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NCT Number: NCT07163013

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

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

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016, China

Location status: Recruiting

Location contact

Xinyu Zhou, Professor

CONTACT

[email protected]

15823396993

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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 curriculum

Other

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.

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. Feasibility of DCBT

    Time frame: 6 weeks

    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.

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

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

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

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

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

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

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

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

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

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Xinyu Zhou, Professor

CONTACT

[email protected]

15823996993

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Official study title

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

Acronym: CADS-D

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2025
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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