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.
Aged 14-60 years (including 14 and 60), no gender restriction;
HAMD >= 14;
Written informed consent obtained from the patient; written informed consent obtained from the guardian for minors.
Persons with severe suicidal tendencies (item 10 of the MADRS scale ≥ 5).
Single group
a digital product based on CBT
DeviceThe 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 Al-guided course work and homework.
Change from baseline in Hamilton Depression Rating Scale (HAMD)
The outcome is assessed by 17-item Hamilton Depression Rating Scale (HAMD-17) Scale. Total HAMD scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. The change of HAMD from baseline to 8-week (after intervention) was used as the primary outcome.
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
The outcome is assessed by Montgomery-Asberg Depression Rating Scale (MADRS). Total MADRS score ranges from 0 to 60, with higher scores indicating greater severity of depression. The change of MADRS from baseline to 8-week (after intervention) was used.
Change from baseline in Positive and Negative Syndrome Scale (PANSS)
The outcome is assessed by the Positive and Negative Syndrome Scale (PANSS). The PANSS consists of 30 items, divided into three subscales: Positive Symptoms (7 items), Negative Symptoms (7 items), and General Psychopathology (16 items). Each item is rated on a 7-point scale from 1 (absent) to 7 (extreme), with higher scores indicating more severe symptoms. The total PANSS score ranges from 30 to 210, with higher scores reflecting greater symptom severity.
Response to treatment
Reduction rate of Hamilton Depression Scale (HAMD-17) or Montgomery-Asberg Depression Rating Scale (MADRS) score ≥50% was recognized as response to treatment.
Clinical Global Impression-Severity of Illness (CGI-S)
The outcome was assessed by the Clinical Global Impression-Severity of Illness (CGI-S) scale. It is rated on a 7-point scale. Higher scores indicate more severe symptoms.
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Peking University
Lead sponsor
Peking University Sixth Hospital
Sponsor institution
