Depressive Symptom
Conditions
Keywords
Depressive symptoms, Digital cognitive behavioral therapy, Adolescent
Brief summary
CADS-D aimes to evaluate the effectiveness and feasibility of a newly DCBT program for Chinese adolescents with depressive symptoms.
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.
Interventions
OTHERDigital 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.
OTHERRegular 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.
Sponsors
First Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Present study is a single center, two arms, and open-label randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in CDRS-R (Children's Depression Rating Scale) scores from baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of DCBT | 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. |
| Changes in PHQ (9-item Patient Health Questionnaire) scores from baseline | 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. |
| 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) | Improvement in self-reported anxiety symptom. Total scores range from 0-21, with higher scores indicating greater severity of self-reported anxiety symptoms. |
| Changes in CD-RISC ( Connor-Davidson Resilience Scale) scores from baseline | 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. |
| 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) | Improvement of adolescents' quality of life. The total scores range from 14-70，with higher scores indicating greater enjoyment and satisfaction with life. |
Countries
China
Contacts
CONTACTXinyu Zhou, Professor
Outcome results
None listed