Clinical trial Recruiting at 1 site Interventional Ages 55 and up

Telephone/video behavioral activation to prevent depression after a first stroke in low-income older adults

Official title: Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors (LIVE-WEL)

Run by The University of Texas Health Science Center, Houston · NCT06864715 · Data updated 2026-11-12

This project will test whether coaching-style behavioral activation delivered by trained lay counselors over phone or video can prevent depression in low-income older adults who recently had a first stroke and currently have mild or no depressive symptoms.

Quick facts

Study typeInterventional
Ages55 Years and up
SexAll
Enrollment350 (estimated)
SponsorThe University of Texas Health Science Center, Houston
Academic / other
Locations1 site (Houston, Texas)
StatusRecruiting
StartedApril 10, 2026
Main results expectedNovember 1, 2029
Study endsNovember 1, 2029
Registry record updatedApril 28, 2026
Trial IDNCT06864715 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are community-dwelling older adults within roughly three months of a first ischemic or hemorrhagic stroke, with subthreshold depression (24-item HDRS <15), Mini-MoCA ≥11, household income at or below $45,000, and ability to speak English or Spanish.

Probably not a fit

Patients with moderate-to-severe depression (HDRS ≥15 or PHQ-9 ≥10), active psychotherapy, high suicide risk, severe psychiatric disorders, diagnosed dementia, or currently taking specified cognitive/amyloid medications are unlikely to benefit from this prevention-focused program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The program delivers behavioral activation (BA) remotely through trained lay counselors (Tele-BA-S) and compares this approach to treatment as usual for preventing post-stroke depression. It enrolls community-dwelling, low-income older adults within about three months of a first ischemic or hemorrhagic stroke who have subthreshold depressive symptoms and adequate basic cognition. Participants will be assigned to receive tele-delivered BA sessions in English or Spanish or to continue usual care, with mood outcomes tracked over time. Exclusions include moderate-to-severe depression, active psychotherapy, high suicide risk, severe psychiatric illness, dementia, or certain cognitive medications.

Why it matters

Potential benefit: If successful, the intervention could lower the rate of new depressive episodes after stroke and improve mood and function in underserved older survivors.

How similar studies have gone: Telephone-delivered behavioral activation and BA delivered by non-specialists have shown effectiveness for depression in other populations, but using lay counselors to prevent post-stroke depression in low-income older adults is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 it's running

  • The University of Texas Health Science Center at Houston
    Houston, Texas, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.