Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S) | Experimental |
| |
| Treatment as Usual | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | baseline, 1 month, 2 months, 4 months, 6 months, 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 2 months, 4 months, 6 months, 9 months |
| Change in Emotional Distress as Assessed by the Ryff Psychological Well-being Scale (PWB) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Beauchamp, PhD, RN | Contact | 713-500-2114 | Jennifer.e.Beauchamp@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Beauchamp, PhD, RN | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42252135 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
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). |
| 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. | 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 | From baseline to 9 months |
| Number of Hospitalizations Over the Course of the Study | calculated number of hospitalizations over course of study | 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. | 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. | baseline, 2 months, 4 months, 6 months, 9 months |
| Rehabilitation Adherence Inventory | Greater total scores indicate greater adherence. | baseline, 2 months, 4 months, 6 months, 9 months |
| Barthel Index | Total scores range from 0 to 100, with lower scores indicating higher dependency. | baseline, 2 months, 4 months, 6 months, 9 months |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided