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

NCT06831435 | Recruiting

• 1 other identifier: 2024-83
• Study Type: interventional
• Target: 325
• 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. 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.

Conditions

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

Keywords

i-CBT; a real-world study

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 (13)

• Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)

  Week 4 and 8 of treatment duration

• Change from baseline in Positive and Negative Syndrome Scale (PANSS)

  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

Study Arms (1)

i-CBT group

EXPERIMENTAL

i-CBT combined with conventional drug treatment

Device: a digital product based on CBT

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: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Persons with severe suicidal tendencies (item 10 of the MADRS scale ≥ 5).

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Sixth Hostipal

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Depression; Bipolar Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Central Study Contacts

Weihua Yue

CONTACT

86-010-82805307; dryue@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: November 13, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)