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Distress, EmotionalNCT05510453

Low-intensity Online Intervention for Young People

A study testing Low-intensity online intervention (LiON) in people with Distress, Emotional, run by The University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 (LiON)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteHong Kong
Study dates
1 Sep 2022to 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
  • with symptoms of mental distress (K6≥ 5).

Who cannot join

  • receiving any form of cognitive behavioural therapy (CBT)
  • active suicidal ideation/attempts within the past one month, serious suicidal ideation or self harm risks
  • inability to turn on camera for the course of the LiON intervention
  • inability to provide emergency contact
  • located outside of Hong Kong
  • history of organic brain disorder, psychosis, learning disability (e.g., special school attendance)

Trial locations and contacts

1 site in 1 country.

Yi Nam Suen contact

2255 4486

suenyn@hku.hk

Hong Kong1 site
  • University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Randomised Controlled Trial 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 wait list RCT design. Participants will be randomly assigned using a computer-generated sequence into either the (i) low-intensity online intervention (LiON) group (n = 60) or (ii) wait list control (WLC) group (n = 60) in one-to-one ratio. This study design was adopted to ensure all participants will be able to receive LiON during the period of this study. Random blocks of the size of 4 will be used for randomisation. Stratification will also be applied according to their distress severity (as measured by the Kessler Psychological Distress Scale).

Those randomised to 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. Meanwhile, those randomised to the WLC group will first receive generic self-help tips for a period of 4 weeks, followed by the 4-week LiON 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. All participants will also be provided with generic self-help tips. For those in the LiON intervention group, these self-help tips will be provided after the 4-week LiON. For those in the WLC group, these self-help tips will be provided during the first 4 weeks after randomisation.

Being tested
Low-intensity online intervention (LiON)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-intensity online intervention (LiON)Other

    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.

    The control group will receive the intervention after a waiting period of 4 weeks.

Study groups in NCT05510453
Study groupRoleWhat they receive
InterventionExperimentalNot described
Receives: Other: Low-intensity online intervention (LiON)
Wait-list controlOtherNot described
Receives: Other: Low-intensity online intervention (LiON)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptoms of depression

    Depression subscale (DASS-D) of the 21-item Depression Anxiety Stress Scale (DASS). The scores range from 0 to 42. Higher scores indicate greater depressive symptoms

    Measured: Changes from baseline to immediate post-intervention to 1-month post-intervention

  2. Symptoms of anxiety

    Anxiety subscale (DASS-A) of the 21-item Depression Anxiety Stress Scale (DASS). The scores range from 0 to 42. Higher scores indicate greater anxiety symptoms.

    Measured: Changes from baseline to immediate post-intervention to 1-month post-intervention

  3. Symptoms of distress

    6 items from the Kessler Kessler Psychological Distress Scale (K6)

    Measured: Changes from baseline to immediate post-intervention to 1-month post-intervention

Secondary outcomes (6)
  1. Functioning - days of reduced productivity

    1 item from the Kessler Psychological Distress Scale on days of reduced productivity. Responses range from 0 to 30 days. More days indicate poorer functioning

    Measured: Changes from baseline to immediate post-intervention to 1-month post-intervention

  2. Functioning - days of complete productivity loss

    1 item from the Kessler Psychological Distress Scale on days of productivity loss. The responses range from 0 to 30 days. More days indicate poorer functioning.

    Measured: Changes from baseline to immediate post-intervention to 1-month post-intervention

  3. Perceived sleep quality

    1 item from the Pittsburgh Sleep Quality Index (PSQI). The scores ranged from 0 - 4. Higher scores indicate poorer sleep quality.

    Measured: Changes from baseline to immediate post-intervention to 1-month post-intervention

  4. Perceived stress level

    Single item Subjective Level of Stress (SLS-1). The scores ranged from 0 - 10. Higher scores indicate higher perceived stress level.

    Measured: Changes from baseline to immediate post-intervention to 1-month post-intervention

  5. Stress coping abilities

    Brief Resilience Scale (BRS). The scores ranged from 6 - 30. Higher scores indicate poorer sleep quality.

    Measured: Changes from baseline to immediate post-intervention to 1-month post-intervention

  6. General self-efficacy

    General Self-Efficacy Scale (GSE). The scores range from 2-8. Higher scores indicate poorer self-efficacy

    Measured: Changes from baseline to immediate post-intervention to 1-month post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2022
  2. Study start1 Sep 2022 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05510453
Sponsor's protocol ID
LiON RCT
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
Individual data sharing
No

Publications

  • Suen YN, Hui CLM, Lei LKS, Leung CM, Wong SMY, Lai GCH, Chau EHS, Wong MTH, Chan SKW, Wong GHY, Chen EYH. Low-Intensity Online Intervention for Mental Distress Among Help-Seeking Young People in Hong Kong: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2454675. doi: 10.1001/jamanetworkopen.2024.54675.

    PubMed 39813032

Questions about this trial

What is this clinical trial studying?

A study testing Low-intensity online intervention (LiON) 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 3 inclusion and 6 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?

Contact Yi Nam Suen (2255 4486, suenyn@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptoms of depression (time frame: Changes from baseline to immediate post-intervention to 1-month post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05510453, which also lists 1 linked publication.

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.

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