Stepped Care for Aphasia

NCT05851573 | Completed Results

• 1 other identifier: Pro00125313
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia; Stroke

Outcome Measures

Primary Outcomes (2)

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

  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.

  through intervention completion, an average of 7 weeks

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

  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.

  through intervention completion, an average of 7 weeks

Secondary Outcomes (6)

• 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

Study Arms (1)

Psychosocial intervention

EXPERIMENTAL

Behavioral: Psychosocial intervention

Interventions

Psychosocial intervention BEHAVIORAL

an SLP-administered 5-week treatment focused on psychological well-being

Psychosocial intervention

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Aphasia; Stroke

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Deena Schwen Blackett
• Organization: University of Central Florida

deena.blackett@ucf.edu

407-823-0909

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: May 9, 2023
• Study Start: March 31, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)