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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00283153
Other study ID # DR-050573-BW-2300
Secondary ID NIDRR H133G08004
Status Completed
Phase Phase 2/Phase 3
First received January 24, 2006
Last updated August 1, 2014
Start date October 2008
Est. completion date August 2014

Study information

Verified date August 2014
Source University at Buffalo
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardNew Zealand: Health and Disability Ethics CommitteesCanada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


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.

1. 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.

2. 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.

3. 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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Facial Affect Recognition Training
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.
Other:
Stories of Emotional Inference
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.

Locations

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

Sponsors (5)

Lead Sponsor Collaborator
University at Buffalo Brock University, Carolinas Healthcare System, Massey University, U.S. Department of Education

Countries where clinical trial is conducted

United States,  Canada,  New Zealand, 

References & Publications (8)

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

Outcome

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