An interventional study of Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S) and Treatment as Usual in Post-stroke Depression and Subthreshold Depression, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Prevention
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).
The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S)
Behavioral: Treatment as Usual
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.
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.
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.
Time frame: 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.
Time frame: baseline, 1 month, 2 months, 4 months, 6 months, 9 months
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.
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)
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).
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)
Total score on the SS-QOL ranges from 12-60, with a higher score indicating better functioning.
Time frame: 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
Time frame: From baseline to 9 months
Number of Hospitalizations Over the Course of the Study
calculated number of hospitalizations over course of study
Time frame: 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.
Time frame: 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.
Time frame: baseline, 2 months, 4 months, 6 months, 9 months
Rehabilitation Adherence Inventory
Greater total scores indicate greater adherence.
Time frame: baseline, 2 months, 4 months, 6 months, 9 months
Barthel Index
Total scores range from 0 to 100, with lower scores indicating higher dependency.
Time frame: baseline, 2 months, 4 months, 6 months, 9 months
Plan to share: No
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The University of Texas Health Science Center, Houston