NCT02432300

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

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

April 24, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

November 22, 2017

Completed
Last Updated

November 22, 2017

Status Verified

November 1, 2017

Enrollment Period

1.1 years

First QC Date

April 24, 2015

Results QC Date

March 1, 2017

Last Update Submit

November 20, 2017

Conditions

Traumatic Brain InjuryAlexithymia

Keywords

Traumatic Brain InjuryAlexithymiaEmotions

Outcome Measures

Primary Outcomes (2)

  • Toronto Alexithymia Scale-20 (TAS-20)

    This is a 20-item self-report questionnaire comprised of three sub-constructs (Difficulty Identifying feelings, Difficulty Describing Feelings, Externally-oriented Thinking). The full scale range is 20-100 (higher scores indicate higher alexithymia). Subscales are summed to compute a total score Scores between 52 and 60 indicate moderate alexithymia; scores 61 and higher indicate high alexithymia.

    Week 6

  • Levels of Emotional Awareness Scale (LEAS)

    The LEAS is comprised of ten hypothetical scenarios that are three or four sentences in length. Participants must respond how they think they would feel and how another person would feel in response to the hypothetical scenario. The more discrete emotions (e.g., bad vs sad) receive higher points, as well as blended emotions (e.g. sad and angry). There are 10 items on this measure. The minimum score for each item is 0 and the max score for each item is 5. The item scores are summed to calculate a total score. Thus, the total scores range from 0-50; 0=lowest awareness and 50=highest awareness. A computerized scoring system and parallel forms were used.

    Week 6

Secondary Outcomes (2)

  • Patient Health Questionnaire-9 (PHQ-9) as an Assessment of Depression

    Week 6

  • State Trait Anxiety Inventory (STAI)

    Week 6

Study Arms (1)

Intervention

EXPERIMENTAL

Treatment sessions with a virtual treatment program called Emotion Builder

Behavioral: Emotion Builder

Interventions

Emotion BuilderBEHAVIORAL

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

Intervention

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Health Facilities

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • 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.

    PMID: 28060205DERIVED

MeSH Terms

Conditions

Brain Injuries, TraumaticAffective Symptoms

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBehavioral SymptomsBehavior

Results Point of Contact

Title
Dawn Neumann
Organization
EmotEd, LLC
dneumann73@gmail.com
716-713-5048

Study Officials

  • Dawn Neumann, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Research Professor, Department of Physical Medicine and Rehabilitation, IU School of Medicine

Study Record Dates

First Submitted

April 24, 2015

First Posted

May 4, 2015

Study Start

May 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 22, 2017

Results First Posted

November 22, 2017

Record last verified: 2017-11

Locations

US(1)