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Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression

NCT ID: NCT06685861

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-11

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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i-CBT group

i-CBT combined with conventional drug treatment

Group Type EXPERIMENTAL

a digital product based on CBT

Intervention Type 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.

control group

conventional drug treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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a digital product based on CBT

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.

Intervention Type DEVICE

Eligibility Criteria

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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-Ⅴ);
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;
8. Individuals with severe suicidal tendencies or at risk of harming others.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shantou University Mental Health Center

UNKNOWN

Sponsor Role collaborator

Hebei Provincial Mental Health Center

UNKNOWN

Sponsor Role collaborator

Peking University

OTHER

Sponsor Role lead

Responsible Party

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Weihua Yue

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University Sixth Hostipal

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2024-59

Identifier Type: -

Identifier Source: org_study_id