Online Cognitive Behavioural Therapy for Adolescents With Depression - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Chinese Depression Anxiety Stress Scale (DASS-Y)
研究概览
简要总结
Background. Almost two thirds of adolescents experience a mental disorder before the age of 25. Among mental disorders, depression is one of the most common among young people aged between 15 to 24, with a prevalence of 13.5% to 15.8% worldwide and 13.2% in Hong Kong, which is alarming.
Cognitive behavioural therapy and online cognitive behavioural therapy has been shown to be effective on reducing depression. Also, online cognitive behavioural therapy has also been shown to be useful for people with mild to moderate depression. However, there is a lack of an effective short-term online cognitive behavioural therapy for adolescents with depression, named online cognitive behavioural therapy in Hong Kong.
Objectives: This study aims to explore the efficacy and effectiveness of a short-term online cognitive behavioural therapy for adolescents with depressive symptoms.
Hypothesis:
i. The online cognitive behavioural therapy, as compared to an online relaxation program, is significantly more effective on improving mental health, including reducing anxiety and depressive symptoms, and increasing psychological well-being for participants.
iii. The treatment outcomes, as stated in (i), are predicted by individual's uptake, adherence and dropout rate of online cognitive behavioural therapy.
Research Design. A multicentre blinded randomized controlled two-arm parallel-group trial will be adopted. Participating adolescents will be recruited from collaborating secondary schools. Using block randomization, subjects will be assigned in a 1:1 ratio to an online cognitive behavioural therapy and an online relaxation program. Both online cognitive behavioural therapy and online relaxation program will provide six online modules for participants to learn through computer and/or smartphone. Participants will complete the same online assessment tools at pre-intervention, post-intervention, and 2-month follow-up periods.
Subjects Inclusion Criteria. Subjects inclusion criteria includes: (a) aged between 12 and 18 years old; (b) students of a local collaborating secondary school; (c) having mild to moderate depressive symptoms as assessed with a standardized assessment tool, i.e. Chinese Depression Anxiety Stress Scale (DASS-Y; Cao et al., 2023) with a DASS Depression score of between 7 and 13; and (d) provide parental consent. Those with severe depression or at risk of suicide are excluded from this study.
Significance: This study aims to make a significant contribution to the development of an online cognitive behavioural therapy for Chinese adolescents with depressive symptoms. In particular, the online cognitive behavioural therapy could be used in secondary schools to serve those students with mental health problems who are reluctant to seek help from traditional face-to-face counselling.
详细描述
Introduction Almost two thirds (62.5%) of adolescents experience a mental disorder before the age of 25. Among mental disorders, major depressive disorder is one of the most common among young people aged between 15 to 24, with a prevalence of 13.5% to 15.8% worldwide and 13.2% in Hong Kong, which is alarming. Depression has negative effects on adolescents' mental and physical health and school performance, including suicide, alcohol and drug abuse, smoking, binge eating, diabetes, asthma and poor school performance.
Research evidences have consistently supported the efficacy and effectiveness of cognitive behavioural therapy on reducing depression in the Western, Asian, and Chinese societies.
Online cognitive behavioural therapy has been developed in which cognitive behavioural therapy is delivered via the internet helping individual to reduce their mental health problems using various skills developed by CBT. Online cognitive behavioural therapy has been reported to overcome the aforementioned barriers of traditional face-to-face psychological treatment by providing participants with flexible learning opportunities to read and learn the techniques and skills of cognitive behavioural therapy via an online platform that is accessible anytime, anywhere, anonymously, short-term, and in a structured manner. Research reviews have shown that online cognitive behavioural therapy is effective in reducing depression in adolescents with a small to medium effect size and the treatment effect of online cognitive behavioural therapy is comparable to that of face-to-face CBT.
Research Gap Currently, there is a lack of an effective short-term online cognitive behavioural therapy for adolescents with depression in Hong Kong and Chinese societies.
Objectives. This research project aims to design and investigate the intervention effects, uptake rate, and adherence rate and of a short-term online cognitive behavioural therapy for adolescents, named iCBT-A, with depressive symptoms in Hong Kong. Additionally, the predicting impact of uptake and adherence rates on treatment effects will also be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
A research staff, who does not involve in the group allocation and delivery of group interventions, conduct the intervention outcomes assessment of the participants before and after the intervention and 3-months follow-up. Actually, participants will complete the same online assessment tools at pre-intervention, post-intervention, and 3-month follow-up periods.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged between 12 and 18 years old;
- •students of a local collaborating secondary school and/or youth service units;
- •having mild to moderate depressive symptoms as assessed with a standardized assessment tool, i.e. Chinese Depression Anxiety Stress Scale (DASS-Y; Cao et al., 2023) with a DASS Depression score of between 7 and 13; and
- •provide parental consent.
排除标准
- •Those with severe depression (i.e., a DASS Depression score 14 or more) or at risk of suicide are excluded from this study.
研究组 & 干预措施
Online cognitive behavioural therapy
The online cognitive behavioural therapy (iCBT-A) offers six self-learning modules that participants can access via computer or smartphone to learn various CBT skills for managing emotional distress.
干预措施: Online Cognitive Behaviural Therapy (Behavioral)
Online relaxation
The online relaxation programme (iRelaxation) offers six self-learning modules that allow participants to use a computer or smartphone to learn various relaxation skills for managing emotional distress.
干预措施: Online Relaxation (Behavioral)
结局指标
主要结局
Chinese Depression Anxiety Stress Scale (DASS-Y)
时间窗: DASS-Y will be used before intervention, after 6 weeks intervention, and 2-month follow-up.
The DASS-Y is a 21-item scale to assess participant's self-reported mental health problems including depressive symptoms, anxiety symptoms and stress, with good validity and reliability (α = 0.80 for anxiety subscale, 0.83 for depression subscale, 0.82 for stress subscale, and 0.92 for whole scale; Cao et al., 2023). Each item (e.g. I felt down-hearted and blue) is scored from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). The scores are summed over the items with higher scores indicating a higher severity of symptoms. Each DASS-Y subscale score ranges from 0 to 21, while the DASS-Y total score ranges from 0 to 63.
次要结局
- Chinese Flourishing Scale (FS)(FS will be used before intervention, after 6 weeks intervention, and 2-month follow-up.)
- Adolescent Self-Rating Life Events (ASLEC)(ASLEC will be used before intervention, after 6 weeks intervention, and 2-month follow-up.)
- Chinese Hope Scale (HOPE)(Chinese Hope Scale (HOPE) will be used before intervention, after 6 weeks intervention, and 2-month follow-up.)
研究者
Daniel Young
Professor
City University of Hong Kong