Clinical trial NCT05380037: Post-stroke Psychosocial Recovery
Official title: Developing a Novel Cognitive-Behavioral Intervention for Psychosocial Rehabilitation in Chronic Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: quality of life
rehabilitation
depression
anxiety
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-05-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

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.

Primary outcomes:
measure: Qualitative report of psychosocial function
timeFrame: Once at cross-sectional assessment on one day for approximately 2-3 hours
measure: Inventory of Psychosocial Functioning
timeFrame: Once at cross-sectional assessment on one day for approximately 2-3 hours
measure: Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
timeFrame: Once at cross-sectional assessment on one day for approximately 2-3 hours
measure: Brief-COPE
timeFrame: Once at cross-sectional assessment on one day for approximately 2-3 hours
measure: Stroke Impact Scale
timeFrame: Once at cross-sectional assessment on one day for approximately 2-3 hours
Secondary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: Once at cross-sectional assessment on one day for approximately 2-3 hours
measure: Mini-International Neuropsychiatric Interview
timeFrame: Once at cross-sectional assessment on one day for approximately 2-3 hours
measure: PTSD Checklist-5
timeFrame: Once at cross-sectional assessment on one day for approximately 2-3 hours
measure: Life Events Checklist
timeFrame: Once at cross-sectional assessment on one day for approximately 2-3 hours
measure: Patient Health Questionnaire-9
timeFrame: Once at cross-sectional assessment on one day for approximately 2-3 hours
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
name: Lisa M. McTeague, PhD
role: PRINCIPAL_INVESTIGATOR
References: