Zero-time Exercise on Inactive Adults With Insomnia Disorder: A Randomized Controlled Trial and Mixed-method Process Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in the Insomnia Severity Index score
研究概览
简要总结
This randomized controlled trial (RCT) with a longitudinal mixed-method process evaluation aims to (1) determine the effectiveness of a ZTEx intervention program, which is a lifestyle-integrated physical activity program, on sleep and related outcomes in inactive adults with insomnia disorder
详细描述
This randomized controlled trial (RCT) with a longitudinal mixed-method process evaluation aims to (1) determine the effectiveness of a ZTEx intervention program, which is a lifestyle-integrated physical activity program, on sleep and related outcomes in inactive adults with insomnia disorder; (2) identify the facilitators and barriers of ZTEx adherence, (3) explore the possible mechanisms of impact on ZTEx adherence and the same abovementioned outcomes.
This RCT consists of two phases. In the first phase (baseline to week 8), 136 subjects will be randomly allocated to the ZTEx intervention or the sleep hygiene education (SHE) comparison group. They will receive two 2-hour ZTEx training or SHE lessons and practice ZTEx or follow the sleep hygiene instruction for 24 weeks. After assessment at week 8, for the second phase of the study (weeks 9-24), which is a proof-of-concept pilot nested in the RCT, subjects in the ZTEx group will be randomly divided into either an ZTEx with WhatsApp reminder (ZTEx+R) subgroup or an ZTEx without WhatsApp reminder (ZTEx alone) subgroup to evaluate the effects of WhatsApp reminders on exercise adherence and the same outcomes. Mixed methods process evaluation will be conducted. Post-training and post-follow-up qualitative focus group interviews will be conducted; facilitators, barriers, and mediators will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hong Kong residents,
- •ethnic Chinese aged 18-65 years with the ability to communicate in Cantonese or Putonghua,
- •who fulfil the DSM-5 diagnostic criteria for insomnia disorder according to a validated diagnostic tool, the Brief Insomnia Questionnaire (we include primary insomnia because it is more homogenous and less complicated than comorbid insomnia; if ZTEx is found to be effective for primary insomnia, then comorbid insomnia can be targeted in future studies),
- •scored at least 10 points in the Insomnia Severity Index,
- •are ambulant and can independently perform daily activities,
- •are physically inactive, defined as not having participated in at least 150 min of moderate intensity or 75 min of vigorous intensity physical activity a week, or the equivalent combination over the previous 3 months by self-report
- •have a smartphone compatible with WhatsApp, and
- •willing to give informed consent
排除标准
- •any current diagnosis fulfilling the DSM-IV criteria of a major depressive disorder, generalized anxiety disorders, post-traumatic stress disorder, panic disorder, substance use disorders, or schizophrenia as screened using the Chinese version of the Structured Clinical Interview for DSM-IV;
- •other sleep disorders, including circadian rhythm disorder, narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) as determined based on cut-off scores (≥ 7 on narcolepsy; ≥ 8 on circadian rhythm disorder; ≥ 15 on OSA; ≥ 7 on RLS/PLMD) using SLEEP-
- •If in doubt, subjects will be referred to our team psychiatrist (KF Chung) for further assessment;
- •any current medical conditions or side-effects of medication that are contributing significantly to the subject's insomnia;
- •taking medications or currently participating in other psychotherapies for insomnia or other psychiatric disorders;
- •impaired cognitive functioning (<22 points in HK-MoCA) or with difficulty in giving consent or understanding instructions;
- •shift work;
- •whose physical condition is such that physicians recommend that they refrain from exercising; and
- •fulfilling the criterion for obesity for Asians (body mass index, of 27.5 or above)
研究组 & 干预措施
Zero Time Exercise training
Subjects in this group will attend two 2-hour ZTEx training lessons. Each subject will receive a handout and an exercise log. The handout includes a picture-illustrating ZTEx step-by-step protocol. The exercise log is for them to record their time spending on performing the ZTEx.
干预措施: Zero Time Exercise (Other)
Sleep hygiene education
Subjects in this group will receive two 2-hour lessons of sleep hygiene education delivered by a registered nurse. Each subject will receive a handout and a sleep hygiene log.Subjects will be told to record their daily compliance with sleep hygiene instructions using yes/no questions in the sleep hygiene log.
干预措施: Sleep hygiene education (Other)
结局指标
主要结局
Change in the Insomnia Severity Index score
时间窗: Baseline, week 8, week 16, week 24
The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point scale. The score ranges from 0 to 28. The higher the score, the worse the outcome is.
次要结局
- Change in the Wisconsin Card Sorting Test(baseline, week 8, week 16, week 24)
- Sleep diary (7-day)(baseline, week 8, week 16, week 24)
- Change in Digit Span-backward test(baseline, week 8, week 16, week 24)
- Hospital Anxiety and Depression Scale(baseline, week 8, week 16, week 24)
- Multidimensional fatigue inventory-20(baseline, week 8, week 16, week 24)
- Actigraphy (7-day)(baseline, week 8, week 16, week 24)
- Accelerometer (7-day)(baseline, week 8, week 16, week 24)
- Change in WAIS-IV Color Trails Test(baseline, week 8, week 16, week 24)
- Change in WAIS-IV Stroop color-word Test(baseline, week 8, week 16, week 24)
研究者
YEUNG Wing Fai
Assistant Professor
The Hong Kong Polytechnic University