Recruiting
Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors
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).
ClinicalTrials.gov IDNCT06864715
PhaseNA
Enrollment350
SponsorThe University of Texas Health Science Center, Houston
Age55 Years and older
SexALL
Conditions studied
Post-stroke Depression, Subthreshold Depression
About this study
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).
Interventions
- Behavioral: Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S) — The Tele-BA-S intervention will comprise 5 weekly video-conferenced BA sessions delivered by trained lay counselors, homework, and 2 monthly follow-up booster calls. Participants will receive the standard hospital discharge post-stroke educational packet and a scheduled follow-up appointment with a stroke practitioner to evaluate patients at 7-14 days and 3 months ±14 days, according to current standard of care. They will be seen over video or in-person, according to their preference and capabilities.
- Behavioral: Treatment as Usual — Participants will receive the standard hospital discharge post-stroke educational packet and a scheduled follow-up appointment with a stroke practitioner to evaluate patients at 7-14 days and 3 months ±14 days, according to current standard of care. They will be seen over video or in-person, according to their preference and capabilities.
Primary outcomes
- Post-Stroke Depression as Assessed by Score on the Hamilton Depression Rating Scale (HDRS) 24-item (baseline, 2 months, 4 months, 6 months, 9 months)
- Subthreshold Depression (Depressive Symptoms) as Assessed by the Patient Health Questionnaire (PHQ-9) (baseline, 1 month, 2 months, 4 months, 6 months, 9 months)
Eligibility information
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
Study locations
- The University of Texas Health Science Center at Houston, Houston, Texas 77030 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-01.