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

NCT ID: NCT07163013

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-12

Study Completion Date

2026-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Depressive Symptom

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Present study is a single center, two arms, and open-label randomized controlled trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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Digital cognitive behavioral therapy Group

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.

Group Type EXPERIMENTAL

Digital cognitive behavioral therapy(DCBT)

Intervention Type 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 Group

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

Group Type OTHER

Regular mental health curriculum

Intervention Type 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.

Interventions

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Digital cognitive behavioral therapy(DCBT)

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.

Intervention Type OTHER

Regular mental health curriculum

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xinyu Zhou

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xinyu Zhou, Professor

Role: CONTACT

15823996993

Facility Contacts

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Xinyu Zhou, Professor

Role: primary

15823396993

References

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Other Identifiers

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1stChongqingMu2

Identifier Type: -

Identifier Source: org_study_id

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