Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07719517

Morning Activation to Improve Mood After Stroke

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Stroke Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Depression Depressive Symptoms Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

Location status: Recruiting

Location contact

Stephen Lau

CONTACT

[email protected]

+852 2766 4283

Stephen Lau, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Morning Activation Program

Behavioral

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 Program

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Change in Depressive Symptoms

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stephen Lau

CONTACT

[email protected]

+852 2766 4283

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.