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Depressive SymptomCADS-DNCT07163013

Digital Cognitive Behavioral Therapy for Chinese Adolescents With Depressive Symptoms(CADS-D )

A study testing Digital cognitive behavioral therapy(DCBT) and Regular mental health curriculum in people with Depressive Symptom, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

CADS-D aimes to evaluate the effectiveness and feasibility of a newly DCBT program for Chinese adolescents with depressive symptoms. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Depressive Symptom
What is being tested?
Digital cognitive behavioral therapy(DCBT) and Regular mental health curriculum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
12 May 2025to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age 12 to 18 years;
  • Scored 28 or higher on the children's depression rating scale-revised (CDRS-R);
  • Have the ability to read and write in Chinese;
  • Participant and at least one of their guardians provided written consent;
  • Have access to mobile phone and internet.

Who cannot join

  • The researchers assessed that the adolescent's depressive symptoms were too severe to participate to CADS-D;
  • Scored 5 or higher on item 13 (suicidal ideation) on CDRS-R;
  • Participants who met diagnosis of other mental disorder except depression;
  • Severe physical illnesses or other physical disabilities that prevented the use of DCBT;
  • Within the past three months or currently undergoing any antidepressant treatment, including medication therapy, psychotherapy, and physical therapy;
  • Unavailability to follow up months after intervention.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xinyu Zhou, Professor contact

15823996993

zhouxinyu@cqmu.edu.cn

China1 site, 1 recruiting
  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016

    Xinyu Zhou, Professor, 15823396993, zhouxinyu@cqmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Digital Cognitive Behavioral Therapy for Chinese Adolescents With Depressive Symptoms(CADS-D ): A Randomized Clinical Trial

CADS-D aimes to evaluate the effectiveness and feasibility of a newly DCBT program for Chinese adolescents with depressive symptoms.

Read the detailed description

CADS-D is a single-center, two-arm, open-label randomized controlled trial. The trial targeted 12-18 years adolescents with depressive symptoms. Intervention group receives the digital cognitive behavioral therapy (DCBT) program for 6 weeks, while the control group receives the regular mental health curriculum provided by school staff for 6 weeks. Assessments are conducted at three time points: baseline, post-intervention (6 weeks), and at 3 months follow-up (18 weeks). The primary outcome is the effectiveness of DCBT. Secondary outcomes include the feasibility of DCBT, self-reported depressive severity, anxiety severity, psychological resilience, and the quality of life enjoyment and satisfaction.

Being tested
Digital cognitive behavioral therapy(DCBT), Regular mental health curriculum
Keywords
Depressive symptoms, Digital cognitive behavioral therapy, Adolescent
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital cognitive behavioral therapy(DCBT)Other

    Moca is a mobile application designed to deliver structural CBT for adolescents with mood problems. Moca provides six-twelve guided sessions with an estimated proceeding duration of 25-45min each, developed to be processed weekly. The content of each session includes the introduction of the core concepts and principles of CBT, psychological counseling dialogue, skill exercises, and homework. Content presentation forms include text, animation, audio, comics, etc. At the end of each module, the participants will be asked to submit homework that will ask them to apply their learned skills to nursing or daily life situations that they personally perceive as stressful. Participants can review the completed sessions and record their mood status during the intervention period.

  • Regular mental health curriculumOther

    The content of regular mental health curriculum includes mental health education lecture. Few lectures address the knowledge and skills involved in CBT in such education lecture.

Study groups in NCT07163013
Study groupRoleWhat they receive
Digital cognitive behavioral therapy GroupExperimentalParticipants in the intervention group are required to complete two module a week and all modules were be delivered in 6 weeks after the program starts.
Receives: Other: Digital cognitive behavioral therapy(DCBT)
Regular mental health curriculum GroupOtherThe participants of control group are allocated to regular mental health curriculum provided by school staff for 6 weeks.
Receives: Other: Regular mental health curriculum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in CDRS-R (Children's Depression Rating Scale) scores from baseline

    Children's Depression Rating Scale is a 17 items observer-rated scale developed specifically for children and adolescents. Total scores range from 17-113, with higher scores indicating greater severity of depressive symptoms.

    Measured: Baseline of intervention period, 6 weeks, and 3 months follow-up (18 weeks)

Secondary outcomes (5)
  1. Feasibility of DCBT

    Feasibility is assessmented by an acceptability and satisfaction questionnaire. The questionnaire constitutes 10 items which designed to examine acceptability and satisfaction with DCBT. In the first 8 questions, participants rated each item on a 5-point Likert scale. In last 2 questions, participants are asked to write the best and worst things about DCBT.

    Measured: 6 weeks

  2. Changes in PHQ (9-item Patient Health Questionnaire) scores from baseline

    Improvement in self-reported depressive symptoms. Total scores range from 0-27, with higher scores indicating greater severity of self-reported depressive symptoms.

    Measured: Baseline of intervention period, 6 weeks, and 3 months follow-up (18 weeks)

  3. Changes in GAD-7 (Generalized Anxiety Disorder 7-item Scale) scores from baseline

    Improvement in self-reported anxiety symptom. Total scores range from 0-21, with higher scores indicating greater severity of self-reported anxiety symptoms.

    Measured: Baseline of intervention period, 6 weeks, and 3 months follow-up (18 weeks)

  4. Changes in CD-RISC ( Connor-Davidson Resilience Scale) scores from baseline

    Improvement in psychological resilience assessed by Connor-Davidson Resilience Scale. Total scores range from 0-100, with higher total scores indicating stronger psychological resilience.

    Measured: Baseline of intervention period, 6 weeks, and 3 months follow-up (18 weeks)

  5. Changes in PQ-LES-Q (The Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire) scores from baseline

    Improvement of adolescents' quality of life. The total scores range from 14-70,with higher scores indicating greater enjoyment and satisfaction with life.

    Measured: Baseline of intervention period, 6 weeks, and 3 months follow-up (18 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2025
  2. Study start12 May 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Present study is a single center, two arms, and open-label randomized controlled trial.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07163013
Sponsor's protocol ID
1stChongqingMu2
Acronym
CADS-D
Status last verified
Sep 2025
First submitted
1 Sep 2025
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Barker MM, Beresford B, Bland M, Fraser LK. Prevalence and Incidence of Anxiety and Depression Among Children, Adolescents, and Young Adults With Life-Limiting Conditions: A Systematic Review and Meta-analysis. JAMA Pediatr. 2019 Sep 1;173(9):835-844. doi: 10.1001/jamapediatrics.2019.1712.

    PubMed 31282938
  • Janssens KA, Rosmalen JG, Ormel J, van Oort FV, Oldehinkel AJ. Anxiety and depression are risk factors rather than consequences of functional somatic symptoms in a general population of adolescents: the TRAILS study. J Child Psychol Psychiatry. 2010 Mar;51(3):304-12. doi: 10.1111/j.1469-7610.2009.02174.x. Epub 2009 Sep 28.

    PubMed 19788552
  • Pettit JW, Lewinsohn PM, Roberts RE, Seeley JR, Monteith L. The long-term course of depression: development of an empirical index and identification of early adult outcomes. Psychol Med. 2009 Mar;39(3):403-12. doi: 10.1017/S0033291708003851. Epub 2008 Jul 8.

    PubMed 18606049
  • Weissman MM, Wolk S, Goldstein RB, Moreau D, Adams P, Greenwald S, Klier CM, Ryan ND, Dahl RE, Wickramaratne P. Depressed adolescents grown up. JAMA. 1999 May 12;281(18):1707-13. doi: 10.1001/jama.281.18.1707.

    PubMed 10328070
  • O'Keeffe S, Martin P, Goodyer IM, Kelvin R, Dubicka B; IMPACT Consortium; Midgley N. Prognostic Implications for Adolescents With Depression Who Drop Out of Psychological Treatment During a Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2019 Oct;58(10):983-992. doi: 10.1016/j.jaac.2018.11.019. Epub 2019 Apr 1.

    PubMed 30946974
  • Thapar A, Collishaw S, Pine DS, Thapar AK. Depression in adolescence. Lancet. 2012 Mar 17;379(9820):1056-67. doi: 10.1016/S0140-6736(11)60871-4. Epub 2012 Feb 2.

    PubMed 22305766
  • Davey CG, Chanen AM, Hetrick SE, Cotton SM, Ratheesh A, Amminger GP, Koutsogiannis J, Phelan M, Mullen E, Harrison BJ, Rice S, Parker AG, Dean OM, Weller A, Kerr M, Quinn AL, Catania L, Kazantzis N, McGorry PD, Berk M. The addition of fluoxetine to cognitive behavioural therapy for youth depression (YoDA-C): a randomised, double-blind, placebo-controlled, multicentre clinical trial. Lancet Psychiatry. 2019 Sep;6(9):735-744. doi: 10.1016/S2215-0366(19)30215-9. Epub 2019 Jul 29.

    PubMed 31371212
  • Zhou X, Teng T, Zhang Y, Del Giovane C, Furukawa TA, Weisz JR, Li X, Cuijpers P, Coghill D, Xiang Y, Hetrick SE, Leucht S, Qin M, Barth J, Ravindran AV, Yang L, Curry J, Fan L, Silva SG, Cipriani A, Xie P. Comparative efficacy and acceptability of antidepressants, psychotherapies, and their combination for acute treatment of children and adolescents with depressive disorder: a systematic review and network meta-analysis. Lancet Psychiatry. 2020 Jul;7(7):581-601. doi: 10.1016/S2215-0366(20)30137-1.

    PubMed 32563306
  • Fitzpatrick KK, Darcy A, Vierhile M. Delivering Cognitive Behavior Therapy to Young Adults With Symptoms of Depression and Anxiety Using a Fully Automated Conversational Agent (Woebot): A Randomized Controlled Trial. JMIR Ment Health. 2017 Jun 6;4(2):e19. doi: 10.2196/mental.7785.

    PubMed 28588005
  • Rushton J, Bruckman D, Kelleher K. Primary care referral of children with psychosocial problems. Arch Pediatr Adolesc Med. 2002 Jun;156(6):592-8. doi: 10.1001/archpedi.156.6.592.

    PubMed 12038893
  • Ritterband LM, Andersson G, Christensen HM, Carlbring P, Cuijpers P. Directions for the International Society for Research on Internet Interventions (ISRII). J Med Internet Res. 2006 Sep 29;8(3):e23. doi: 10.2196/jmir.8.3.e23.

    PubMed 17032639
  • Imamura K, Kawakami N, Furukawa TA, Matsuyama Y, Shimazu A, Umanodan R, Kawakami S, Kasai K. Does Internet-based cognitive behavioral therapy (iCBT) prevent major depressive episode for workers? A 12-month follow-up of a randomized controlled trial. Psychol Med. 2015 Jul;45(9):1907-17. doi: 10.1017/S0033291714003006. Epub 2015 Jan 7.

    PubMed 25562115
  • Hallgren M, Helgadottir B, Herring MP, Zeebari Z, Lindefors N, Kaldo V, Ojehagen A, Forsell Y. Exercise and internet-based cognitive-behavioural therapy for depression: multicentre randomised controlled trial with 12-month follow-up. Br J Psychiatry. 2016 Nov;209(5):414-420. doi: 10.1192/bjp.bp.115.177576. Epub 2016 Sep 8.

    PubMed 27609813
  • Thase ME, Wright JH, Eells TD, Barrett MS, Wisniewski SR, Balasubramani GK, McCrone P, Brown GK. Improving the Efficiency of Psychotherapy for Depression: Computer-Assisted Versus Standard CBT. Am J Psychiatry. 2018 Mar 1;175(3):242-250. doi: 10.1176/appi.ajp.2017.17010089. Epub 2017 Oct 3.

    PubMed 28969439
  • Kaltenthaler E, Parry G, Beverley C, Ferriter M. Computerised cognitive-behavioural therapy for depression: systematic review. Br J Psychiatry. 2008 Sep;193(3):181-4. doi: 10.1192/bjp.bp.106.025981.

    PubMed 18757972

Questions about this trial

What is this clinical trial studying?

A study testing Digital cognitive behavioral therapy(DCBT) and Regular mental health curriculum in people with Depressive Symptom, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xinyu Zhou, Professor (15823996993, zhouxinyu@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in CDRS-R (Children's Depression Rating Scale) scores from baseline (time frame: Baseline of intervention period, 6 weeks, and 3 months follow-up (18 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07163013, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.

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