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| Name | Class |
|---|---|
| The Hong Kong Jockey Club Charities Trust | OTHER |
| The Boys' and Girls' Clubs Association of Hong Kong | OTHER |
| Caritas Medical Centre, Hong Kong | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBTi Intervention | Active Comparator | 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. |
|
| Waitlist Control | No Intervention | Participants allocated to the waitlist control group will wait for 10 weeks (6 + 4 weeks) before receiving the CBTi intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Behavioral | Participants will receive the Cognitive Behavioral Therapy for Insomnia designed to improve youths' sleep quality. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | Baseline, 6-week, 10-week |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological Distress | The 6-item Kessler Psychological Distress Scale (scores range from 0 to 24 where a higher score indicates a worse outcome) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christy Lai Ming Hui, PhD | Contact | +852 2255 4486 | christy@lmhui.com | |
| Yi Nam Suen, PhD | Contact | +852 3917 6612 | suenyn@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Christy Lai Ming Hui, PhD | The University of Hong Kong | Principal Investigator |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Hong Kong Christian Service |
| OTHER |
| Neighbourhood Advice-Action Council | OTHER |
| St. James' Settlement | OTHER |
| Tung Wah Group of Hospitals | OTHER |
| Hong Kong Young Women's Christian Association | OTHER |
| Yan Oi Tong | UNKNOWN |
| The Salvation Army, Hong Kong and Macau Command | OTHER |
| Hong Kong Playground Association (HKPA) | UNKNOWN |
| Hong Kong Sheng Kung Hui Welfare Council Limited | OTHER |
| Hong Kong Children and Youth Services (HKCYS) | UNKNOWN |
| Hong Kong Federation of Youth's Group (HKFYG) | OTHER |
| Chinese YMCA of Hong Kong | UNKNOWN |
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| 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) | 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) | 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) | 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) | 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) | Baseline, 6-week, 10-week |
| D001523 |
| Mental Disorders |