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

Last updated: March 3, 2025
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Depression

Cerebral Ischemia

Stroke

Treatment

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

Treatment as Usual

Clinical Study ID

NCT06864715
HSC-SN-25-XXXX
  • Ages > 55
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 ofdepression

  • 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

Exclusion Criteria:

  • Stroke event unrelated to vascular risk factors (e.g., drug use) or transientischemic 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 activepsychosis)

  • Diagnosed dementia

  • Diagnosed aphasia, visual, and/or severe cognitive impairments [Montreal CognitiveAssessment (MoCA) score ≤ 17]

Study Design

Total Participants: 280
Treatment Group(s): 2
Primary Treatment: Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S)
Phase:
Study Start date:
April 01, 2025
Estimated Completion Date:
June 01, 2029

Study 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.

Connect with a study center

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

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