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Starting soon Not applicable

Online Self-healing Program

NCT07374653 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-09-01
Last updated
2026-04-24

Condition(s) studied

Mild to Moderate Depressive Symptoms

Investigational drug(s) / intervention(s)

Online Cognitive Behaviural TherapyOnline Relaxation

Online Cognitive Behaviural Therapy: The online cognitive behavioural therapy (iCBT-A) provides six self-learning online modules for participants to learn via computer and/or smartphone a variety of CBT skills to manage their emotional distress. Participants in the intervention group will receive iCBT-A over a six-week period, completing one module per week. The iCBT-A includes the following topics: psychoeducation and normalization of the experience of mental health problems, and abdominal breathing (session 1); introduction to the basic concepts of CBT, identifying cognitive distortions and learning further relaxation techniques, including listening to relaxation music and imagery relaxation (sessions 2-3); learning cognitive restructuring skills (sessions 4-5); and developing a healthy lifestyle (session 6). Participants will receive weekly text and voice messages from student counsellors

Online Relaxation: The online relaxation program (iRelaxation) provides six self-learning modules for participants to learn via computer and/or smartphone a variety of relaxation skills (such as breathing relaxation) to manage their emotional distress. Control group participants will receive the online relaxation program over a six-week intervention period, completing one module per week. The iRelaxation includes the following topics: abdominal breathing (sessions 1-2); imagery relaxation (sessions 3-4); and listening to relaxation music (sessions 5-6). Participants will receive weekly text and voice messages from student counsellors.

Study summary

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
18 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Chinese Depression Anxiety Stress Scale (DASS-Y) — 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.

Trial sites (1)

FacilityCityRegionStatus
Tangwei Wanli School Shenzhen Guangzhou
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07374653 on ClinicalTrials.gov ↗ ← All trials in China