Stroke Clinical Trial
Official title:
Developing a Novel Cognitive-Behavioral Intervention for Psychosocial Rehabilitation in Chronic Stroke
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | August 1, 2025 |
Est. primary completion date | January 13, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Qualitative report of psychosocial function | Qualitative responses to an interview on the impact of stroke on psychosocial function in multiple domains and unmet needs for rehabilitation | Once at cross-sectional assessment on one day for approximately 2-3 hours | |
Primary | Inventory of Psychosocial Functioning | All Veteran chronic stroke survivors will complete the self-report Inventory of Psychosocial Functioning (IPF; Rodriguez et al., 2018). The Inventory of Psychosocial Functioning is an 80-item self-report measure used to assess functional impairment across multiple psychosocial domains within the last 30 days. Items are rated in regards to frequency (never to always). Total score range=0-480, with higher scores indicating greater impairment. | Once at cross-sectional assessment on one day for approximately 2-3 hours | |
Primary | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form is a self-reported questionnaire, with 16 items, designed to assess overall enjoyment and satisfaction with physical health, mood, work, household and leisure activities, social and family relationships, daily functioning, sexual life, economic status, overall well-being and medications. Responses are scored on a 5-point scale ('not at all or never' to 'frequently or all the time'), where higher scores indicate better enjoyment and satisfaction with life (possible range 14-70). Fourteen summated items create the total Q-LES-Q - SF score. Two last items on medications and overall life satisfaction, are independent scores. Total score range=16-80, with higher scores indicating greater satisfaction. | Once at cross-sectional assessment on one day for approximately 2-3 hours | |
Primary | Brief-COPE | The Brief COPE is a 28-item self-report measure of coping strategies used for responding to stressors. Items are rated on a scale from 1, I haven't been doing this at all, to 4, I've been doing this a lot. There are 14 two-item subscales within the Brief COPE, and each is analyzed separately with a score from 2 to 8 for each subscale: (1) self-distraction, (2) active coping, (3) denial, (4) substance use, (5) use of emotional support, (6) use of instrumental support, (7) behavioral disengagement, (8) venting, (9) positive reframing, (10) planning, (11) humor, (12) acceptance, (13) religion, and (14) self-blame. Higher scores indicate higher usage of that coping strategy. | Once at cross-sectional assessment on one day for approximately 2-3 hours | |
Primary | Stroke Impact Scale | The stroke impact scale is a self-report measure of a quality of life across multiple domains of functioning since stroke. | Once at cross-sectional assessment on one day for approximately 2-3 hours | |
Secondary | Montreal Cognitive Assessment | The Montreal Cognitive Assessment is a rapid neuropsychological screening instrument for cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Total score ranges from 0-30 with a higher score reflecting better performance. | Once at cross-sectional assessment on one day for approximately 2-3 hours | |
Secondary | Mini-International Neuropsychiatric Interview | The Mini-International Neuropsychiatric Interview is a short structured diagnostic interview for DSM-IV and ICD-10 psychiatric disorders. Diagnostic threshold is indicated by presence (0) or absence (1). In addition to characterizing the diagnostic profile, the number of disorders can be summed for a total score of psychiatric morbidity. Total score range 0-17 with a higher count reflecting more diagnoses. | Once at cross-sectional assessment on one day for approximately 2-3 hours | |
Secondary | PTSD Checklist-5 | PTSD Checklist-5 is a self-report measure of symptoms of posttraumatic stress. Total score range is 0-18 with a higher score reflecting more posttraumatic stress. | Once at cross-sectional assessment on one day for approximately 2-3 hours | |
Secondary | Life Events Checklist | The Life Events Checklist is a self-report checklist of lifetime exposure to potentially traumatic events and stressors. Total score range is 0-16 with a higher score reflecting more potentially traumatic events and stressors. | Once at cross-sectional assessment on one day for approximately 2-3 hours | |
Secondary | Patient Health Questionnaire-9 | The Patient Health Questionnaire-9 is a self-report measure of symptoms of depression. Total score range is 0-27 with a higher score reflecting more depression. | Once at cross-sectional assessment on one day for approximately 2-3 hours |
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