Self-help Lifestyle Medicine for Insomnia
2021年1月7日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (予想される)
70
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Sha Tin、香港
- The Chinese University of Hong Kong
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：待機リスト コントロール グループ
待機リスト コントロール グループの参加者は、治療直後の評価後に介入を受けます。
|
|
|
実験的：Lifestyle Medicine Group
Lifestyle intervention with components including exercise, diet, stress management, and sleep management
|
Lifestyle intervention with components including exercise, diet, stress management, and sleep management
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in the Insomnia Severity Index (ISI)
時間枠：Baseline, immediately post-intervention, and 1-month post-intervention
|
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.
|
Baseline, immediately post-intervention, and 1-month post-intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
自己開発調査
時間枠：ベースライン
|
自己開発した調査では、人口統計学的情報 (年齢、性別、教育レベル、就労産業、交際状況、居住地など)、物質使用、体格指数 (BMI)、休息活動パターン、および社会のリズムなど
|
ベースライン
|
|
Change in the Hospital Anxiety and Depression Scale (HADS)
時間枠：Baseline, immediately post-intervention, and 1-month post-intervention
|
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.
|
Baseline, immediately post-intervention, and 1-month post-intervention
|
|
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
時間枠：Baseline, immediately post-intervention, and 1-month post-intervention
|
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.
|
Baseline, immediately post-intervention, and 1-month post-intervention
|
|
Change in the Health-Promoting Lifestyle Profile (HPLP II)
時間枠：Baseline, immediately post-intervention, and 1-month post-intervention
|
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.
|
Baseline, immediately post-intervention, and 1-month post-intervention
|
|
Change in the Sheehan Disability Scale (SDS)
時間枠：Baseline, immediately post-intervention, and 1-month post-intervention
|
SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life.
|
Baseline, immediately post-intervention, and 1-month post-intervention
|
|
Change in the Credibility-Expectancy Questionnaire (CEQ)
時間枠：Baseline, immediately post-intervention, and 1-month post-intervention
|
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
|
Baseline, immediately post-intervention, and 1-month post-intervention
|
|
Change in the Pittsburgh sleep quality index (PSQI)
時間枠：Baseline, immediately post-intervention, and 1-month post-intervention
|
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.
|
Baseline, immediately post-intervention, and 1-month post-intervention
|
|
Change in the Consensus Sleep Diary (CSD-M)
時間枠：Baseline, immediately post-intervention, and 1-month post-intervention
|
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.
|
Baseline, immediately post-intervention, and 1-month post-intervention
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2021年3月1日
一次修了 (予想される)
2021年8月1日
研究の完了 (予想される)
2021年10月1日
試験登録日
最初に提出
2021年1月7日
QC基準を満たした最初の提出物
2021年1月7日
最初の投稿 (実際)
2021年1月11日
学習記録の更新
投稿された最後の更新 (実際)
2021年1月11日
QC基準を満たした最後の更新が送信されました
2021年1月7日
最終確認日
2021年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。