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).
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
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
Parallel
Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S)
BehavioralThe 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
BehavioralParticipants 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.
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.
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.
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).
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.
Number of Self-Reported Emergency Room Visits Over the Course of the Study
calculated number of emergency room visits over course of study
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center, Houston
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
