Low-intensity Online Intervention for Young People

Distress, Emotional Clinical Trial

Official title:

A Randomised Controlled Trial of Low-Intensity Online Intervention (LiON) for Distressed Youths in Hong Kong

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05510453
• Other study ID #: LiON RCT
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2022
• Source: The University of Hong Kong
• Contact: Yi Nam Suen
• Phone: 2255 4486
• Email: suenyn[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Distress, Emotional

Intervention

Other:
• Low-intensity online intervention (LiON)
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.

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes from baseline to immediate post-intervention to 1-month post-intervention
Primary	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.	Changes from baseline to immediate post-intervention to 1-month post-intervention
Primary	Symptoms of distress	6 items from the Kessler Kessler Psychological Distress Scale (K6)	Changes from baseline to immediate post-intervention to 1-month post-intervention
Secondary	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	Changes from baseline to immediate post-intervention to 1-month post-intervention
Secondary	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.	Changes from baseline to immediate post-intervention to 1-month post-intervention
Secondary	Perceived sleep quality	1 item from the Pittsburgh Sleep Quality Index (PSQI). The scores ranged from 0 - 4. Higher scores indicate poorer sleep quality.	Changes from baseline to immediate post-intervention to 1-month post-intervention
Secondary	Perceived stress level	Single item Subjective Level of Stress (SLS-1). The scores ranged from 0 - 10. Higher scores indicate higher perceived stress level.	Changes from baseline to immediate post-intervention to 1-month post-intervention
Secondary	Stress coping abilities	Brief Resilience Scale (BRS). The scores ranged from 6 - 30. Higher scores indicate poorer sleep quality.	Changes from baseline to immediate post-intervention to 1-month post-intervention
Secondary	General self-efficacy	General Self-Efficacy Scale (GSE). The scores range from 2-8. Higher scores indicate poorer self-efficacy	Changes from baseline to immediate post-intervention to 1-month post-intervention