Post-stroke Psychosocial Recovery

NCT ID: NCT05380037

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2025-08-01

Brief Summary

Stroke is a neurological injury that adversely impacts psychosocial functioning and quality of life. This may occur due to direct insult to the brain circuits integral to adaptive psychosocial functioning, and/or indirectly via significant disruption to routine motor, sensory and cognitive performance. Yet, few evidence-based interventions exist for addressing the broad disruption to emotional and interpersonal functioning specific to stroke, highlighting a clear unmet need. The investigators propose that 1) identifying the most significant disruptions and 2) developing a cognitive-behavioral intervention to promote psychosocial functioning post-stroke is particularly important for overall quality of life, but additionally for adherence to physical rehabilitation and related interventions intended to promote holistic recovery.

Detailed Description

Stroke is a neurological injury that adversely impacts psychosocial functioning and quality of life. This may occur due to direct insult to the neurocircuit substrates of adaptive psychosocial functioning, and/or indirectly via significant disruption to routine motor, sensory and cognitive performance. For example, the sequelae of stroke often prompt role changes, and associated occupational and financial strain that could have profound impact on the daily functioning of stroke survivors and their loved ones. This is likely not only in the acute aftermath of stroke, but also in the chronic stage when the potential durability of impairments becomes clear. While rehabilitation interventions for post-stroke motor and sensory impairments are well established, relatively few options exist for cognitive impairment. With the exception of post-stroke depression, few evidence-based interventions exist for addressing the broad disruption to emotional and interpersonal functioning specific to stroke, highlighting a clear unmet need. The investigators propose that adaptive psychosocial functioning post-stroke is likely particularly important for overall quality of life, but additionally for adherence to physical rehabilitation and related interventions intended to promote holistic recovery.

The long-term purpose of this line of research is to establish an efficacious, evidence-based, cognitive-behavioral intervention for psychosocial rehabilitation in chronic stroke toward optimally enhancing Veteran quality of life and functional independence. The short-term purpose of this line of research is to rigorously establish the domains of psychosocial functioning most adversely impacted by chronic stroke and to develop a cognitive-behavioral intervention (CBT) tailored to addressing corresponding psychosocial impairments, which could ultimately be delivered alone or adjunctively to physical rehabilitation. Importantly, the investigators additionally propose that such an intervention would be most broadly applicable and effective for Veterans with chronic stroke if CBT modules did not focus on comorbid diagnoses of mental illness, but rather focused on domains of post-stroke psychosocial impairment. The VA Healthcare System is a world leader in the dissemination of evidence-based CBT and is already staffed with mental healthcare providers who are experts, particularly in psychosocial adjustment to stressors and trauma. Thus, a scalable, remote, post-stroke tailored CBT intervention could be readily implemented within the VA Healthcare System.

To forward this novel line of work, the investigators propose as Aim 1, to complete via VA Video Connect (VVC) a single, cross-sectional qualitative assessment of 1) Veteran chronic stroke survivors (n=50), 2) their loved ones/caregivers (n=25), and 3) VA stroke rehabilitation providers (e.g., physical, speech, and occupational therapists, neurologists, neuropsychologists; n=25). For characterization relative to normed quantitative measures, Veterans (n=50) and loved ones n=25) who complete qualitative interviews from Aim1 will also complete quantitative measures of psychosocial functioning (Aim 2).

The investigators hypothesize that identified domains will include a range of psychosocial domains typically not addressed in stroke physical rehabilitation and related to post-stroke adjustment including: emotional functioning (stress, anxiety about observable impairments, coping), sleep, behavioral activation, parenting, intimate relationships, substance use. The investigators also expect concordance across informants regarding domains of greatest impairment, thus facilitating identification of productive candidates for intervention. The investigators further hypothesize that brief CBT modules that attend to the intersection of stroke recovery and psychosocial functioning will be deemed important and rated as acceptable and credible. Taken together, these findings will foundationally inform on psychosocial functioning in chronic stroke and point to a means of intervening with evidence-based cognitive-behavioral techniques, tailored to chronic stroke and readily scalable in the VA Healthcare System.

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Veterans with chronic stroke

Veterans with chronic stroke (n=50) must 1) have ischemic or hemorrhagic stroke, primary intracerebral hematoma, or subarachnoid hemorrhage with at least 6 month chronicity; 2) demonstrate ability to perform the interview and complete questionnaires and 3) endorse mild to severe psychosocial impairment

No interventions assigned to this group

Caregiver/Loved ones

Caregiver/Loved ones (n=25) must be familiar with the trajectory of function and recovery of the identified Veteran with chronic stroke

No interventions assigned to this group

Rehabilitation providers

Rehabilitation providers (n=25) of Veterans with chronic stroke must provide stroke-related care in the VA Healthcare system including (but not limited to) physical, speech, and occupational therapists, neurologists, and neuropsychologists

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Participants must be 18 years or greater and will be recruited from all racial, ethnic and gender categories.
• Veterans with chronic stroke (n=50) must:

• 1) have ischemic or hemorrhagic stroke, primary intracerebral hematoma, or subarachnoid hemorrhage with at least 6 month chronicity
• 2) demonstrate ability to perform the interview and complete questionnaires
• 3) endorse mild to severe psychosocial impairment on the Brief Inventory of Psychosocial Functioning (B-IPF; Rodriguez et al., 2018), a 7-item measure developed specifically on Veterans with impairment in important domains of daily psychosocial function
• Caregiver/Loved ones (n=25) must be familiar with the trajectory of function and recovery of the identified Veteran with chronic stroke.
• Rehabilitation providers (n=25) of Veterans with chronic stroke must provide stroke-related care in the VA Healthcare system including (but not limited to) physical, speech, and occupational therapists, neurologists, and neuropsychologists.

Exclusion Criteria

• Veterans with chronic stroke will be excluded for moderate to severe global aphasia that precludes qualitative interview completion, if those individuals cannot or do not wish to complete study procedures via written responses. (Note that to avoid limiting generalizability, these individuals will be invited to complete the questionnaire-based assessments in Aim 2).
• Participants will also be excluded for comorbid conditions that impact recall of stroke recovery history (e.g., dementia or psychosis).
• Caregiver/Loved ones will be excluded if the veteran stroke survivor has not provided consent for caregiver/loved one participation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa M. McTeague, PhD

Role: PRINCIPAL_INVESTIGATOR

Ralph H. Johnson VA Medical Center, Charleston, SC

Locations

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lisa M McTeague, PhD

Role: CONTACT

Lisa.Mcteague@va.gov

(843) 577-5011

Anouk L Grubaugh, PhD MA BS

Role: CONTACT

Anouk.Grubaugh@va.gov

(843) 789-6664

Facility Contacts

Lisa M McTeague, PhD

Role: primary

Lisa.Mcteague@va.gov

843-577-5011

Other Identifiers

I21RX003881-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

D3881-P

Identifier Type: -

Identifier Source: org_study_id