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

NCT ID: NCT06864715

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2029-06-01

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.

Conditions

Post-stroke Depression; Subthreshold Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Treatment as Usual

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: BEHAVIORAL

Participants will receive an educational packet and blood pressure (BP) monitor prior to hospital discharge. They will be contacted by a Licensed Clinical Social Worker (LCSW) at 48-72 hours to determine if they have received their medications and appointments. The stroke practitioner will 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.

Interventions

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

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.

Intervention Type: BEHAVIORAL

Treatment as Usual

Participants will receive an educational packet and blood pressure (BP) monitor prior to hospital discharge. They will be contacted by a Licensed Clinical Social Worker (LCSW) at 48-72 hours to determine if they have received their medications and appointments. The stroke practitioner will 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.

Intervention Type: BEHAVIORAL

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]

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Beauchamp

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Beauchamp, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Central Contacts

Jennifer Beauchamp, PhD, RN

Role: CONTACT

Jennifer.e.Beauchamp@uth.tmc.edu

713-500-2114

Facility Contacts

Jennifer Beauchamp, PhD, RN

Role: primary

Jennifer.e.Beauchamp@uth.tmc.edu

713-500-2114

Other Identifiers

HSC-SN-25-XXXX

Identifier Type: -

Identifier Source: org_study_id