Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors (LIVE-WEL)

The University of Texas System (UT)

Status

Not yet enrolling

Conditions

Subthreshold Depression

Post-stroke Depression

Treatments

Behavioral: Treatment as Usual

Behavioral: Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06864715

HSC-SN-25-XXXX

Details and patient eligibility

About

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).

Full 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.

Enrollment

280 estimated patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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]