Enhancing Self-Advocacy After Traumatic Brain Injury: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the efficacy of a novel intervention aimed at enhancing self-advocacy in individuals living with traumatic brain injury (TBI). SETTING: Community. PARTICIPANTS: Sixty-seven (35 allocated to treatment, 32 to control) community-dwelling adults 9 months or more post-TBI (mean of 8.9 years postinjury); previously discharged from inpatient or outpatient TBI rehabilitation; able to travel independently in the community, indicating a level of independence needed to engage in self-advocacy. DESIGN: Longitudinal randomized 2-arm controlled trial (NCT no. 03385824). Computer-generated block randomization allocated participants to treatment/intervention or control/no-intervention. All outcome assessments completed by blinded study staff. INTERVENTION: A manualized group intervention, Self-Advocacy for Independent Life (SAIL), addressing the self-efficacy beliefs, knowledge, and skills for self-advocacy following TBI. MAIN OUTCOME MEASURES: The Self-Advocacy Scale (SAS) (primary); General Self-Efficacy Scale (GSE); Personal Advocacy Activity Scale (PAAS); Satisfaction With Life Scale (SWLS). RESULTS: The treatment group showed significantly greater improvement than controls from baseline to posttreatment on the primary measure (SAS) of self-efficacy specific to self-advocacy after TBI (effect size = 0.22). Similar improvements were found on secondary measures of general self-efficacy and satisfaction with life from baseline to posttreatment. However, significant between-groups gains for primary and secondary measures were not maintained over 6- and 12-week follow-up. CONCLUSIONS: Individuals living with chronic TBI sequelae can increase self-efficacy specific to self-advocacy, general self-efficacy, and satisfaction with life, through a TBI-specific intervention aimed at empowering individuals to advocate for their own needs and wishes. Sustaining gains over time may require ongoing community collaboration and support. This could involve community-based systems of self-advocacy education, resources, and peer support.

Improving well-being after traumatic brain injury through volunteering: a randomized controlled trial.

OBJECTIVE: To evaluate the efficacy of a novel intervention facilitating volunteer activity to improve well-being in individuals with traumatic brain injury (TBI). DESIGN: Randomized two-arm controlled trial, with a wait-list control condition (ClinicalTrials.gov NCT#01728350). SETTING: Community-based setting. PARTICIPANTS: Seventy-four community-dwelling individuals at least 1-year post TBI, who had completed inpatient or outpatient TBI rehabilitation. INTERVENTIONS: A novel intervention, HOPE - Helping Others through Purpose and Engagement, involving orientation/training and a 3-month volunteer placement for the participant, along with training for community agencies regarding TBI. MAIN OUTCOME MEASURE(S: ): Satisfaction With Life Scale (SWLS); Flourishing Scale (FS); Brief Symptom Inventory-18 (BSI-18); Scale of Positive and Negative Experience (SPANE); Purpose in Life subscale (one of six in the Ryff Scale of Psychological Well-Being - 54 item version). RESULTS: There were significantly greater improvements in life satisfaction (SWLS) and self-perceived success (FS) in the intervention group compared to the control group. There were no significant treatment effects on the additional secondary measures of well-being, although they trended in a positive direction. CONCLUSIONS: This study supports our primary hypothesis that individuals who take part in a volunteer intervention will demonstrate greater psychological well-being in comparison to a control group.

Social Competence Treatment After Traumatic Brain Injury: A Multicenter, Randomized Controlled Trial of Interactive Group Treatment Versus Noninteractive Treatment.

OBJECTIVE: To evaluate the effectiveness of a replicable group treatment program for improving social competence after traumatic brain injury (TBI). DESIGN: Multicenter randomized controlled trial comparing 2 methods of conducting a social competency skills program, an interactive group format versus a classroom lecture. SETTING: Community and veteran rehabilitation centers. PARTICIPANTS: Civilian, military, and veteran adults with TBI and social competence difficulties (N=179), at least 6 months postinjury. INTERVENTIONS: The experimental intervention consisted of 13 weekly group interactive sessions (1.5h) with structured and facilitated group interactions to improve social competence, and the control consisted of 13 traditional classroom sessions using the same curriculum with brief supplemental individual sessions but without structured group interaction. MAIN OUTCOME MEASURES: Profile of Pragmatic Impairment in Communication (PPIC), an objective behavioral rating of social communication impairments after TBI. LaTrobe Communication Questionnaire (LCQ), Goal Attainment Scale (GAS), Satisfaction with Life Scale, Posttraumatic Stress Disorder Checklist-C (PCL) civilian version, Brief Symptom Inventory 18 (BSI-18), Scale of Perceived Social Self-Efficacy (PSSE). RESULTS: Social competence goals (GAS) were achieved and maintained for most participants regardless of treatment method. Significant improvements in the primary outcome (PPIC) and 2 of the secondary outcomes (LCQ and BSI) were seen immediately posttreatment and at 3 months posttreatment in the alternative treatment arm only; however, these improvements were not significantly different between the group interactive structured treatment and alternative treatment arms. Similar trends were observed for PSSE and PCL-C. CONCLUSIONS: Social competence skills improved for persons with TBI in both treatment conditions. The group interactive format was not found to be a superior method of treatment delivery in this study.

Psychological well-being in individuals living in the community with traumatic brain injury.

BACKGROUND: Well-being and quality of life issues remain a long-term problem for many individuals with traumatic brain injury (TBI). Meaningful activity is key to developing life satisfaction and a sense of contribution to society, yet individuals with TBI are often unable to return to competitive employment. OBJECTIVE: To describe the self-reported psychological well-being of a cohort of unemployed individuals living in the community at least 1 year post TBI with low life satisfaction. METHODS: Seventy-four unemployed individuals with low life satisfaction at least 1 year post TBI were administered measures of psychological well-being and cognitive functioning. RESULTS: This cohort of 74 participants demonstrated cognitive impairment and elevated levels of emotional distress. Significant bivariate relationships were noted among nearly all measures of well-being, and associations were in the directions as expected. Individuals reported low life satisfaction and well-being. Two newer measures of well-being correlated with established measures used with this population. CONCLUSIONS: Individuals with TBI living in the community who are not employed but who seek to be productive reported low life satisfaction and well-being. This study highlights the need for interventions aimed at increasing productivity and meaning in life for individuals with TBI, and a broader understanding of psychological health after TBI.

Cannabis Use in Individuals With Spinal Cord Injury or Moderate to Severe Traumatic Brain Injury in Colorado.

OBJECTIVES: To describe the prevalence of cannabis use in an adult sample with spinal cord injury (SCI) or traumatic brain injury (TBI) in Colorado, and to describe the self-reported reasons and side effects of cannabis use in this sample. DESIGN: Mixed-methods observational study, using focus group data and telephone survey. SETTING: Community. PARTICIPANTS: Colorado adults who sustained SCI or moderate to severe TBI and received services through Craig Hospital. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Survey. RESULTS: Focus group participants identified issues that were then included in the survey development. Seventy percent of the 116 participants surveyed reported cannabis use before their injury (67% SCI, 74% TBI) and 48% reported use after their injury (53% SCI, 45% TBI). Overall, the most common reason for use was recreational (67%), followed by reducing stress/anxiety (62.5%) and improving sleep (59%). Among the respondents with SCI, the most common reasons for use were to reduce spasticity (70%), recreation (63%), and to improve sleep (63%). Among those with TBI, reasons endorsed were recreational (72%), reducing stress/anxiety (62%), and improving sleep (55%). Smoking was the most common method of use. CONCLUSIONS: A majority of this sample reported using cannabis before injury, and approximately half reported using cannabis after injury. Both groups reported recreational use, whereas the group with SCI also highly endorsed using cannabis to address chronic medical conditions. Clinicians should be aware of the high prevalence of cannabis use in these populations and the impact such use may have on the individual's medical management. Further research in this area is needed.

Improving personal self-advocacy skills for individuals with brain injury: A randomized pilot feasibility study.

OBJECTIVE: To investigate the feasibility of a self-advocacy intervention for individuals with acquired brain injury (ABI). DESIGN: Two-arm, parallel-design, randomized feasibility study. METHODS: Twelve participants, 1-year or more post-ABI (TBI and cerebral vascular accident (CVA)), were randomized into treatment/control groups. The treatment group received a group intervention and workbook; the control group received the workbook only. Outcome measures, taken at baseline, post-treatment and 6-weeks follow-up, included the General Self-Efficacy Scale (GSES), Satisfaction with Life Scale (SWLS) and Goal Attainment Scale (GAS) and two exploratory measures developed for the study: the Self Advocacy Scale (SAS) and the Personal Advocacy Activity Scale (PAAS). RESULTS: Participants were successfully recruited and treated per protocol. The treatment group exhibited improvements from baseline to post-treatment on all measures; the control group improved on the GSES and declined on all others. Both groups exhibited improvement on all measures at follow-up, except the PAAS, which declined. There were no significant group differences on non-parametric analysis at any assessment points; however, the magnitude of change at post-treatment approached significance for the SAS and PAAS. CONCLUSIONS: Initial feasibility for the methodology was demonstrated. Positive trends were noted. Further research could result in an evidence-based intervention to enhance self-advocacy post-ABI.

Initial validation of personal self-advocacy measures for individuals with acquired brain injury.

PURPOSE/OBJECTIVE: The purpose of this study was to evaluate the psychometric properties of 2 novel measures assessing personal advocacy, self-efficacy and personal advocacy activities in individuals with acquired brain injury (ABI). DESIGN: This was an instrument development study using (a) expert panel review with a content validity index, (b) consumer survey, and (c) Rasch analysis. Participants were adults (N = 162) with ABI recruited through a community survey. MAIN OUTCOME MEASURE: Participants completed the Self-Advocacy Scale (SAS) and the Personal Advocacy Activity Scale (PAAS). RESULTS: Using Rasch analysis to inform instrument development, after modification on the basis of item response theory analysis, the SAS, a measure of advocacy self-efficacy, was found to be unidimensional with an eigenvalue of 1.6, exhibited monotonicity, and had an item reliability of 0.97. Similarly, the PAAS, a measure of advocacy activity, was found to exhibit monotonicity, is unidimensional (eigenvalue of 1.7) and had an item reliability of 0.97. Both measures demonstrated concurrent validity, because they were significantly correlated with other established measures of related constructs and with each other. A separation reliability of 0.97 (real not model) for both the SAS and PAAS suggests that items will likely hold their relative positions in a similar sample. CONCLUSIONS: This study supported the PAAS and the SAS as reliable and valid measures of personal advocacy activity and associated self-efficacy in individuals post-ABI. (PsycINFO Database Record

Atomoxetine for attention deficits following traumatic brain injury: results from a randomized controlled trial.

OBJECTIVE: To determine if atomoxetine would improve attention impairment following traumatic brain injury (TBI). SETTING: Outpatients from a free-standing, private, not-for-profit rehabilitation hospital. POPULATION: Fifty-five adult participants with a history of a single moderate-to-severe TBI, who were at least 1 year from injury and with self-reported complaints of attention difficulties. INTERVENTION: Atomoxetine, a selective norepinephrine re-uptake inhibitor with a primary indication for attention dosed at 40 mg twice a day for 2 weeks, compared to placebo. DESIGN: Randomized double-blind placebo controlled trial, with placebo run-in. MEASURES: Cognitive Drug Research (CDR), Computerized Cognitive Assessment System, Stroop Color and Word Test, Adult ADHD Self-Report Scale (ASRS-v1.1), Neurobehavioural Functioning Inventory (NFI). RESULTS: Atomoxetine was well-tolerated by the subject sample. The use of atomoxetine by individuals with reported attention difficulty following TBI did not significantly improve scores on measures of attention, the CDR Power of Attention domain or the Stroop Interference score. In addition, no significant relationship was found between atomoxetine use and self-reported symptoms of attention or depression. CONCLUSION: Atomoxetine did not significantly improve performance on measures of attention among individuals post-TBI with difficulties with attention. This study follows a trend of other pharmacological studies not demonstrating significant results among those with a history of TBI. Various possibilities are discussed, including the need for a more sophisticated system of classification of TBI.

A health and wellness intervention for those with moderate to severe traumatic brain injury: a randomized controlled trial.

OBJECTIVES: To assess the efficacy of a standardized 12-week health and wellness group intervention for those with moderate to severe traumatic brain injury (TBI). STUDY DESIGN: Randomized controlled trial. PARTICIPANTS: Seventy-four individuals with moderate to severe TBI recruited from the outpatient program at a rehabilitation hospital, a Veterans Affairs Medical Center, and the community. METHOD: Eligible participants were randomized to treatment (health and wellness therapy group) or wait-list control (treatment, n = 37; wait-list, n = 37). The primary outcome was the Health Promoting Lifestyle Profile-II. RESULTS: The results of the mixed-model repeated-measures analysis indicated no differences between treatment and control groups engaging in activities to increase their health and well-being. CONCLUSIONS: Findings did not support the efficacy of the intervention. Results may have been impacted by the wide variability of individualized health and wellness goals selected by group members, the structure and/or content of the group, and/or the outcome measures selected.

Health and wellness characteristics of persons with traumatic brain injury.

OBJECTIVE: To describe health and wellness characteristics of persons with TBI living in the community, compare to other disability populations and evaluate the associations between health-related constructs. DESIGN: Observational. SETTING: Outpatient rehabilitation hospital and a Veterans Affairs Medical Centre. PARTICIPANTS: Seventy-four community-dwelling adults with moderate-to-severe TBI. INTERVENTIONS: None. MAIN MEASURES: Health Promoting Lifestyle Profile II (HPLP-II), Self Rated Abilities Health Practices Scale (SRAHP), Barriers to Health Promoting Activities for Disabled Scale (BHPAD), Medical Outcomes Study 12-Item Health Status Survey Short Form (SF-12), Personal Resource Questionnaire-adapted (PRQ-a), Perceived Wellness Survey (PWS), Diener Satisfaction with Life Scale (SWLS) and Participation Assessment with Recombined Tools-Objective (PART-O). RESULTS: Health-promoting behaviours, self-efficacy and barriers to health were comparable to other disability populations. Perceived health status, participation and life satisfaction were decreased. Measures of health promotion and self-efficacy were positively associated with perceived mental health status, life satisfaction and participation. Barriers to healthy activities were negatively associated with health promotion, self-efficacy and perceived mental health status. CONCLUSIONS: Health and wellness status was below desired levels for the study cohort, and comparable to other disability populations. Better understanding of associations among health-related constructs is needed. Continued research on conceptually-based health and wellness interventions for persons with TBI is recommended.

Social communication skills group treatment: a feasibility study for persons with traumatic brain injury and comorbid conditions.

OBJECTIVES: To evaluate the feasibility of improving impaired social communication skills in persons with traumatic brain injury (TBI) and concomitant neurological or psychiatric conditions, using an intervention with evidence of efficacy in a TBI cohort without such complications. RESEARCH DESIGN: Cohort study with pre-post intervention and follow-up assessments. METHODS: Thirty individuals with TBI ≥ 1 year post-injury and identified social communication problems participated in a group intervention to improve social communication skills. INTERVENTIONS: Group Interactive Structured Treatment (GIST) for Social Competence; 13 week, 1.5 hour manualized intervention. OUTCOME MEASURES: Profile of Pragmatic Impairment in Communication (PPIC); Social Communication Skills Questionnaire-Adapted (SCSQ-A); LaTrobe Communication Questionnaire (LCQ); Goal Attainment Scale (GAS), Awareness Questionnaire (AQ), Satisfaction with Life Scale (SWLS); Participation Assessment with Recombined Tools (PART). MAIN OUTCOMES AND RESULTS: Participants made statistically significant gains on the SCSQ-A, GAS and SWLS post-treatment and at 6 months follow-up, using self and other ratings. Gains on the PPIC did not reach statistical significance but trended toward improvement. Treatment effects were not noted in analyses of the AQ or the PART. The LCQ showed statistically significant gains post-treatment and at follow-up. CONCLUSIONS: Participants showed improvement on subjective social communication skills measures post-treatment and at follow-up, demonstrating potential efficacy of the intervention in a broader population of persons with TBI, worthy of further investigation.

The impact of female reproductive function on outcomes after traumatic brain injury.

OBJECTIVES: To determine the impact of traumatic brain injury (TBI) on female menstrual and reproductive functioning and to examine the relationships between severity of injury, duration of amenorrhea, and TBI outcomes. DESIGN: Retrospective cohort survey. SETTING: Telephone interview. PARTICIPANTS: Women (N=30; age range, 18-45y), between 1 and 3 years postinjury, who had completed inpatient rehabilitation for TBI. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Data collected included menstrual and reproductive functioning pre- and postinjury, demographic, and injury characteristics. Outcome measures included the Glasgow Outcome Scale-Extended (GOS-E), the Mayo-Portland Adaptability Inventory-4 (MPAI-4), and the Medical Outcome Study 12-Item Short-Form Health Survey, Version 2 (SF-12v2). RESULTS: The median duration of amenorrhea was 61 days (range, 20-344d). Many subjects' menstrual function changed after TBI, reporting a significant increase in skipped menses postinjury (P<.001) and a trend toward more painful menses (P=.061). More severe TBI, as measured by the duration of posttraumatic amnesia, was significantly predictive of a longer duration of amenorrhea (P=.004). Subjects with a shorter duration of amenorrhea scored significantly better on the SF-12 physical component subscale (P=.004), the GOS-E (P=.05), and the MPAI-4 participation subscale (P=.05) after controlling for age, injury severity, and time postinjury. CONCLUSIONS: The severity of TBI was predictive of duration of amenorrhea and a shorter duration of amenorrhea was predictive of better ratings of global outcome, community participation, and health-related quality of life postinjury.

A randomized trial of modafinil for the treatment of fatigue and excessive daytime sleepiness in individuals with chronic traumatic brain injury.

BACKGROUND: This study examines the efficacy of modafinil in treating fatigue and excessive daytime sleepiness in individuals with traumatic brain injury (TBI). METHODS: A single-center, double-blind, placebo-controlled cross-over trial, where 53 participants with TBI were randomly assigned to receive up to 400 mg of modafinil, or equal number of inactive placebo tablets. Main eligibility criteria were being at least 1 year post-TBI severe enough to require inpatient rehabilitation. The primary outcome measures were fatigue (Fatigue Severity Scale, FSS) and daytime sleepiness (Epworth Sleepiness Scale, ESS). RESULTS: After adjusting for baseline scores and period effects, there were no statistically significant differences between improvements seen with modafinil and placebo in the FSS at week 4 (-0.5 +/- 1.88; P = .80) or week 10 (-1.4 +/- 2.75; P = .61). For ESS, average changes were significantly greater with modafinil than placebo at week 4 (-1.2 +/- 0.49; P = .02) but not at week 10 (-0.5 +/- 0.87; P = .56). Modafinil was safe and well tolerated, although insomnia was reported significantly more often with modafinil than placebo (P = .03). CONCLUSIONS: While there were sporadic statistically significant differences identified, a clear beneficial pattern from modafinil was not seen at either week 4 or week 10 for any of the 12 outcomes. There was no consistent and persistent clinically significant difference between treatment with modafinil and placebo.

Treatment efficacy of social communication skills training after traumatic brain injury: a randomized treatment and deferred treatment controlled trial.

OBJECTIVE: To evaluate the efficacy of a replicable group treatment program to improve social communication skills after traumatic brain injury (TBI). DESIGN: Randomized treatment and deferred treatment controlled trial, with follow-up at 3, 6, and 9 months post-treatment. SETTING: Community. PARTICIPANTS: Volunteer sample of 52 people with TBI who were at least 1 year postinjury, who received rehabilitation, and who had identified social communication deficits. INTERVENTION: Twelve weekly group sessions (1.5 h each) to improve social communication. MAIN OUTCOME MEASURES: The Profile of Functional Impairment in Communication (PFIC), Social Communication Skills Questionnaire-Adapted (SCSQ-A), Goal Attainment Scale (GAS), Craig Handicap Assessment and Reporting Technique-Short Form social integration and occupation subscales, Community Integration Questionnaire social integration and productivity subscales, and Satisfaction With Life Scale (SWLS). RESULTS: Independent samples t test analysis showed significant treatment effect compared with no treatment on 7 of 10 of the PFIC subscales (P range, .024 to <.001) and the SCSQ-A (P=.005) after the first 12 weeks of the study. After 12 weeks of treatment for all participants, repeated-measures analysis showed significant improvements from baseline on 9 of 10 PFIC subscales (P range, .01-.001), SCSQ-A (P < or = .001), GAS (P < or = .001), and SWLS (P = .011). At 6-month follow-up, scores were significantly better than baseline on 6 of 10 PFIC scales (P range, .01-.001), the SCSQ-A (P < or = .001), GAS (P < or = .001), and SWLS (P < or = .001). CONCLUSIONS: TBI subjects who received social communication skills training had improved communication skills that were maintained on follow-up. Overall life satisfaction for participants was improved.

Social communication skills in persons with post-acute traumatic brain injury: three perspectives.

OBJECTIVE: To describe social communication skills problems identified by individuals with traumatic brain injury (TBI) compared to significant other (SO) and clinician ratings; and associations between these skills and participation outcome measures. DESIGN: Cohort study. METHODS: Sixty individuals with TBI > or = 1 year post-injury were administered measures of social communication, societal participation, social integration and life satisfaction. Clinicians and SOs rated the social communication skills of the subjects. RESULTS: Subjects were able to identify social communication skills problems, associated with lower ratings of community integration and satisfaction with life. Males reported higher scores in social communication and social integration than females. SOs and clinicians identified more social skills problems than subjects. CONCLUSIONS: Persons with TBI experience social communication skills deficits, associated with decreased societal participation and life satisfaction. Further research is needed to determine efficacy of social communication skills treatment and association with improved participation and satisfaction with life.

The effect of Aricept in persons with persistent memory disorder following traumatic brain injury: a pilot study.

PRIMARY OBJECTIVE: To investigate the effectiveness of donepezil hydrochloride (Aricept) in treating persistent memory deficits in people with traumatic brain injury. RESEARCH DESIGN: Single subject ABAC design was used so that each participant could serve as their own control. METHODS AND PROCEDURES: Seven TBI survivors with persistent memory dysfunction, at least 1.5 years post-injury, underwent two 6-month trials of Aricept. The following tests were used to assess memory and cognition: Brief Visual Memory Test-Revised (BVMT-R), Hopkins Verbal Learning Test, Digit Span and Letter Number Sequence sub-test of the Wechsler Adult Intelligence Scale-III, Controlled Oral Word Association Test and Memory Functioning Questionnaire. EXPERIMENTAL INTERVENTION: During the first treatment phase, participants received 5 mg/day of Aricept for 1 month, increasing to 10 mg/day of Aricept for an additional 5 months. During the second treatment phase, participants received 5 mg/day of Aricept for the entire 6 months. MAIN OUTCOMES AND RESULTS: A repeated measures analysis of variance indicated significant improvement on immediate and delayed memory portions of the BVMT-R when taking 10 mg/day of Aricept. CONCLUSIONS: Findings contribute to the growing body of research into the use of Aricept in treating memory deficits in TBI survivors and support the need for further research.