Stepped Care for Aphasia

Not Applicable

Completed

• Conditions: Stroke; Aphasia
• Interventions: Behavioral: Psychosocial intervention

• Registration Number: NCT05851573
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-31
• Study First Submitted: 2023-04-07
• Study First Submitted QC: 2023-05-01
• Study First Posted: 2023-05-09
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Results First Submitted: 2024-12-17
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Results First Posted: 2025-02-24
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Psychosocial intervention	Psychosocial intervention	-

Primary Outcome Measures

Name	Time	Method
Change in the Depression Score on Hospital Anxiety and Depression Scale at Post-Intervention	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	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 Outcome Measures

Name	Time	Method
Change in Dynamic Visual Analogue Mood Scales at Post-Intervention	through study completion, an average of 7 weeks	Total summary score (min: 0, max: 100, higher scores indicate better outcome) and sadness score (min: 0, max: 100, higher scores indicate better outcome) (baseline-post-treatment). Positive number indicate worsening in mood, negative numbers indicate an improvement in mood.
Change in Stroke Aphasia Depression Questionnaire - 10 at Post-Intervention	through intervention completion, an average of 7 weeks	Total score (min: 0, max: 30, higher scores indicate worse outcome); baseline-post-treatment; positive scores indicate improvement in symptoms, negative score indicate worsening of symptoms
Change in Behavioural Outcomes of Anxiety Scale at Post-Intervention	through intervention completion, an average of 7 weeks	Total score (min: 0, max: 30, higher scores indicate worse outcome); baseline-post-intervention; positive scores indicate an improvement in symptoms, negative scores indicate a worsening in symptoms.
Change in Modified Perceived Stress Scale at Post-Intervention	through intervention completion, an average of 7 weeks	Total score (min: 0, max: 40, higher scores indicate worse outcome); baseline-post-intervention; positive numbers indicate an improvement in symptoms, negative numbers indicate a worsening in symptoms
Change in Stroke Aphasia Quality of Life - 39 at Post-Intervention	through intervention completion, an average of 7 weeks	Total score (min: 1, max: 5), baseline-post-intervention, positive numbers indicate a worsening of quality of life, negative numbers indicate an improvement in quality of life
Change in Communication Confidence Rating Scale for Aphasia at Post-Intervention	through intervention completion, an average of 7 weeks	Total score (min: 10, max: 40, higher scores indicate better confidence); baseline-post-intervention, positive numbers indicate a worsening in communication confidence and negative numbers indicate an improvement in communication confidence

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States