Clinical trial NCT05510453: Low-intensity Online Intervention for Young People
Official title: A Randomised Controlled Trial of Low-Intensity Online Intervention (LiON) for Distressed Youths in Hong Kong
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distress, Emotional
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Symptoms of depression
timeFrame: Changes from baseline to immediate post-intervention to 1-month post-intervention
measure: Symptoms of anxiety
timeFrame: Changes from baseline to immediate post-intervention to 1-month post-intervention
measure: Symptoms of distress
timeFrame: Changes from baseline to immediate post-intervention to 1-month post-intervention
Secondary outcomes:
measure: Functioning - days of reduced productivity
timeFrame: Changes from baseline to immediate post-intervention to 1-month post-intervention
measure: Functioning - days of complete productivity loss
timeFrame: Changes from baseline to immediate post-intervention to 1-month post-intervention
measure: Perceived sleep quality
timeFrame: Changes from baseline to immediate post-intervention to 1-month post-intervention
measure: Perceived stress level
timeFrame: Changes from baseline to immediate post-intervention to 1-month post-intervention
measure: Stress coping abilities
timeFrame: Changes from baseline to immediate post-intervention to 1-month post-intervention
measure: General self-efficacy
timeFrame: Changes from baseline to immediate post-intervention to 1-month post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
References: