StrokeNCT07719517
Morning Activation to Improve Mood After Stroke
A study testing Morning Activation Program and Health Education Program in people with Stroke and Depressive Symptoms, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This pilot randomized controlled trial will evaluate the feasibility and preliminary effects of a six-week behavioral intervention designed to improve mood and daily functioning in adults who have experienced a stroke and report depressive symptoms and difficulty becoming engaged in activities after waking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Depressive Symptoms
- What is being tested?
- Morning Activation Program and Health Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 May 2026to Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- History of stroke at least 6 months before enrollment.
- Patient Health Questionnaire-9 score of 10 or higher.
- Difficulty getting started or engaging in activities in the morning.
- Able to provide informed consent.
Who cannot join
- Conditions that would interfere with study participation.
- Neurological condition other than stroke.
- Currently receiving psychological therapy for depression.
- Significant cognitive impairment or dementia.
- Current or past diagnosis of psychosis, bipolar disorder, or mania.
- Hospitalization that would interfere with study participation.
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- Acute or significant suicidal ideation
- Alcohol or substance use problems within the past month.
- Use of antidepressant or anti-anxiety medication unless the dosage has been stable for at least 4 weeks and no changes are planned during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Stephen Lau, +852 2766 4283, chun-lun-stephen.lau@polyu.edu.hk
Stephen Lau, PhD
About this study
This pilot randomized controlled trial will evaluate the feasibility and preliminary effects of a six-week behavioral intervention designed to improve mood and daily functioning in adults who have experienced a stroke and report depressive symptoms and difficulty becoming engaged in activities after waking.
Participants will be randomly assigned to either the behavioral intervention or a health education program. Assessments will be completed before and immediately after the six-week program and will include questionnaires and seven-day monitoring of sleep, activity, and mood. The study will also examine feasibility indices such as participant retention, intervention attendance, acceptability, and preliminary changes in mood.
- Conditions
- Stroke, Depressive Symptoms
- Being tested
- Morning Activation Program, Health Education Program
- Medical subject headings
- Stroke, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning Activation ProgramBehavioural
A six-week individualized behavioral program delivered in weekly sessions of approximately 60 minutes. The program is designed to support engagement in daily activities after waking, establish consistent daily routines, and improve mood and functioning after stroke. Sessions will be tailored to participants' needs and abilities.
Health Education ProgramBehavioural
A six-week health education program delivered in weekly sessions of approximately 60 minutes. The program will provide general information relevant to health and recovery after stroke and will be matched to the experimental program in session frequency and duration. It will not include the individualized behavioral strategies provided in the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| Morning Activation Program | Experimental | Participants will receive a six-week individualized behavioral program delivered in weekly sessions of approximately 60 minutes. The program is designed to support engagement in daily activities after waking, establish consistent daily routines, and improve mood and functioning after stroke. Receives: Behavioral: Morning Activation Program |
| Health Education Program | Active comparator | Participants will receive a six-week health education program delivered in weekly sessions of approximately 60 minutes. The program will provide general information relevant to health and recovery after stroke and will be matched to the experimental program in session frequency and duration. It will not include the individualized behavioral strategies provided in the experimental arm. Receives: Behavioral: Health Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number of participants enrolled divided by the number of months of active recruitment.
Measured: From the start of recruitment until enrollment of the final participant.
Retention Rate
Number of randomized participants who complete the immediate post-intervention assessment divided by the total number randomized, expressed as a percentage.
Measured: Immediately after completion of the 6-week intervention
Intervention Attendance
Number and percentage of scheduled intervention or health education sessions attended by each participant during the 6-week program.
Measured: Throughout the 6-week intervention period
Intervention Acceptability
Acceptability of the assigned program assessed using the 4-item Acceptability of Intervention Measure. Each item is rated from 1 to 5, producing a total score ranging from 4 to 20. Higher scores indicate greater intervention acceptability.
Measured: Immediately after completion of the 6-week intervention
Participants Experiencing Adverse Events
Number of adverse events considered related or possibly related to study participation.
Measured: From enrollment through completion of the immediate post-intervention assessment.
Secondary outcomes (1)
Change in Depressive Symptoms
Depressive symptom severity assessed using the 9-item Patient Health Questionnaire-9. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Measured: Baseline and immediately after completion of the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start15 May 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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 Hong Kong Polytechnic UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. LAU Chun Lun Stephen, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719517
- Sponsor's protocol ID
- HSEARS20260321001
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morning Activation to Improve Mood After Stroke
- ClinicalTrials.gov ID
- NCT07719517
- Acronym / sponsor ID
- HSEARS20260321001
- Conditions
- Stroke, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jul 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.
This pilot randomized controlled trial will evaluate the feasibility and preliminary effects of a six-week behavioral intervention designed to improve mood and daily functioning in adults who have experienced a stroke and report depressive symptoms and difficulty becoming engaged in activities after waking.
Participants will be randomly assigned to either the behavioral intervention or a health education program. Assessments will be completed before and immediately after the six-week program and will include questionnaires and seven-day monitoring of sleep, activity, and mood. The study will also examine feasibility indices such as participant retention, intervention attendance, acceptability, and preliminary changes in mood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning Activation Program | Experimental | Behavioral: Morning Activation ProgramParticipants will receive a six-week individualized behavioral program delivered in weekly sessions of approximately 60 minutes. The program is designed to support engagement in daily activities after waking, establish consistent daily routines, and improve mood and functioning after stroke. |
| Health Education Program | Active comparator | Behavioral: Health Education ProgramParticipants will receive a six-week health education program delivered in weekly sessions of approximately 60 minutes. The program will provide general information relevant to health and recovery after stroke and will be matched to the experimental program in session frequency and duration. It will not include the individualized behavioral strategies provided in the experimental arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older.
- History of stroke at least 6 months before enrollment.
- Patient Health Questionnaire-9 score of 10 or higher.
- Difficulty getting started or engaging in activities in the morning.
- Able to provide informed consent.
Key exclusion criteria (9 listed)
- Conditions that would interfere with study participation.
- Neurological condition other than stroke.
- Currently receiving psychological therapy for depression.
- Significant cognitive impairment or dementia.
- Current or past diagnosis of psychosis, bipolar disorder, or mania.
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 |
|---|---|---|
| Morning Activation ProgramA six-week individualized behavioral program delivered in weekly sessions of approximately 60 minutes. The program is designed to support engagement in daily activities after waking, establish consistent daily routines, and improve mood and functioning after stroke. Sessions will be tailored to participants' needs and abilities. | Behavioural | Morning Activation Program |
| Health Education ProgramA six-week health education program delivered in weekly sessions of approximately 60 minutes. The program will provide general information relevant to health and recovery after stroke and will be matched to the experimental program in session frequency and duration. It will not include the individualized behavioral strategies provided in the experimental arm. | Behavioural | Health Education Program |
Primary outcome
Recruitment Rate
Time frame: From the start of recruitment until enrollment of the final participant.
Number of participants enrolled divided by the number of months of active recruitment.
Retention Rate
Time frame: Immediately after completion of the 6-week intervention
Number of randomized participants who complete the immediate post-intervention assessment divided by the total number randomized, expressed as a percentage.
Intervention Attendance
Time frame: Throughout the 6-week intervention period
Number and percentage of scheduled intervention or health education sessions attended by each participant during the 6-week program.
Intervention Acceptability
Time frame: Immediately after completion of the 6-week intervention
Acceptability of the assigned program assessed using the 4-item Acceptability of Intervention Measure. Each item is rated from 1 to 5, producing a total score ranging from 4 to 20. Higher scores indicate greater intervention acceptability.
Participants Experiencing Adverse Events
Time frame: From enrollment through completion of the immediate post-intervention assessment.
Number of adverse events considered related or possibly related to study participation.
1 secondary outcome
Change in Depressive Symptoms
Time frame: Baseline and immediately after completion of the 6-week 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 22 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning Activation Program and Health Education Program in people with Stroke and Depressive Symptoms, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Stephen Lau (+852 2766 4283, chun-lun-stephen.lau@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: From the start of recruitment until enrollment of the final participant.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2026.