Stepped Care for Aphasia

Stroke Clinical Trial

Official title:

Stepped Care Model of Psychological Care for Aphasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05851573
• Other study ID #: Pro00125313
• Status: Completed
• Phase: N/A
• Start date: March 31, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 81 Years

Eligibility

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)

Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

Behavioral:
• Psychosocial intervention
an SLP-administered 5-week treatment focused on psychological well-being

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Hospital Anxiety and Depression Scale at 1-Month Follow-Up	Change in the total depression and anxiety Hospital Anxiety and Depression Scale scores between baseline and at 1-month post-treatment. Minimum score 0, maximum score 21 for each scale. Higher scores mean a worse outcome.	through study completion, an average of 10 weeks
Secondary	Change in Dynamic Visual Analogue Mood Scales at 1-Month Follow-Up	Total summary score (min: 0, max: 100, higher scores indicate better outcome) and sadness score (min: 0, max: 100, higher scores indicate better outcome)	through study completion, an average of 10 weeks
Secondary	Change in Stroke Aphasia Depression Questionnaire - 10 at 1-Month Follow-Up	Total score (min: 0, max: 30, higher scores indicate worse outcome)	through study completion, an average of 10 weeks
Secondary	Change in Behavioural Outcomes of Anxiety Scale at 1-Month Follow-Up	Total score (min: 0, max: 30, higher scores indicate worse outcome)	through study completion, an average of 10 weeks
Secondary	Change in Modified Perceived Stress Scale at 1-Month Follow-Up	Total score (min: 0, max: 40, higher scores indicate worse outcome)	through study completion, an average of 10 weeks
Secondary	Change in Stroke Aphasia Quality of Life - 39 at 1-Month Follow-Up	Total score (min: 1, max: 5), physical score (min: 1, max: 5), psychosocial score (min: 1, max: 5), and communication score (min: 1, max: 5), higher scores on all scales indicate better outcomes	through study completion, an average of 10 weeks
Secondary	Change in Communication Confidence Rating Scale for Aphasia at 1-Month Follow-Up	Total score (min: 10, max: 40, higher scores indicate better outcome)	through study completion, an average of 10 weeks