Insomnia, Mental Distress
Conditions
Keywords
cognitive behavioural therapy for insomnia, youths, mental distress, randomised controlled trial
Brief summary
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy for Insomnia
Participants will receive the Cognitive Behavioral Therapy for Insomnia designed to improve youths' sleep quality.
Sponsors
The University of Hong Kong
The Hong Kong Jockey Club Charities Trust
The Boys' and Girls' Clubs Association of Hong Kong
Caritas Medical Centre, Hong Kong
Hong Kong Christian Service
Neighbourhood Advice-Action Council
St. James' Settlement
Tung Wah Group of Hospitals
Hong Kong Young Women's Christian Association
Yan Oi Tong
The Salvation Army, Hong Kong and Macau Command
Hong Kong Playground Association (HKPA)
Hong Kong Sheng Kung Hui Welfare Council Limited
Hong Kong Children and Youth Services (HKCYS)
Hong Kong Federation of Youth's Group (HKFYG)
Chinese YMCA of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
| Health-related Quality of Life | Baseline, 6-week, 10-week | The 12-item Short-Form 12 Health Survey (scores range from 0 to 100 where a higher score indicates a better outcome) |
Contacts
CONTACTChristy Lai Ming Hui, PhD
CONTACTYi Nam Suen, PhD
PRINCIPAL_INVESTIGATORChristy Lai Ming Hui, PhD
The University of Hong Kong
Outcome results
None listed