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

NCT07163013 | Recruiting DMC

• 1 other identifier: 1stChongqingMu2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depressive Symptom

Keywords

Depressive symptoms; Digital cognitive behavioral therapy; Adolescent

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• Feasibility of DCBT

  6 weeks

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

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

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

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

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

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

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

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

Study Arms (2)

Digital cognitive behavioral therapy Group

EXPERIMENTAL

Participants 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.

Other: Digital cognitive behavioral therapy(DCBT)

Regular mental health curriculum Group

OTHER

The participants of control group are allocated to regular mental health curriculum provided by school staff for 6 weeks.

Other: Regular mental health curriculum

Interventions

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.

Digital cognitive behavioral therapy Group

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.

Regular mental health curriculum Group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016, China

RECRUITING

Related Publications (20)

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MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Xinyu Zhou, Professor

CONTACT

15823996993; zhouxinyu@cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: As the intervention measure set in this study, it is impossible to blind participants or intervention providers. Trained research assistants who are blinded to intervention will conduct the assessment, and data analyst are kept blind to the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Present study is a single center, two arms, and open-label randomized controlled trial.

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: May 12, 2025
• Primary Completion: June 30, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)