NCT01465269

Brief Summary

The aim of this study is to determine the effectiveness of holistic group treatment program (called Group Interactive Structured Treatment, or GIST) to improve social communication skills for individuals with Traumatic Brain Injury. Hypothesis: Compared to an alternative intervention, those receiving the GIST intervention will show improved social competence, improved quality of life, and stronger group cohesion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
231

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

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

November 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

2.7 years

First QC Date

November 1, 2011

Last Update Submit

July 27, 2015

Conditions

Traumatic Brain Injury

Keywords

TBISocial Competence

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline on Profile of Pragmatic Impairment in Communication (PPIC)

    This tool is designed to measure social communication impairments following TBI. It focuses not only on communication skills but also on other aspects of socially competent behavior, such as social perception and adherence to social boundaries. Videotaped conversations at the 3 time points will be evaluated using the PPIC to assess change from baseline.

    Baseline, 13 weeks (post-treatment), 25 weeks (3 mos post-treatment)

Secondary Outcomes (4)

  • Change from Baseline on LaTrobe Communication Questionnaire (LCQ)

    Baseline, 13 weeks (post-treatment), 25 weeks (3-mos post-treatment)

  • Change from baseline on Goal Attainment Scale

    3 weeks into intervention, 13 weeks (post-intervention), 25 weeks (3-mos post-intervention)

  • Change from Baseline on Brief Symptom Inventory-18

    Baseline, 13 weeks (post treatment), 25 weeks (3 mos post-treatment)

  • Change from Baseline on Satisfaction with Life Scale

    Baseline, 13 weeks (post-treatment), 25 weeks (3 mos post-treatment)

Study Arms (2)

GIST Intervention

EXPERIMENTAL
Behavioral: Group Interactive Structured Treatment

Alternative Intervention

ACTIVE COMPARATOR
Behavioral: Alternative Intervention

Interventions

Group Interactive Structured TreatmentBEHAVIORAL

GIST groups consist of 8 group participants and two group therapists. Group members receive the workbook and are asked to bring it to each session. During each of the 13, 1.5 hour sessions, key concepts from the previous session are reviewed, a new topic is discussed, strategies and skills are practiced interactively, and real-life social problems are addressed. Previously covered topics are integrated into each session through discussion and problem solving to provide repetition and reinforcement of information.

GIST Intervention
Alternative InterventionBEHAVIORAL

Participants in the alternative treatment will attend 13 weekly classroom sessions, where they will view video presentations of the same curriculum topics covered in the GIST workbook. The group therapists will serve as moderators and will meet with participants individually. Group interaction will not be encouraged. Homework exercises will be offered but participants will not be asked to return their homework and will not receive any feedback.

Alternative Intervention

Eligibility Criteria

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

You may qualify if:

  • Have a history of a TBI as evidenced by self report on OSU TBI ID screen
  • Sustained a TBI anytime after October 2001;
  • are at least 6 months post injury
  • score at Level 1 (Independent) or Level 2 (Overnight Supervision) on the Supervision Rating Scale;
  • are 18 years of age or older at the time of the study;
  • have adequate receptive/expressive communication skills functional for group participation, (score \>5 on the Comprehension and Expression of the Functional Independence Measure (FIM)70 based on results of screening interview;
  • possess the English language skills necessary to participate in the group intervention and complete study measures;
  • demonstrate some aspect of problematic social competence by responding "yes" to at least one of 5 screening statements listed here, as reported by the participant or their support person.
  • provide Informed Consent to participate.

You may not qualify if:

  • are unable to verbally communicate, or require augmentative communication system;
  • are unable to attend the majority of group sessions (e.g., living at a distance from the site without consistent transportation; going on an extended vacation, planned surgeries, planning to move);
  • are currently involved in ongoing structured group psycho-social therapy;
  • are currently participating in another clinical trial.
  • are currently in one-on-one therapy with one of the therapists
  • have already participated in the GIST intervention
  • in the opinion of the PI, have any conditions which might interfere with complete of the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Polytrauma Rehabilitation Center

Palo Alto, California, 94304, United States

Location

Craig Hospital

Englewood, Colorado, 80113, United States

Location

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46202, United States

Location

Rehabilitation Institute of Michigan

Detroit, Michigan, 48201, United States

Location

Hunter Holmes McGuire Medical Center

Richmond, Virginia, 23249, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • Harrison-Felix C, Newman JK, Hawley L, Morey C, Ketchum JM, Walker WC, Bell KR, Millis SR, Braden C, Malec J, Hammond FM, Eagye CB, Howe L. Social Competence Treatment After Traumatic Brain Injury: A Multicenter, Randomized Controlled Trial of Interactive Group Treatment Versus Noninteractive Treatment. Arch Phys Med Rehabil. 2018 Nov;99(11):2131-2142. doi: 10.1016/j.apmr.2018.05.030. Epub 2018 Jun 30.

    PMID: 29966645DERIVED

MeSH Terms

Conditions

Brain Injuries, TraumaticSocial Skills

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Director of Research

Study Record Dates

First Submitted

November 1, 2011

First Posted

November 4, 2011

Study Start

July 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

July 29, 2015

Record last verified: 2015-07

Locations

US(6)