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The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury

E

EmotEd

Status

Completed

Conditions

Alexithymia
Traumatic Brain Injury

Treatments

Behavioral: Emotion Builder

Study type

Interventional

Funder types

Industry
NIH

Identifiers

NCT02432300
1404681990 (Other Identifier)
1R41HD077967-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to examine a web-based training program for treating emotional problems in people who have suffered a traumatic brain injury (TBI).

Full description

This is a pilot study to examine how subjects with TBI feel about the virtual reality program as a treatment and to assess the effectiveness of the virtual reality program at increasing subjects' awareness and understanding of emotions.

Enrollment

17 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • TBI (injury due to an external physical force);
  • Moderate to severe TBI, defined either by74 Glasgow Coma Score at time of injury (≤12), or post-traumatic amnesia (≥1 day), or loss of consciousness (≥30 minutes);
  • ≥1 year post-injury;
  • between 18-65 years old;
  • Have a moderate to high alexithymia score (≥52) on the TAS-2070 at screening.

Exclusion criteria

  • Diagnosed with pre-morbid neurological disorders (e.g. stroke, autism, alzheimer's disease, Parkinson's disease);
  • Formerly diagnosed with a developmental disability;
  • Pre-morbid diagnosis of major psychiatric disorders (e.g. schizophrenia);
  • Unable to follow directions;
  • Uncorrected visual or hearing impairments that would prevent sufficient task participation;
  • No access to reliable transportation.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

Intervention
Experimental group
Description:
Treatment sessions with a virtual treatment program called Emotion Builder
Treatment:
Behavioral: Emotion Builder

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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