NCT06864715 · The University of Texas Health Science Center, Houston
Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors
(LIVE-WEL)
What this study is about
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).
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 28, 2026 · Source of record for eligibility and locations