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Completed

NCT Number: NCT05851573

Stepped Care for Aphasia

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.

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Key information

Conditions

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

Age range

18 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Psychosocial intervention

Behavioral

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

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Change in Dynamic Visual Analogue Mood Scales at Post-Intervention

    Time frame: 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.

  2. Change in Stroke Aphasia Depression Questionnaire - 10 at Post-Intervention

    Time frame: 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

  3. Change in Behavioural Outcomes of Anxiety Scale at Post-Intervention

    Time frame: 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.

  4. Change in Modified Perceived Stress Scale at Post-Intervention

    Time frame: 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

  5. Change in Stroke Aphasia Quality of Life - 39 at Post-Intervention

    Time frame: 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

  6. Change in Communication Confidence Rating Scale for Aphasia at Post-Intervention

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Stepped Care Model of Psychological Care for Aphasia

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 9, 2023
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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