Traumatic Brain InjuryNCT01465269
Treatment of Social Competence After Traumatic Brain Injury
A study testing Group Interactive Structured Treatment and Alternative Intervention in people with Traumatic Brain Injury, run by Craig Hospital at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Group Interactive Structured Treatment and Alternative Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Rehabilitation Institute of Michigan
Detroit, Michigan, 48201
Craig Hospital
Englewood, Colorado, 80113
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46202
Polytrauma Rehabilitation Center
Palo Alto, California, 94304
Hunter Holmes McGuire Medical Center
Richmond, Virginia, 23249
University of Washington
Seattle, Washington, 98195
About this study
Official title: Treatment of Social Competence in Military Veterans, Service Members, and Civilians With Traumatic Brain Injury
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.
Read the detailed 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Group Interactive Structured Treatment, Alternative Intervention
- Keywords
- TBI, Social Competence
- Medical subject headings
- Brain Injuries, Traumatic, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Interactive Structured TreatmentBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| GIST Intervention | Experimental | Not described Receives: Behavioral: Group Interactive Structured Treatment |
| Alternative Intervention | Active comparator | Not described Receives: Behavioral: Alternative Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 13 weeks (post-treatment), 25 weeks (3 mos post-treatment)
Secondary outcomes (4)
Change from Baseline on LaTrobe Communication Questionnaire (LCQ)
A 30-item questionnaire that measures cognitive-communication ability, a subjective secondary outcome measure.
Measured: Baseline, 13 weeks (post-treatment), 25 weeks (3-mos post-treatment)
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
Measured: 3 weeks into intervention, 13 weeks (post-intervention), 25 weeks (3-mos post-intervention)
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.
Measured: Baseline, 13 weeks (post treatment), 25 weeks (3 mos post-treatment)
Change from Baseline on Satisfaction with Life Scale
A subjective, 5-item scale of self-rating of global life satisfaction
Measured: Baseline, 13 weeks (post-treatment), 25 weeks (3 mos post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startJul 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rehabilitation Hospital of Indiana, Hunter Holmes McGuire VA Medical Center, VA Palo Alto Health Care System, Wayne State University, University of Washington
- Responsible party
- Principal investigator, Cynthia Harrison-Felix, PhD, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465269
- Sponsor's protocol ID
- PT100068
- Status last verified
- Jul 2015
- First submitted
- 1 Nov 2011
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29966645
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Social Competence in Military Veterans, Service Members, and Civilians With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01465269
- Acronym / sponsor ID
- PT100068
- Conditions
- Traumatic Brain Injury
- Keywords
- TBI, Social Competence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Collaborators
- Rehabilitation Hospital of Indiana, Hunter Holmes McGuire VA Medical Center, VA Palo Alto Health Care System, Wayne State University, University of Washington
- Study start
- Jul 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 4 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GIST Intervention | Experimental | Behavioral: Group Interactive Structured Treatment |
| Alternative Intervention | Active comparator | Behavioral: Alternative Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Interactive Structured TreatmentGIST 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. | Behavioural | GIST Intervention |
| Alternative InterventionParticipants 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. | Behavioural | Alternative Intervention |
Primary outcome
Change from Baseline on Profile of Pragmatic Impairment in Communication (PPIC)
Time frame: Baseline, 13 weeks (post-treatment), 25 weeks (3 mos post-treatment)
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.
4 secondary outcomes
Change from Baseline on LaTrobe Communication Questionnaire (LCQ)
Time frame: Baseline, 13 weeks (post-treatment), 25 weeks (3-mos post-treatment)
Change from baseline on Goal Attainment Scale
Time frame: 3 weeks into intervention, 13 weeks (post-intervention), 25 weeks (3-mos post-intervention)
Change from Baseline on Brief Symptom Inventory-18
Time frame: Baseline, 13 weeks (post treatment), 25 weeks (3 mos post-treatment)
Change from Baseline on Satisfaction with Life Scale
Time frame: Baseline, 13 weeks (post-treatment), 25 weeks (3 mos post-treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Derived from this study: PubMed 29966645Harrison-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Interactive Structured Treatment and Alternative Intervention in people with Traumatic Brain Injury, run by Craig Hospital at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline on Profile of Pragmatic Impairment in Communication (PPIC) (time frame: Baseline, 13 weeks (post-treatment), 25 weeks (3 mos post-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01465269, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.