An adaptive method for assigning clinical trials wait-times for controls.

Wait-list control clinical trials are popular among psychologists and rehabilitation specialists partly because all participants receive the intervention. In 2 arm wait-list control trials, individuals randomized to the treatment group receive immediate treatment whereas individuals randomized to the control group wait a fixed amount of time before intervention is initiated. For interventions that have varying durations, careful consideration must be given to the period that participants in the control group have a delay until treatment begins, as incongruent wait times compared to the intervention durations of the treatment group may introduce confounding into the evaluation of the treatment differences. To alleviate this issue, we propose to adaptively assign wait times to individuals randomized to the control group based on the intervention duration of those in the treatment group. Simulations demonstrate the that our method not only results in similar timing distributions between participants in the treatment and control groups, but also allows participants in the control group to initiate treatment earlier than the traditional design. The latter characteristic may reduce dropout and result in more efficient study enrollment.

Evaluation of a Brief, Skill-Building, Supportive, and Educational Intervention for Couples After Brain Injury.

OBJECTIVE: To examine the effectiveness of an intervention (Therapeutic Couples Intervention, TCI) designed to improve relationship quality for couples after acquired brain injury. SETTING: Outpatient brain injury rehabilitation center. PARTICIPANTS: Persons with brain injury (n = 75) and their intimate partners (n = 75). DESIGN: Two-arm parallel, randomized, controlled trial with wait-listed control. METHODS: Composed of 5 to 6 2-hour sessions, the TCI is a manualized, treatment program designed to enhance relationship quality by addressing issues and concerns most often identified by persons with brain injury and their partners. MAIN MEASURE: Revised Dyadic Adjustment Scale completed by the persons with brain injury and their partners. RESULTS: Persons with brain injury and their partners in the treatment group showed an improvement in relationship quality, both compared with their own baseline values and the control group. CONCLUSIONS: Investigation provided evidence that a curriculum-based education, skill-building, and supportive intervention can benefit couples for up to 3 months after treatment. Additional research is needed to ascertain the long-term benefits of intervention and the efficacy of alternative delivery methods (eg, Internet, telephone, and group).

Can a couples' intervention reduce unmet needs and caregiver burden after brain injury?

OBJECTIVE: To examine the effectiveness of the Therapeutic Couples Intervention (TCI) on caregiver needs and burden after brain injury. RESEARCH METHOD: Individuals with brain injury and their intimate partners/caregivers (n = 75) participated in a 2-arm, parallel, randomized trial with a waitlist control. The TCI consisted of 5 2-hr sessions, with a sixth optional session for parents. The Family Needs Questionnaire-R (FNQ-R) and the Zarit Burden Interview (ZBI) were secondary outcome measures. RESULTS: After adjusting for baseline characteristics, caregivers in the TCI group demonstrated reduction in unmet needs for 5 of the 6 FNQ-R subscales, whereas those in the waitlist control group did not. ZBI scores improved significantly for TCI caregivers but not for controls. At the 3-month follow-up, benefits were maintained for the ZBI and 4 of the 6 FNQ-R subscales (Health Information, Emotional Support, Professional Support, and Community Support Network). CONCLUSIONS: The present investigation provided evidence that, following brain injury, a structured couples intervention can reduce unmet needs and burden in caregivers. Future multicenter research examining long-term durability of treatment gains and specific characteristics of positive responders is warranted. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Outcome prediction from post-injury resilience in patients with TBI.

PURPOSE/OBJECTIVE: The objective of the study was to evaluate the extent to which 1- and 2-year outcomes after traumatic brain injury (TBI) are predicted by resilience. Research Method/Design: This was an observational, longitudinal study of persons (n = 158) with moderate or severe TBI who completed both 1- and 2-year outcome assessments. Outcomes included anxiety (Generalized Anxiety Disorder-7), depression (Patient Health Questionnaire-9), life satisfaction (Satisfaction with Life Scale), substance misuse, and return-to-work measures. The Connor-Davidson Resilience Scale was used to assess resilience at 3 or 6 months after injury. RESULTS: Greater resilience predicted less anxiety, depression, and substance use and better satisfaction with life and return to work at 1 year after injury for both adjusted and unadjusted models. Standardized regression coefficients were all greater than 0.38 for continuous outcomes, whereas odds ratios were 1.34 and 0.81 for the return to work and substance misuse outcomes, respectively (p < .05). Similar but weaker trends were found at 2 years after injury, with statistical significance no longer met for all outcomes. CONCLUSIONS/IMPLICATIONS: Resilience was shown to have predictive ability for outcomes at 1 and 2 years after TBI. Resilience appears to be a salient and important variable for long-term outcomes in person with TBI after adjusting for injury and demographic characteristics. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

A Randomized Controlled Pilot Study of a Manualized Intervention for Caregivers of Patients With Traumatic Brain Injury in Inpatient Rehabilitation.

OBJECTIVE: Investigate effectiveness of a 5-session manualized intervention for addressing needs of caregivers of persons in acute traumatic brain injury (TBI) rehabilitation. DESIGN: Prospective, pilot randomized controlled trial. SETTING: Inpatient brain injury rehabilitation unit, level 1 trauma center. PARTICIPANTS: Patients (N=93) with moderate-to-severe TBI and their family members were enrolled in the study with 42 randomized to the treatment group, 51 to the control group. INTERVENTION: Five-session manualized caregiver intervention with educational, stress and anxiety self-management, coping, and emotional support components. MAIN OUTCOME MEASURES: Family Needs Questionnaire-Revised, knowledge assessment, Zarit Family Burden Scale, and Brief Symptom Inventory-18 were collected at pretreatment, posttreatment, and 3-month follow-up. RESULTS: Treatment group caregivers showed an increase in met needs for emotional, instrumental, and professional support, and brain injury knowledge from baseline to posttreatment, whereas controls did not. Between-group differences were significant for only emotional support needs. Treatment effects were not sustained at 3-month follow-up. CONCLUSIONS: Caregivers of persons undergoing acute TBI rehabilitation may benefit from interventions that target their unique needs. Caregivers may require additional and longer-term supports to sustain treatment benefits.

Using Decision Tree Methodology to Predict Employment After Moderate to Severe Traumatic Brain Injury.

OBJECTIVE: To build decision tree prediction models for long-term employment outcomes of individuals after moderate to severe closed traumatic brain injury (TBI) and assess model accuracy in an independent sample. SETTING: TBI Model Systems Centers. PARTICIPANTS: TBI Model Systems National Database participants injured between January 1997 and January 2017 with moderate to severe closed TBI. Sample sizes were 7867 (year 1 postinjury), 6783 (year 2 postinjury), and 4927 (year 5 postinjury). DESIGN: Cross-sectional analyses using flexible classification tree methodology and validation using an independent subset of TBI Model Systems National Database participants. MAIN MEASURES: Competitive employment at 1, 2, and 5 years postinjury. RESULTS: In the final employment prediction models, posttraumatic amnesia duration was the most important predictor of employment in each outcome year. Additional variables consistently contributing were age, preinjury education, productivity, and occupational category. Generally, individuals spending fewer days in posttraumatic amnesia, who were competitively employed preinjury, and more highly educated had better outcomes. Predictability in test data sets ranged from a C-statistic of 0.72 (year 5; confidence interval: 0.68-0.76) to 0.77 (year 1; confidence interval: 0.74-0.80). CONCLUSION: An easy-to-use decision tree tool was created to provide prognostic information on long-term competitive employment outcomes in individuals with moderate to severe closed TBI. Length of posttraumatic amnesia, a clinical marker of injury severity, and preinjury education and employment status were the most important predictors.

Efficacy of the resilience and adjustment intervention after traumatic brain injury: a randomized controlled trial.

OBJECTIVE: Examine a psychoeducational and skill-building intervention's effectiveness for individuals after traumatic brain injury (TBI), using a two-arm, parallel, randomized, controlled trial with wait-listed control. METHODS: The Resilience and Adjustment Intervention (RAI) targets adjustment challenges and emphasizes education, skill-building and psychological support. Overall, 160 outpatients were randomly assigned to a treatment or wait-list control (WLC) group. The manualized treatment was delivered in seven 1-h sessions. The Connor-Davidson Resilience Scale (CD-RISC) was the primary outcome measure. Secondary measures included the Mayo Portland Adaptability Inventory-4 (MPAI-4), Brief Symptom Inventory-18 (BSI-18) and 13-Item Stress Test. RESULTS: After adjusting for injury severity, education and time postinjury, the RAI group (N = 75) demonstrated a significantly greater increase in resilience (effect size = 1.03) compared to the WLC group (N = 73). Participants in the RAI group demonstrated more favourable scores on the MPAI-4 Adjustment and Ability Indices, BSI-18 and the 13-item Stress Test. However, only the CD-RISC and BSI-18 demonstrated a clinically significant difference. In addition, RAI participants demonstrated maintenance of gains from pre-treatment to 3-month follow-up; however, only the BSI-18 maintained a clinically significant difference. CONCLUSIONS: Investigation provided evidence that a resilience-focused intervention can improve psychological health and adjustment after TBI. Additional research is needed to ascertain the longer term benefits of intervention and the efficacy of alternative delivery methods (e.g., via telephone, Internet).

Family Needs on an Inpatient Brain Injury Rehabilitation Unit: A Quantitative Assessment.

OBJECTIVE: To examine the needs of family members in an inpatient setting and factors predicting extent to which needs are perceived as met. SETTING: University health system inpatient rehabilitation unit. PARTICIPANTS: Adult survivors of traumatic brain injury and family members (n = 85). DESIGN: Prospective, cross-sectional. MAIN MEASURE: Family Needs Questionnaire-Revised (FNQ-R). RESULTS: Needs related to the Health Information subscale were most frequently rated as met, whereas needs related to the Instrumental Support and Emotional Support subscales were most frequently rated as unmet. Predictors related to the FNQ-R included family income, gender, and ethnicity. For 4 of 6 subscales, white family members were more likely to rate needs as unmet than minority members. For 3 subscales, females were more likely to rate needs as unmet than males. Greater household income was associated with fewer met needs for 2 subscales. CONCLUSIONS: The ranking of met and unmet needs in the present study was remarkably similar to previous studies within and outside the United States. Clinicians should not assume that families with relatively higher incomes will experience fewer unmet needs. Through structured assessment, clinicians can reveal perceived needs that might have otherwise been unrecognized and facilitate appropriate supports. Findings provide direction for inpatient program development.

Predicting Long-Term Global Outcome after Traumatic Brain Injury: Development of a Practical Prognostic Tool Using the Traumatic Brain Injury Model Systems National Database.

For patients surviving serious traumatic brain injury (TBI), families and other stakeholders often desire information on long-term functional prognosis, but accurate and easy-to-use clinical tools are lacking. We aimed to build utilitarian decision trees from commonly collected clinical variables to predict Glasgow Outcome Scale (GOS) functional levels at 1, 2, and 5 years after moderate-to-severe closed TBI. Flexible classification tree statistical modeling was used on prospectively collected data from the TBI-Model Systems (TBIMS) inception cohort study. Enrollments occurred at 17 designated, or previously designated, TBIMS inpatient rehabilitation facilities. Analysis included all participants with nonpenetrating TBI injured between January 1997 and January 2017. Sample sizes were 10,125 (year-1), 8,821 (year-2), and 6,165 (year-5) after cross-sectional exclusions (death, vegetative state, insufficient post-injury time, and unavailable outcome). In our final models, post-traumatic amnesia (PTA) duration consistently dominated branching hierarchy and was the lone injury characteristic significantly contributing to GOS predictability. Lower-order variables that added predictability were age, pre-morbid education, productivity, and occupational category. Generally, patient outcomes improved with shorter PTA, younger age, greater pre-morbid productivity, and higher pre-morbid vocational or educational achievement. Across all prognostic groups, the best and worst good recovery rates were 65.7% and 10.9%, respectively, and the best and worst severe disability rates were 3.9% and 64.1%. Predictability in test data sets ranged from C-statistic of 0.691 (year-1; confidence interval [CI], 0.675, 0.711) to 0.731 (year-2; CI, 0.724, 0.738). In conclusion, we developed a clinically useful tool to provide prognostic information on long-term functional outcomes for adult survivors of moderate and severe closed TBI. Predictive accuracy for GOS level was demonstrated in an independent test sample. Length of PTA, a clinical marker of injury severity, was by far the most critical outcome determinant.

Longitudinal Examination of Resilience After Traumatic Brain Injury: A Traumatic Brain Injury Model Systems Study.

OBJECTIVES: To evaluate (1) the trajectory of resilience during the first year after a moderate-severe traumatic brain injury (TBI); (2) factors associated with resilience at 3, 6, and 12 months postinjury; and (3) changing relationships over time between resilience and other factors. DESIGN: Longitudinal analysis of an observational cohort. SETTING: Five inpatient rehabilitation centers. PARTICIPANTS: Patients with TBI (N=195) enrolled in the resilience module of the TBI Model Systems study with data collected at 3-, 6-, and 12-month follow-up. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Connor-Davidson Resilience Scale. RESULTS: Initially, resilience levels appeared to be stable during the first year postinjury. Individual growth curve models were used to examine resilience over time in relation to demographic, psychosocial, and injury characteristics. After adjusting for these characteristics, resilience actually declined over time. Higher levels of resilience were related to nonminority status, absence of preinjury substance abuse, lower anxiety and disability level, and greater life satisfaction. CONCLUSIONS: Resilience is a construct that is relevant to understanding brain injury outcomes and has potential value in planning clinical interventions.

Relationship Stability After Traumatic Brain Injury Among Veterans and Service Members: A VA TBI Model Systems Study.

OBJECTIVE: To explore stability of relationships and predictors of change in relationship status 2 years following TBI/polytrauma. SETTING: Five Department of Veterans Affairs Polytrauma Rehabilitation Centers (VA PRCs). PARTICIPANTS: A total of 357 active duty service members and Veterans enrolled in the Veterans Affairs Polytrauma Rehabilitation Centers Traumatic Brain Injury Model Systems database with complete marital status information at 2 years postinjury. DESIGN: Prospective, longitudinal, multisite. MAIN MEASURES: Relationship status change was defined as change in marital status (single/never married; married; divorced/separated) at 2-year follow-up, compared with status at enrollment. RESULTS: At the time of enrollment, 134 participants (38%) were single/never married; 151 (42%) were married, and 72 (20%) were divorced/separated. Of those married at enrollment, 78% remained married at year 2 while 22% underwent negative change. Multivariable analyses revealed that age and education at the time of injury and mental health utilization prior to injury were significant predictors of relationship change. Among those who were single/divorced/separated at the time of enrollment, 87% remained so at year 2 while 13% underwent positive change. Injury during deployment significantly predicted positive relationship change. CONCLUSIONS: The unmalleable, preinjury characteristics identified may be used as potential triggers for education, prevention, surveillance, and couples therapy, if needed.

The top 100 cited neurorehabilitation papers.

BACKGROUND: Neurorehabilitation covers a large range of disorders, assessment approaches and treatment methods. There have been previous citation analyses of rehabilitation and of its subfields. However, there has never been a comprehensive citation analysis in neurorehabilitation. OBJECTIVE: The present study reports findings from a citation analysis of the top 100 most cited neurorehabilitation papers to describe the research trends in the field. METHODS: A de-novo keyword search of papers indexed in the Web of Science Core Collection database yielded 52,581 papers. A candidate pool of the 200 most-cited papers published between 2005 and 2016 was reviewed by the clinician authors. The papers in the top 100 deemed to be irrelevant were discarded and replaced by the most highly-cited articles in the second tier deemed to be clinically relevant. RESULTS: The most frequently cited neurorehablitation papers appeared in Stroke, Movement Disorders, and Neurology. Papers tended to focus on treatments, especially for stroke. Authorship trends suggest that top cited papers result from group endeavors, with 90% of the papers involving a collaboration among 3 or more authors. CONCLUSION: Treatment studies, often focused on stroke, appear to have the highest impact in the field of neurorehabilitation.

Marital instability after brain injury: An exploratory analysis.

BACKGROUND: Spousal caregivers have an important role in recovery after brain injury, and there is evidence that injury has an adverse impact on uninjured partners as well as survivors. Unfortunately, the impact of brain injury on coupled relationships has received limited attention from clinical researchers. OBJECTIVE: To characterize marital stability after traumatic brain injury considering the perspectives of the patient and the uninjured partner. To identify predictors of marital stability. METHODS: Forty-two couples with mild to severe injury completed the Marital Status Inventory, a measure of relationship stability, and the Revised Dyadic Adjustment Scale (RDAS), a measure of relationship quality. RESULTS: Twenty-four percent (24%) of patients viewed their marriage as unstable as did 29% of partners. Most individuals (72%) agreed with their partner regarding the stability of their relationship. About half of patients (52%) and partners (50%) reported clinically significant levels of marital dissatisfaction. Multivariate logistic regression indicated that the RDAS was a salient predictor of marital stability. Findings indicate relatively high levels of marital stability despite high levels of marital distress. CONCLUSIONS: Marital stability can be classified beyond labeling couples as married, separated, or divorced. Researchers have suggested that postinjury marital relationships are prone to instability and divorce in comparison to the general population. The present findings suggest otherwise.

Theoretical Applications of Positive Psychology to Vocational Rehabilitation After Traumatic Brain Injury.

PURPOSE: Traumatic brain injury (TBI) produces broad-reaching and often persistent challenges that impact an individual's ability to engage in vocational productivity. Return to work (RTW) rates after TBI are markedly poor and the efficacy of current TBI vocational rehabilitation (VR) practices is unclear. Positive psychology, the practice of fostering positive emotions and traits, offers novel approaches that might enhance the effectiveness of existing TBI VR practices. This article assesses the potential relevance of positive psychology principles and practices to VR for clients recovering from TBI. METHODS: A literature search was conducted using the database resources of a large university hospital, including PubMed, ProQuest, PsycINFO, and Web of Science. Content from this search was reviewed and synthesized, including literature on VR for TBI, vocational applications of positive psychology, and general rehabilitation applications of positive psychology. RESULTS: Ten guiding principles for positively-informed TBI VR are proposed. Specific positive psychology measures and interventions for improving emotional, social, and cognitive functioning are identified and discussed as they might be applied to TBI VR. CONCLUSIONS: Theoretically, positive psychology principles and practices appear to be well suited to improving VR outcomes for individuals with TBI. In addition to examining the feasibility of incorporating positive psychology techniques, future research should examine the impact of positive psychology interventions on RTW rates, job satisfaction, job stability, and other vocational outcomes. With additional investigation, positive psychology measures and interventions may prove to be a beneficial compliment to existing VR practices.

Resilience Following Traumatic Brain Injury: A Traumatic Brain Injury Model Systems Study.

OBJECTIVE: To examine resilience at 3 months after traumatic brain injury (TBI). DESIGN: Cross-sectional analysis of an ongoing observational cohort. SETTING: Five inpatient rehabilitation centers, with 3-month follow-up conducted primarily by telephone. PARTICIPANTS: Persons with TBI (N=160) enrolled in the resilience module of the TBI Model System study with 3-month follow-up completed. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Connor-Davidson Resilience Scale. RESULTS: Resilience scores were lower than those of the general population. A multivariable regression model, adjusting for other predictors, showed that higher education, absence of preinjury substance abuse, and less anxiety at follow-up were significantly related to greater resilience. CONCLUSIONS: Analysis suggests that lack of resilience may be an issue for some individuals after moderate to severe TBI. Identifying persons most likely at risk for low resilience may be useful in planning clinical interventions.

Efficacy of the Brain Injury Family Intervention: Impact on Family Members.

OBJECTIVE: Examine the effectiveness of an intervention (Brain Injury Family Intervention) for family caregivers after acquired brain injury. RESEARCH DESIGN: Prospective, controlled repeated-measures design. METHODS: The Brain Injury Family Intervention was designed as a whole family approach to addressing needs, emphasizing education, skill building, and psychological support. One hundred eight families of outpatients were assigned to either a treatment or wait list control group. The manualized treatment focused on highly relevant topics (eg, common injury effects, coping with loss and change, communication, and stress management) and was composed of five 2-hour sessions with outcome measurement pretreatment, posttreatment, and at 3 months following. Outcome measures included the Family Needs Questionnaire, the Service Obstacles Scale, and the Zarit Burden Interview. RESULTS: Treatment group caregivers showed an increase in met needs, greater satisfaction with services, and reduced burden relative to pretesting, whereas controls did not. Between-group differences for Professional Support needs were identified. CONCLUSIONS: Investigation provided evidence that a curriculum-based education, skill-building, and support intervention can benefit caregivers for up to 3 months. Additional research is needed to ascertain the longer-term benefits of intervention and the efficacy of alternative delivery methods (eg, via telephone and the Internet).

Relationship Between Resilience, Adjustment, and Psychological Functioning After Traumatic Brain Injury: A Preliminary Report.

OBJECTIVE: To examine the relationship between resilience, psychological distress, adjustment, and community participation after traumatic brain injury (TBI). SETTING: Large university health system. PARTICIPANTS: Adult survivors of mild to severe TBI (N = 96). DESIGN: Descriptive, preliminary. MAIN MEASURES: The Connor-Davidson Resilience Scale (10-item version) was used to assess resilience, the Brief Symptom Inventory (BSI-18) was used to characterize psychological distress, and the Mayo-Portland Adaptability Index (MPAI-4) was used to measure ability, adjustment, and participation. RESULTS: Resilience scores were substantially lower than those of the general population. Significant relationships were found between resilience, psychological distress, and adjustment. Partial correlations (adjusting for the other MPAI-4 indices) showed significant correlation (P < .05) between MPAI-4 Adjustment and resilience. Partial correlations (adjusting for the other BSI-18 scales) also showed significance for Depression (P < .01) and resilience. Resilience scores differed significantly (P < .001) between individuals meeting BSI-18 caseness criteria for psychological distress (n = 55) and those not meeting criteria (n = 41). CONCLUSIONS: Individuals with TBI are at risk for low resilience, which was found to correlate with psychological distress and psychosocial maladjustment. Developing interventions to strengthen resilience skills has the potential to improve postinjury psychosocial adjustment, an important area for future research.

Prevalence of traumatic brain injury in cocaine-dependent research volunteers.

BACKGROUND: There is a high prevalence of traumatic brain injury (TBI) among those with substance dependence. However, TBI often remains undiagnosed in these individuals, due to lack of routine screening in substance use treatment settings or due to overlap in some of the cognitive sequelae (eg impulsivity, disinhibition) of TBI and cocaine dependence. METHODS: The prevalence of self-reported mild to moderate TBI in a group of cocaine-dependent (n = 95) and a group of healthy volunteers (n = 75) enrolled at the same facility was assessed. Additionally, the relationship between TBI and clinically relevant correlates, including impulsivity, cocaine use history, and treatment outcome in the cocaine-dependent group was also examined. RESULTS: A higher proportion of individuals with cocaine dependence (29.5%) reported having suffered a TBI in their lifetime compared to controls (8%) on a Closed Head Injury scale. Among cocaine users, the average age of sustaining TBI was significantly lower than the age of initiating cocaine use. Presence of TBI was not associated with higher impulsivity on the Barratt Impulsiveness Scale-11 or self-reported years of cocaine use. No differences were noted on treatment outcome for cocaine dependence as measured by treatment effectiveness scores (TES) between cocaine users with TBI and their non-TBI counterparts. CONCLUSIONS: These results are the first to highlight the high prevalence of TBI among individuals with cocaine dependence. This study underscores the possible role of TBI history as a risk factor for onset of cocaine use, however, more research is needed to determine the impact of co-morbid TBI as a complicating factor in the substance abuse treatment setting.