Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Self-help Lifestyle Medicine for Insomnia

7. januar 2021 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Venteliste kontrolgruppe
Deltagere i ventelistekontrolgruppen vil modtage interventionen efter den umiddelbare vurdering efter behandlingen
Eksperimentel: Lifestyle Medicine Group
Lifestyle intervention with components including exercise, diet, stress management, and sleep management
Adfærdsmæssigt: Lifestyle Medicine
Lifestyle intervention with components including exercise, diet, stress management, and sleep management

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in the Insomnia Severity Index (ISI)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Selvudviklet undersøgelse
Tidsramme: Baseline
Den selvudviklede undersøgelse vil indsamle oplysninger, herunder demografiske oplysninger (f.eks. alder, køn, uddannelsesniveau, arbejdsindustri, forholdsstatus og bopæl), stofbrug, body mass index (BMI), hvileaktivitetsmønster og sociale rytmer mv.
Baseline
Change in the Hospital Anxiety and Depression Scale (HADS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chinese University of Hong Kong

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. marts 2021

Primær færdiggørelse (Forventet)

1. august 2021

Studieafslutning (Forventet)

1. oktober 2021

Datoer for studieregistrering

Først indsendt

7. januar 2021

Først indsendt, der opfyldte QC-kriterier

7. januar 2021

Først opslået (Faktiske)

11. januar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. januar 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PSY012

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Søvnløshed

Kliniske forsøg med Lifestyle Medicine

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in South Korea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner