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

Official title

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

Overview

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 capabil
• 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 outcome measures

• 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]

Secondary outcome measures (9)

• Anxiety as Assessed by the Generalized Anxiety Disorder- 7 Item (GAD-7) [Time frame: baseline, 2 months, 4 months, 6 months, 9 months]
• Change in Emotional Distress as Assessed by the Ryff Psychological Well-being Scale (PWB) [Time frame: 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) [Time frame: baseline, 2 months, 4 months, 6 months, 9 months]
• Number of Self-Reported Emergency Room Visits Over the Course of the Study [Time frame: From baseline to 9 months]
• Number of Hospitalizations Over the Course of the Study [Time frame: From baseline to 9 months]
• Disability as Assessed by the Modified Rankin Scale (mRS) [Time frame: baseline, 2 months, 4 months, 6 months, 9 months]
• Medication Adherence Report Scale-5 [Time frame: baseline, 2 months, 4 months, 6 months, 9 months]
• Rehabilitation Adherence Inventory [Time frame: baseline, 2 months, 4 months, 6 months, 9 months]
• Barthel Index [Time frame: baseline, 2 months, 4 months, 6 months, 9 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 1 center

• The University of Texas Health Science Center at Houston — Houston

Publications

• Beauchamp JES, Savitz SI, Sharrief A, Reininger BM, Acierno R, Suchting R, Burnett J, Rosales L, Albaqali JA, Rajan R, Choi NG. Behavioural activation for the prevention of poststroke depression in low-income older stroke survivors (LIVE WEL): protocol for a randomised controlled trial. BMJ Open. 2026 Jun 7;16(6):e120452. doi: 10.1136/bmjopen-2026-120452. PMID 42252135

Identifiers

NCT: NCT06864715 · HSC-SN-25-0265

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗