Recruiting

Tele-BA-S

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06864715

Conditions

Post-stroke Depression

Subthreshold Depression

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S)

Treatment as Usual

Study Details

Brief summary:

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

Post-stroke Depression

Subthreshold Depression

Study ID

NCT06864715

Start date

Apr 10, 2026

Status verified date

Apr, 2026

Completion date

Nov 1, 2029

Anticipated

Primary completion date

Nov 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S)

active comparator: Treatment as Usual

Interventions

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.

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 outcome measure

  • Post-Stroke Depression as Assessed by Score on the Hamilton Depression Rating Scale (HDRS) 24-item [ Time Frame: baseline, 2 months, 4 months, 6 months, 9 months ]
  • Subthreshold Depression (Depressive Symptoms) as Assessed by the Patient Health Questionnaire (PHQ-9) [ Time Frame: baseline, 1 month, 2 months, 4 months, 6 months, 9 months ]

Central Contacts and Locations

Central contacts

Jennifer Beauchamp, PhD, RN

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Jennifer Beauchamp, PhD, RN

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-04-28.