Stepped Care for Aphasia

Sponsor
Medical University of South Carolina (Other)
Overall Status
Recruiting
CT.gov ID
NCT05851573
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Psychosocial intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Stepped Care Model of Psychological Care for Aphasia
Actual Study Start Date :
Mar 31, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Psychosocial intervention

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

Outcome Measures

Primary Outcome Measures

  1. Change in the Hospital Anxiety and Depression Scale at 1-Month Follow-Up [through study completion, an average of 10 weeks]

    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.

Secondary Outcome Measures

  1. Change in Dynamic Visual Analogue Mood Scales at 1-Month Follow-Up [through study completion, an average of 10 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)

  2. Change in Stroke Aphasia Depression Questionnaire - 10 at 1-Month Follow-Up [through study completion, an average of 10 weeks]

    Total score (min: 0, max: 30, higher scores indicate worse outcome)

  3. Change in Behavioural Outcomes of Anxiety Scale at 1-Month Follow-Up [through study completion, an average of 10 weeks]

    Total score (min: 0, max: 30, higher scores indicate worse outcome)

  4. Change in Modified Perceived Stress Scale at 1-Month Follow-Up [through study completion, an average of 10 weeks]

    Total score (min: 0, max: 40, higher scores indicate worse outcome)

  5. Change in Stroke Aphasia Quality of Life - 39 at 1-Month Follow-Up [through study completion, an average of 10 weeks]

    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

  6. Change in Communication Confidence Rating Scale for Aphasia at 1-Month Follow-Up [through study completion, an average of 10 weeks]

    Total score (min: 10, max: 40, higher scores indicate better outcome)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 81 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of South Carolina Charleston South Carolina United States 29425

Sponsors and Collaborators

  • Medical University of South Carolina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Deena Blackett, Principal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT05851573
Other Study ID Numbers:
  • Pro00125313
First Posted:
May 9, 2023
Last Update Posted:
May 9, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2023