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CADS-D aimes to evaluate the effectiveness and feasibility of a newly DCBT program for Chinese adolescents with depressive symptoms.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinyu Zhou, Professor | Contact | 15823996993 | zhouxinyu@cqmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | 400016 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31282938 | Background | 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. | |
| 19788552 | Background |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Present study is a single center, two arms, and open-label randomized controlled trial.
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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.
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| 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. |
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| 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. | 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 | Improvement in self-reported anxiety symptom. Total scores range from 0-21, with higher scores indicating greater severity of self-reported anxiety symptoms. | Baseline of intervention period, 6 weeks, and 3 months follow-up (18 weeks) |
| 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. | 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 | Improvement of adolescents' quality of life. The total scores range from 14-70,with higher scores indicating greater enjoyment and satisfaction with life. | Baseline of intervention period, 6 weeks, and 3 months follow-up (18 weeks) |
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