Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Device: a digital product based on CBT

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, Beijing 100191
      • Peking University Sixth Hostipal

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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.
No Intervention: control group; conventional drug treatment

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
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.
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

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Hebei Provincial Mental Health Center; Shantou University Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Actual): December 30, 2025
• Study Completion (Actual): March 1, 2026

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: i-CBT
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: 2024-59

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