Distress, EmotionalNCT05509504
Low-intensity Online Intervention for Young People (Service)
A study testing Low-intensity online intervention in people with Distress, Emotional, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Distress, Emotional
- What is being tested?
- Low-intensity online intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- young people aged between 12-30
- who have sufficient proficiency in Chinese to understand verbal and written instructions and give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
University of Hong Kong
Hong Kong
Yi Nam Suen, 2255 4486, suenyn@hku.hk
About this study
Official title: 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).
Read more
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.
- Conditions
- Distress, Emotional
- Being tested
- Low-intensity online intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity online interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Low-intensity online intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of distress
6 items from the Kessler Kessler Psychological Distress Scale (K6). The scores range from 0 - 24. Higher scores indicate greater distress level.
Measured: Immediate post-intervention
Secondary outcomes (3)
Perceived sleep quality
1 item from the Pittsburgh Sleep Quality Index (PSQI). The scores range from 1 - 4. Higher scores indicate poorer sleep quality.
Measured: Immediate post-intervention
Stress coping abilities
Brief Resilience Scale (BRS). The scores range from 6-30. Higher scores indicate lower level of resilience.
Measured: Immediate post-intervention
General self-efficacy
General Self-Efficacy Scale (GSE). The scores range from 2-8. Higher scores indicate lower level of self-efficacy
Measured: Immediate post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Dec 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distress, EmotionalStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yi-Nam Suen, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509504
- Sponsor's protocol ID
- LiON
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Low-Intensity Online Intervention (LiON) for Distressed Youths in Hong Kong
- ClinicalTrials.gov ID
- NCT05509504
- Acronym / sponsor ID
- LiON
- Conditions
- Distress, Emotional
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Low-intensity online intervention |
| Control | No intervention | – |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- young people aged between 12-30
- who have sufficient proficiency in Chinese to understand verbal and written instructions and give informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-intensity online interventionThe 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. | Other | Intervention |
Primary outcome
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.
3 secondary outcomes
Perceived sleep quality
Time frame: Immediate post-intervention
Stress coping abilities
Time frame: Immediate post-intervention
General self-efficacy
Time frame: Immediate post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity online intervention in people with Distress, Emotional, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of distress (time frame: Immediate post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.