Cognitive Behavioural Therapy for Insomnia Among Young People With Moderate Level of Mental Distress in Hong Kong
- Conditions
- Mental DistressInsomnia
- Registration Number
- NCT07230899
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
This cluster randomized controlled trial (cRCT) 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 seven clusters, each based on community hubs, which will be randomly assigned to either the intervention group or a wait-list control group. Clusters assigned to the intervention group will receive six weekly face-to-face sessions led by trained youth workers. Control clusters 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 770
- JC LevelMind @ Community users at risk for mental distress (Tier 2), with K6 scores ranging from 11 to 14
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Sleep Quality and Disturbance 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 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)
- Secondary Outcome Measures
Name Time Method Psychological Distress Baseline, 6-week, 10-week The 6-item Kessler Psychological Distress Scale (scores range from 0 to 24 where a higher score indicates a worse outcome)
Depression Baseline, 6-week, 10-week The 9-item Patient Health Questionnaire (scores range of 0 to 27 where a higher score indicates a worse outcome)
Depression and Anxiety Symptoms Baseline, 6-week, 10-week Depression Anxiety Stress Scales (scores range from 0 to 63 where a higher score indicates more severe symptoms)
Social and Occupational Functioning Baseline, 6-week, 10-week Social and Occupational Functioning Assessment Scale (scores range from 0 to 100 where a higher score indicates a better outcome)
Anxiety Baseline, 6-week, 10-week The 7-item Generalized Anxiety Stress Scale (scores range from 0 to 21 where a higher score indicates a worse outcome)
Health-related Quality of Life Baseline, 6-week, 10-week The Short Form 6-Dimension (scores range from 0 to 1 where a higher score indicates a better outcome)