Incorporating Ecological Momentary Assessment and Intervention Into Cognitive Behavioural Therapy for Insomnia Using mHealth and Wearable Technologies: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Changes in Insomnia Severity Index (ISI)
研究概览
简要总结
This study will be a randomised controlled trial to investigate an integrated platform that incorporates ecological momentary assessments/interventions (EMA/I) into cognitive behavioural therapy for insomnia (CBT-I) using mHealth and wearable technology. The intervention is a promising prospect to address current challenges in the context of sleep medicine to provide real-time and real-world intervention with accuracy, low cost, and easy accessibility.
详细描述
It will be a randomised, assessor-blind controlled trial embedding both outcome and process evaluation, of the EMA/I CBT-I in conjunction with wearable sensors. The outcome evaluation will examine the treatment effect of EMA/I CBT-I compared with care-as-usual (CAU), whilst process evaluation will enhance the understanding of the causal assumptions that underpin EMA/I CBT-I to inform policy and clinical practice. 60 eligible participants will be randomly assigned to the EMA/I CBT-I group and CAU in a 1:1 allocation ratio. The participants in the EMA/I CBT-I group will receive 6 weeks of smartphone-based EMA/I CBT-I supported by a therapist. The trained therapist will prescribe EMI, provide personalised sleep advice, and adjust the treatment by dynamically adapting real-time rest-activity assessments collected using EMA and wearable devices. Assessments will be managed by an independent assessor (a research assistant) who is blind to group allocation at baseline, week 7 (1 week after treatment), and week 18 (12 weeks after treatment). The proposed study will follow the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) and will be registered on ClinicalTrials.gov to ensure compliance with study design and results reporting requirements. The treatment will be provided free of charge.
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
- Double (Participant, 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 at least 18 years of age;
- •able to read Chinese and type in Chinese or English;
- •meet the DSM-5 diagnostic criteria of insomnia disorder (difficulty initiating and/or maintaining sleep or early morning awakening, alongside clinically significant daytime impairment) based on the Brief Insomnia Questionnaire (BIQ), a diagnostic tool validated by the team;
- •have an Insomnia Severity Index (ISI) score of at least 10 indicating clinical-level insomnia;
- •have adequate opportunity and circumstances for sleep to occur;
- •have an Internet-enabled mobile device (iOS or Android operating system), and
- •are willing to provide informed consent.
排除标准
- •To mimic real-world settings, a less stringent set of exclusion criteria will be adopted.
- •A 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);
- •involvement in CBT-I in the past 6 months;
- •a history of severe mental illness (e.g., bipolar disorder, psychotic disorder);
- •major medical or neurocognitive disorders or side effects of medication that contribute significantly to insomnia or make participation infeasible based on the team's clinical experience;
- •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) in SLEEP-50;
- •taking over-the-counter medication or psychotropic drugs that target insomnia within 2 weeks prior to the baseline assessment; and
- •shift work, pregnancy, family or other commitments that interfere with regular sleep-wake patterns.
结局指标
主要结局
Changes in Insomnia Severity Index (ISI)
时间窗: Baseline, Immediate post-treatment, 12-week follow up
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, noticeable impairment attributed to the sleep problem, and level of distress caused by the sleep problem.
次要结局
- Changes in 7-Day Consensus Sleep Diary(Baseline, Immediate post-treatment, 12-week follow up)
- Changes in Short Form (Six-Dimension) Health Survey (SF-6D)(Baseline, Immediate post-treatment, 12-week follow up)
- Changes in Credibility-Expectancy Questionnaire (CEQ)(Baseline, Immediate post-treatment)
- Changes in Sheehan Disability Scale (SDS)(Baseline, Immediate post-treatment, 12-week follow up)
- Changes in Insomnia Treatment Acceptability Scale (ITAS)(Baseline, Immediate post-treatment)
- Changes in the Pittsburgh Sleep Quality Index (PSQI-19)(Baseline, Immediate post-treatment, 12-week follow up)
- Changes in Hospital Anxiety and Depression Scale (HADS)(Baseline, Immediate post-treatment, 12-week follow up)
- Changes in Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)(Baseline, Immediate post-treatment, 12-week follow up)
- Changes in the Epworth Sleepiness Scale (ESS)(Baseline, Immediate post-treatment, 12-week follow up)
- Changes in Multidimensional Fatigue Inventory (MFI)(Baseline, Immediate post-treatment, 12-week follow up)
研究者
Fiona YY Ho
Associate Professor
Chinese University of Hong Kong