Stroke Survivor-Caregiver Dyads: Feasibility of a Brief Psychosocial Intervention for Depressive Symptoms and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Study Retention
研究概览
简要总结
The purpose of this feasibility study is to determine whether it is practical and helpful to provide problem-solving therapy to stroke survivors and their spouses/partners (caregivers) together. It will also compare the experiences of participants who receive problem-solving therapy to those who receive stroke-related health education.
Many stroke survivors and caregivers report feeling sad or blue at some point after the stroke. These feelings can impact quality of life. Encountering problems is a part of daily life. These problems can be big or small, but sometimes they can pile up and feel overwhelming, contributing to feelings of sadness. Problem-solving therapy is a tool that teaches structured ways to address current problems or challenges in your life.
Participants who are assigned to receive problem-solving therapy will work with a research team member for six, one-hour sessions. During each session, participants will identify a problem (big or small) and create a plan to work on that problem.
Participants who are assigned to receive stroke-related health education will work with a research team member who will teach them about various topics related to stroke over six, one-hour sessions. Each session will cover information about a different topic related to stroke.
Outcomes data will be collected at approximately 4 weeks, 8 weeks, and 13 weeks from baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both dyad participants are at least 18 years of age.
- •The stroke survivor experienced an ischemic or hemorrhagic stroke at least 3 months prior to enrollment.
- •The caregiver is a spouse/partner who provides regular, unpaid support for the survivor in activities of daily living.
- •Both dyad members are willing and able understand and comply with protocol requirements.
排除标准
- •The stroke survivor has severe expressive or receptive aphasia or global aphasia, as documented in the medical record by a speech pathologist or other provider.
- •Either dyad member is unable to write, as this will interfere with completion of MiniCog assessment.
- •Either dyad member has significant cognitive impairment, evidenced by MiniCog score <4 at screening.
- •Either dyad member reports an intent to harm him/herself or others.
- •Either dyad member has any concurrent conditions that would interfere with participation.
结局指标
主要结局
Study Retention
时间窗: Through study completion, an average of 13 weeks.
Total percentage of participants who complete the study.
Protocol Adherence
时间窗: Through study completion, an average of 13 weeks.
Total percentage of protocol-specified activities completed by enrolled participants.
Intervention Acceptability
时间窗: Post-intervention, at approximately 8 weeks.
Participant experience collected via self-report survey.
Study Recruitment Success
时间窗: At initial contact.
Percentage of eligible candidates who enroll in the study.
次要结局
- Pre/post-intervention changes in depressive symptoms among caregivers.(Baseline and post-intervention, covering an average of 8 weeks.)
- Pre/post-intervention changes in quality of life among caregivers.(Baseline and post-intervention, covering an average of 8 weeks.)
- Pre/post-intervention changes in depressive symptoms among stoke survivors.(Baseline and post-intervention, covering an average of 8 weeks.)
- Pre/post-intervention changes in quality of life among stoke survivors.(Baseline and post-intervention, covering an average of 8 weeks.)