N/A N=11 Treatment

Stepped Care for Aphasia

Aphasia · Stroke

Bottom Line

View on ClinicalTrials.gov: NCT05851573 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: Primary: Change in the Depression Score on Hospital Anxiety and Depression Scale at Post-Intervention — 2.2 units on a scale — p=< .05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Psychosocial intervention (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Depression Score on Hospital Anxiety and Depression Scale at Post-Intervention	2.2	< .05 sig
PRIMARY Change in the Anxiety Score on Hospital Anxiety and Depression Scale at Post-Intervention	0.40	= .775
SECONDARY Change in Dynamic Visual Analogue Mood Scales at Post-Intervention	-4.18	= .444
SECONDARY Change in Stroke Aphasia Depression Questionnaire - 10 at Post-Intervention	0.10	.959
SECONDARY Change in Behavioural Outcomes of Anxiety Scale at Post-Intervention	2.00	.068
SECONDARY Change in Modified Perceived Stress Scale at Post-Intervention	3.36	= .119
SECONDARY Change in Stroke Aphasia Quality of Life - 39 at Post-Intervention	-.093	= .258
SECONDARY Change in Communication Confidence Rating Scale for Aphasia at Post-Intervention	-.818	= .593

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05851573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.