Clinical trial NCT06685861: Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression
Official title: Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: i-CBT
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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. 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.


Eligibility criteria: Inclusion Criteria:

1. Aged 18-45 years (including 18 and 45), no gender restriction;
2. Meets the diagnostic criteria for depressive disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-IV);
3. Outpatients or inpatients; Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥ 17; Clinical Global Impressions-Severity (CGI-S) score = 4;
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;
5. Written informed consent obtained from the patient.

Exclusion Criteria:

1. Diagnosed with other mental disorders, including schizophrenia, bipolar disorder, alcohol or substance abuse/dependence, eating disorders, etc.;
2. 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;
3. 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;
4. Currently undergoing systematic psychological therapy;
5. Individuals who had been treated with convulsion-free electroconvulsive therapy within the last month;
6. Pregnant women or individuals with contraindications to MRI examinations;
7. Individuals who don't know how to use or don't have a smartphone;

10. Individuals with severe suicidal tendencies or at risk of harming others.

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: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Sixth Hostipal
state: Beijing
Study officials:
References: