Depressive Symptoms, Stroke
Conditions
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.
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.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | From the start of recruitment until enrollment of the final participant. | Number of participants enrolled divided by the number of months of active recruitment. |
| Retention Rate | 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. |
| Intervention Attendance | 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. |
| Intervention Acceptability | 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. |
| Participants Experiencing Adverse Events | From enrollment through completion of the immediate post-intervention assessment. | Number of adverse events considered related or possibly related to study participation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depressive Symptoms | 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. |
Countries
Hong Kong
Contacts
CONTACTStephen Lau
Outcome results
None listed