Stepped Care for Aphasia

NCT ID: NCT05851573

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2023-12-31

Brief Summary

This study is recruiting people who had a stroke at least 1 month ago and now have a language impairment called aphasia. Living with aphasia can have devastating effects on communication and quality of life, and it is not uncommon for survivors with aphasia to face psychological problems like depression and anxiety. Participants who are eligible for this study will undergo baseline testing, engage in a 5-week treatment focused on psychological well-being, undergo post-treatment testing, and then testing again 1-month later. Check-in phone calls will be conducted during the 1-month off period and participants will be interviewed about their experience at the end of the study as well. Compensation will be provided to participants with aphasia.

Conditions

Aphasia; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Psychosocial intervention

Group Type: EXPERIMENTAL

Psychosocial intervention

Intervention Type: BEHAVIORAL

an SLP-administered 5-week treatment focused on psychological well-being

Interventions

Psychosocial intervention

an SLP-administered 5-week treatment focused on psychological well-being

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18-81 years old
• Native English speaker (English fluency by age 7)
• Aphasia as a result of a left-hemisphere ischemic or hemorrhagic stroke (WAB-R Aphasia Quotient < 93.8)
• At least 1-month post-stroke
• Confirmation of left hemisphere stroke per medical records
• Discharged from hospital
• Participant is willing and able to consent for themselves.

Exclusion Criteria

• Uncorrected hearing or visual impairment that prevents completion of experimental activities as determined by self-report
• History of other neurological disorder or disease beside stroke (e.g., dementia, traumatic brain injury) as determined by self-report and/or medical records
• Self-reported history of premorbid learning disability
• Severe auditory comprehension deficits (as indicated by a score of more than two standard deviations below norms on the Auditory Verbal section of WAB-R)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Deena Blackett

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00125313

Identifier Type: -

Identifier Source: org_study_id