Self-help Lifestyle Medicine for Insomnia
7 de janeiro de 2021 atualizado por: 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.
Visão geral do estudo
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
70
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Sha Tin, Hong Kong
- The Chinese University of Hong Kong
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Sem intervenção: Grupo de controle de lista de espera
Os participantes do grupo de controle da lista de espera receberão a intervenção após a avaliação pós-tratamento imediato
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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in the Insomnia Severity Index (ISI)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Pesquisa autodesenvolvida
Prazo: Linha de base
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A pesquisa autodesenvolvida coletará informações, incluindo informações demográficas (por exemplo, idade, sexo, nível de educação, setor de trabalho, status de relacionamento e local de residência), uso de substâncias, índice de massa corporal (IMC), padrão de atividade em repouso e ritmos sociais, etc.
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Linha de base
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Change in the Hospital Anxiety and Depression Scale (HADS)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
1 de março de 2021
Conclusão Primária (Antecipado)
1 de agosto de 2021
Conclusão do estudo (Antecipado)
1 de outubro de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
7 de janeiro de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de janeiro de 2021
Primeira postagem (Real)
11 de janeiro de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de janeiro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de janeiro de 2021
Última verificação
1 de janeiro de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PSY012
Informações sobre medicamentos e dispositivos, documentos de estudo
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Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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