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Acquired Brain Injury (Including Stroke)Phase 2/3NCT00283153

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

A Phase 2/3 study testing Facial Affect Recognition Training and Stories of Emotional Inference in people with Acquired Brain Injury (Including Stroke), run by University at Buffalo at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Acquired Brain Injury (Including Stroke)
What is being tested?
Facial Affect Recognition Training and Stories of Emotional Inference
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
4 sitesin 3 countries
Study dates
Oct 2008to Aug 2014
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

United States2 sites

  • University at Buffalo

    Buffalo, New York, 14215

  • Carolinas HealthCare System

    Charlotte, North Carolina, 28203

Other trials in United States

Canada1 site

  • Brock University

    St. Catharines, Ontario

Other trials in Canada

New Zealand1 site

  • Massey University

    Wellington

Other trials in New Zealand

About this study

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

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.

Read the 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.

Being tested
Facial Affect Recognition Training, Stories of Emotional Inference
Keywords
Traumatic Brain Injury, Stroke, Emotion Recognition, Affect, Interventions
Medical subject headings
Brain Injuries, Brain Injuries, Traumatic, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Facial Affect Recognition TrainingBehavioural

    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.

  • Stories of Emotional InferenceOther

    Also called Cognitive intervention

    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.

Study groups in NCT00283153
Study groupRoleWhat they receive
FARExperimentalFacial affect recognition training (with computer assistance)
Receives: Behavioral: Facial Affect Recognition Training
SEIExperimentalStories of Emotional Inference
Receives: Other: Stories of Emotional Inference

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Seven months

  2. Emotional Inference From Stories Test

    Measured: Seven months

Secondary outcomes (2)

  1. Interpersonal Reactivity Index

    Measured: Seven Months

  2. Neuropsychiatric Inventory

    Measured: Seven Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2006 (estimated)
  2. Study startOct 2008
  3. Primary completionSep 2012
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00283153
Sponsor's protocol ID
DR-050573-BW-2300
Other IDs
NIDRR H133G080043A
Status last verified
Aug 2014
First submitted
24 Jan 2006
Last updated
4 Aug 2014
Results posted
No
Data monitoring committee
No

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.

    PubMed 18692197

  • 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.

    PubMed 17676438

  • 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.

    PubMed 19858965

  • 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.

    PubMed 21463043

  • 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.

    PubMed 24842590

  • 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.

    PubMed 24701988

  • 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.

    PubMed 23895556

  • 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.

    PubMed 22446155

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Facial Affect Recognition Training and Stories of Emotional Inference in people with Acquired Brain Injury (Including Stroke), run by University at Buffalo at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Canada, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic Assessment of Nonverbal Affect-Adult Faces (DANVA2-AF) (time frame: Seven months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00283153, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2014.

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