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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
770
Participants will receive the Cognitive Behavioral Therapy for Insomnia designed to improve youths' sleep quality.
Sleep Quality and Disturbance
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)
Time frame: Baseline, 6-week, 10-week
Insomnia Severity
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)
Time frame: Baseline, 6-week, 10-week
Psychological Distress
The 6-item Kessler Psychological Distress Scale (scores range from 0 to 24 where a higher score indicates a worse outcome)
Time frame: Baseline, 6-week, 10-week
Depression
The 9-item Patient Health Questionnaire (scores range of 0 to 27 where a higher score indicates a worse outcome)
Time frame: Baseline, 6-week, 10-week
Depression and Anxiety Symptoms
Depression Anxiety Stress Scales (scores range from 0 to 63 where a higher score indicates more severe symptoms)
Time frame: Baseline, 6-week, 10-week
Anxiety
The 7-item Generalized Anxiety Stress Scale (scores range from 0 to 21 where a higher score indicates a worse outcome)
Time frame: Baseline, 6-week, 10-week
Social and Occupational Functioning
Social and Occupational Functioning Assessment Scale (scores range from 0 to 100 where a higher score indicates a better outcome)
Time frame: Baseline, 6-week, 10-week
Health-related Quality of Life
The 12-item Short-Form 12 Health Survey (scores range from 0 to 100 where a higher score indicates a better outcome)
Time frame: Baseline, 6-week, 10-week
Health-related Quality of Life
The Short Form 6-Dimension (scores range from 0 to 1 where a higher score indicates a better outcome)
Time frame: Baseline, 6-week, 10-week
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