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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Post-stroke Depression; Subthreshold Depression
• Intervention / Treatment: Behavioral: Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S); Behavioral: Treatment as Usual

Detailed Description

Post-stroke depression (PSD) affects an estimated 33% of survivors. Subthreshold depression (SD; clinically relevant depressive symptoms that do not meet diagnostic criteria for a clinical disorder) can affect up to 60% of stroke survivors and, if untreated, likely progresses to PSD. PSD is associated with recurrent stroke, mortality (including suicide), neurological deficits, and diminished functioning and quality of life (QOL). Older survivors are at particularly high risk for PSD owing to age-related life stressors (e.g., chronic disabilities and conditions, polypharmacy, bereavement, and dependence on others). For low-income, older stroke survivors, financial strain is an added risk factor for PSD. Treating SD may prevent PSD. However, first-line pharmacological treatment for PSD prevention can be problematic for older survivors who may fear dependency and can be sensitive to adverse effects and drug-drug interactions. Behavioral activation (BA) is an efficacious depression treatment that increases engagement in value-based, reinforcing activities and decreases avoidance behaviors. BA does not require licensed therapists, is less costly and as effective as cognitive therapy for reducing depression, and can be modified to effectively target behaviors that have been empirically associated with risk for PSD. The overall objective of the proposal is to determine the effectiveness of tele-delivered BA by trained lay counselors (Tele-BA-S) to prevent PSD in low-income, older stroke survivors with SD. A randomized controlled trial will be conducted (Tele-BA-S vs. treatment-as-usual [TAU]; n=294) with follow-up at 2-months, 4-months, 6-months, and 9-months after baseline to test the short- and long-term effectiveness of Tele-BA-S. Participants will be low-income, older (≥ 55 years) first-time ischemic or hemorrhagic survivors (≤ 3 months after stroke) with SD. The intervention will comprise 5 weekly video-conferenced BA sessions delivered by trained lay counselors, homework, and 2 monthly follow-up booster calls. Aim 1 is to test the effectiveness of Tele-BA-S vs. TAU on reducing symptoms of SD and the proportion of survivors that develop PSD (primary clinical outcome). Aim 2 is to test the effectiveness of Tele-BA-S vs TAU on reducing anxiety, emotional distress, and healthcare visits and improving QOL and disability (secondary outcomes). Aim 3 is to investigate self-efficacy, motivation, and activity engagement as mediators of Tele-BA-S effectiveness for reducing symptoms of SD and the proportion of survivors that develop PSD.

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Beauchamp, PhD, RN; Phone Number: 713-500-2114; Email: Jennifer.e.Beauchamp@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Jennifer Beauchamp, PhD, RN; Phone Number: 713-500-2114; Email: Jennifer.e.Beauchamp@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety as Assessed by the Generalized Anxiety Disorder- 7 Item (GAD-7)	Total score on the GAD-7 ranges from 0 to 15, with a higher score indicating greater anxiety.	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)	Total score on the SS-QOL ranges from 12-60, with a higher score indicating better functioning.	baseline, 2 months, 4 months, 6 months, 9 months
Number of Self-Reported Emergency Room Visits Over the Course of the Study	calculated number of emergency room visits over course of study	From baseline to 9 months
Number of Hospitalizations Over the Course of the Study	calculated number of hospitalizations over course of study	From baseline to 9 months
Disability as Assessed by the Modified Rankin Scale (mRS)	Total score on the mRS ranges from 0-6, with a higher score indicating greater disability.	baseline, 2 months, 4 months, 6 months, 9 months
Medication Adherence Report Scale-5	Total score ranges from 5 to 25, with higher scores indicating higher self-reported adherence.	baseline, 2 months, 4 months, 6 months, 9 months
Rehabilitation Adherence Inventory	Greater total scores indicate greater adherence.	baseline, 2 months, 4 months, 6 months, 9 months
Barthel Index	Total scores range from 0 to 100, with lower scores indicating higher dependency.	baseline, 2 months, 4 months, 6 months, 9 months
Change in Emotional Distress as Assessed by the Ryff Psychological Well-being Scale (PWB)	Emotional distress will be evaluated using the Ryff Psychological Well-Being Scale (PWB), a validated self-report instrument measuring psychological well-being across six domains: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Participants rate agreement with statements on a 6-point Likert scale ranging from strongly disagree to strongly agree. Scores are calculated for each domain and/or as a total composite score, with higher scores indicating greater psychological well-being (lower emotional distress).	baseline, 2 months, 4 months, 6 months, 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Self-Efficacy Questionnaire	Total scores range from 0 to 130, with higher scores indicating greater self-efficacy	baseline, 2 months, 4 months, 6 months, 9 months
Motivation for Rehabilitation Scale	Total scores range from 17 to 119 with higher scores indicating more motivation.	baseline, 2 months, 4 months, 6 months, 9 months
Neuro-QOL Short Form Ability to Participate in Roles and Activities	Higher total scores indicate better capability.	baseline, 2 months, 4 months, 6 months, 9 months

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Jennifer Beauchamp, PhD, RN, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 7, 2025

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Behavioral Symptoms; Mood Disorders; Stroke; Depression; Depressive Disorder; Therapeutics
• Other Study ID Numbers: HSC-SN-25-0265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No