Minimal Clinically Important Difference for the Rasch Neuropsychiatric Inventory Irritability and Aggression Scale for Traumatic Brain Injury

Objective To determine the minimal clinically important difference (MCID) for a Rasch measure derived from the Irritability/Lability and Agitation/Aggression subscales of the Neuropsychiatric Inventory (NPI)—the Rasch NPI Irritability and Aggression Scale for Traumatic Brain Injury (NPI-TBI-IA). Design Distribution-based statistical methods were applied to retrospective data to determine candidates for the MCID. These candidates were evaluated by anchoring the NPI-TBI-IA to Global Impression of Change (GIC) ratings by participants, significant others, and a supervising physician. Setting Postacute rehabilitation outpatient clinic. Participants 274 cases with observer ratings; 232 cases with self-ratings by participants with moderate-severe TBI at least 6 months postinjury. Interventions Not applicable. Main Outcome Measure NPI-TBI-IA. Results For observer ratings on the NPI-TBI-IA, anchored comparisons found an improvement of 0.5 SD was associated with at least minimal general improvement on GIC by a significant majority (69%–80%); 0.5 SD improvement on participant NPI-TBI-IA self-ratings was also associated with at least minimal improvement on the GIC by a substantial majority (77%–83%). The percentage indicating significant global improvement did not increase markedly on most ratings at higher levels of improvement on the NPI-TBI-IA. Conclusions A 0.5 SD improvement on the NPI-TBI-IA indicates the MCID for both observer and participant ratings on this measure

Negative Attribution Bias and Anger After Traumatic Brain Injury

Objectives: Negative attributions pertain to judgments of intent, hostility, and blame regarding others' behaviors. This study compared negative attributions made by people with and without traumatic brain injury (TBI) and examined the degree to which these negative attributions predicted angry ratings in response to situations. Setting: Outpatient rehabilitation hospital. Participants: Forty-six adults with moderate to severe TBI and 49 healthy controls. Design: Cross-sectional study using a quasi-experimental research design. Main Measures: In response to hypothetical scenarios, participants rated how irritated and angry they would be, and how intentional, hostile, and blameworthy they perceived characters' behaviors. There were 3 scenario types differentiated by the portrayal of characters' actions: benign, ambiguous, or hostile. All scenarios theoretically resulted in unpleasant outcomes for participants. Results: Participants with TBI had significantly higher ratings for feeling “irritated” and “angry” and attributions of “intent,” “hostility,” and “blame” compared with healthy controls for all scenario types. Negative attribution ratings accounted for 72.4% and 65.3% of the anger rating variance for participants with and without TBI, respectively. Conclusion: People with TBI may have negative attribution bias, in which they disproportionately judge the intent, hostility, and blameworthiness of others' behaviors. These attributions contributed to their ratings of feeling angry. This suggests that participants with TBI who have anger problems should be evaluated for this bias, and anger treatments should possibly aim to alter negative attributions. However, before implementing clinical practice changes, there is a need for replication with larger samples, and further investigation of the characteristics associated with negative attribution bias

Reductions in Alexithymia and Emotion Dysregulation After Training Emotional Self-Awareness Following Traumatic Brain Injury: A Phase I Trial

OBJECTIVES: To examine the acceptability and initial efficacy of an emotional self-awareness treatment at reducing alexithymia and emotion dysregulation in participants with traumatic brain injury (TBI). SETTING: An outpatient rehabilitation hospital. PARTICIPANTS: Seventeen adults with moderate to severe TBI and alexithymia. Time postinjury ranged 1 to 33 years. DESIGN: Within subject design, with 3 assessment times: baseline, posttest, and 2-month follow-up. INTERVENTION: Eight lessons incorporated psychoeducational information and skill-building exercises teaching emotional vocabulary, labeling, and differentiating self-emotions; interoceptive awareness; and distinguishing emotions from thoughts, actions, and sensations. MEASURES: Toronto Alexithymia Scale-20 (TAS-20); Levels of Emotional Awareness Scale (LEAS); Trait Anxiety Inventory (TAI); Patient Health Questionnaire-9 (PHQ-9); State-Trait Anger Expression Inventory (STAXI); Difficulty With Emotion Regulation Scale (DERS); and Positive and Negative Affect Scale (PANAS). RESULTS: Thirteen participants completed the treatment. Repeated-measures analysis of variance revealed changes on the TAS-20 (P = .003), LEAS (P < .001), TAI (P = .014), STAXI (P = .015), DERS (P = .020), and positive affect (P < .005). Paired t tests indicated significant baseline to posttest improvements on these measures. Gains were maintained at follow-up for the TAS, LEAS, and positive affect. Treatment satisfaction was high. CONCLUSION: This is the first study published on treating alexithymia post-TBI. Positive changes were identified for emotional self-awareness and emotion regulation; some changes were maintained several months posttreatment. Findings justify advancing to the next investigational phase for this novel intervention

The Relations of Self-Reported Aggression to Alexithymia, Depression, and Anxiety After Traumatic Brain Injury

Objectives: To compare self-reported aggression in people with and without traumatic brain injury (TBI) and examine the relations of aggression to alexithymia (poor emotional insight), depression, and anxiety. Setting: Rehabilitation hospital. Participants: Forty-six adults with moderate to severe TBI who were at least 3 months postinjury; 49 healthy controls (HCs); groups were frequency matched for age and gender. Design: Cross-sectional study using a quasi-experimental design. MainMeasures:Aggression (Buss-Perry Aggression Questionnaire); alexithymia (Toronto Alexithymia Scale-20); depression (Patient Health Questionnaire-9); and trait anxiety (State-Trait Anxiety Inventory). Results: Participants with TBI had significantly higher aggression scores than HCs. For participants with TBI, 34.2% of the adjusted variance of aggression was significantly explained by alexithymia, depression, and anxiety; alexithymia accounted for the largest unique portion of the variance in this model (16.2%). Alexithymia, depression, and anxiety explained 46% of the adjusted variance of aggression in HCs; in contrast to participants with TBI, depression was the largest unique contributor to aggression (15.9%). Conclusion: This was the first empirical study showing that poor emotional insight (alexithymia) significantly contributes to aggression after TBI. This relation, and the potential clinical implications it may have for the treatment of aggression, warrants further investigation

Behavioral Recovery and Early Decision Making in Patients with Prolonged Disturbance in Consciousness after Traumatic Brain Injury

The extent of behavioral recovery that occurs in patients with traumatic disorders of consciousness (DoC) following discharge from the acute care setting has been under-studied and increases the risk of overly pessimistic outcome prediction. The aim of this observational cohort study was to systematically track behavioral and functional recovery in patients with prolonged traumatic DoC following discharge from the acute care setting. Standardized behavioral data were acquired from 95 patients in a minimally conscious (MCS) or vegetative state (VS) recruited from 11 clinic sites and randomly assigned to the placebo arm of a previously completed prospective clinical trial. Patients were followed for 6 weeks by blinded observers to determine frequency of recovery of six target behaviors associated with functional status. The Coma Recovery Scale-Revised and Disability Rating Scale were used to track reemergence of target behaviors and assess degree of functional disability, respectively. Twenty percent (95% confidence interval [CI]: 13-30%) of participants (mean age 37.2; median 47 days post-injury; 69 men) recovered all six target behaviors within the 6 week observation period. The odds of recovering a specific target behavior were 3.2 (95% CI: 1.2-8.1) to 7.8 (95% CI: 2.7-23.0) times higher for patients in MCS than for those in VS. Patients with preserved language function ("MCS+") recovered the most behaviors (p ≤ 0.002) and had the least disability (p ≤ 0.002) at follow-up. These findings suggest that recovery of high-level behaviors underpinning functional independence is common in patients with prolonged traumatic DoC. Clinicians involved in early prognostic counseling should recognize that failure to emerge from traumatic DoC before 28 days does not necessarily portend unfavorable outcome

Safety, Tolerability, and Effectiveness of Dextromethorphan/Quinidine for Pseudobulbar Affect Among Study Participants With Traumatic Brain Injury: Results From the PRISM-II Open Label Study

Background Dextromethorphan 20 mg / quinidine 10 mg (DM/Q) was approved to treat pseudobulbar affect (PBA) based on phase 3 trials conducted in participants with amyotrophic lateral sclerosis or multiple sclerosis. PRISM II evaluated DM/Q effectiveness, safety, and tolerability for PBA following stroke, dementia, or traumatic brain injury (TBI). Objective To report results from the TBI cohort of PRISM II, including a TBI-specific functional scale. Design Open-label trial evaluating twice-daily DM/Q over 90 days. Study participants Adults (n = 120) with a clinical diagnosis of PBA secondary to nonpenetrating TBI; stable psychiatric medications were allowed. Methods PRISM II was an open-label, 12-week trial enrolling adults with PBA secondary to dementia, stroke, or TBI. All study participants received DM/Q 20/10 mg twice daily. Study visits occurred at baseline and at day 30 and day 90. Setting 150 U.S. centers. Main Outcome Measurements Primary endpoint was change in Center for Neurologic Study–Lability Scale (CNS-LS) score from baseline to day 90. Secondary outcomes included PBA episode count, Clinical and Patient Global Impression of Change (CGI-C; PGI-C), Quality of Life–Visual Analog Scale (QOL-VAS), treatment satisfaction, Neurobehavioral Functioning Inventory (NFI), Patient Health Questionnaire (PHQ-9), and Mini Mental State Examination (MMSE). Results DM/Q-treated participants showed significant mean (SD) reductions in CNS-LS from baseline (day 30, –5.6 [5.2]; day 90, –8.5 [5.2]; both, P<.001). Compared with baseline, PBA episodes were reduced by 61.3% and 78.5% at days 30 and 90 (both, P<.001). At day 90, 78% and 73% of study participants had “much improved” or “very much improved” on the CGI-C and PGI-C. QOL-VAS scores were significantly reduced from baseline (–3.7 [3.3], P<.001). Mean (SD) PHQ-9 scores improved compared to baseline at day 30 (–3.2 [5.3], P<.001) and 90 (–5.2 [6.4], P<.001). NFI T scores were significantly improved (P<.001), whereas MMSE scores were unchanged. Adverse events (AEs) were consistent with the known DM/Q safety profile; the most common AE was diarrhea (8.3%). Conclusions DM/Q was well tolerated, and it significantly reduced PBA episodes in study participants with TBI. Changes in CNS-LS and PBA episode count were similar to changes with DM/Q in phase 3 trials

Investigation of a New Couples Intervention for Individuals with Brain Injury: A Randomized Controlled Trial

d to (1) examine the efficacy of a treatment to enhance a couple’s relationship after brain injury (BI) particularly in relationship satisfaction and communication; and (2) determine couples’ satisfaction with this type of intervention. Design: Randomized Wait-list Controlled (WC) Trial. Setting: Midwestern outpatient BI rehabilitation center. Intervention: The Couples CARE intervention is a 16 week, 2-hour, manualized small group treatment utilizing psychoeducation, affect recognition and empathy training, cognitive and dialectical behavioral treatments (CBT, DBT), communication skills training, and Gottman’s theoretical framework for couples. Participants: Forty-four participants (22 persons with BI and their intimate partner) were randomized by couples to the intervention or WC group, with 11 couples in each group. Main Outcome Measures: Dyadic Adjustment Scale (DAS); Quality of Marriage Index (QMI); 4 Horsemen of the Apocalypse communication questionnaire. Measures were completed by the person with BI and their partner at 3 time points: baseline, immediate post-intervention, 3-month follow-up. Results The experimental group showed significant improvement at post-test and follow-up on the DAS and the Horsemen questionnaire compared to baseline and to the WC group which showed no significant changes on these measures. No significant effects were observed on the QMI for either group. Satisfaction scores were largely favorable. Conclusion suggest this intervention can improve couples’ dyadic adjustment and communication after BI. High satisfaction ratings suggest this small group intervention is feasible with couples following BI. Future directions for this intervention are discussed

Contextualized Treatment in Traumatic Brain Injury Inpatient Rehabilitation: Effects on Outcomes During the First Year after Discharge

Objective To evaluate the effect of providing a greater percentage of therapy as contextualized treatment on acute traumatic brain injury (TBI) rehabilitation outcomes. Design Propensity score methods are applied to the TBI-Practice-Based Evidence (TBI-PBE) database, a database consisting of multi-site, prospective, longitudinal observational data. Setting Acute inpatient rehabilitation. Participants Patients enrolled in the TBI-PBE study (n=1843), aged 14 years or older, who sustained a severe, moderate, or complicated mild TBI, receiving their first IRF admission in the US, and consented to follow-up 3 and 9 months post discharge from inpatient rehabilitation. Interventions Not applicable. Main Outcome Measures Participation Assessment with Recombined Tools-Objective- -17, FIMTM Motor and Cognitive scores, Satisfaction with Life Scale and Patient Health Questionnaire-9. Results Increasing the percentage of contextualized treatment during inpatient TBI rehabilitation leads to better outcomes, specifically in regard to community participation. Conclusions Increasing the proportion of treatment provided in the context of real-life activities appears to have a beneficial impact on outcome. Although the effect sizes are small, the results are consistent with other studies supporting functional-based interventions effecting better outcomes. Furthermore, any positive findings, regardless of size or strength, are endorsed as important by consumers (survivors of TBI). While the findings do not imply that decontextualized treatment should not be used, when the therapy goal can be addressed with either approach, the findings suggest that better outcomes may result if the contextualized approach is used

Impact of Level of Effort on the Effects of Compliance with the 3-Hour Rule

Objective To determine if patients’ level of effort (LOE) in therapy sessions during traumatic brain injury (TBI) rehabilitation modifies the effect of compliance with the 3-Hour Rule of the Centers for Medicare & Medicaid Services. Design Propensity score methodology applied to the TBI-Practice-Based Evidence (TBI-PBE) database, consisting of multi-site, prospective, longitudinal observational data. Setting Acute inpatient rehabilitation facilities (IRF). Participants Patients (n=1820) who received their first IRF admission for TBI in the US and were enrolled for 3 and 9 month follow-up. Main Outcome Measures Participation Assessment with Recombined Tools-Objective-17, FIMTM Motor and Cognitive scores, Satisfaction with Life Scale, and Patient Health Questionnaire-9. Results When the full cohort was examined, no strong main effect of compliance with the 3-Hour Rule was identified and LOE did not modify the effect of compliance with the 3-Hour Rule. In contrast, LOE had a strong positive main effect on all outcomes, except depression. When the sample was stratified by level of disability, LOE modified the effect of compliance, particularly on the outcomes of participants with less severe disability. For these patients, providing 3 hours of therapy for 50%+ of therapy days in the context of low effort resulted in poorer performance on select outcome measures at discharge and up to 9 months post discharge compared to patients with <50% of 3-hr therapy days. Conclusions LOE is an active ingredient in inpatient TBI rehabilitation, while compliance with the 3-Hour Rule was not found to have a substantive impact on the outcomes. The results support matching time in therapy during acute TBI rehabilitation to patients’ LOE in order to optimize long-term benefits on outcomes

Voting Characteristics of Individuals With Traumatic Brain Injury

Voting is the foundation of democracy. Limited data exist about voting characteristics of individuals with neurologic impairment including those living with a traumatic brain injury (TBI). To statistically examine voting characteristics using a convenience sample of registered voters with TBI during elections held in Mecklenburg County, North Carolina—2007, 2008. Data were collected on 51 participants with TBI during May 2007, 2008 general, and 2008 Presidential Election. (i) There was a significant difference between the Competence Assessment Tool for Voting (CAT‐V) total score of participants with TBI who voted and the CAT‐V total score of participants with TBI who did not vote and the CAT‐V total score predicted voting; (ii) the age of the participants with TBI was predictive of voting; and (iii) being married was inversely related to voting. We find that there is variation in voting even among this small sample interviewed for the present study, and that the variation is predictable. Those with the highest CAT‐Vs are most likely to vote. In addition, we find that traditional predictors of voting simply are not predictors among this TBI group, and even one, whether the person is married, has a negative effect on voting