ACTRN12624001196538尚未招募Unknown
The effectiveness of self-guided versus clinician-guided digital cognitive behavioural therapy for insomnia, versus digital sleep health education, on insomnia symptom severity in primary care priority populations: A three-arm randomised controlled effectiveness-implementation trial.
Department of Health and Aged Care - Medical Research Future Fund (MRFF)0 个研究点目标入组 405 人开始时间: 2024年9月30日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 405
- 主要终点
- Insomnia Severity Index (ISI) questionnaire.<br><br>[Between-group change in self-reported insomnia severity on the Insomnia Severity Index (ISI) questionnaire. Between-group change in ISI scores from baseline to 10-weeks and 6-month follow-up post-randomisation.]
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 No limit（—）
- 性别
- All
入选标准
- •General practitioner inclusion criteria;
- •Currently practicing as a general practitioner in Australia.Patient inclusion criteria;
- •Aged at least 18 years
- •Referred by a participating general practitioner, according to GP-identified insomnia symptoms, general practice electronic medical record notes identifying diagnosis or clinical problem of insomnia lasting at least 3 months, and/or prescription of sedatives or hypnotics for insomnia symptoms
- •Reliable access to a computer, tablet, or smartphone with internet access.
- •Basic English language comprehension as required for CBTi program participation.
- •Active patients of the participating general practice clinic (have attended at least 3 times in the last two years).
- •Insomnia symptoms according to an Insomnia Severity Index score of at least 15, that have persisted for at least 3 months (indicative of chronic insomnia)
排除标准
- •Doctor-diagnosed sleep disorders other than insomnia (e.g. sleep apnoea, narcolepsy).
- •Excessive daytime sleepiness (Epworth Sleepiness Scale Score >15).
- •Current psychological treatment for insomnia,
- •Shift work within the past 3 months,
- •Significant cognitive impairment, terminal illness, severe psychiatric condition (e.g., bipolar disorder or schizophrenia disorder), or epilepsy.
- •Currently pregnant.
- •Previous sleepiness-related motor-vehicle accident.
- •Driver, pilot, or operates heavy machinery for work.
- •No self-reported risk of self-harm (identified by a score of greater than or equal to 1 on the PHQ-9, item 9).
结局指标
主要结局
Insomnia Severity Index (ISI) questionnaire.<br><br>[Between-group change in self-reported insomnia severity on the Insomnia Severity Index (ISI) questionnaire. Between-group change in ISI scores from baseline to 10-weeks and 6-month follow-up post-randomisation.]
次要结局
- Depressive symptoms.[Between-group change in self-reported depressive symptoms on the Patient Health Questionnaire (PHQ-9). Between-group change in PHQ-9 scores from baseline to 10-weeks and 6-month follow-up post-randomisation.];Use of medicines for insomnia (Assessed as a composite secondary outcome including prescription and over-the-counter medicines for insomnia).[Self-reported use of sedative-hypnotic, and over-the-counter medicines used for insomnia in the previous month. Assessed via self-report during online questionnaire batteries. Between-group difference in self-reported use of medicines for insomnia (binary outcome) at 10-weeks and 6-month follow-up post-randomisation.]
研究者
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