StrokeNCT07336888

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

A study testing The positive psychological counseling platform of the "Doubao" software in people with Stroke and Post Stroke Depression, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Stroke, Post Stroke Depression
What is being tested?: The positive psychological counseling platform of the "Doubao" software
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: No sites listed yet
Study dates: 1 Jan 2027to 31 Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

About this study

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.

Conditions: Stroke, Post Stroke Depression
Being tested: The positive psychological counseling platform of the "Doubao" software
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The positive psychological counseling platform of the "Doubao" softwareOther
Utilize an active psychological counseling platform based on the "Doubao" software

Study groups in NCT07336888
Study group	Role	What they receive
Doubao Software Group Application Team	Experimental	Utilize an active psychological counseling platform based on the "Doubao" software Receives: Other: The positive psychological counseling platform of the "Doubao" software
Conventional control group	No intervention	Standard psychological care plan

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Before the intervention and 3 months after the intervention

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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%.
Measured: 3 months after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202731 Dec 2027

First posted13 Jan 2026
Study start1 Jan 2027 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 240 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07336888
Sponsor's protocol ID: KY-2025-303
Status last verified: Dec 2025
First submitted: 4 Dec 2025
Last updated: 13 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study on the Application of Positive Psychological Counseling Based on "Dou Bao" Software in Patients With Post-stroke Depression
ClinicalTrials.gov ID: NCT07336888
Acronym / sponsor ID: KY-2025-303
Conditions: Stroke, Post Stroke Depression
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 240 participants (estimated)
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
Study start: 1 Jan 2027 (estimated)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 13 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Doubao Software Group Application Team	Experimental	Other: The positive psychological counseling platform of the "Doubao" softwareUtilize an active psychological counseling platform based on the "Doubao" software
Conventional control group	No intervention	–Standard psychological care plan

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The positive psychological counseling platform of the "Doubao" softwareUtilize an active psychological counseling platform based on the "Doubao" software	Other	Doubao Software Group Application Team

Primary outcome

Depression assessment
Time frame: Before the intervention and 3 months after the intervention
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.

3 secondary outcomes

appraisal of life quality
Time frame: Before the intervention and 3 months after the intervention
the satisfaction of patients
Time frame: 3 months after the intervention
Research dropout rate
Time frame: 3 months after the intervention

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
Individual participant dataSharing planned: No

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression assessment (time frame: Before the intervention and 3 months after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07336888.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.