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

Chongqing Medical University

Status: Enrolling

Conditions: Depressive Symptom

Treatments: Other: Digital cognitive behavioral therapy(DCBT); Other: Regular mental health curriculum

Study type: Interventional

Funder types: Other

Identifiers

NCT07163013

1stChongqingMu2

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Digital cognitive behavioral therapy Group

Experimental group

Description:

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.

Treatment:

Other: Digital cognitive behavioral therapy(DCBT)

Regular mental health curriculum Group

Other group

Description:

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

Treatment:

Other: Regular mental health curriculum