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Self-help Lifestyle Medicine for Insomnia

7 januari 2021 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

70

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Hong Kong
      • Sha Tin, Hong Kong
        • The Chinese University of Hong Kong

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Väntelista kontrollgrupp
Deltagarna i väntelistans kontrollgrupp kommer att få interventionen efter bedömningen omedelbart efter behandlingen
Experimentell: Lifestyle Medicine Group
Lifestyle intervention with components including exercise, diet, stress management, and sleep management
Beteende: Lifestyle Medicine
Lifestyle intervention with components including exercise, diet, stress management, and sleep management

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in the Insomnia Severity Index (ISI)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Egenutvecklad undersökning
Tidsram: Baslinje
Den egenutvecklade undersökningen kommer att samla in information inklusive demografisk information (t.ex. ålder, kön, utbildningsnivå, arbetsindustri, relationsstatus och bostad), droganvändning, kroppsmassaindex (BMI), viloaktivitetsmönster och sociala rytmer osv.
Baslinje
Change in the Hospital Anxiety and Depression Scale (HADS)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Chinese University of Hong Kong

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

1 mars 2021

Primärt slutförande (Förväntat)

1 augusti 2021

Avslutad studie (Förväntat)

1 oktober 2021

Studieregistreringsdatum

Först inskickad

7 januari 2021

Först inskickad som uppfyllde QC-kriterierna

7 januari 2021

Första postat (Faktisk)

11 januari 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 januari 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 januari 2021

Senast verifierad

1 januari 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PSY012

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Nej

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