Online Self-healing Program

NCT07374653 | Not Yet Recruiting

• 1 other identifier: HU-STA-00001939
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild to Moderate Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• Chinese Depression Anxiety Stress Scale (DASS-Y)

  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.

  DASS-Y will be used before intervention, after 6 weeks intervention, and 2-month follow-up.

Secondary Outcomes (3)

• 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.

Study Arms (2)

Online cognitive behavioural therapy

EXPERIMENTAL

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.

Behavioral: Online Cognitive Behaviural Therapy

Online relaxation

ACTIVE COMPARATOR

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.

Behavioral: Online Relaxation

Interventions

Online Cognitive Behaviural Therapy BEHAVIORAL

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 cognitive behavioural therapy

Online Relaxation BEHAVIORAL

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.

Online relaxation

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Those with severe depression (i.e., a DASS Depression score 14 or more) or at risk of suicide are excluded from this study.

Sponsors & Collaborators

• City University of Hong Kong: lead

Study Sites (1)

Tangwei Wanli School

Shenzhen, Guangzhou, China

Location

Related Publications (11)

• Zhou K, Chen J, Huang C, Tang S. Prevalence of and factors influencing depression and anxiety among Chinese adolescents: a protocol for a systematic review. BMJ Open. 2023 Mar 23;13(3):e068119. doi: 10.1136/bmjopen-2022-068119.

  PMID: 36958770 RESULT

• Wickersham A, Barack T, Cross L, Downs J. Computerized Cognitive Behavioral Therapy for Treatment of Depression and Anxiety in Adolescents: Systematic Review and Meta-analysis. J Med Internet Res. 2022 Apr 11;24(4):e29842. doi: 10.2196/29842.

  PMID: 35404263 RESULT

• Racine N, McArthur BA, Cooke JE, Eirich R, Zhu J, Madigan S. Global Prevalence of Depressive and Anxiety Symptoms in Children and Adolescents During COVID-19: A Meta-analysis. JAMA Pediatr. 2021 Nov 1;175(11):1142-1150. doi: 10.1001/jamapediatrics.2021.2482.

  PMID: 34369987 RESULT

• Solmi M, Radua J, Olivola M, Croce E, Soardo L, Salazar de Pablo G, Il Shin J, Kirkbride JB, Jones P, Kim JH, Kim JY, Carvalho AF, Seeman MV, Correll CU, Fusar-Poli P. Age at onset of mental disorders worldwide: large-scale meta-analysis of 192 epidemiological studies. Mol Psychiatry. 2022 Jan;27(1):281-295. doi: 10.1038/s41380-021-01161-7. Epub 2021 Jun 2.

  PMID: 34079068 RESULT

• Wong SMY, Chen EYH, Suen YN, Wong CSM, Chang WC, Chan SKW, McGorry PD, Morgan C, van Os J, McDaid D, Jones PB, Lam TH, Lam LCW, Lee EHM, Tang EYH, Ip CH, Ho WWK, McGhee SM, Sham PC, Hui CLM. Prevalence, time trends, and correlates of major depressive episode and other psychiatric conditions among young people amid major social unrest and COVID-19 in Hong Kong: a representative epidemiological study from 2019 to 2022. Lancet Reg Health West Pac. 2023 Aug 19;40:100881. doi: 10.1016/j.lanwpc.2023.100881. eCollection 2023 Nov.

  PMID: 37654623 RESULT

• Komariah M, Amirah S, Faisal EG, Prayogo SA, Maulana S, Platini H, Suryani S, Yosep I, Arifin H. Efficacy of Internet-Based Cognitive Behavioral Therapy for Depression and Anxiety among Global Population during the COVID-19 Pandemic: A Systematic Review and Meta-Analysis of a Randomized Controlled Trial Study. Healthcare (Basel). 2022 Jun 30;10(7):1224. doi: 10.3390/healthcare10071224.

  PMID: 35885751 RESULT

• Grist R, Croker A, Denne M, Stallard P. Technology Delivered Interventions for Depression and Anxiety in Children and Adolescents: A Systematic Review and Meta-analysis. Clin Child Fam Psychol Rev. 2019 Jun;22(2):147-171. doi: 10.1007/s10567-018-0271-8.

  PMID: 30229343 RESULT

• Cao CH, Liao XL, Gamble JH, Li LL, Jiang XY, Li XD, Griffiths MD, Chen IH, Lin CY. Evaluating the psychometric properties of the Chinese Depression Anxiety Stress Scale for Youth (DASS-Y) and DASS-21. Child Adolesc Psychiatry Ment Health. 2023 Sep 7;17(1):106. doi: 10.1186/s13034-023-00655-2.

  PMID: 37679819 RESULT

• Christ C, Schouten MJ, Blankers M, van Schaik DJ, Beekman AT, Wisman MA, Stikkelbroek YA, Dekker JJ. Internet and Computer-Based Cognitive Behavioral Therapy for Anxiety and Depression in Adolescents and Young Adults: Systematic Review and Meta-Analysis. J Med Internet Res. 2020 Sep 25;22(9):e17831. doi: 10.2196/17831.

  PMID: 32673212 RESULT

• Tong, K. K., & Wang, Y. Y. (2017). Validation of the Flourishing Scale and scale of positive and negative experience in a Chinese community sample. PloS one, 12(8), e0181616. https://doi.org/10.1371/journal.pone.0181616

  RESULT

• Liu, X., Liu, L., Yang, J., Chai, F., Wang, A., Sun, L., Zhao, G., & Ma, D. (1997). The Adolescent Self-Rating Life Events Checklist and its reliability and validity. Chinese Journal of Clinical Psychology, 5(1), 34-36

  RESULT

Related Links

• Related Info

Central Study Contacts

Kim-wan Daniel Young, PhD

CONTACT

+85234428954; dkwyoung@cityu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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 3-month follow-up periods. Participants will receive weekly text and voice messages from student counsellors to promote adherence. In case, participants need more intensive support and individual counselling, participants, after giving their consent, will be referred by student counsellors to school social work services or counselling service of local social service by student counsellors. All student counsellors will be supervised by an experienced social worker and/or counsel

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-02

Locations

CN (1)