Self-help Lifestyle Medicine for Insomnia
2021년 1월 7일 업데이트: Fiona YY Ho, Chinese University of Hong Kong
Effect of a Self-help Smartphone-based Lifestyle Intervention in Reducing Insomnia Symptoms: A Randomized Controlled Trial
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (예상)
70
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Sha Tin, 홍콩
- The Chinese University of Hong Kong
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 대기자 명단 제어 그룹
대기자 명단 통제 그룹의 참가자는 즉각적인 치료 후 평가 후 중재를 받게 됩니다.
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실험적: Lifestyle Medicine Group
Lifestyle intervention with components including exercise, diet, stress management, and sleep management
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Lifestyle intervention with components including exercise, diet, stress management, and sleep management
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in the Insomnia Severity Index (ISI)
기간: Baseline, immediately post-intervention, and 1-month post-intervention
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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.
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Baseline, immediately post-intervention, and 1-month post-intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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자체 개발 설문조사
기간: 기준선
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자체 개발 설문조사는 인구통계학적 정보(예: 연령, 성별, 교육 수준, 직업 산업, 관계 상태 및 거주지), 약물 사용, 체질량 지수(BMI), 휴식 활동 패턴 및 사회적 리듬 등
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기준선
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Change in the Hospital Anxiety and Depression Scale (HADS)
기간: Baseline, immediately post-intervention, and 1-month post-intervention
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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.
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Baseline, immediately post-intervention, and 1-month post-intervention
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Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
기간: Baseline, immediately post-intervention, and 1-month post-intervention
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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.
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Baseline, immediately post-intervention, and 1-month post-intervention
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Change in the Health-Promoting Lifestyle Profile (HPLP II)
기간: Baseline, immediately post-intervention, and 1-month post-intervention
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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.
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Baseline, immediately post-intervention, and 1-month post-intervention
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Change in the Sheehan Disability Scale (SDS)
기간: Baseline, immediately post-intervention, and 1-month post-intervention
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SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life.
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Baseline, immediately post-intervention, and 1-month post-intervention
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Change in the Credibility-Expectancy Questionnaire (CEQ)
기간: Baseline, immediately post-intervention, and 1-month post-intervention
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The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
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Baseline, immediately post-intervention, and 1-month post-intervention
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Change in the Pittsburgh sleep quality index (PSQI)
기간: Baseline, immediately post-intervention, and 1-month post-intervention
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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.
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Baseline, immediately post-intervention, and 1-month post-intervention
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Change in the Consensus Sleep Diary (CSD-M)
기간: Baseline, immediately post-intervention, and 1-month post-intervention
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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.
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Baseline, immediately post-intervention, and 1-month post-intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (예상)
2021년 3월 1일
기본 완료 (예상)
2021년 8월 1일
연구 완료 (예상)
2021년 10월 1일
연구 등록 날짜
최초 제출
2021년 1월 7일
QC 기준을 충족하는 최초 제출
2021년 1월 7일
처음 게시됨 (실제)
2021년 1월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 1월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 1월 7일
마지막으로 확인됨
2021년 1월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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