Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors

NCT06864715 | Recruiting DMC

• 1 other identifier: HSC-SN-25-0265
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Post-Stroke Depression as Assessed by Score on the Hamilton Depression Rating Scale (HDRS) 24-item

  Total score on the 24-item HDRS ranges from 0 to 52, with a higher score indicating greater depression.

  baseline, 2 months, 4 months, 6 months, 9 months

• Subthreshold Depression (Depressive Symptoms) as Assessed by the Patient Health Questionnaire (PHQ-9)

  Total score on the PHQ-9 ranges from 0 to 27, with a higher score indicating greater depression.

  baseline, 1 month, 2 months, 4 months, 6 months, 9 months

Secondary Outcomes (9)

• Anxiety as Assessed by the Generalized Anxiety Disorder- 7 Item (GAD-7)

  baseline, 2 months, 4 months, 6 months, 9 months

• Change in Emotional Distress as Assessed by the Ryff Psychological Well-being Scale (PWB)

  baseline, 2 months, 4 months, 6 months, 9 months

• Quality of Life (QOL) as Assessed by the Short Form Stroke Specific Quality of Life Scale (SS-QOL)

  baseline, 2 months, 4 months, 6 months, 9 months

• Number of Self-Reported Emergency Room Visits Over the Course of the Study

  From baseline to 9 months

• Number of Hospitalizations Over the Course of the Study

  From baseline to 9 months

Study Arms (2)

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

EXPERIMENTAL

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

Treatment as Usual

ACTIVE COMPARATOR

Behavioral: Treatment as Usual

Interventions

Treatment as Usual BEHAVIORAL

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

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

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.

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

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrollment within 3-months +2 weeks of a first-time ischemic or hemorrhagic stroke
• 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

You may not qualify if:

• Stroke event unrelated to vascular risk factors (e.g., drug use) or transient ischemic attack
• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Interventions

Therapeutics

Study Officials

• Jennifer Beauchamp, PhD, RN

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Beauchamp, PhD, RN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: April 10, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)