Aphasia, Stroke
Conditions
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.
Interventions
BEHAVIORALPsychosocial intervention
an SLP-administered 5-week treatment focused on psychological well-being
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 81 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Depression Score on Hospital Anxiety and Depression Scale at Post-Intervention | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Behavioural Outcomes of Anxiety Scale at Post-Intervention | 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. |
| Change in Modified Perceived Stress Scale at Post-Intervention | 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 |
| Change in Dynamic Visual Analogue Mood Scales at Post-Intervention | 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. |
| Change in Communication Confidence Rating Scale for Aphasia at Post-Intervention | 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 |
| Change in Stroke Aphasia Quality of Life - 39 at Post-Intervention | 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 |
| Change in Stroke Aphasia Depression Questionnaire - 10 at Post-Intervention | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Psychosocial Intervention Psychosocial intervention: an SLP-administered 5-week treatment focused on psychological well-being | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Psychosocial Intervention |
|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 11.6 |
| Cognitive Assessment of Stroke Patients | 30.3 units on a scale STANDARD_DEVIATION 2.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Months Post-Stroke | 43.6 months STANDARD_DEVIATION 41.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 8 Participants |
| Western Aphasia Battery-Revised Aphasia Quotient | 74.0 units on a scale STANDARD_DEVIATION 18 |
| Years of Education | 15.8 years STANDARD_DEVIATION 2.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
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.
Time frame: through intervention completion, an average of 7 weeks
Population: One participant was excluded due to missing HADS data at post-intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Intervention | Change in the Anxiety Score on Hospital Anxiety and Depression Scale at Post-Intervention | 0.40 units on a scale | Standard Deviation 4.3 |
p-value: =0.775t-test, 2 sided
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.
Time frame: through intervention completion, an average of 7 weeks
Population: One participant was excluded due to missing HADS data at post-intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Intervention | Change in the Depression Score on Hospital Anxiety and Depression Scale at Post-Intervention | 2.2 units on a scale | Standard Deviation 2.82 |
p-value: <0.05t-test, 2 sided
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.
Time frame: through intervention completion, an average of 7 weeks
Population: One participant was missing data from this measure at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Intervention | Change in Behavioural Outcomes of Anxiety Scale at Post-Intervention | 2.00 units on a scale | Standard Deviation 3.01 |
p-value: 0.068t-test, 2 sided
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
Time frame: through intervention completion, an average of 7 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Intervention | Change in Communication Confidence Rating Scale for Aphasia at Post-Intervention | -.818 units on a scale | Standard Deviation 4.92 |
p-value: =0.593t-test, 2 sided
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.
Time frame: through study completion, an average of 7 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Intervention | Change in Dynamic Visual Analogue Mood Scales at Post-Intervention | -4.18 units on a scale | Standard Deviation 17.42 |
p-value: =0.444t-test, 2 sided
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
Time frame: through intervention completion, an average of 7 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Intervention | Change in Modified Perceived Stress Scale at Post-Intervention | 3.36 units on a scale | Standard Deviation 6.55 |
p-value: =0.119t-test, 2 sided
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
Time frame: through intervention completion, an average of 7 weeks
Population: One participant was missing data on SADQ-10 at post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Intervention | Change in Stroke Aphasia Depression Questionnaire - 10 at Post-Intervention | 0.10 units on a scale | Standard Deviation 5.9 |
p-value: 0.959t-test, 2 sided
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
Time frame: through intervention completion, an average of 7 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Intervention | Change in Stroke Aphasia Quality of Life - 39 at Post-Intervention | -.093 units on a scale | Standard Deviation 0.258 |
p-value: =0.258t-test, 2 sided