A Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia Among Young People With Moderate Level of Mental Distress in Hong Kong
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- Sleep Quality and Disturbance
研究概览
简要总结
This randomized controlled trial (RCT) aims to evaluate the effectiveness of a Cognitive Behavioral Therapy for Insomnia (CBTi) intervention in enhancing sleep quality, overall quality of life, functional ability, and reducing mental distress among at-risk youths in Hong Kong. Participants are youths with moderate mental health concerns, indicated by K6 scores ranging from 11 to 14.
The study involves 160 participants who will be randomly assigned to either the intervention group or a wait-list control group. Participants assigned to the intervention group will receive six weekly face-to-face sessions led by trained youth workers, while those in the control group will receive the same intervention after the initial follow-up period.
Participants will be evaluated at baseline, post-intervention, and one-month follow-up. An interim analysis is built for the sake of evaluation of the collected data from the ongoing trial, in which the primary research question is addressed, and which has the potential for modifying the conduct of the study. Furthermore, a qualitative follow-up will be conducted after the trial, involving both participants and the workers delivering the CBTi intervention. This qualitative component aims to gather feedback on participants' experiences, and inform potential revisions to enhance future implementation.
It is hypothesized that youths receiving the CBTi intervention will show significantly greater improvements in sleep quality, quality of life, and functioning, along with reductions in mental distress, as well as depressive and anxiety symptoms, compared to those in the wait-list control group.
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
- None
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •JC LevelMind @ Community users at least at risk for mild mental distress (Tier 2), with K6 scores above or equal to 11, or clinicians' endorsement after reviewing the case to have other issues/problems
- •Aged between 12 and 24 years
- •Insomnia Severity Index (ISI) score greater than 7
- •Sufficiently proficient in Chinese to comprehend verbal instructions
- •Able to provide written informed consent (parental consent for participant aged 12-17)
排除标准
- •Young people with mild distress (K6 scores between 0 and 10)
- •Known diagnosis of intellectual disability
- •Organic brain disorder
- •Established psychiatric diagnosis
- •Current substance abuse
- •Receiving other structured psychological therapies such as module-based psychological therapy, mentalization-based therapy, low-intensity online interventions, cognitive-behavioral therapy, narrative therapy, mindfulness, or art-informed therapy within the hub setting or any others outside the hub setting
- •Presence of current or active suicidal ideation or attempts
研究组 & 干预措施
Waitlist Control
Participants allocated to the waitlist control group will wait for 10 weeks (6 + 4 weeks) before receiving the CBTi intervention
CBTi Intervention
The CBTi program, designed to improve youths' sleep quality, comprises six sessions scheduled to be delivered over a six-week period. The intervention will be conducted in a small-group format (4 or above participants per group). Each session is one hour long and is led by a trained LevelMind@JC worker. All sessions will be delivered in a face-to-face format by frontline social or youth workers who have undergone training by a clinical psychologist ensuring they possess the necessary expertise to effectively implement the CBTi intervention.
干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)
结局指标
主要结局
Sleep Quality and Disturbance
时间窗: Baseline, 6-week, 10-week
Pittsburgh Sleep Quality Index Scale (scores range from 0 to 21 where a higher score indicate poorer sleep quality, and a score greater than 5 suggesting significant sleep difficulties)
Insomnia Severity
时间窗: Baseline, 6-week, 10-week
Insomnia Severity Index Scale (scores range from 0 to 28 where a higher score indicates greater insomnia severity and a score of 7 or less suggested no clinical insomnia)
次要结局
- Health-related Quality of Life(Baseline, 6-week, 10-week)
- Psychological Distress(Baseline, 6-week, 10-week)
- Depression(Baseline, 6-week, 10-week)
- Depression and Anxiety Symptoms(Baseline, 6-week, 10-week)
- Social and Occupational Functioning(Baseline, 6-week, 10-week)
- Anxiety(Baseline, 6-week, 10-week)
研究者
Dr. Christy Lai-ming Hui
Associate Professor
The University of Hong Kong