Clinical trial NCT05851573: Stepped Care for Aphasia
Official title: Stepped Care Model of Psychological Care for Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Stroke
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in the Depression Score on Hospital Anxiety and Depression Scale at Post-Intervention
timeFrame: through intervention completion, an average of 7 weeks
measure: Change in the Anxiety Score on Hospital Anxiety and Depression Scale at Post-Intervention
timeFrame: through intervention completion, an average of 7 weeks
Secondary outcomes:
measure: Change in Dynamic Visual Analogue Mood Scales at Post-Intervention
timeFrame: through study completion, an average of 7 weeks
measure: Change in Stroke Aphasia Depression Questionnaire - 10 at Post-Intervention
timeFrame: through intervention completion, an average of 7 weeks
measure: Change in Behavioural Outcomes of Anxiety Scale at Post-Intervention
timeFrame: through intervention completion, an average of 7 weeks
measure: Change in Modified Perceived Stress Scale at Post-Intervention
timeFrame: through intervention completion, an average of 7 weeks
measure: Change in Stroke Aphasia Quality of Life - 39 at Post-Intervention
timeFrame: through intervention completion, an average of 7 weeks
measure: Change in Communication Confidence Rating Scale for Aphasia at Post-Intervention
timeFrame: through intervention completion, an average of 7 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: