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Предстои набиране Не е приложимо NCT07374653

Online Self-healing Program

Не е приложима фаза (напр. обсервационно)
Заболявания: Mild to Moderate Depressive Symptoms

Спонсор: City University of Hong Kong

Налично на: БГ
Обобщение
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.
Описание
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. Hypothesis. i. The iCBT-A is significantly more effective than an online relaxation program on reducing depressive symptoms, and increasing psychological well-being for participants. ii. The treatment outcomes, as stated in (i), are predicted by individual's uptake, adherence and dropout rate of iCBT-A. Research Design. A clustered randomized controlled two-arm parallel-group trial will be adopted. Eligible adolescents will be openly recruited into activity groups from collaborating secondary schools. The activity groups are randomly allocated to the intervention groups and a control group on 1:1 ratio. Intervention group will receive iCBT-A. While the control group will receive online relaxation program (i.e., iRelaxation). Participants will complete the same online assessment tools at pre-intervention, post-intervention, and 2-month follow-up periods.
Кой може да участва
Inclusion Criteria: 1. aged between 12 and 18 years old; 2. students of a local collaborating secondary school and/or youth service units; 3. 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 4. provide parental consent. Exclusion Criteria: Those with severe depression (i.e., a DASS Depression score 14 or more) or at risk of suicide are excluded from this study.
Интервенции
Online Cognitive Behaviural Therapy
BEHAVIORAL
Online Relaxation
BEHAVIORAL
Места на провеждане 1
Китай (1)
Tangwei Wanli School
Shenzhen , Guangzhou
Li Tao Huang, Bsc (Education)
Технически детайли
Статус
Предстои набиране
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
12 Years
Максимална възраст
18 Years
Здрави доброволци
Не
Начална дата
01.09.2026
Крайна дата
31.08.2027
Регистрационен номер
NCT07374653
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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