Treatment of Social Competence After Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Treatment of Social Competence in Military Veterans, Service Members, and Civilians With Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465269
• Other study ID #: PT100068
• Status: Completed
• Phase: N/A
• First received: November 1, 2011
• Last updated: July 27, 2015
• Start date: July 2012
• Est. completion date: March 2015

Study information

• Verified date: July 2015
• Source: Craig Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: USAMRMC ORP HRPO
• Study type: Interventional

Clinical Trial 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.

Description:

Background: Impairments in social competence are among the most prevalent sequelae after traumatic brain injury (TBI). Without successful social skills a person is often isolated, in conflict with others, and denied access to social and vocational opportunities. The aim of this study is to determine the effectiveness of a manualized group treatment program to improve and maintain social competence for individuals with TBI with identified social skill deficits. The Group Interactive Structured Treatment (GIST) - Social Competence program is a holistic, dual-disciplinary intervention targeting the pervasive interpersonal and communication problems that often interfere with participation at work, home, school and in the community after TBI.

Aims and Hypotheses: Aim 1: Measure the effectiveness of the GIST intervention with multisite implementation. Hypothesis 1a: Those receiving the GIST will demonstrate significant improvement in social competence, compared to those receiving the alternative treatment, as measured by the Profile of Pragmatic Impairment in Communication (PPIC). Hypothesis 1b: Compared to the alternative intervention, those receiving the GIST will maintain improvement in social competence at 3 months post-intervention, as measured by the PPIC. Hypothesis 1c: Compared to the alternative intervention, those receiving the GIST will demonstrate improvement in additional aspects related to social competence at 3 months post-intervention, as measured by the LaTrobe Communication Questionnaire, the Goal Attainment Scale, the Brief Symptom Inventory-18, and the Post Traumatic Stress Disorder Check List - Civilian version. Hypothesis 1d: Compared to the alternative intervention, those receiving the GIST will demonstrate improvement at 3 months post intervention in quality of life, as measured by the Satisfaction with Life Scale. Aim 2: Identify the potent ingredients associated with the GIST. Hypothesis 2a: FOr participants in the GIST intervention, higher group cohesion measured by the TFI: Cohesiveness Scale will be associated with improved social competence. Hypothesis 2b: Compared to the alternative intervention, those receiving the GIST will demonstrate stronger social self efficacy associated with improved social competence, as measured by the Scale of Perceived Self Efficacy.

Study Design: This study uses a two-arm, multi-centered randomized controlled clinical trial design to compare the GIST treatment to an alternative treatment, in which participants are presented information from the GIST treatment program without the group process. A total of 192 military, veteran and civilian participants with mild to moderate TBI will be enrolled by six centers. Measures will be collected at baseline, post-treatment, and 3 months post-treatment. Videotapes of participants will be evaluated for social competence by blinded independent raters, and progress on individualized social skills goals will be assessed. Replicable training of group leaders will include a 2 ½ day in-person workshop followed by feedback during a pilot of the intervention and alternative intervention. The fidelity of the intervention will be assessed by independent raters using a standardized instrument to ensure that the intervention is implemented consistently. Results of this study will be disseminated to relevant stakeholders via presentations and publications. By the end of this study, the field will have definitive evidence about the effectiveness of a group social competence intervention for people with TBI.

Military Benefit: The proposed study has a high degree of relevance for returning OIF/OEF soldiers and veterans post-TBI due to the prevalence of social reintegration difficulties in this population. The GIST intervention has the potential to assist our soldiers and veterans in returning to full participation in their families, communities and productive activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Behavioral:
• Group Interactive Structured Treatment
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.
• Alternative Intervention
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.

Locations

Country	Name	City	State
United States	Rehabilitation Institute of Michigan	Detroit	Michigan
United States	Craig Hospital	Englewood	Colorado
United States	Rehabilitation Hospital of Indiana	Indianapolis	Indiana
United States	Polytrauma Rehabilitation Center	Palo Alto	California
United States	Hunter Holmes McGuire Medical Center	Richmond	Virginia
United States	University of Washington	Seattle	Washington

Sponsors (6)

Lead Sponsor	Collaborator
Craig Hospital	Hunter Holmes McGuire VA Medical Center, Rehabilitation Hospital of Indiana, University of Washington, VA Palo Alto Health Care System, Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Change from Baseline on LaTrobe Communication Questionnaire (LCQ)	A 30-item questionnaire that measures cognitive-communication ability, a subjective secondary outcome measure.	Baseline, 13 weeks (post-treatment), 25 weeks (3-mos post-treatment)	No
Secondary	Change from baseline on Goal Attainment Scale	A flexible system of measuring outcome goals in individuals with TBI, based on a five-point scale. Levels of goal attainment are expressed objectively in terms of concrete behaviors that can be observed and recorded	3 weeks into intervention, 13 weeks (post-intervention), 25 weeks (3-mos post-intervention)	No
Secondary	Change from Baseline on Brief Symptom Inventory-18	Consists of 18 emotional distress items that are rated on a 5 point Likert scale and yields a Global Severity Index as well as Somatic, Anxiety, and Depressive Dimension scores.	Baseline, 13 weeks (post treatment), 25 weeks (3 mos post-treatment)	No
Secondary	Change from Baseline on Satisfaction with Life Scale	A subjective, 5-item scale of self-rating of global life satisfaction	Baseline, 13 weeks (post-treatment), 25 weeks (3 mos post-treatment)	No