Post-stroke Depression, Subthreshold Depression
Conditions
Brief summary
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
BEHAVIORALTele-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.
BEHAVIORALTreatment 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.
Sponsors
The University of Texas Health Science Center, Houston
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Stroke Depression as Assessed by Score on the Hamilton Depression Rating Scale (HDRS) 24-item | 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. |
| Subthreshold Depression (Depressive Symptoms) as Assessed by the Patient Health Questionnaire (PHQ-9) | 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
| Measure | Time frame | Description |
|---|---|---|
| Anxiety as Assessed by the Generalized Anxiety Disorder- 7 Item (GAD-7) | 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. |
| Change in Emotional Distress as Assessed by the Ryff Psychological Well-being Scale (PWB) | 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). |
| Quality of Life (QOL) as Assessed by the Short Form Stroke Specific Quality of Life Scale (SS-QOL) | 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. |
| Number of Self-Reported Emergency Room Visits Over the Course of the Study | From baseline to 9 months | calculated number of emergency room visits over course of study |
| Number of Hospitalizations Over the Course of the Study | From baseline to 9 months | calculated number of hospitalizations over course of study |
| Disability as Assessed by the Modified Rankin Scale (mRS) | 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. |
| Medication Adherence Report Scale-5 | baseline, 2 months, 4 months, 6 months, 9 months | Total score ranges from 5 to 25, with higher scores indicating higher self-reported adherence. |
| Rehabilitation Adherence Inventory | baseline, 2 months, 4 months, 6 months, 9 months | Greater total scores indicate greater adherence. |
| Barthel Index | baseline, 2 months, 4 months, 6 months, 9 months | Total scores range from 0 to 100, with lower scores indicating higher dependency. |
Countries
United States
Contacts
CONTACTJennifer Beauchamp, PhD, RN
PRINCIPAL_INVESTIGATORJennifer Beauchamp, PhD, RN
The University of Texas Health Science Center, Houston
Outcome results
None listed