A Pilot Randomized Controlled Trial on the Efficacy of Transdiagnostic Sleep and Circadian (TranS-C) Intervention on Anxiety Symptoms
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in the Generalized Anxiety Disorder 7-item Scale (GAD-7)
研究概览
简要总结
This study will examine whether the Transdiagnostic Sleep and Circadian Intervention (TranS-C; Harvey & Buysse, 2017) can improve sleep and circadian functioning and reduce disorder-focused symptoms in patients with anxiety symptoms. Sleep disturbance is highly comorbid with GAD (Dolsen et al., 2014). TranS-C, targeting common sleep disturbances in disorders, has improved disorder-focused symptoms and sleep and circadian functioning in patients with Severe mental illness (SMI). Nonetheless, no study examined TranS-C's efficacy on GAD patients specifically. Hence, this study will be a pilot study that examines the efficacy of TranS-C on people with anxiety symptoms by comparing with a care-as-usual control group (CAU).
Around 80 Hong Kong residents aged 18 or above, with a GAD-7 score 10 or above and at least 1 sleep or circadian problem will be recruited. Eligible participants will be randomized to the TranS-C group or CAU group in a 1:1 ratio. The TranS-C group will receive 2-hour group-based TranS-C intervention delivered by clinical psychology trainees for 6 weeks under the supervision of a clinical psychologist. Both groups will complete a set of questionnaires at baseline, immediate post-treatment and 12-week follow-up. They will also complete sleep diaries throughout as homework. The outcome measures include mood, sleep, quality of life etc. This study will test whether theTranS-C intervention apparoach can be considered as a treatment for people with anxiety symptoms and sleep problems.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hong Kong residents aged ≥ 18 years;
- •Cantonese language fluency;
- •Score on GAD-7 is 10 or above (Johnson et al., 2019, Spitzer et al., 2006);
- •At least 1 sleep or circadian problem according to the Sleep and Circadian Problem Checklist, including time needed to fall asleep more than 30 minutes for more than 3 nights per week, less than 6 hours of sleep per night or at least 9 hour of sleep per night per 24 hour period for at least 3 nights per week, variability in the sleep-wake schedule at least 2.78 hours within a week, and falling asleep after 2 am on at least 3 nights per week;
- •Adequate opportunity and circumstances for sleep to occur; and willing to give informed consent and comply with the trial protocol.
排除标准
- •Presence of other psychiatric disorders as defined by the DSM-V diagnostic criteria;
- •Have suicidal ideation based on Beck Depression Inventory (BDI-II) Item 9 score ≥ 2;
- •Major medical or neurocognitive disorders that make participation infeasible;
- •Untreated sleep disorders based on SLEEP-50 (≥ 7 on narcolepsy; ≥ 15 on OSA; ≥ 7 on RLS/PLMD);
- •Past or current involvement in a psychological treatment programme for anxiety disorder and/or sleep problems;
- •Shift work, pregnancy, work, family, or other commitments that interfere with regular night-time sleep patterns;
- •Hospitalization;
- •A change in psychotropic drugs within 2 weeks before baseline assessment
结局指标
主要结局
Change in the Generalized Anxiety Disorder 7-item Scale (GAD-7)
时间窗: baseline, immediate post-treatment and 12-week follow-up
A brief 7-item instrument for screening for GAD and assessing its severity in clinical practice and research. Anxiety severity is categorized using scores of 5-9 (mild), 10-14 (moderate) and 15 or more (severe).
次要结局
- Change in the Hospital Anxiety and Depression Scale (HADS)(baseline, immediate post-treatment and 12-week follow-up)
- Change in the 7-day Consensus Sleep Diary(baseline, immediate post-treatment and 12-week follow-up)
- Change in the Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version(baseline, immediate post-treatment and 12-week follow-up)
- Change in the Multidimensional Fatigue Inventory (MFI)(baseline, immediate post-treatment and 12-week follow-up)
- Change in the Insomnia Treatment Acceptability Scale (ITAS)(baseline, immediate post-treatment and 12-week follow-up)
- Change in the Insomnia Severity Index (ISI)(baseline, immediate post-treatment and 12-week follow-up)
- Change in the Credibility-Expectancy Questionnaire (CEQ)(baseline, immediate post-treatment and 12-week follow-up)
研究者
Fiona YY Ho
Assistant Professor
Chinese University of Hong Kong