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NCT Number: NCT06864715

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

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).

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Key information

Conditions

Post-stroke Depression Subthreshold Depression

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

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

  2. 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

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

Secondary outcomes

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

    Time frame: baseline, 2 months, 4 months, 6 months, 9 months

    Total score on the GAD-7 ranges from 0 to 15, with a higher score indicating greater anxiety.

  2. 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

    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).

  3. 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

    Total score on the SS-QOL ranges from 12-60, with a higher score indicating better functioning.

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

    Time frame: From baseline to 9 months

    calculated number of emergency room visits over course of study

  5. Number of Hospitalizations Over the Course of the Study

    Time frame: From baseline to 9 months

    calculated number of hospitalizations over course of study

  6. Disability as Assessed by the Modified Rankin Scale (mRS)

    Time frame: baseline, 2 months, 4 months, 6 months, 9 months

    Total score on the mRS ranges from 0-6, with a higher score indicating greater disability.

  7. Medication Adherence Report Scale-5

    Time frame: baseline, 2 months, 4 months, 6 months, 9 months

    Total score ranges from 5 to 25, with higher scores indicating higher self-reported adherence.

  8. Rehabilitation Adherence Inventory

    Time frame: baseline, 2 months, 4 months, 6 months, 9 months

    Greater total scores indicate greater adherence.

  9. Barthel Index

    Time frame: baseline, 2 months, 4 months, 6 months, 9 months

    Total scores range from 0 to 100, with lower scores indicating higher dependency.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: LIVE-WEL

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 7, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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