Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors (LIVE-WEL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Post-Stroke Depression as Assessed by Score on the Hamilton Depression Rating Scale (HDRS) 24-item
研究概览
简要总结
The overall objective of the project is to determine the effectiveness of tele-delivered behavioral activation (BA) by trained lay counselors (Tele-BA-S) to prevent Post-stroke depression (PSD) in low-income, older stroke survivors with subthreshold depression (SD).
详细描述
Post-stroke depression (PSD) affects an estimated 33% of survivors. Subthreshold depression (SD; clinically relevant depressive symptoms that do not meet diagnostic criteria for a clinical disorder) can affect up to 60% of stroke survivors and, if untreated, likely progresses to PSD. PSD is associated with recurrent stroke, mortality (including suicide), neurological deficits, and diminished functioning and quality of life (QOL). Older survivors are at particularly high risk for PSD owing to age-related life stressors (e.g., chronic disabilities and conditions, polypharmacy, bereavement, and dependence on others). For low-income, older stroke survivors, financial strain is an added risk factor for PSD. Treating SD may prevent PSD. However, first-line pharmacological treatment for PSD prevention can be problematic for older survivors who may fear dependency and can be sensitive to adverse effects and drug-drug interactions. Behavioral activation (BA) is an efficacious depression treatment that increases engagement in value-based, reinforcing activities and decreases avoidance behaviors. BA does not require licensed therapists, is less costly and as effective as cognitive therapy for reducing depression, and can be modified to effectively target behaviors that have been empirically associated with risk for PSD. The overall objective of the proposal is to determine the effectiveness of tele-delivered BA by trained lay counselors (Tele-BA-S) to prevent PSD in low-income, older stroke survivors with SD. A randomized controlled trial will be conducted (Tele-BA-S vs. treatment-as-usual [TAU]; n=294) with follow-up at 2-months, 4-months, 6-months, and 9-months after baseline to test the short- and long-term effectiveness of Tele-BA-S. Participants will be low-income, older (≥ 55 years) first-time ischemic or hemorrhagic survivors (≤ 3 months after stroke) with SD. The intervention will comprise 5 weekly video-conferenced BA sessions delivered by trained lay counselors, homework, and 2 monthly follow-up booster calls. Aim 1 is to test the effectiveness of Tele-BA-S vs. TAU on reducing symptoms of SD and the proportion of survivors that develop PSD (primary clinical outcome). Aim 2 is to test the effectiveness of Tele-BA-S vs TAU on reducing anxiety, emotional distress, and healthcare visits and improving QOL and disability (secondary outcomes). Aim 3 is to investigate self-efficacy, motivation, and activity engagement as mediators of Tele-BA-S effectiveness for reducing symptoms of SD and the proportion of survivors that develop PSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrollment within 3-months +2 weeks of a first-time ischemic or hemorrhagic stroke
- •24-item HDRS score < 15 indicating subthreshold depression defined as the absence of depressive symptoms or presence of mild symptoms of depression
- •Single person income less than or equal to $45,000
- •Residing in a community residence
- •Ability to speak and read in English or Spanish
- •Mini-MoCA score > or equal to 11
排除标准
- •Stroke event unrelated to vascular risk factors (e.g., drug use) or transient ischemic attack
- •24-item HDRS score > or equal to 15 indicating moderate to severe depression
- •Actively participating in psychotherapy
- •high suicide risk or severe psychiatric illness (e.g., bipolar disorder and active psychosis) and/or actively taking antipsychotics
- •Diagnosed dementia and/or currently taking cognitive enhancers, amyloid-targeting medications, or orexin receptor antagonists
- •Patient Health Questionnaire 9 score > or equal to 10 and/or answers positive to Q9
- •Diagnosed aphasia and/or severe cognitive impairments
- •high-risk alcohol or drug misuse
- •receiving medications for mood disorders and a change in dose or type within the last 4 weeks
研究组 & 干预措施
Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S)
干预措施: Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S) (Behavioral)
Treatment as Usual
干预措施: Treatment as Usual (Behavioral)
结局指标
主要结局
Post-Stroke Depression as Assessed by Score on the Hamilton Depression Rating Scale (HDRS) 24-item
时间窗: baseline, 2 months, 4 months, 6 months, 9 months
Total score on the 24-item HDRS ranges from 0 to 52, with a higher score indicating greater depression.
Subthreshold Depression (Depressive Symptoms) as Assessed by the Patient Health Questionnaire (PHQ-9)
时间窗: baseline, 1 month, 2 months, 4 months, 6 months, 9 months
Total score on the PHQ-9 ranges from 0 to 27, with a higher score indicating greater depression.
次要结局
- Change in Emotional Distress as Assessed by the Ryff Psychological Well-being Scale (PWB)(baseline, 2 months, 4 months, 6 months, 9 months)
- Anxiety as Assessed by the Generalized Anxiety Disorder- 7 Item (GAD-7)(baseline, 2 months, 4 months, 6 months, 9 months)
- Number of Self-Reported Emergency Room Visits Over the Course of the Study(From baseline to 9 months)
- Number of Hospitalizations Over the Course of the Study(From baseline to 9 months)
- Disability as Assessed by the Modified Rankin Scale (mRS)(baseline, 2 months, 4 months, 6 months, 9 months)
- Quality of Life (QOL) as Assessed by the Short Form Stroke Specific Quality of Life Scale (SS-QOL)(baseline, 2 months, 4 months, 6 months, 9 months)
- Medication Adherence Report Scale-5(baseline, 2 months, 4 months, 6 months, 9 months)
- Rehabilitation Adherence Inventory(baseline, 2 months, 4 months, 6 months, 9 months)
- Barthel Index(baseline, 2 months, 4 months, 6 months, 9 months)
研究者
Jennifer Beauchamp
Associate Professor
The University of Texas Health Science Center, Houston