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Completed

NCT Number: NCT03582228

Bridging Recovery Allies in Virtual Environments

The Bridging Recovery Allies in Virtual Environments (BRAVE) study aims to evaluate the acceptability and feasibility of implementing a virtual environment (VE) social support group for social communication training among adults with traumatic brain injury (TBI).

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Key information

Conditions

Traumatic Brain Injury Behavior Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Communication Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TIRR Memorial Hermann, Houston, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • subjects with a traumatic brain injury
  • between the age of 18 and 80
  • living in the community
  • able to read and speak English,
  • are more than 1-year post-injury
  • are accessible by phone,
  • report independent computer usage over the last 6 months
  • have access to a computer meeting minimum specifications for the Learning in Virtual Environments (LIVE) platform (requires Windows)
  • have broadband Internet connection,
  • achieve a Galveston Orientation Assessment Test (GOAT) score >75 to ensure appropriate levels of cognition for the study
  • and score >93.8 on the Western Battery Aphasia-Revised (WAB-R) scale to indicate sufficient communicative abilities to participate in a social support group and exit interview group.
  • able to understand and independently consent for the study and provide written consent prior to enrollment in the study

Exclusion criteria

  • verbal communication impairments will be excluded as measured by the WAB-R, as this study intends to focus on persons with social communication deficits rather than verbal deficits.

Treatment and study plan

Virtual Envrionment for Social Communication

Behavioral

Once the Virtual Envrionment for Social Communication intervention begins, participants will meet online from home for one-hour sessions twice a week (twelve sessions over six weeks).

Weekly sessions will follow a standardized format:

  • 15 minutes- Social support group (guided discussion of experiences related to weekly topic)
  • 20 minutes- Didactic instruction
  • 15 minutes- Role playing
  • 10 minutes- Debriefing and group feedback

Primary outcomes

  1. Perceived Usability as Assessed by the System Usability Scale (SUS)

    Time frame: about 1 week after the end of the intervention

    Scores on the System Usability Scale (SUS) range from 0-100, with higher scores indicating greater usability (which is the desired outcome).

  2. Acceptability as Assessed by the Acceptability E-Scale

    Time frame: about 1 week after the end of the intervention

    Scores on the Acceptability E-scale range from 6-30, with higher scores indicating greater acceptability (which is the desired outcome).

  3. Feasibility as Assessed by Participation Rate

    Time frame: from the start of the intervention to the end of the intervention (6 weeks)

    Scores on the LaTrobe Social Communication Questionnaire (LCQ) range from 30-120, with lower score indicating less social communication impairment (which is the desired outcome).

  4. Feasibility as Assessed by Attrition Rate

    Time frame: from the start of the intervention to the end of the intervention (6 weeks)

Secondary outcomes

  1. Change in Social Communication as Assessed by the LaTrobe Communication Questionnaire (LCQ)

    Time frame: baseline, about 1 week after the end of the intervention

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • The Institute for Rehabilitaion and Research Foundation

Registry information

Official study title

Bridging Recovery Allies in Virtual Environments (BRAVE)-Understanding Feasibility and Acceptability of Using Virtual Environments for Social Communication in Persons With TBI

Acronym: BRAVE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 10, 2018
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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