NCT07336888

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable stroke

Timeline
12mo left

Started Jan 2027

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 13, 2026

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

December 4, 2025

Last Update Submit

January 7, 2026

Conditions

StrokePost Stroke Depression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • appraisal of life quality

    Before the intervention and 3 months after the intervention

  • the satisfaction of patients

    3 months after the intervention

  • Research dropout rate

    3 months after the intervention

Study Arms (2)

Doubao Software Group Application Team

EXPERIMENTAL

Utilize an active psychological counseling platform based on the "Doubao" software

Other: The positive psychological counseling platform of the "Doubao" software

Conventional control group

NO INTERVENTION

Standard psychological care plan

Interventions

The positive psychological counseling platform of the "Doubao" softwareOTHER

Utilize an active psychological counseling platform based on the "Doubao" software

Doubao Software Group Application Team

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2025

First Posted

January 13, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 13, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share