Tessa Hart, PhD Moss Rehabilitation Research Institute Elkins Park, PA

 The Traumatic Brain Injury Model System: A study (collection of studies) that spans acute care  rehabilitation  long-term outcome  Recent example of a TBI treatment study at Moss that focuses on a major problem in post-acute phase of recovery

 A multi-center, longitudinal project on the short- and long-term outcomes of TBI, and how to improve them  The TBIMS program has been funded since 1987 by the National Institute on Disability and Rehabilitation Research, US Department of Education  Moss has been a TBIMS center since 1997

 “The Traumatic Brain Injury Model Systems program seeks to improve the lives of persons who experience traumatic brain injury, their families and their communities by creating and disseminating new knowledge about the course, treatment and outcomes of their condition.”

◦ TBI is defined as damage to brain tissue caused by an external mechanical force as evidenced by medically documented loss of consciousness or post traumatic amnesia (PTA) due to brain trauma or by objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination.

 Prospective, multi-center longitudinal research on people with TBI and their families and communities ◦ Determine long-term outcomes, and what affects them ◦ What are most common and important problems?  Treatment research ◦ Pilot studies to develop promising treatments ◦ Larger collaborative studies to test their effects

 The TBIMS program supports other projects designed to fulfill the mission: ◦ Conferences, seminars, networking opportunities for people with brain injury & their families ◦ Websites and materials for dissemination of new knowledge ◦ Collaborations between TBIMS centers and others with similar missions:  Brain Injury Association (national & state chapters)  HRSA projects within states

 16 ‘centers of excellence’ for TBI treatment and research  Clinical excellence: Must have state-of-the- art care for TBI from the time of injury, through emergency and acute care, to inpatient rehabilitation  Research excellence: Must be able to conduct innovative research to create new knowledge about TBI

Currently Funded Follow-up Center Previously Funded

 National Database ◦ All 16 centers collect same data on patients enrolled in TBIMS  From emergency/ acute care  From rehab hospital: all patients in the database receive inpatient TBI rehabilitation  From follow-up at years 1, 2, 5, 10, 15, 20…… after the TBI ◦ Currently >9000 patients in the National Database (since 1989…. starting 20 yr follow-ups)

 Form I – 8,775 cases (as of 3/31/2009)  Form II – 26,352 follow-ups* - 22% attrition (6%**) ◦ Year 1 – 8,085 – 16% attrition (3%**) ◦ Year 2 – 6,931 – 19% attrition (6%**) ◦ Year 5 – 4,382 – 22% attrition (13%**) ◦ Year 10 – 1,172 – 27% attrition (9%**) ◦ Year 15 – 418 – 21% attrition (14%**) ◦ Year 20 – 9 – 22% attrition (0%**) *There are some follow-ups in database that were performed at 3, 4, and 6 years post-injury. **Additional percent attrition due to loss of center funding.

 To see how people with TBI and their caregivers do over time… a long time  To identify the most persistent and pressing problems that require long-term treatment and support  To examine the factors that predict who will do well, who not so well

 Mild TBI ◦ TBIMS enrollment is from inpatient TBI rehab units; most are moderate/ severe (this is a moving target due to changes in policy over 20+ years)  Non-traumatic BI  Children: TBIMS includes ages 16 and up  Uninsured or under-insured ◦ If no funding for inpatient rehab, can’t be enrolled (this varies by state)  People who do not get rehab (i.e., no “control group”

 Basic information about person’s background-- age, race, gender, education & occupation, drug & alcohol history, family, etc.  Injury information--cause, severity, CT scan findings, etc.  Status & improvement during rehabilitation ◦ FIM ◦ Disability Rating Scale (DRS)

 After discharge from rehab, person and/ or family are telephoned at 1, 2, 5, 10, 15, 20….. years after injury  Moss is following >800 people with TBI  Structured interview to assess long term outcomes: ◦ Work, social life, other community participation ◦ Health issues (rehospitalization) ◦ Emotional status, quality of life

[Includes data from 01/01/1989 – 12/31/2008]

mean = 39; n = 8779

Age at Admission to Rehab

n = 8778

n = 8777

n = 8749

n = 8575

At Emergency Department Admission* * excludes cases not tested = 23% mean = 68.7; n = 6461

 Amount and location of brain damage is hard to visualize  Typical damage is to the frontal and temporal poles, and diffuse axonal injury (DAI) Focal injury may show up on brain scans, but DAI often does not. The best gauge of the amount of DAI is the depth & duration of impaired consciousness after the TBI.

TIME Normal conscious- ness Depth of coma at time of TBI (GCS score) (Coma ) Disorientation Normal or impaired conscious- ness *Post-Traumatic Amnesia Retro- grade Amnesia Duration of Unconsciousness

At Emergency Department Admission* mean = 9.4; n = 6668

mean = 8.6 days; n = 8358

mean = 24.9 days; n = 6536 (Moderate/Severe) (Very Severe) (Extremely Severe)

Complete Independence Modified Independence Supervision Minimal Assistance Moderate Assistance Maximal Assistance Total Assistance Mean Scores converted to 7-point scale

 Work is one of the most important– and best studied– outcomes  TBI affects many young people in (or just starting) productive years  Costs of people with TBI not working are enormous ◦ To injured individuals (financial & personal) ◦ To families who must support another person ◦ To family members who have to quit work to care for injured person ◦ To society

 The consequences of TBI are important (especially cognitive/ behavioral problems), but pre-injury factors may be even more so  Being employed at the time of TBI ◦ But even if you are, risk of unemployment 3-5 years after TBI is 5x greater than general population for men… 3x for women  What “level” of job you have ◦ Professional/ managerial vs blue collar vs unskilled  “Vicious cycle” of pre-injury disadvantages:

…how should we intervene in this cycle to improve outcomes? Poor education Poor employment history Substance abuseViolent injury Low income/ poor insurance More needs unmet by services Non-white

To view all variables in the TBIMS National Database

Online TBI Model Systems National Database Syllabus

Center for Outcome Measurement in Brain Injury

 Center at University of Washington that is working with all TBIMS centers (+ SCI, Burn Model Systems) to help translate research information for clinicians, and consumers affected by disability  “Knowledge Translation” refers to the newer models of active transfer from research to usable clinical information… older models (“dissemination”) were more passive

 Anger/ irritability is an important problem after TBI: ◦ Frequent complaint (up to 1/3 of survivors) ◦ Range of symptoms from irritability, “crankiness” to verbal and physical aggression ◦ Occurs across spectrum of injury severity, from mild to severe ◦ Persistent problem, may even worsen over time ◦ Important problem-- contributes to family burden, social isolation and vocational failure ◦ Difficult to treat– may exclude people from therapy programs

 Very few  Some medications may be used, but little evidence base; and meds may not be acceptable to patients  We set out to develop a testable, non-drug treatment for TBI-related anger that could stand alone or be incorporated into outpatient therapy programs.

 In designing a new treatment, it’s often helpful to build in ‘active ingredients’ that get at the (hypothesized) root causes of a problem, e.g.: ◦ Attention problems are caused by certain neurotransmitter deficiencies ◦ Methylphenidate (Ritalin) boosts levels of those neurotransmitters ◦ Therefore, it should alleviate attention problems

 Primary/ organic ◦ Damage to frontal/ temporal areas, limbic system; neurochemical changes  Secondary to brain injury ◦ Cognitive deficits such as ↓ attention, language, memory, reasoning can  frustration & anger  Secondary to life changes ◦ Loss of independence ◦ ↓ social life, ↓ income, etc., etc.  Premorbid factors  Can’t pinpoint/ measure the relative magnitude of these for a given patient

 No matter what other causes exist, we reasoned that 2 characteristic aspects of executive dysfunction contribute to anger after TBI: (1) Impaired self awareness, especially of behavioral/ emotional problems and their impact on others -- reduced ability to monitor anger episodes -- tendency to blame others when things go wrong

(2) Impaired Problem Solving  Loss of cognitive and behavioral flexibility  Difficulty in appreciating consequences of actions  Anger or irritability can become a stereotyped response to threat (change, confusion, any problem situation) after TBI  Anger is gratifying in an immediate sense, but highly maladaptive in the long run  Even if person recognizes need for change, he/ she lacks the problem-solving ability to modify behavior

 Built around 2 main ingredients: ◦ Self-Awareness/ Self-Monitoring training ◦ Training of specific methods for Problem Solving in anger situations  Designed for people with brain injury ◦ At a range of cognitive levels ◦ With or without participating SOs  Fully manualized ◦ Standardized therapist-workbook format for replication across centers, therapists, patients

 8 ~weekly sessions, 1:1; Significant Other (if any) attends portions of 3 sessions  ‘Psycho-educational model’ with: ◦ Didactic material on anger, its relationship to TBI, etc…… “normalization” ◦ Skill training in the 2 main ingredients:  Self-monitoring of anger, triggers, consequences, characteristic behaviors, patterns, etc.  Problem-solving using simplified and modified “anger management” methods successful in the general population ◦ “Outside Practice” (never homework!)

 Pre-post test design (no control group)  Is it feasible? ◦ Will people understand it?  It is acceptable? ◦ Will people like it? --hate it? ◦ Will they show up? Will they drop out?  Will it reduce self-reported anger? ◦ Or will the focus on anger monitoring have the opposite effect?  Estimate effect size for larger trial  If changes observed, are they clinically meaningful?

 8 Male, 2 Female  6 White, 4 African-American  Age: 23 – 59 (mean, 44)  Time post-TBI: 6 months – 20 years (median, 4 yr)  4 MVA, 4 assault (1 GSW), 2 fall  PTA duration: Median 51 days (11 days – “2 years”)  Severe cognitive deficits, especially in memory  No severe emotional disturbances other than anger problems

 Self-report and SO (proxy) report pre and post treatment  State-Trait Anger Expression Inventory-2 (STAXI-2): 2 subscales ◦ Trait Anger: measures general tendency toward anger, “hot headedness,” whether expressed or not ◦ Anger Expression-Out: Outward expression: sarcasm, hostility, verbal/ physical aggression  Brief Anger Aggression Questionnaire (BAAQ) ◦ Captures more extreme “acting-out” or passive aggression

ScalePre TxPost TxP ValueEffect Size Trait Anger (T score) 63 (11) 54 (9) Anger Expression- Out (T score) 71 (10) 58 (15) BAAQ (raw score 14 (5) 9 (3) SO report showed similar trends (all scales decreased) but less dramatic. The AX-O change was significant for SOs (effect size = 0.9)

 All participants rated themselves “a little better” or “a lot better” overall at handling their anger  SOs rated participants as “a little better” or “a lot better” except for 1 (no change)  7/10 participants and 6/ 8 SOs rated anger as having less impact on daily life (relationships, mood, community function) after treatment  Cognitive deficits seemed to have little impact on ability to improve with treatment

 “I didn’t think this was going to do a damn thing for me, but it helped me a lot”  “I give this study an A+”  Program is not long enough– there is so much more to learn (several comments)  Many specific suggestions for how to improve program, such as ◦ More SO involvement ◦ More repetition / reminders between sessions or sessions closer together ◦ Support / booster group for program “graduates”

 3-center study (with control group) has just been funded by NIH to begin summer 2011  Trajectory of treatment effects ◦ Do we need all 8 sessions to get an effect? Would 4 sessions work just as well? ◦ Do positive effects persist after treatment?  Are there broader effects on other aspects of daily living?  For whom does it work? Do people benefit more at a given level of cognitive ability, time post TBI, etc?

Thanks for your attention!