A Study on the Application of Positive Psychological Counseling Based on "Dou Bao" Software in Patients With Post-stroke Depression

Patients with PSD have the characteristics of high incidence rate, difficult identification and great harm. However, the existing AI chat platforms have not developed any relevant software or programs for PSD patients. Given that the chatbot function in the "Douba" software is relatively mature and can flexibly modify the corresponding intelligent agent according to user needs, this study intends to appropriately supplement and optimize the AI agent in the "Douba" software to explore the effect of the chatbot in the software in alleviating the symptoms of PSD patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Post Stroke Depression
• Intervention / Treatment: Other: The positive psychological counseling platform of the "Doubao" software

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Meets the criteria of either the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke" or the "Chinese Guidelines for the Diagnosis and Treatment of Acute Cerebral Hemorrhage" and is confirmed by CT or MRI;
• Patients with stable vital signs and conditions;
• Meets the "Third Edition of the Classification and Diagnosis Criteria for Mental Disorders in China" and has a score of ≥5 on the 9-item Patient Health Questionnaire (PHQ-9) scale;
• Patients are over 18 years old;
• Can understand the relevant content of the scale correctly and provide answers independently or with the help of others, have clear consciousness and sign the consent form;
• Can use smartphones.

Exclusion Criteria:

• Those with severe functional impairments of important organs such as the heart, lungs, liver and kidneys;
• Those without a smart phone;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Doubao Software Group Application Team; Utilize an active psychological counseling platform based on the "Doubao" software	Other: The positive psychological counseling platform of the "Doubao" software; Utilize an active psychological counseling platform based on the "Doubao" software
No Intervention: Conventional control group; Standard psychological care plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression assessment	Use the PHQ-9 scale,The sensitivity of this scale in diagnosing depression was 0.82, and the specificity was 0.87. The PHQ-9 scale collects information on the degree to which the evaluated individuals are troubled by different depressive symptoms, including loss of interest, low mood, sleep disorders, feeling tired, changes in appetite, poor self-perception, lack of concentration, slow movements or irritability, and suicidal thoughts. The score for each item ranges from 0 (none at all) to 3 (almost every day), and the total score ranges from 0 to 27. The higher the score, the more severe the symptoms.	Before the intervention and 3 months after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
appraisal of life quality	The assessment was conducted using the short version of the stroke-specific quality of life scale (SV-SS-QoL). This scale consists of 2 dimensions and 12 items. Each item is scored using the Likert 5-point scale, with values ranging from 1 to 5. The total score ranges from 12 to 60. A higher scale score indicates better quality of life. The Cronbach's α coefficient of this scale is 0.882, the split-half reliability is 0.845, and the test-retest reliability is 0.839.	Before the intervention and 3 months after the intervention
the satisfaction of patients	Have the patients rate their satisfaction with the psychological counseling method used in this study on a scale of 1 to 5. If they feel extremely dissatisfied, they should give a score of 1; if they are dissatisfied, 2; if they are basically satisfied, 3; if they are moderately satisfied, 4; and if they feel extremely satisfied, 5. For those who give a score of extremely dissatisfied or extremely satisfied, ask them for the specific reasons to prevent them from giving random scores.	3 months after the intervention
Research dropout rate	After comparing the two groups of patients 3 months later, the study withdrawal rates were determined. The study withdrawal rate = the number of people in this group 3 months later / the initial number of people in this group in the study × 100%.	3 months after the intervention

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: KY-2025-303

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