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Clinical Trials/NCT00283153
NCT00283153CompletedPhase 2

Controlled Study of Affect Recognition Training for Individuals With Acquired Brain Injury

University at Buffalo4 sites in 3 countries71 target enrollmentStarted: October 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
71
Locations
4
Primary Endpoint
Diagnostic Assessment of Nonverbal Affect-Adult Faces (DANVA2-AF)

Study Overview

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.

  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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

FAR

Experimental

Facial affect recognition training (with computer assistance)

Intervention: Facial Affect Recognition Training (Behavioral)

SEI

Experimental

Stories of Emotional Inference

Intervention: Stories of Emotional Inference (Other)

Outcomes

Primary Outcomes

Diagnostic Assessment of Nonverbal Affect-Adult Faces (DANVA2-AF)

Time Frame: Seven months

Emotional Inference From Stories Test

Time Frame: Seven months

Secondary Outcomes

  • Interpersonal Reactivity Index(Seven Months)
  • Neuropsychiatric Inventory(Seven Months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Barry Willer

Professor

University at Buffalo

Study Sites (4)

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