Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression

Last updated: December 11, 2024
Sponsor: Peking University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Treatment

a digital product based on CBT

Clinical Study ID

NCT06685861
2024-59
  • Ages 18-45
  • All Genders

Study 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

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 Diagnosticand 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 SerotoninReuptake Inhibitors (SSRIs) for at least 4 weeks, or no previous treatment withantidepressants, 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

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 otherreasons, or those lacking or having incomplete civil capacity during the onset ofillness;

  3. Suffering from neurological or organic brain diseases (such as stroke, cerebralhemorrhage, brain tumors, Parkinson's disease, epilepsy, etc.) and a history ofsevere traumatic brain injury;

  4. Currently undergoing systematic psychological therapy;

  5. Individuals who had been treated with convulsion-free electroconvulsive therapywithin 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;

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

Study Design

Total Participants: 146
Treatment Group(s): 1
Primary Treatment: a digital product based on CBT
Phase:
Study Start date:
November 11, 2024
Estimated Completion Date:
August 01, 2025

Connect with a study center

  • Peking University Sixth Hostipal

    Beijing, Beijing Beijing 100191
    China

    Active - Recruiting

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