Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression: a Real-world Study

Peking University

Status: Enrolling

Conditions: Schizophenia Disorder; Bipolar Affective Disorder; Psychiatric &Amp;or Mood Disorder; Depression

Treatments: Device: a digital product based on CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT06831435

2024-83

Details and patient eligibility

About

The project proposes to develop a digital product based on cognitive behavioral therapy for the assisted treatment of depression. The digital cognitive behavioral therapy in this study is conducted based on a self-developed mobile applet. The therapy is developed by psychotherapists, which is conducted for a total of 8 weeks, with weekly sessions including AI-guided course work and homework. This study aims to evaluate the therapeutic effects of CBT-based digital products for depression in patients through a real-world study, and to explore its genetic and neuroimaging mechanisms.

Enrollment: 325 estimated patients

Sex: All

Ages: 14 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 14-60 years (including 14 and 60), no gender restriction;
2. HAMD >= 14;
3. Written informed consent obtained from the patient; written informed consent obtained from the guardian for minors.

Exclusion criteria

• Persons with severe suicidal tendencies (item 10 of the MADRS scale ≥ 5).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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325 participants in 1 patient group

i-CBT group

Experimental group

Description:

i-CBT combined with conventional drug treatment

Treatment:

Device: a digital product based on CBT