Clinical trial NCT06831435: Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression: a Real-world Study
Official title: Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression: a Real-world Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Bipolar Affective Disorder
Schizophenia Disorder
Psychiatric &amp;or Mood Disorder
Keywords: i-CBT
a real-world study
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 325
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Aged 14-60 years (including 14 and 60), no gender restriction;
2. HAMD \>= 17;
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).

Primary outcomes:
measure: Change from baseline in Hamilton Depression Rating Scale (HAMD)
timeFrame: Week 4 and 8 of treatment duration
Secondary outcomes:
measure: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Week 4 and 8 of treatment duration
measure: Change from baseline in Positive and Negative Syndrome Scale (PANSS)
timeFrame: Week 4 and 8 of treatment duration
measure: Response to treatment
timeFrame: Week 4 and 8 of treatment duration
measure: Clinical Global Impression-Severity of Illness (CGI-S)
timeFrame: Week 4 and 8 of treatment duration
measure: Change from baseline in Hamilton Anxiety Rating Scale (HAMA)
timeFrame: Week 4 and 8 of treatment duration
measure: Change from baseline in Ruminative Responses Scale (RRS)
timeFrame: Week 4 and 8 of treatment duration
measure: Change from baseline in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Week 4 and 8 of treatment duration
measure: Change from baseline in Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: Week 4 and 8 of treatment duration
measure: Change from baseline in Thinc-Integrated Tool(THINC-it)
timeFrame: Week 8 of treatment duration
measure: Mood Disorder Questionnaire (MDQ)
timeFrame: Week 4 and 8 of treatment duration
measure: Rating Scale for Side Effects（SERS）
timeFrame: Week 4 and 8 of treatment duration
measure: Client Satisfaction Questionnaire-3 （CSQ-3)
timeFrame: Week 8 of treatment duration
measure: Change from baseline in Young Mania Rating Scale (YMRS)
timeFrame: Week 4 and 8 of treatment duration
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Sixth Hostipal
state: Beijing
Study officials:
References: