Clinical trial NCT06864715: Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors
Official title: Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors (LIVE-WEL)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-stroke Depression
Subthreshold Depression
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-03-07
Enrollment: 280
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Detailed description: Post-stroke depression (PSD) affects an estimated 33% of survivors. Subthreshold depression (SD; clinically relevant depressive symptoms that do not meet diagnostic criteria for a clinical disorder) can affect up to 60% of stroke survivors and, if untreated, likely progresses to PSD. PSD is associated with recurrent stroke, mortality (including suicide), neurological deficits, and diminished functioning and quality of life (QOL). Older survivors are at particularly high risk for PSD owing to age-related life stressors (e.g., chronic disabilities and conditions, polypharmacy, bereavement, and dependence on others). For low-income, older stroke survivors, financial strain is an added risk factor for PSD. Treating SD may prevent PSD. However, first-line pharmacological treatment for PSD prevention can be problematic for older survivors who may fear dependency and can be sensitive to adverse effects and drug-drug interactions. Behavioral activation (BA) is an efficacious depression treatment that increases engagement in value-based, reinforcing activities and decreases avoidance behaviors. BA does not require licensed therapists, is less costly and as effective as cognitive therapy for reducing depression, and can be modified to effectively target behaviors that have been empirically associated with risk for PSD. The overall objective of the proposal is to determine the effectiveness of tele-delivered BA by trained lay counselors (Tele-BA-S) to prevent PSD in low-income, older stroke survivors with SD. A randomized controlled trial will be conducted (Tele-BA-S vs. treatment-as-usual \[TAU\]; n=280) with follow-up at 2-months, 4-months, 6-months, and 9-months after baseline to test the short- and long-term effectiveness of Tele-BA-S. Participants will be low-income, older (≥ 55 years) first-time ischemic or hemorrhagic survivors (≤ 6 months after stroke) with SD. The intervention will comprise 5 weekly video-conferenced BA sessions delivered by trained lay counselors, homework, and 2 monthly follow-up booster calls. Aim 1 is to test the effectiveness of Tele-BA-S vs. TAU on reducing symptoms of SD and the proportion of survivors that develop PSD (primary clinical outcome). Aim 2 is to test the effectiveness of Tele-BA-S vs TAU on reducing anxiety, emotional distress, and healthcare visits and improving QOL and disability (secondary outcomes). Aim 3 is to investigate self-efficacy, motivation, and activity engagement as mediators of Tele-BA-S effectiveness for reducing symptoms of SD and the proportion of survivors that develop PSD.

Eligibility criteria: Inclusion Criteria:

* Enrollment within 6-months of a first-time ischemic or hemorrhagic stroke
* 24-item HDRS score between 5 to 8 indicating the 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

Exclusion Criteria:

* Stroke event unrelated to vascular risk factors (e.g., drug use) or transient ischemic attack
* 24-item HDRS score \> 8 indicating moderate to severe depression
* Actively participating in psychotherapy
* high suicide risk or severe psychiatric illness (e.g., bipolar disorder and active psychosis)
* Diagnosed dementia
* Diagnosed aphasia, visual, and/or severe cognitive impairments \[Montreal Cognitive Assessment (MoCA) score ≤ 17\]

Primary outcomes:
measure: Post-Stroke Depression as Assessed by Score on the Hamilton Depression Rating Scale (HDRS) 24-item
timeFrame: baseline, 2 months, 4 months, 6 months, 9 months
measure: Subthreshold Depression as Assessed by the Patient Health Questionnaire (PHQ-9)
timeFrame: baseline, 1 month, 2 months, 4 months, 6 months, 9 months
Secondary outcomes:
measure: Anxiety as Assessed by the Generalized Anxiety Disorder- 7 Item (GAD-7)
timeFrame: baseline, 2 months, 4 months, 6 months, 9 months
measure: Emotional Distress as Assessed by the General Health Questionnaire-28 (GHQ-28)
timeFrame: baseline, 2 months, 4 months, 6 months, 9 months
measure: Quality of Life (QOL) as Assessed by the Stroke Specific Quality of Life Scale (SS-QOL)
timeFrame: baseline, 2 months, 4 months, 6 months, 9 months
measure: Number of Self-Reported Emergency Room Visits Over the Course of the Study
timeFrame: From baseline to 9 months
measure: Number of Hospitalizations Over the Course of the Study
timeFrame: From baseline to 9 months
measure: Disability as Assessed by the Modified Rankin Scale (mRS)
timeFrame: baseline, 2 months, 4 months, 6 months, 9 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jennifer Beauchamp, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: