Acquired Brain Injury (Including Stroke) Clinical Trial
Official title:
Controlled Study of Affect Recognition Training for Individuals With Acquired Brain Injury
The purpose of this research is to evaluate the effectiveness of three training programs designed to teach persons with acquired brain injury (ABI) to recognize emotions. It is hypothesized that the training programs will enhance several aspects of emotion recognition in persons with ABI. Furthermore, it is expected that these effects will be maintained over time, and will positively influence participants' social behavior and integration.
Status | Completed |
Enrollment | 71 |
Est. completion date | August 2014 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Age between eighteen and sixty-five years old. - At minimum, one year post-injury. - Glasgow Coma Score (GCS) of 12 or less, or stroke with hemi-paresis signifying a moderate to severe acquired brain injury. - A TBI that resulted in either a closed or open head injury or a stroke that resulted in severe disability - Perform at least one standard deviation below the norm on the DANVA2-Adult Faces test, a standardized assessment of facial affect recognition. - Verbally able to express a basic understanding of emotional descriptors (e.g. Happy, sad, angry, fearful). - Demonstrate basic comprehension for short paragraphs presented in 2 ways: 1)auditorily and 2)silent reading. This measure is part of the Discourse Comprehension Test. Exclusion Criteria: - Diagnosed mental illness. - Uncorrected visual acuity. - Uncorrected hearing impairment. - Perceptual impairment (visual neglect and/or visual discrimination). - Impaired verbal expression/ aphasia - Alcohol or substance abuse. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Brock University | St. Catharines | Ontario |
New Zealand | Massey University | Wellington | |
United States | University at Buffalo | Buffalo | New York |
United States | Carolinas HealthCare System | Charlotte | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University at Buffalo | Brock University, Carolinas Healthcare System, Massey University, U.S. Department of Education |
United States, Canada, New Zealand,
Babbage DR, Yim J, Zupan B, Neumann D, Tomita MR, Willer B. Meta-analysis of facial affect recognition difficulties after traumatic brain injury. Neuropsychology. 2011 May;25(3):277-85. doi: 10.1037/a0021908. — View Citation
Neumann D, Babbage DR, Zupan B, Willer B. A randomized controlled trial of emotion recognition training after traumatic brain injury. J Head Trauma Rehabil. 2015 May-Jun;30(3):E12-23. doi: 10.1097/HTR.0000000000000054. — View Citation
Neumann D, Zupan B, Babbage DR, Radnovich AJ, Tomita M, Hammond F, Willer B. Affect recognition, empathy, and dysosmia after traumatic brain injury. Arch Phys Med Rehabil. 2012 Aug;93(8):1414-20. doi: 10.1016/j.apmr.2012.03.009. Epub 2012 Mar 23. — View Citation
Radice-Neumann D, Zupan B, Babbage DR, Willer B. Overview of impaired facial affect recognition in persons with traumatic brain injury. Brain Inj. 2007 Jul;21(8):807-16. Review. — View Citation
Radice-Neumann D, Zupan B, Tomita M, Willer B. Training emotional processing in persons with brain injury. J Head Trauma Rehabil. 2009 Sep-Oct;24(5):313-23. doi: 10.1097/HTR.0b013e3181b09160. — View Citation
Yim J, Babbage DR, Zupan B, Neumann D, Willer B. The relationship between facial affect recognition and cognitive functioning after traumatic brain injury. Brain Inj. 2013;27(10):1155-61. doi: 10.3109/02699052.2013.804203. Epub 2013 Jul 29. — View Citation
Zupan B, Babbage D, Neumann D, Willer B. Recognition of facial and vocal affect following traumatic brain injury. Brain Inj. 2014;28(8):1087-95. doi: 10.3109/02699052.2014.901560. Epub 2014 Apr 4. — View Citation
Zupan B, Neumann D, Babbage DR, Willer B. The importance of vocal affect to bimodal processing of emotion: implications for individuals with traumatic brain injury. J Commun Disord. 2009 Jan-Feb;42(1):1-17. doi: 10.1016/j.jcomdis.2008.06.001. Epub 2008 Jul 9. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic Assessment of Nonverbal Affect-Adult Faces (DANVA2-AF) | Seven months | No | |
Primary | Emotional Inference From Stories Test | Seven months | No | |
Secondary | Interpersonal Reactivity Index | Seven Months | No | |
Secondary | Neuropsychiatric Inventory | Seven Months | Yes |