Morning Activation to Improve Mood After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Recruitment Rate
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: From enrollment through completion of the immediate post-intervention assessment.
Number of adverse events considered related or possibly related to study participation.
次要结局
- Change in Depressive Symptoms(Baseline and immediately after completion of the 6-week intervention)
研究者
Prof. LAU Chun Lun Stephen
Assistant Professor
The Hong Kong Polytechnic University