Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S)
  • 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.
Active Comparator
Treatment as Usual
  • 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.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Jennifer Beauchamp, PhD, RN
713-500-2114
Jennifer.e.Beauchamp@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.