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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Bipolar Affective Disorder; Schizophenia Disorder; Psychiatric &Amp;or Mood Disorder
• Intervention / Treatment: Device: a digital product based on CBT

• Study Type: Interventional
• Enrollment (Estimated): 325
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weihua Yue; Phone Number: 86-010-82805307; Email: dryue@bjmu.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Recruiting
      • Peking University Sixth Hostipal
      • Contact: Weihua Yue; Phone Number: 86-010-82805307; Email: dryue@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: i-CBT group; i-CBT combined with conventional drug treatment	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to treatment	Reduction rate of Hamilton Depression Scale (HAMD-17) or Montgomery-Asberg Depression Rating Scale (MADRS) score ≥50% was recognized as response to treatment.	Week 4 and 8 of treatment duration
Clinical Global Impression-Severity of Illness (CGI-S)	The outcome was assessed by the Clinical Global Impression-Severity of Illness (CGI-S) scale. It is rated on a 7-point scale. Higher scores indicate more severe symptoms.	Week 4 and 8 of treatment duration
Change from baseline in Hamilton Anxiety Rating Scale (HAMA)	The outcome is assessed by 14-item Hamilton Anxiety Scale (HAMA). Total score ranges from 0 to 56, with higher scores indicating greater severity of anxiety. The change of HAMA from baseline to 8-week (after intervention) was used.	Week 4 and 8 of treatment duration
Change from baseline in Ruminative Responses Scale (RRS)	This outcome is assessed by Ruminative Responses Scale (RRS). Total score ranges from 22 to 88, with higher scores indicating greater severity of rumination. The change of RRS from baseline to 8-week (after intervention) was used.	Week 4 and 8 of treatment duration
Change from baseline in Pittsburgh Sleep Quality Index (PSQI)	This outcome is assessed by Pittsburgh Sleep Quality Index (PSQI). Total score ranges from 0 to 21, with higher scores indicating greater severity of sleep problems. The change of PSQI from baseline to 8-week (after intervention) was used.	Week 4 and 8 of treatment duration
Change from baseline in Connor-Davidson Resilience Scale (CD-RISC)	This outcome is assessed by Connor-Davidson Resilience Scale (CD-RISC). Total score ranges from 0 to 100, with higher scores indicating greater resilience. The change of CD-RISC from baseline to 8-week (after intervention) was used.	Week 4 and 8 of treatment duration
Change from baseline in Thinc-Integrated Tool(THINC-it)	Cognitive function was assessed by Thinc-Integrated Tool(THINC-it) using digital device. The change of THINC-it from baseline to 8-week (after intervention) was used.	Week 8 of treatment duration
Client Satisfaction Questionnaire-3 （CSQ-3)	User's satisfaction was assessed by Client Satisfaction Questionnaire-3 （CSQ-3). Total score ranges from 3 to 12. with higher scores indicating greater satisfaction.	Week 8 of treatment duration
Mood Disorder Questionnaire (MDQ)	This outcome is assessed by Mood Disorder Questionnaire (MDQ), which is used to assess the positive symptom of bipolar. A positive screening for bipolar disorder is determined when there are ≥7 of the 13 screening symptoms present, at least one "yes" response in the second section indicating the co-occurrence of several symptoms, and a severity level of "moderate" or "serious problem" in the third section.	Week 4 and 8 of treatment duration
Rating Scale for Side Effects（SERS）	This outcome is assessed by Rating Scale for Side Effects (SERS), which assess 13 side-effects. Total score ranges from 13 to 52, with higher scores indicating more side-effects.	Week 4 and 8 of treatment duration
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)	The outcome is assessed by Montgomery-Asberg Depression Rating Scale (MADRS). Total MADRS score ranges from 0 to 60, with higher scores indicating greater severity of depression. The change of MADRS from baseline to 8-week (after intervention) was used.	Week 4 and 8 of treatment duration
Change from baseline in Positive and Negative Syndrome Scale (PANSS)	The outcome is assessed by the Positive and Negative Syndrome Scale (PANSS). The PANSS consists of 30 items, divided into three subscales: Positive Symptoms (7 items), Negative Symptoms (7 items), and General Psychopathology (16 items). Each item is rated on a 7-point scale from 1 (absent) to 7 (extreme), with higher scores indicating more severe symptoms. The total PANSS score ranges from 30 to 210, with higher scores reflecting greater symptom severity.	Week 4 and 8 of treatment duration
Change from baseline in Young Mania Rating Scale (YMRS)	The outcome is assessed by the Young Mania Rating Scale (YMRS). The YMRS consists of 11 items that assess the severity of manic symptoms, including mood, speech, motor activity, sexual interest, sleep, and other behaviors. Each item is rated on a scale from 0 to 4, with higher scores indicating greater severity of manic symptoms. The total YMRS score can range from 0 to 44, with higher scores reflecting more severe mania.	Week 4 and 8 of treatment duration

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: i-CBT; a real-world study
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Behavioral Symptoms; Mood Disorders; Behavior; Depression; Bipolar Disorder
• Other Study ID Numbers: 2024-83

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No