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Clinical Trials/NCT05851573
NCT05851573
Completed
Not Applicable

Stepped Care Model of Psychological Care for Aphasia

Medical University of South Carolina1 site in 1 country11 target enrollmentMarch 31, 2023
ConditionsAphasiaStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aphasia
Sponsor
Medical University of South Carolina
Enrollment
11
Locations
1
Primary Endpoint
Change in the Depression Score on Hospital Anxiety and Depression Scale at Post-Intervention
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 31, 2023
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Deena Blackett

Principal Investigator

Medical University of South Carolina

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)

Outcomes

Primary Outcomes

Change in the Depression Score on Hospital Anxiety and Depression Scale at Post-Intervention

Time Frame: through intervention completion, an average of 7 weeks

Change in the total depression Hospital Anxiety and Depression Scale scores between baseline and post-treatment (baseline-post-treatment). Minimum score 0, maximum score 21. Positive scores indicate an improvement in symptoms, negative scores indicate a worsening in symptoms.

Change in the Anxiety Score on Hospital Anxiety and Depression Scale at Post-Intervention

Time Frame: through intervention completion, an average of 7 weeks

Change in the total anxiety Hospital Anxiety and Depression Scale scores between baseline and post-treatment (baseline-post-treatment). Minimum score 0, maximum score 21. Positive scores indicate an improvement in symptoms, negative scores indicate a worsening in symptoms.

Secondary Outcomes

  • Change in Dynamic Visual Analogue Mood Scales at Post-Intervention(through study completion, an average of 7 weeks)
  • Change in Stroke Aphasia Depression Questionnaire - 10 at Post-Intervention(through intervention completion, an average of 7 weeks)
  • Change in Behavioural Outcomes of Anxiety Scale at Post-Intervention(through intervention completion, an average of 7 weeks)
  • Change in Modified Perceived Stress Scale at Post-Intervention(through intervention completion, an average of 7 weeks)
  • Change in Stroke Aphasia Quality of Life - 39 at Post-Intervention(through intervention completion, an average of 7 weeks)
  • Change in Communication Confidence Rating Scale for Aphasia at Post-Intervention(through intervention completion, an average of 7 weeks)

Study Sites (1)

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