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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
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.
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.
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
RECRUITINGRecruitment 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.
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
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
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
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.
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
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