Morning Activation to Improve Mood After Stroke

NCT07719517 | Recruiting

• 1 other identifier: HSEARS20260321001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Depressive Symptoms

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate

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

  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.

  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.

  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.

  Immediately after completion of the 6-week intervention

• Participants Experiencing Adverse Events

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

  From enrollment through completion of the immediate post-intervention assessment.

Secondary Outcomes (1)

• Change in Depressive Symptoms

  Baseline and immediately after completion of the 6-week intervention

Study Arms (2)

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.

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.

Behavioral: Health Education Program

Interventions

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.

Health Education Program

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.

Morning Activation Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke; Depression

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Central Study Contacts

Stephen Lau

CONTACT

+852 2766 4283; chun-lun-stephen.lau@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and intervention providers will not be masked to treatment assignment. Post-intervention outcome assessments will be conducted by a member of the research team who is not informed of treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)