RECRUITING

Post-stroke Psychosocial Recovery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Developing a Novel Cognitive-Behavioral Intervention for Psychosocial Rehabilitation in Chronic Stroke

Quick Facts

Study Start:2023-01-09
Study Completion:2025-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05380037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must be 18 years or greater and will be recruited from all racial, ethnic and gender categories.
  2. * Veterans with chronic stroke (n=50) must:
  3. * 1) have ischemic or hemorrhagic stroke, primary intracerebral hematoma, or subarachnoid hemorrhage with at least 6 month chronicity
  4. * 2) demonstrate ability to perform the interview and complete questionnaires
  5. * 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
  6. * Caregiver/Loved ones (n=25) must be familiar with the trajectory of function and recovery of the identified Veteran with chronic stroke.
  7. * 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.
  1. * 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).
  2. * Participants will also be excluded for comorbid conditions that impact recall of stroke recovery history (e.g., dementia or psychosis).
  3. * Caregiver/Loved ones will be excluded if the veteran stroke survivor has not provided consent for caregiver/loved one participation.

Contacts and Locations

Study Contact

Lisa M McTeague, PhD
CONTACT
(843) 577-5011
Lisa.Mcteague@va.gov
Anouk L Grubaugh, PhD MA BS
CONTACT
(843) 789-6664
Anouk.Grubaugh@va.gov

Principal Investigator

Lisa M. McTeague, PhD
PRINCIPAL_INVESTIGATOR
Ralph H. Johnson VA Medical Center, Charleston, SC

Study Locations (Sites)

Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Lisa M. McTeague, PhD, PRINCIPAL_INVESTIGATOR, Ralph H. Johnson VA Medical Center, Charleston, SC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-09
Study Completion Date2025-08-01

Study Record Updates

Study Start Date2023-01-09
Study Completion Date2025-08-01

Terms related to this study

Keywords Provided by Researchers

  • quality of life
  • rehabilitation
  • depression
  • anxiety

Additional Relevant MeSH Terms

  • Stroke