AphasiaNCT05851573
Stepped Care for Aphasia
A study testing Psychosocial intervention in people with Aphasia and Stroke, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 81 years
- What is being tested?
- Psychosocial intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Stepped Care Model of Psychological 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.
- Being tested
- Psychosocial intervention
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial interventionBehavioural
an SLP-administered 5-week treatment focused on psychological well-being
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial intervention | Experimental | Not described Receives: Behavioral: Psychosocial intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through intervention completion, an average of 7 weeks
Secondary outcomes (6)
Change in Dynamic Visual Analogue Mood Scales at Post-Intervention
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.
Measured: through study completion, an average of 7 weeks
Change in Stroke Aphasia Depression Questionnaire - 10 at Post-Intervention
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
Measured: through intervention completion, an average of 7 weeks
Change in Behavioural Outcomes of Anxiety Scale at Post-Intervention
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.
Measured: through intervention completion, an average of 7 weeks
Change in Modified Perceived Stress Scale at Post-Intervention
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
Measured: through intervention completion, an average of 7 weeks
Change in Stroke Aphasia Quality of Life - 39 at Post-Intervention
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
Measured: through intervention completion, an average of 7 weeks
Change in Communication Confidence Rating Scale for Aphasia at Post-Intervention
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
Measured: through intervention completion, an average of 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start31 Mar 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deena Blackett, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851573
- Sponsor's protocol ID
- Pro00125313
- Status last verified
- Feb 2025
- First submitted
- 7 Apr 2023
- Last updated
- 24 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Care Model of Psychological Care for Aphasia
- ClinicalTrials.gov ID
- NCT05851573
- Acronym / sponsor ID
- Pro00125313
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Posted 24 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychosocial intervention | Experimental | Behavioral: Psychosocial intervention |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial interventionan SLP-administered 5-week treatment focused on psychological well-being | Behavioural | Psychosocial intervention |
Primary outcome
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.
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.
6 secondary outcomes
Change in Dynamic Visual Analogue Mood Scales at Post-Intervention
Time frame: through study completion, an average of 7 weeks
Change in Stroke Aphasia Depression Questionnaire - 10 at Post-Intervention
Time frame: through intervention completion, an average of 7 weeks
Change in Behavioural Outcomes of Anxiety Scale at Post-Intervention
Time frame: through intervention completion, an average of 7 weeks
Change in Modified Perceived Stress Scale at Post-Intervention
Time frame: through intervention completion, an average of 7 weeks
Change in Stroke Aphasia Quality of Life - 39 at Post-Intervention
Time frame: through intervention completion, an average of 7 weeks
Change in Communication Confidence Rating Scale for Aphasia at Post-Intervention
Time frame: through intervention completion, an average of 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial intervention in people with Aphasia and Stroke, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Depression Score on Hospital Anxiety and Depression Scale at Post-Intervention (time frame: through intervention completion, an average of 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.