- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05509504
Low-intensity Online Intervention for Young People (Service)
A Feasibility Study of Low-Intensity Online Intervention (LiON) for Distressed Youths in Hong Kong
Studies have found up to 75% of mental disorders in adulthood have their onset before the age of 25 (Lin et al., 2008; Kessler et al., 2005), suggesting youth marks a critical period of intervention. Across the various psychiatric conditions, depressive and anxiety disorders have consistently been reported to be two of the most common conditions in young people globally (Merikangas et al., 2010; Racine et al., 2021).
Both depressive and anxiety disorders are related to various negative impacts on youths' lives, such as undermining academic achievements, with other negative influences found in past studies (Birmaher et al., 1996; Fletcher, 2008, Woodward and Fergusson, 2001; Swan and Kendall, 2016). Notably, an increasing number of studies have found not only can clinical disorders, but also early symptoms of such conditions, can cause significant burden on the individual, their family and peers, as well as the larger society (Spencer et al., 2018; Lynch and Clarke, 2006; Wingrove and Rickwood, 2020).
Existing healthcare services, however, tend to prioritise service targeting those with severe mental health needs. Knowledge about subtle mental health symptoms is lacking among the general public, which can contribute to delayed care and treatment (Fung et al., 2021). In addition, mental health services in Hong Kong are not only characterised by long waiting times but are also coupled with significant stigma, which can in turn prevent help-seeking, especially among young people (Sun et al., 2017; Yap, Wright, and Jorm, 2011). In view of the significance of early engagement and intervention for those with mental health needs and the current situation in Hong Kong, the implementation of low-intensity online-based interventions (LiON) for mental health appears to be a largely promising approach.
Low-intensity refers to low usage of "specialist therapist time" (Bower and Gilbody, 2005), or usage in a cost-effective way, such as in a group-based Cognitive Behavioural Therapy context. Low-intensity interventions focus on delivering self-help and self-management skills which can be led by non-specialists, which in turn help to reduce the cost required in both training and the delivering of intervention. Recent studies have also increasingly highlighted young people's preference to access mental health services through online platforms (Becker et al., 2016). Due to limited mental health resources and the high demand for mental health services in Hong Kong, such online-based low-intensity interventions - when shown to be effective - can be largely helpful in reducing societal costs, reduce the barriers to help-seeking, and facilitate large-scale implementation of mental health services on a population level.
This study will adopt an open labelled non-randomised controlled design. Participants will be youths receiving low-intensity online intervention (LiON) group or community youths who had no intervention.
The LiON intervention group will first receive the 4-week LiON, with generic self-help tips provided to each participant before completing the T2 assessment.
Prior to the commencement of the LiON, all participants will first be screened for eligibility for participation by a professional clinician of the research team (i.e., psychiatrists or psychologist, senior social worker). A review session via Zoom will also be first provided by the trained interventionist (who will be a graduate with background in psychology, social work, or other related mental health disciplines with prior and ongoing training from senior clinicians of the research team) to each participant to determine his or her needs and ensure all inclusion and exclusion criteria are met. Briefing about the LiON, such as module structure and components of focus will also be provided during this session.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- young people aged between 12-30
- who have sufficient proficiency in Chinese to understand verbal and written instructions and give informed consent
Exclusion Criteria:
- receiving any form of cognitive behavioural therapy (CBT)
- active suicidal ideation/attempts, serious suicidal ideation or self harm risks within the past one month
- inability to turn on camera for the course of the LiON intervention
- inability to provide emergency contact
- located outside of Hong Kong
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
|
The LiON in the current study is comprised of three core modules identified to be core areas of stress and needs of participants based on clinical experiences of the research team.
The three modules include (1) stress management, (2) sleep and relaxation, and (3) problem-solving skills.
Each module consists of four 1-on-1 sessions which will be conducted through online platforms (such as Zoom) that lasts for ~45 minutes.
Participants will attend these sessions once a week.
|
|
No Intervention: Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptoms of distress
Time Frame: Immediate post-intervention
|
6 items from the Kessler Kessler Psychological Distress Scale (K6).
The scores range from 0 - 24.
Higher scores indicate greater distress level.
|
Immediate post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived sleep quality
Time Frame: Immediate post-intervention
|
1 item from the Pittsburgh Sleep Quality Index (PSQI).
The scores range from 1 - 4. Higher scores indicate poorer sleep quality.
|
Immediate post-intervention
|
|
Stress coping abilities
Time Frame: Immediate post-intervention
|
Brief Resilience Scale (BRS).
The scores range from 6-30.
Higher scores indicate lower level of resilience.
|
Immediate post-intervention
|
|
General self-efficacy
Time Frame: Immediate post-intervention
|
General Self-Efficacy Scale (GSE).
The scores range from 2-8.
Higher scores indicate lower level of self-efficacy
|
Immediate post-intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LION
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Distress, Emotional
-
Peking UniversityNot yet recruitingEmotional Disorder | Emotional DistressChina
-
Universita di VeronaUniversity of Roma La SapienzaRecruitingDistress, Emotional | Distress, PsychologicalItaly
-
Peking UniversityNot yet recruitingEmotional DistressChina
-
Xinghua LiuNot yet recruiting
-
Peking UniversityNot yet recruitingEmotional DistressChina
-
Peking UniversityNot yet recruiting
-
The University of Hong KongNot yet recruiting
-
Boise State UniversityNational Institute of General Medical Sciences (NIGMS)Recruiting
-
Peking UniversityNot yet recruitingEmotional DistressChina
-
University of Wisconsin, MadisonActive, not recruiting
Clinical Trials on Low-intensity online intervention
-
The University of Hong KongNot yet recruiting
-
NYU Langone HealthCompletedGeneralized Anxiety Disorder | Social Anxiety | Panic DisorderUnited States
-
University of TorontoUnknownPostpartum WomenCanada
-
Centre for Addiction and Mental HealthThe Hospital for Sick Children; University of Toronto; Trillium Health Centre; Medical...CompletedPsychosis | Cardiovascular Risk Factor | Metabolic DiseaseCanada
-
Hellenic Anticancer SocietyNational and Kapodistrian University of AthensCompleted
-
Fundació d'investigació Sanitària de les Illes...Completed
-
University of UtahDepartment of Health and Human ServicesCompletedObesity | Diabetes | Physical ActivityUnited States
-
VA Office of Research and DevelopmentCompletedStroke | Cerebrovascular AccidentUnited States
-
University of Nevada, Las VegasCompleted