Telephone/video behavioral activation to prevent depression after a first stroke in low-income older adults
Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors (LIVE-WEL)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06864715 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Beauchamp, PhD, RN — The University of Texas Health Science Center, Houston
- Study coordinator: Jennifer Beauchamp, PhD, RN
- Email: Jennifer.e.Beauchamp@uth.tmc.edu
- Phone: 713-500-2114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.