Digital cognitive behavioral therapy for treating depression

Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression

This study tests whether a new mobile app using digital cognitive behavioral therapy can help people with depression feel better over eight weeks.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 146 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Peking University (other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06685861 on ClinicalTrials.gov

What this trial studies

This project aims to develop a digital product based on cognitive behavioral therapy (CBT) to assist in the treatment of depression. The therapy is delivered through a self-developed mobile app over a period of 8 weeks, featuring weekly sessions that include AI-guided coursework and homework assignments. The study will evaluate the effectiveness of this digital CBT approach through a randomized controlled trial and explore its underlying genetic imaging mechanisms.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-45 who meet the diagnostic criteria for depressive disorders and have a moderate to severe level of depression.

Not a fit: Patients with other mental disorders, such as schizophrenia or bipolar disorder, or those unable to cooperate due to intellectual disabilities will not benefit from this study.

Why it matters

Potential benefit: If successful, this digital therapy could provide an accessible and effective treatment option for individuals suffering from depression.

How similar studies have performed: Other studies have shown promise in using digital CBT approaches for treating depression, indicating potential for success in this novel application.

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.

Where this trial is running

Beijing, Beijing

• Peking University Sixth Hostipal — Beijing, Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Weihua Yue

Conditions: Depression, i-CBT