Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Sur… (NCT06864715) | Clinical Trial Compass
RecruitingNot Applicable
Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors
United States350 participantsStarted 2026-04-10
Plain-language summary
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).
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Post-Stroke Depression as Assessed by Score on the Hamilton Depression Rating Scale (HDRS) 24-item