- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00283153
Affect Recognition: Enhancing Performance of Persons With Acquired Brain Injury (ABI)
Controlled Study of Affect Recognition Training for Individuals With Acquired Brain Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Research has demonstrated that persons with acquired brain injury (ABI) often have difficulty recognizing emotions. This includes emotions portrayed in facial expressions, as well as inferring emotions based on social context. The ability to identify emotions in others is an essential component for the engagement of successful social interactions. It has been suggested that a decreased ability to recognize emotions may result in inappropriate behaviors and have a detrimental impact on social relationships. Despite the significance of this problem, very few studies have addressed this need in the ABI population.
Comparisons: Three groups receiving computer-based training programs. Two of the groups are trained to learn how to identify emotions of happy, sad, angry and fearful. The third training experience presents participants with a variety of learning tasks from managing money to grocery shopping.
- Facial Affect Recognition (FAR) group: This group is shown faces on the computer and asked to identify the emotion being expressed. Subjects are also asked to describe situations that they associate with the emotions being trained, as well as mimic facial expressions in a mirror.
- Stories of Emotional Inference (SEI) group: This group is asked to read stories on the computer that describe the interaction of events with characters' beliefs, wants and behaviors. From this information, subjects are asked to infer the emotions of the characters throughout the stories.
- Cognitive Training Group (CTG): This group is given educational experiences in a variety of life skill areas including banking and applying for a job. This training is aimed at resolving some of the frustrations experienced by persons with ABI. Subjects may learn various computer skills including, Word, Excel, Internet Search or Games.
Before and after training, emotion recognition will be measured with pictures of faces; vocal recordings; stories that give the contextual cues to emotion; and hypothetical situations. In addition, participants' cognitive skills, social behavior and integration will also be assessed.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Ontario
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St. Catharines, Ontario, Canada
- Brock University
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Wellington, New Zealand
- Massey University
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New York
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Buffalo, New York, United States, 14215
- University at Buffalo
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North Carolina
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Charlotte, North Carolina, United States, 28203
- Carolinas Healthcare System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: FAR
Facial affect recognition training (with computer assistance)
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A series of pictures of faces displaying various emotions are presented one at a time using a computerized training program.Participants are taught to recognize how emotions affect facial features such as the mouth and eyes.Participants are also taught how to recognize their own emotions.
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Experimental: SEI
Stories of Emotional Inference
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Participants are presented with a series of short stories one at a time.
Each story presents various contextual cues regarding the emotions the characters are likely to experience.
Participants learn to connect the cues to specific emotions.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Diagnostic Assessment of Nonverbal Affect-Adult Faces (DANVA2-AF)
Time Frame: Seven months
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Seven months
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Emotional Inference From Stories Test
Time Frame: Seven months
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Seven months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Interpersonal Reactivity Index
Time Frame: Seven Months
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Seven Months
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Neuropsychiatric Inventory
Time Frame: Seven Months
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Seven Months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Barry Willer, Ph.D., University at Buffalo, Department of Psychiatry
Publications and helpful links
General Publications
- 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.
- 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. doi: 10.1080/02699050701504281.
- 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.
- 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):277-285. doi: 10.1037/a0021908.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DR-050573-BW-2300
- NIDRR H133G080043A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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