Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression: a Real-world Study

NCT ID: NCT06831435

Last Updated: 2025-12-15

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

RECRUITING

Clinical Phase

NA

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-13

Study Completion Date

2026-12-31

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. This study aims to evaluate the therapeutic effects of CBT-based digital products for depression in patients through a real-world study, and to explore its genetic and neuroimaging mechanisms.

Detailed Description

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Conditions

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Depression Bipolar Affective Disorder Schizophenia Disorder Psychiatric &Amp;or Mood Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

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 14-60 years (including 14 and 60), no gender restriction;
2. HAMD \>= 14;
3. Written informed consent obtained from the patient; written informed consent obtained from the guardian for minors.

Exclusion Criteria

* Persons with severe suicidal tendencies (item 10 of the MADRS scale ≥ 5).
Minimum Eligible Age

14 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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 RECRUITING

Countries

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China

Central Contacts

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Weihua Yue

Role: CONTACT

86-010-82805307

Facility Contacts

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Weihua Yue

Role: primary

86-010-82805307

Other Identifiers

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2024-83

Identifier Type: -

Identifier Source: org_study_id

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