Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- Change from baseline in Hamilton Depression Rating Scale (HAMD)
Study Overview
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. The aim of this study is to evaluate the therapeutic effect of a digital product based on cognitive behavioral therapy for the assisted treatment of depression in patients through a randomised controlled trial, and to explore its genetic imaging mechanisms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18-45 years (including 18 and 45), no gender restriction;
- •Meets the diagnostic criteria for depressive disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-Ⅴ);
- •Outpatients or inpatients; Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥ 17; Clinical Global Impressions-Severity (CGI-S) score = 4;
- •Maintenance treatment with antidepressants in the class of Selective Serotonin Reuptake Inhibitors (SSRIs) for at least 4 weeks, or no previous treatment with antidepressants, and can be combined with Lorazepam 0.5mg/dose and Zolpidem Tartrate 5-10mg/n during insomnia and anxiety attacks;
- •Written informed consent obtained from the patient.
Exclusion Criteria
- •Diagnosed with other mental disorders, including schizophrenia, bipolar disorder, alcohol or substance abuse/dependence, eating disorders, etc.;
- •Individuals with intellectual disabilities or who are unable to cooperate for other reasons, or those lacking or having incomplete civil capacity during the onset of illness;
- •Suffering from neurological or organic brain diseases (such as stroke, cerebral hemorrhage, brain tumors, Parkinson's disease, epilepsy, etc.) and a history of severe traumatic brain injury;
- •Currently undergoing systematic psychological therapy;
- •Individuals who had been treated with convulsion-free electroconvulsive therapy within the last month;
- •Pregnant women or individuals with contraindications to MRI examinations;
- •Individuals who don't know how to use or don't have a smartphone;
- •Individuals with severe suicidal tendencies or at risk of harming others.
Arms & Interventions
control group
conventional drug treatment
i-CBT group
i-CBT combined with conventional drug treatment
Intervention: a digital product based on CBT (Device)
Outcomes
Primary Outcomes
Change from baseline in Hamilton Depression Rating Scale (HAMD)
Time Frame: Week 4 and 8 of treatment duration
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 Hamilton Depression Rating Scale (HAMD)
Time Frame: Week 4 and 8 of treatment duration
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.
Secondary Outcomes
- Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)(Week 4 and 8 of treatment duration.)
- Response to treatment(Week 4 and 8 of treatment duration)
- Clinical Global Impression-Severity of Illness (CGI-S)(Week 4 and 8 of treatment duration)
- Change from baseline in Hamilton Anxiety Rating Scale (HAMA)(Week 4 and 8 of treatment duration)
- Change from baseline in Ruminative Responses Scale (RRS)(Week 4 and 8 of treatment duration)
- Change from baseline in Pittsburgh Sleep Quality Index (PSQI)(Week 4 and 8 of treatment duration)
- Change from baseline in Connor-Davidson Resilience Scale (CD-RISC)(Week 4 and 8 of treatment duration)
- Change from baseline in Thinc-Integrated Tool(THINC-it)(Week 8 of treatment duration)
- Mood Disorder Questionnaire (MDQ)(Week 4 and 8 of treatment duration)
- Rating Scale for Side Effects（SERS）(Week 4 and 8 of treatment duration)
- Client Satisfaction Questionnaire-3 （CSQ-3)(Week 8 of treatment duration)
Investigators
Weihua Yue
Professor
Peking University Sixth Hospital