NCT00283153

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_2

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
2.7 years until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 4, 2014

Status Verified

August 1, 2014

Enrollment Period

3.9 years

First QC Date

January 24, 2006

Last Update Submit

August 1, 2014

Conditions

Acquired Brain Injury (Including Stroke)

Keywords

Traumatic Brain InjuryStrokeEmotion RecognitionAffectInterventions

Outcome Measures

Primary Outcomes (2)

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

    Seven months

  • Emotional Inference From Stories Test

    Seven months

Secondary Outcomes (2)

  • Interpersonal Reactivity Index

    Seven Months

  • Neuropsychiatric Inventory

    Seven Months

Study Arms (2)

FAR

EXPERIMENTAL

Facial affect recognition training (with computer assistance)

Behavioral: Facial Affect Recognition Training

SEI

EXPERIMENTAL

Stories of Emotional Inference

Other: Stories of Emotional Inference

Interventions

Facial Affect Recognition TrainingBEHAVIORAL

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.

FAR
Stories of Emotional InferenceOTHER

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.

Also known as: Cognitive intervention
SEI

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University at Buffalo

Buffalo, New York, 14215, United States

Location

Carolinas HealthCare System

Charlotte, North Carolina, 28203, United States

Location

Brock University

St. Catharines, Ontario, Canada

Location

Massey University

Wellington, New Zealand

Location

Related Publications (8)

  • 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.

    PMID: 18692197BACKGROUND

  • 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.

    PMID: 17676438BACKGROUND

  • 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.

    PMID: 19858965BACKGROUND

  • 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.

    PMID: 21463043BACKGROUND

  • 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.

    PMID: 24842590RESULT

  • 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.

    PMID: 24701988RESULT

  • 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.

    PMID: 23895556RESULT

  • 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.

    PMID: 22446155RESULT

MeSH Terms

Conditions

Brain InjuriesBrain Injuries, TraumaticStroke

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Barry Willer, Ph.D.

    University at Buffalo, Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 24, 2006

First Posted

January 27, 2006

Study Start

October 1, 2008

Primary Completion

September 1, 2012

Study Completion

August 1, 2014

Last Updated

August 4, 2014

Record last verified: 2014-08

Locations

NZ(1)CA(1)US(2)