Morning Activation to Improve Mood After Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Morning Activation Program, Health Education Program.
- Who it may be relevant to
- Registry conditions: Stroke, Depressive Symptoms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Behavioral Morning 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. - Behavioral Health 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.
Primary outcome measures
- Recruitment Rate [Time frame: From the start of recruitment until enrollment of the final participant.]
- Retention Rate [Time frame: Immediately after completion of the 6-week intervention]
- Intervention Attendance [Time frame: Throughout the 6-week intervention period]
- Intervention Acceptability [Time frame: Immediately after completion of the 6-week intervention]
- Participants Experiencing Adverse Events [Time frame: From enrollment through completion of the immediate post-intervention assessment.]
Secondary outcome measures (1)
- Change in Depressive Symptoms [Time frame: Baseline and immediately after completion of the 6-week intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- The Hong Kong Polytechnic University — Hong Kong
Identifiers
NCT: NCT07719517 · HSEARS20260321001