Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression: a Real-world Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: a digital product based on CBT.
- Who it may be relevant to
- Registry conditions: Depression, Bipolar Affective Disorder, Schizophenia Disorder, Psychiatric &Amp;or Mood Disorder. Basic parameters: 14 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device a digital product based on CBT
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 Al-guided course work and homework.
Primary outcome measures
- Change from baseline in Hamilton Depression Rating Scale (HAMD) [Time frame: Week 4 and 8 of treatment duration]
Secondary outcome measures (12)
- Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) [Time frame: Week 4 and 8 of treatment duration]
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) [Time frame: Week 4 and 8 of treatment duration]
- Response to treatment [Time frame: Week 4 and 8 of treatment duration]
- Clinical Global Impression-Severity of Illness (CGI-S) [Time frame: Week 4 and 8 of treatment duration]
- Change from baseline in Hamilton Anxiety Rating Scale (HAMA) [Time frame: Week 4 and 8 of treatment duration]
- Change from baseline in Ruminative Responses Scale (RRS) [Time frame: Week 4 and 8 of treatment duration]
- Change from baseline in Pittsburgh Sleep Quality Index (PSQI) [Time frame: Week 4 and 8 of treatment duration]
- Change from baseline in Connor-Davidson Resilience Scale (CD-RISC) [Time frame: Week 4 and 8 of treatment duration]
- Change from baseline in Thinc-Integrated Tool(THINC-it) [Time frame: Week 8 of treatment duration]
- Mood Disorder Questionnaire (MDQ) [Time frame: Week 4 and 8 of treatment duration]
- Rating Scale for Side Effects（SERS） [Time frame: Week 4 and 8 of treatment duration]
- Client Satisfaction Questionnaire-3 （CSQ-3) [Time frame: Week 8 of treatment duration]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Persons with severe suicidal tendencies (item 10 of the MADRS scale ≥ 5).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Sixth Hostipal — Beijing
Identifiers
NCT: NCT06831435 · 2024-83