Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression

NCT06685861 | Active Not Recruiting

• 1 other identifier: 2024-59
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

i-CBT

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Hamilton Depression Rating Scale (HAMD)

  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.

  Week 4 and 8 of treatment duration

Secondary Outcomes (11)

• 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

Study Arms (2)

i-CBT group

EXPERIMENTAL

i-CBT combined with conventional drug treatment

Device: a digital product based on CBT

control group

NO INTERVENTION

conventional drug treatment

Interventions

a digital product based on CBT DEVICE

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.

i-CBT group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead
• Shantou University Mental Health Center: collaborator
• Hebei Provincial Mental Health Center: collaborator

Study Sites (1)

Peking University Sixth Hostipal

Beijing, Beijing Municipality, Beijing 100191, China

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 13, 2024
• Study Start: November 11, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)