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RecruitingNCT07719517Updated Jul 22, 2026

Morning Activation to Improve Mood After Stroke

An interventional study of Morning Activation Program and Health Education Program in Stroke and Depressive Symptoms, sponsored by The Hong Kong Polytechnic University. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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.

02

Conditions studied

  • Stroke
  • Depressive Symptoms
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Morning Activation Program

    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.

    Behavioral: Morning Activation Program

  • Active comparator
    Health Education Program

    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.

    Behavioral: Health Education Program

Interventions

  • BehavioralMorning Activation Program

    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.

  • BehavioralHealth Education Program

    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.

06

What researchers measure

Primary outcomes

  1. Recruitment Rate

    Number of participants enrolled divided by the number of months of active recruitment.

    Time frame: From the start of recruitment until enrollment of the final participant.

  2. Retention Rate

    Number of randomized participants who complete the immediate post-intervention assessment divided by the total number randomized, expressed as a percentage.

    Time frame: Immediately after completion of the 6-week intervention

  3. Intervention Attendance

    Number and percentage of scheduled intervention or health education sessions attended by each participant during the 6-week program.

    Time frame: Throughout the 6-week intervention period

  4. 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.

    Time frame: Immediately after completion of the 6-week intervention

  5. Participants Experiencing Adverse Events

    Number of adverse events considered related or possibly related to study participation.

    Time frame: 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.

    Time frame: Baseline and immediately after completion of the 6-week intervention

07

Study locations

1 of 1 sites recruiting
  • The Hong Kong Polytechnic University
    Hong Kong, Hong Kong
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07719517
Lead sponsor
The Hong Kong Polytechnic University
Responsible party
Prof. LAU Chun Lun Stephen (Assistant Professor, The Hong Kong Polytechnic University) — Principal investigator
First posted
Jul 22, 2026
Start date
May 15, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jul 22, 2026

Study contacts

Stephen Lau
Contact
chun-lun-stephen.lau@polyu.edu.hk
+852 2766 4283

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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