Internet-based Cognitive Behavioral Therapy to Reduce Depressive Symptoms After Stroke Pilot/Feasibility Study
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
- Change in Depressive Symptoms Over Time
研究概览
简要总结
Mood disorders occur in 25-30% of stroke patients and are associated with lower quality of life, higher mortality, increased healthcare utilization, and higher costs. Cognitive behavioral therapy (CBT) interventions have been shown to both treat and prevent post-stroke mood disorders, thus having the ability to improve quality of life and reduce costs. This study aims to test the feasibility of internet-based CBT combined with a telephone/email based coaching service after stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years of age
- •Acute ischemic stroke within the past 3 months
- •Regular access to the internet, sufficient to allow a minimum of interactions with the internet daily, either through a personal smartphone or web-based internet browser.
- •Subject is willing and able to participate in internet-based cognitive behavioral therapy
- •Can participate in the program in English
- •Willingness and ability to sign informed consent by the patient
- •Symptoms of mild to moderately depressed mood, defined as a score of 5-19 on the Patient Health Questionnaire-9 at the time of study enrollment.
排除标准
- •Severely depressed patients, defined by a score of 20+ on the Patient Health Questionnare-9 are excluded
- •Patients with an active bipolar disorder diagnosis are excluded
- •Patients with personality disorder diagnoses are excluded
- •Patients with active suicidality or past suicide attempts are excluded
- •History of schizophrenia or schizoaffective disorder
- •Active participation in face-to-face psychotherapy prior to stroke
- •Patients with a history of dementia are excluded
- •Patients with aphasia, defined as a score of 1 or greater on NIH Stroke Scale Item 9 are excluded.
- •Patients without regular internet access through a computer, tablet or smartphone are excluded.
- •Subjects requiring long-term inpatient nursing care are excluded. For patients enrolled as inpatients, individuals being discharged to both home and acute rehab are eligible. Individuals being discharged to a skilled nursing facility or hospice are excluded.
- •Expected life expectancy less than 6 months or other inability to comply with study follow-up.
- •Pregnant women and prisoners are excluded
结局指标
主要结局
Change in Depressive Symptoms Over Time
时间窗: Baseline and 90 days
Subject's depressive symptoms will be quantified using the Patient Health Questionnaire 9. This assessment includes 9 close-ended questions with a scoring system ranging from 0 to 27. Scores greater than 10 are considered "positive" for depressive symptoms. We will compare the average PHQ-9 score at study enrollment to the PHQ-9 at 90 days to determine the reduction in depressive symptoms over time.
次要结局
- Quality of Life Assessed by the EuroQOL-5D(90 days)
研究者
Michael Mullen
Assistant Professor of Neurology
University of Pennsylvania