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

The University of Texas Health Science Center, Houston350 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

350

Conditions

Post-stroke Depression Subthreshold Depression

Interventions

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.

Treatment as UsualBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: baseline, 1 month, 2 months, 4 months, 6 months, 9 months

Secondary Outcomes

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.

Time frame: baseline, 2 months, 4 months, 6 months, 9 months

Change in Emotional Distress as Assessed by the Ryff Psychological Well-being Scale (PWB)

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).

Time frame: 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.

Time frame: baseline, 2 months, 4 months, 6 months, 9 months

Central Contacts

Jennifer Beauchamp, PhD, RN

CONTACT

713-500-2114 Jennifer.e.Beauchamp@uth.tmc.edu

Data from ClinicalTrials.gov

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