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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychosocial intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosocial intervention | Behavioral | an SLP-administered 5-week treatment focused on psychological well-being |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 7 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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Interested participants provided informed consent and were then screened to determine if they meet all eligibility criteria. After enrollment, all participants were assigned to the same intervention arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Psychosocial Intervention | Psychosocial intervention: an SLP-administered 5-week treatment focused on psychological well-being |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Psychosocial Intervention | Psychosocial intervention: an SLP-administered 5-week treatment focused on psychological well-being |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One participant was excluded due to missing HADS data at post-intervention. | Posted | Mean | Standard Deviation | units on a scale | through intervention completion, an average of 7 weeks |
|
up to 11 weeks
Participants were monitored for adverse events for the duration that the participant was enrolled from their baseline session to their 1-month follow-up session, which, for most participants, was about 11 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Psychosocial Intervention | Psychosocial intervention: an SLP-administered 5-week treatment focused on psychological well-being |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deena Schwen Blackett | University of Central Florida | 407-823-0909 | deena.blackett@ucf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2024 | Feb 3, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 23, 2023 | Feb 20, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001037 | Aphasia |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D000083626 | Psychosocial Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 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 | 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. | 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 | 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 | 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 | through intervention completion, an average of 7 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Western Aphasia Battery-Revised Aphasia Quotient | Western Aphasia Battery - Revised Aphasia Quotient: This is a measure of overall aphasia severity (severity of language impairment) and is calculated based on performance on the subscales included on the WAB-R per WAB-R scoring protocols. The total range of this scale is 0 to 100. A higher score indicates better language function (less severe aphasia). | Mean | Standard Deviation | units on a scale |
|
| Months Post-Stroke | Mean | Standard Deviation | months |
|
| Years of Education | Mean | Standard Deviation | years |
|
| Cognitive Assessment of Stroke Patients | The Cognitive Assessment of Stroke Patients is a measure of general cognitive function for stroke survivors. The total range of this measure is 0 to 36. Higher scores indicate better cognitive function. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | 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. | One participant was excluded due to missing HADS data at post-intervention. | Posted | Mean | Standard Deviation | units on a scale | through intervention completion, an average of 7 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | through study completion, an average of 7 weeks |
|
|
|
|
| Secondary | 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 | One participant was missing data on SADQ-10 at post-intervention | Posted | Mean | Standard Deviation | units on a scale | through intervention completion, an average of 7 weeks |
|
|
|
|
| Secondary | 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. | One participant was missing data from this measure at baseline. | Posted | Mean | Standard Deviation | units on a scale | through intervention completion, an average of 7 weeks |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | through intervention completion, an average of 7 weeks |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | through intervention completion, an average of 7 weeks |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | through intervention completion, an average of 7 weeks |
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| 11 |
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| 11 |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |