interfere with the adherence to the lifestyle modification
Other untreated sleep disorders, including narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) based on the cut-off scores (≥ 7 on narcolepsy; ≥ 15 on OSA; ≥ 7 on RLS/PLMD) of individual sections in SLEEP-50
Shift work, pregnancy, work, family, or other commitments that interfere with regular night-time sleep patterns
Hospitalization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Wing-Hei Wong
Phone
+852 3943 6575
Email
vincentwongwh@link.cuhk.edu.hk
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Sha Tin
Country
Hong Kong
12. IPD Sharing Statement
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Self-help Lifestyle Medicine for Insomnia
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