跳至主要内容
临床试验/NCT07383467
NCT07383467招募中不适用

No Time to Wait: A Randomized Control Trial of Online Single-Session Intervention for Children and Adolescents on Psychotherapy Waitlists in Hong Kong

United Christian Hospital1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2026年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
124
试验地点
1
主要终点
Patient Health Questionnaire-9

研究概览

简要总结

Mental health problems in youth are prevalent, but early intervention effectively reduces symptoms, substance abuse risk, suicide, and comorbidities. In Hong Kong, however, only 26% of people with common mental disorders seek services, and even then, they face long delays-e.g., 90 weeks (90th percentile) for stable cases in public psychiatry clinics (Hospital Authority, 2024). Barriers include high costs, transportation issues, stigma, and preference for self-help, creating a strong need for scalable, accessible digital solutions, especially for youth.

Single-Session Interventions (SSI) offer promise as brief, time-efficient tools that provide immediate support with minimal engagement burden. Online SSIs are often free, publicly available, and evidence-based. Research shows they reduce symptoms (moderate effect size Hedges' g = 0.32; 58% chance of better outcome vs. control), improve functioning, and boost satisfaction. They work well for specific phobias and acute stress. Yet, their real-world acceptability, effectiveness outside trials, and integration with public services remain understudied-particularly for children/adolescents on waitlists.

This pilot study evaluates an online single-session psychotherapy for youth (children/adolescents) on Hong Kong public psychotherapy waitlists, targeting depression and anxiety symptoms. It extends prior work by:

Targeting two key constructs prominent in Asian contexts:

Alexithymia - difficulty identifying/describing emotions; affects ~10% generally but 36% of Hong Kong adolescents (higher in females). It worsens depression, lowers well-being, complicates therapy, and reduces help-seeking.

Fixed mindset (vs. growth mindset) - Asian groups show lower growth mindset levels; growth mindset buffers mental health issues (meta-analysis r = -0.220 with anxiety/depression/stress) and promotes better emotional regulation and treatment engagement.

Examining how SSI influences acceptability and expectancy toward subsequent face-to-face psychotherapy.

Hypotheses:

SSI will reduce depression/anxiety symptoms more than treatment-as-usual. SSI will increase acceptability and positive expectancy for future in-person treatment.

Change mechanisms-perceived behavioral control and emotional control-will mediate and sustain post-intervention outcomes.

Overall, the study aims to test SSI as a bridge intervention to bridge service gaps, address culturally relevant barriers, and inform scalable mental health strategies in resource-constrained settings like Hong Kong's public system.

详细描述

Early intervention has been shown to effectively reduce symptoms of mental disorder, and the subsequent risk of substance abuse, suicide, and other mental disorders. However, in Hong Kong, only 26% of individuals with common mental health disorders seek any mental health service. Even when help is sought, those in need often face lengthy waiting time before receiving treatment, which can have detrimental effects on their mental well-being. For individuals categorized as stable, the average 90th percentile waiting time for psychiatry specialist outpatient clinics amounted to 90 weeks. Numerous systemic and internal barriers further impede access to mental health services, particularly for youth. These barriers include high costs, transportation challenges, stigma, and a preference for self-help options. As the result, there is a pressing need for scalable and accessible digital interventions that can address the gap in service delivery.

Single-session intervention (SSI) has emerged as a time-efficient and accessible intervention that may provide immediate support and mitigate the negative impact of mental health issues. Online SSIs, in particular, hold substantial promise for addressing many challenges associated with traditional digital mental health tools. They can be completed in a single sitting, minimizing user engagement burdens, and many of them are cost-free, publicly accessible, and incorporate evidence-based intervention components. Despite these advantages, the acceptability and effectiveness of online SSIs outside of controlled clinical trials, as well as their synergy with public mental health services, remained underexplored. This study seeks to fill this gap by evaluating the effectiveness and acceptability of single-session psychotherapy for children and adolescents on psychotherapy waitlists in Hong Kong.

Research on SSIs highlights its potential benefits in addressing mental health concerns in a time-limited manner. Single-session interventions, such as the "Walk-in Clinic" and online self-help model, have been implemented successfully in various settings, demonstrating positive outcomes for individuals with a range of psychological difficulties. Studies have shown that single-session interventions can lead to significant symptom reduction, improved functioning, and increased patient satisfaction. A meta-analysis has shown that the calculated effect size (ES) at the end of the intervention was found to be 0.32 according to Hedges' g, indicating a moderate positive impact. This suggests that there was a 58% likelihood of an adolescent who received the single-session intervention (SSI) experiencing better outcomes compared to a youth in the control group. Moreover, single-session psychotherapy has been found to be particularly effective for certain conditions, such as specific phobias and acute stress reactions.

However, limited research has specifically examined the application of single-session psychotherapy for children and adolescents on public mental health service waitlist. Understanding the potential benefits and limitations of single-session psychotherapy in this context can inform mental health service providers and policymakers in developing efficient and accessible interventions for children and adolescents. This study will examine the possibility of SSI in enhancing participants' acceptability toward future psychotherapy. Furthermore, it aims to address specify personality constructs - alexithymia and fixed mindset - that impede the recovery process and are particularly prominent within Asian culture context.

Alexithymia, a condition marked by difficulties in processing emotions and distinguishing them from physical sensations, affects approximately 10% of the general population. However, research indicates that 36% of adolescents in Hong Kong exhibit alexithymic traits, with 34.3% of males and 40% of females affected. First described by Sifneos, alexithymia has been linked in neurobiological studies to impairments in identifying emotions in others. This condition can worsen depressive symptoms and diminish overall well-being. Moreover, alexithymia complicates psychological treatments, often leading to poorer therapeutic outcomes in managing other psychiatric disorders and reducing the likelihood of seeking help.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • (1) being Hong Kong residents aged 12 - 17; (2) having anxiety and/or depression symptoms, scoring 10 or above, in accordance with Patient Health Questionnaire (PHQ-9) or General Anxiety Disorder-7 (GAD-7); (3) having access to the internet and a valid email address for communication, (4) being able to understand and read Chinese and, (5) participants' parent or legal guardian will be willing to give informed consent.

排除标准

  • (1) they have received another psychological treatment for depression and/or anxiety in the past 3 months, (2) they report a diagnosis of other comorbid severe psychiatric disorder, including psychotic disorder, bipolar disorder, dissociative disorder, or other neurocognitive disorders that make participation infeasible or interfere with the adherence to the digital self-help intervention, (3) they would participate in another similar study concurrently, (4) any suicidal ideation is reported (score > 2 on Question 9 of the Beck Depression Inventory), (5) they report substance abuse history, (6) having changes in psychotropic medication within 2 weeks before baseline assessment; or (7) they report pregnancy.

研究组 & 干预措施

Intervention Group

Experimental

Participants who receive online single session intervention

干预措施: Online Single Session Intervention on Growth Mindset (Other)

Control Group

No Intervention

Waitlist Control

结局指标

主要结局

Patient Health Questionnaire-9

时间窗: From enrolment to 1 month after the end of treatment

The Patient Health Questionnaire 9-Item (PHQ-9) is a self-report measure that assesses the severity of depressive symptoms. Each question is a 4-point Likert-scale that generates a total score ranging from 0 to 27, while the score ≥ 10 was widely used as a clinical cut-off, indicating that the diagnosis of Major Depressive Disorder on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).

General Anxiety Disorder-7

时间窗: From enrolment to 1 month after the end of treatment

The Generalized Anxiety Disorder 7-item (GAD-7) is a self-report measure to evaluate the severity of anxiety symptoms. These measures reflect the DSM-IV diagnostic criteria of depression and anxiety respectively. Both measures show good convergent validity with other measures and are widely used in mental health research. These two measures also have a well-established sensitivity to changes after intervention.

PHQ-9

时间窗: From enrolment to 1 month after the end of treatment

GAD-7

时间窗: From enrolment to 1 month after the end of treatment

TAS- 20-C

时间窗: From enrolment to 1 month after the end of treatment

Alexithymia will be measured using the Toronto Alexithymia Scale (TAS-20), a validated self-report questionnaire assessing difficulty in identifying and describing feelings. The TAS- 20-C is a 20-item self-report scale rated on a five-point Likert scale. It includes three subscales: Difficulty Identifying Feelings (DIF) with items like "When I am upset I don't know if I am sad, frightened, or angry"; Difficulty Describing Feelings (DDF) with statements such as "I find it hard to describe how I feel about people"; and Externally Oriented Thinking (EOT), exemplified by "I prefer to just let things happen rather than to understand why they turned out that way." Scores can range from 20 to 100, where higher scores denote higher alexithymia. The TAS-20-C is validated for Chinese populations (Zhu et al., 2007). In this research, the scale achieved a Cronbach's alpha of 0.80.

次要结局

  • Perceived primary (behavioral) control(From Enrolment to 1 month after the end of treatment)
  • Perceived secondary (emotional) control(From enrolment to 1 month after the end of treatment)
  • Attitudes Toward Seeking Professional Psychological Help (ATSPPH) Short Form(From enrolment to 1-month after the end of treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Timmy Tsoi

Clinical Psychologist

United Christian Hospital

研究点 (1)

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