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

NCT ID: NCT02432300

Last Updated: 2017-11-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-06-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Traumatic Brain Injury Alexithymia

Keywords

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Traumatic Brain Injury Alexithymia Emotions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Treatment sessions with a virtual treatment program called Emotion Builder

Group Type EXPERIMENTAL

Emotion Builder

Intervention Type BEHAVIORAL

Total of 8 therapy sessions with the Emotion Builder over approximately four (4) weeks (2 sessions a week)

Interventions

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Emotion Builder

Total of 8 therapy sessions with the Emotion Builder over approximately four (4) weeks (2 sessions a week)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

EmotEd

INDUSTRY

Sponsor Role lead

Responsible Party

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Dawn Neumann

Assistant Research Professor, Department of Physical Medicine and Rehabilitation, IU School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dawn Neumann, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Indiana University Health Facilities

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Neumann D, Malec JF, Hammond FM. Reductions in Alexithymia and Emotion Dysregulation After Training Emotional Self-Awareness Following Traumatic Brain Injury: A Phase I Trial. J Head Trauma Rehabil. 2017 Sep/Oct;32(5):286-295. doi: 10.1097/HTR.0000000000000277.

Reference Type DERIVED
PMID: 28060205 (View on PubMed)

Other Identifiers

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1404681990

Identifier Type: OTHER

Identifier Source: secondary_id

1R41HD077967-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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1R41HD077967-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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