Morning Activation to Improve Mood After Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Hong Kong Polytechnic University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Conditions that would interfere with study participation.
Neurological condition other than stroke.
Currently receiving psychological therapy for depression.
Significant cognitive impairment or dementia.
Trial design
Design model
Parallel
Treatments tested in this trial
Morning Activation Program
BehavioralA 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
BehavioralA 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Morning Activation ProgramExperimental treatment 1 intervention
Group B: Health Education ProgramActive comparator 1 intervention
Trial outcomes
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 intervention3
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 period4
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 interventionSecondary 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 interventionSponsors and contacts
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Source ClinicalTrials.gov