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Affect Recognition: Enhancing Performance of Persons With Acquired Brain Injury (ABI)

Primary Purpose

Acquired Brain Injury (Including Stroke)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Facial Affect Recognition Training
Stories of Emotional Inference
Sponsored by
University at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Brain Injury (Including Stroke) focused on measuring Traumatic Brain Injury, Stroke, Emotion Recognition, Affect, Interventions

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University at Buffalo
  • Carolinas HealthCare System
  • Brock University
  • Massey University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

FAR

SEI

Arm Description

Facial affect recognition training (with computer assistance)

Stories of Emotional Inference

Outcomes

Primary Outcome Measures

Diagnostic Assessment of Nonverbal Affect-Adult Faces (DANVA2-AF)
Emotional Inference From Stories Test

Secondary Outcome Measures

Interpersonal Reactivity Index
Neuropsychiatric Inventory

Full Information

First Posted
January 24, 2006
Last Updated
August 1, 2014
Sponsor
University at Buffalo
Collaborators
U.S. Department of Education, Massey University, Wake Forest University Health Sciences, Brock University
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1. Study Identification

Unique Protocol Identification Number
NCT00283153
Brief Title
Affect Recognition: Enhancing Performance of Persons With Acquired Brain Injury (ABI)
Official Title
Controlled Study of Affect Recognition Training for Individuals With Acquired Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo
Collaborators
U.S. Department of Education, Massey University, Wake Forest University Health Sciences, Brock University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury (Including Stroke)
Keywords
Traumatic Brain Injury, Stroke, Emotion Recognition, Affect, Interventions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FAR
Arm Type
Experimental
Arm Description
Facial affect recognition training (with computer assistance)
Arm Title
SEI
Arm Type
Experimental
Arm Description
Stories of Emotional Inference
Intervention Type
Behavioral
Intervention Name(s)
Facial Affect Recognition Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stories of Emotional Inference
Other Intervention Name(s)
Cognitive intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic Assessment of Nonverbal Affect-Adult Faces (DANVA2-AF)
Time Frame
Seven months
Title
Emotional Inference From Stories Test
Time Frame
Seven months
Secondary Outcome Measure Information:
Title
Interpersonal Reactivity Index
Time Frame
Seven Months
Title
Neuropsychiatric Inventory
Time Frame
Seven Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Willer, Ph.D.
Organizational Affiliation
University at Buffalo, Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Carolinas HealthCare System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Brock University
City
St. Catharines
State/Province
Ontario
Country
Canada
Facility Name
Massey University
City
Wellington
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
18692197
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.
Results Reference
background
PubMed Identifier
17676438
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. doi: 10.1080/02699050701504281.
Results Reference
background
PubMed Identifier
19858965
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.
Results Reference
background
PubMed Identifier
21463043
Citation
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.
Results Reference
background
PubMed Identifier
24842590
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.
Results Reference
result
PubMed Identifier
24701988
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.
Results Reference
result
PubMed Identifier
23895556
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.
Results Reference
result
PubMed Identifier
22446155
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.
Results Reference
result

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Affect Recognition: Enhancing Performance of Persons With Acquired Brain Injury (ABI)

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