Study protocol: exercise training for treating major depressive disorder in multiple sclerosis.

BACKGROUND: Major depressive disorder (MDD) is prevalent, yet sub-optimally treated among persons with multiple sclerosis (MS). We propose that exercise training may be a promising approach for treating depression in persons with MS who have MDD. Our primary hypothesis predicts a reduction in depression severity immediately after an exercise training intervention compared with minimal change in an attention control condition, and the reduction will be maintained during a follow-up period. METHODS: This study involves a parallel-group, assessor-blinded RCT that examines the effect of a 4-month home-based exercise training intervention on depression severity in a sample of persons with MS who have MDD based on the MINI International Neuropsychiatric Interview. The primary outcomes of depression severity are the Patient Health Questionnaire-9 and Hamilton Depression Rating Scale. Participants (N = 146) will be recruited from within 200 miles of the University of Illinois at Chicago and randomized (1:1) into either a home-based exercise training condition or control condition with concealed allocation. The exercise training and social-contact, attention control (i.e., stretching) conditions will be delivered remotely over a 4-month period and supported through eight, 1:1 Zoom-based behavioral coaching sessions guided by social-cognitive theory and conducted by persons who are uninvolved in screening, recruitment, random assignment, and outcome assessment. We will collect outcome data at 0, 4 and 8 months using treatment-blinded assessors, and data analyses will involve intent-to-treat principles. DISCUSSION: If successful, the proposed study will provide the first Class I evidence supporting a home-based exercise training program for treating MDD in persons with MS. This is critical as exercise training would likely have positive secondary effects on symptoms, cognition, and quality of life, and provide a powerful, behavioral approach for managing the many negative outcomes of MDD in MS. The program in the proposed research is accessible and scalable for broad treatment of depression in MS, and provides the potential for integration in the clinical management of MS. TRIAL REGISTRATION: The trial was registered on September 10, 2021 at clinicaltrials.gov with the identifier NCT05051618. The registration occurred before we initiated recruitment on June 2, 2023.

The Temporal Relationship Between Moderate to Vigorous Physical Activity and Secondary Conditions During the First Year After Moderate to Severe Traumatic Brain Injury.

OBJECTIVE: To determine the cross-sectional and temporal relationships between minutes per week of moderate to vigorous physical activity (MVPA) as measured by a wrist-worn accelerometer and secondary conditions in the first year after moderate to severe traumatic brain injury (TBI). DESIGN: Prospective longitudinal cohort study. SETTING: Four inpatient rehabilitation centers. PARTICIPANTS: Individuals (N = 180) with moderate-severe TBI enrolled in the TBI Model Systems Study. INTERVENTIONS: Participants wore a wrist accelerometer for 7 days immediately post discharge, and for 7 consecutive days at 6- and 12-months post injury. MAIN OUTCOME MEASURES: Minutes per week of MVPA from daily averages based on wrist worn accelerometer. Secondary conditions included depression (Patient Health Questionnaire-9), fatigue (PROMIS Fatigue), Pain (Numeric Rating Scale), Sleep (Pittsburgh Sleep Quality Index), and cognition (Brief Test of Adult Cognition by Telephone). RESULTS: At baseline, 6 and 12 months, 61%, 70% and 79% of the sample achieved at least 150 minutes per week of MVPA. The correlations between minutes of MVPA between baseline, 6 and 12 months were significant (r = 0.53-0.73), as were secondary conditions over these time points. However, no significant correlations were observed between minutes of MVPA and any secondary outcomes cross-sectionally or longitudinally at any time point. CONCLUSIONS: Given the robust relationships physical activity has with outcomes in the general population, further research is needed to understand the effect of physical activity in individuals with moderate-severe TBI.

Disparities based on demographic features in the intensity and treatment of chronic pain in US patients with spinal cord injury.

OBJECTIVE: Informed by Minority Stress Theory, to investigate disparities in pain intensity, interference, and care in patients with spinal cord injuries (SCI) based on demographic features. DESIGN: Cross-sectional survey SETTING: Outpatient SCI clinics in two academic medical centers in the northwestern US. PARTICIPANTS: Sample of 242 SCI clinic patients who endorsed SCI-related pain, were 18-years-of-age or older, English-fluent, not diagnosed with bipolar or psychotic disorders, and able to make their own medical decisions. Participants were 74.8% male, an average of 48.5 years (range 18.1-89.8 years), 76.2% White, 31.9% privately insured, and 64.7% making less than $50,000 per year. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE(S): Exploratory analyses of screening data from a randomized controlled trial for pain treatment. Primary outcomes included pain intensity, pain interference, and the patient report of recommended pain treatments by a medical provider, tried by the patient, or that the patient would be willing to try. RESULTS: More treatments recommended was associated with younger age (ρ=-0.14, 95%CI: -0.01 to -0.27, p=.03) and private insurance ((ρ=-0.15, 95%CI: 0.02 to 0.27, p=.03), while more treatments tried was associated with private insurance alone (ρ=0.20, 95%CI: 0.07 to 0.32, p=.003). Number of treatments willing to be tried was associated with lower income (ρ=-0.15, 95%CI: -0.02 to -0.28, p=.03). SCI Patients of Color (POC) reported higher pain intensity (Cohen's D = 0.41, 95%CI:0.11-0.71) and greater odds of receiving psychotherapy for pain (OR: 7.12, 95%CI: 1.25-40.46) than their White peers. CONCLUSION(S): These exploratory findings indicate differences in SCI-related pain intensity based on identifying as POC, and differences in SCI-related pain treatment modalities based on identifying as POC, age, insurance type, and income. Further work exploring differences in SCI-related pain care based on patient social identities is warranted.

Feasibility of Brief, Hypnotic Enhanced Cognitive Therapy for SCI-related Pain During Inpatient Rehabilitation.

OBJECTIVES: (1) Adapt evidence-based hypnosis-enhanced cognitive therapy (HYP-CT) for inpatient rehabilitation setting; and (2) determine feasibility of a clinical trial evaluating the effectiveness of HYP-CT intervention for pain after spinal cord injury (SCI). STUDY DESIGN: Pilot non-randomized controlled trial. SETTING: Inpatient rehabilitation unit. PARTICIPANTS: English-speaking patients admitted to inpatient rehabilitation after SCI reporting current pain of at least 3 on a 0-10 scale. Persons with severe psychiatric illness, recent suicide attempt or elevated risk, or significant cognitive impairment were excluded. Consecutive sample of 53 patients with SCI-related pain enrolled, representing 82% of eligible patients. INTERVENTION: Up to 4 sessions of HYP-CT Intervention, each 30-60 minutes long. METHODS: Participants were assessed at baseline and given the choice to receive HYP-CT or Usual Care. MAIN OUTCOME MEASURES: Participant enrollment and participation and acceptability of intervention. Exploratory analyses examined the effect of intervention on pain and cognitive appraisals of pain. RESULTS: In the HYP-CT group, 71% completed at least 3 treatment sessions and reported treatment benefit and satisfaction with the treatment; no adverse events were reported. Exploratory analyses of effectiveness found pre-post treatment pain reductions after HYP-CT with large effect (P<.001; ß=-1.64). While the study was not powered to detect significant between-group differences at discharge, effect sizes revealed decreases in average pain (Cohen's d=-0.13), pain interference (d=-0.10), and pain catastrophizing (d=-0.20) in the HYP-CT group relative to control and increases in self-efficacy (d=0.27) and pain acceptance (d=0.15). CONCLUSIONS: It is feasible to provide HYP-CT to inpatients with SCI, and HYP-CT results in substantial reductions in SCI pain. The study is the first to show a psychological-based nonpharmacologic intervention that may reduce SCI pain during inpatient rehabilitation. A definitive efficacy trial is warranted.

Dynamics of Perceived Social Isolation, Secondary Conditions, and Daily Activity Patterns Among Individuals With Stroke: A Network Analysis of Ecological Momentary Assessment Data.

OBJECTIVE: To assess contemporaneous and temporal dynamics of perceived social isolation (PSI), secondary conditions, and daily activity patterns in individuals post-stroke. DESIGN: Longitudinal observational study using ecological momentary assessment (EMA) as a real-time assessment of an individual's lived experiences. We conducted dynamic network analyses to examine longitudinal associations among EMA variables. SETTINGS: Home and Community. PARTICIPANTS: 202 individuals with mild-to-moderate chronic stroke (median age=60 years; 45% women; 44% black; 90% ischemic stroke; median NIHSS score=2; N=202). INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: EMA questions measured PSI, secondary conditions (pain, tiredness, stress, anxiety, worthlessness, difficulty concentrating, and cheerfulness), and daily activity patterns (being at home, being alone, and participating in productive activities). RESULTS: The median EMA response rate was 84%. The contemporaneous model showed that PSI was associated with being home, alone, and all symptoms except pain. The temporal model revealed a pathway indicating that feelings of worthlessness predicted PSI (regression coefficient=0.06, P=.019), followed by stress (regression coefficient=0.06, P=.024), and then by being not at home (regression coefficient=-0.04, P=.013). CONCLUSION: Implementing dynamic network analyses on EMA data can uncover dynamic connections among PSI, secondary conditions, and daily activity patterns after stroke. This study found a significant temporal association between PSI and negative emotions. Feeling isolated was followed by feeling stressed, which was followed by a tendency to be out of home, indicating adaptive behaviors in individuals with stroke. These findings highlight the importance of engaging in out-of-home or outdoor activities to mitigate PSI and negative emotions.

Variables Associated With Moderate to High Loneliness Among Individuals Living With Spinal Cord Injuries and Disorders.

OBJECTIVE: To identify variables independently associated with moderate to high loneliness in individuals living with Spinal Cord Injuries or Disorders (SCI/D). DESIGN: A cross-sectional, national survey of a random sample of community-dwelling Veterans with SCI/D in the United States. Survey methodology was used to collect data on demographic and injury characteristics, general health, chronic and SCI-secondary conditions, and loneliness. SETTING: The VHA SCI/D System of Care including 25 regional SCI/D Centers (or Hubs). PARTICIPANTS: Among 2466 Veterans with SCI/D, 592 completed surveys (24%). Most participants were men (91%), white (81%), not currently married (42%), had tetraplegia (33%), and on average injured for 18 years at the time of data collection (N=562). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: The dependent variable, loneliness, was collected using the UCLA-3 instrument. Loneliness was dichotomized into never/low loneliness and moderate/high loneliness (UCLA score ≥ 4). RESULTS: Bivariate analyses assessed unadjusted associations in demographics, injury characteristics, chronic disease, and SCI-secondary conditions. Multivariable logistic regression was used to identify factors independently associated with moderate/high loneliness. Participants had a mean loneliness score of 5.04, SD=1.99. The point prevalence of moderate to high loneliness was 66%. Lower duration of injury, paraplegia, being unmarried, being in fair/poor general health, having dysfunctional sleep, and having a diagnosis of bowel dysfunction were each independently associated with greater odds of moderate/high loneliness. CONCLUSIONS: Findings suggest that interventions to reduce/manage loneliness in the Veteran SCI/D population should focus on those who are more newly injured, have paraplegia, currently unmarried, have bowel problems, and experience dysfunctional sleep.

Predictors of Physical Activity One Year After Moderate to Severe Traumatic Brain Injury.

OBJECTIVE: To identify predictors of moderate to vigorous physical activity (MVPA) at 12-months post-moderate-severe traumatic brain injury (TBI). Setting: Four inpatient rehabilitation centers. PARTICIPANTS: Individuals enrolled in the TBI Model Systems with moderate to severe TBI, admitted to inpatient rehabilitation, and able to ambulate without physical assistance from another person. DESIGN: Prospective longitudinal cohort study. MVPA was measured by having participants wear an ActiGraph GT3X on their wrist for 7 consecutive days. MAIN ANALYSES: We used multivariate regression to predict minutes per week of MVPA at 12 months after TBI. Three classes of predictors were entered hierarchically-demographic and clinical variables (age, sex, body mass index, education, TBI severity, neighborhood walkability score, and self-reported preinjury physical activity [PA] level), baseline TBI-related comorbid conditions (eg, measures of sleep, pain, mood, fatigue, and cognition), and intention to exercise and exercise self-efficacy assessed approximately 1 week after discharge from inpatient rehabilitation. RESULTS: 180 participants (ages 17.7-90.3 years) were enrolled, and 102 provided at least 5 days of valid accelerometer data at 12 months. At 12 months, participants recorded an average of 703 (587) minutes per week of MVPA. In univariate and multivariate analyses, age was the only significant predictor of 12-month MVPA (r = -0.52). A sharp decline in MVPA was observed in the tertile of participants who were over the age of 61. CONCLUSIONS: Older adults with TBI are at elevated risk of being physically inactive. Assuming PA may enhance health after TBI, older adults are a logical target for prevention or early intervention studies. Studies with longer outcomes are needed to understand the trajectory of PA levels after TBI.

Depression, Anxiety, and Suicidality in Individuals With Chronic Traumatic Brain Injury Before and During the COVID-19 Pandemic: A National Institute on Disability, Independent Living, and Rehabilitation Research Traumatic Brain Injury Model Systems Study.

OBJECTIVE: To examine the prevalence, severity, and correlates of depression, anxiety, and suicidal ideation in people with traumatic brain injury (TBI) assessed before and during the COVID-19 pandemic. DESIGN: Retrospective cohort study using data collected through the Traumatic Brain Injury Model Systems (TBIMS) network at 1, 2, 5, 10, 15, 20, 25, or 30 years post TBI. SETTING: United States-based TBIMS rehabilitation centers with telephone assessment of community residing participants. PARTICIPANTS: Adults (72.4% male; mean age, 47.2 years) who enrolled in the TBIMS National Database and completed mental health questionnaires prepandemic (January 1, 2017 to February 29, 2020; n=5000) or during pandemic (April 1, 2022 to June 30, 2021; n=2009) (N=7009). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 questionnaire. RESULTS: Separate linear and logistic regressions were constructed with demographic, psychosocial, injury-related, and functional characteristics, along with a binary indicator of COVID-19 pandemic period (prepandemic vs during pandemic), as predictors of mental health outcomes. No meaningful differences in depression, anxiety, or suicidal ideation were observed before vs during the COVID-19 pandemic. Correlations between predictors and mental health outcomes were similar before and during the pandemic. CONCLUSIONS: Contrary to our predictions, the prevalence, severity, and correlates of mental health conditions were similar before and during the COVID-19 pandemic. Results may reflect generalized resilience and are consistent with the most recent findings from the general population that indicate only small, transient increases in psychological distress associated with the pandemic. While unworsened, depression, anxiety, and suicidal ideation remain prevalent and merit focused treatment and research efforts.

Societal Participation of People With Traumatic Brain Injury Before and During the COVID-19 Pandemic: A NIDILRR Traumatic Brain Injury Model Systems Study.

OBJECTIVE: To examine the effect of the COVID-19 pandemic on societal participation in people with moderate-to-severe traumatic brain injury (TBI). DESIGN: Cross-sectional retrospective cohort. SETTING: National TBI Model Systems centers, United States. PARTICIPANTS: TBI Model Systems enrollees (N=7003), ages 16 and older and 1-30 years postinjury, interviewed either prepandemic (PP) or during the pandemic (DP). The sample was primarily male (72.4%) and White (69.5%), with motor vehicle collisions as the most common cause of injury (55.1%). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: The 3 subscales of the Participation Assessment with Recombined Tools-Objective: Out and About (community involvement), Productivity, and Social Relations. RESULTS: Out and About, but not Productivity or Social Relations, scores were appreciably lower among DP participants compared to PP participants (medium effect). Demographic and clinical characteristics showed similar patterns of association with participation domains across PP and DP. When their unique contributions were examined in regression models, age, self-identified race, education level, employment status, marital status, income level, disability severity, and life satisfaction were variably predictive of participation domains, though most effects were small or medium in size. Depression and anxiety symptom severities each showed small zero-order correlations with participation domains across PP and DP but had negligible effects in regression analyses. CONCLUSIONS: Consistent with the effect of COVID-19 on participation levels in the general population, people with TBI reported less community involvement during the pandemic, potentially compounding existing postinjury challenges to societal integration. The pandemic does not appear to have altered patterns of association between demographic/clinical characteristics and participation. Assessing and addressing barriers to community involvement should be a priority for TBI treatment providers. Longitudinal studies of TBI that consider pandemic-related effects on participation and other societally linked outcomes will help to elucidate the potential longer-term effect the pandemic has on behavioral health in this population.

Cognitive Performance, Depression, and Anxiety 1 Year After Traumatic Brain Injury.

OBJECTIVES: To evaluate associations between depression, anxiety, and cognitive impairment among individuals with complicated mild to severe traumatic brain injury (TBI) 1 year after injury. SETTING: Multiple inpatient rehabilitation units across the United States. PARTICIPANTS: A total of 498 adults 16 years and older who completed inpatient rehabilitation for complicated mild to severe TBI. DESIGN: Secondary analysis of a prospective, multicenter, cross-sectional observational cohort study. MAIN MEASURES: Assessments of depression (Traumatic Brain Injury Quality of Life [TBI-QOL] Depression) and anxiety (TBI-QOL Anxiety) as well as a telephone-based brief screening measure of cognitive functioning (Brief Test of Adult Cognition by Telephone [BTACT]). RESULTS: We found an inverse relationship between self-reported depression symptoms and the BTACT Composite score (ß = -0.18, P < .01) and anxiety symptoms and the BTACT Composite score (ß = -0.20, P < .01). There was no evidence this relationship varied by injury severity. Exploratory analyses showed depression and anxiety were negatively correlated with both BTACT Executive Function factor score and BTACT Memory factor score. CONCLUSIONS: Both depression and anxiety have a small but significant negative association with cognitive performance in the context of complicated mild to severe TBI. These findings highlight the importance of considering depression and anxiety when interpreting TBI-related neuropsychological impairments, even among more severe TBI.

Crash Risk Following Return to Driving After Moderate-to-Severe TBI: A TBI Model Systems Study.

OBJECTIVE: To examine motor vehicle crash frequency and risk factors following moderate-to-severe traumatic brain injury (TBI). SETTING: Eight TBI Model Systems sites. Participants: Adults ( N = 438) with TBI who required inpatient acute rehabilitation. DESIGN: Cross-sectional, observational design. MAIN MEASURES: Driving survey completed at phone follow-up 1 to 30 years after injury. RESULTS: TBI participants reported 1.5 to 2.5 times the frequency of crashes noted in the general population depending on the time frame queried, even when accounting for unreported crashes. Most reported having no crashes; for those who experienced a crash, half of them reported a single incident. Based on logistic regression, age at survey, years since injury, and perception of driving skills were significantly associated with crashes. CONCLUSION: Compared with national statistics, crash risk is higher following TBI based on self-report. Older age and less time since resuming driving were associated with lower crash risk. When driving was resumed was not associated with crash risk. These results do not justify restricting people from driving after TBI, given that the most who resumed driving did not report experiencing any crashes. However, there is a need to identify and address factors that increase crash risk after TBI.

Barriers to driving and psychosocial outcomes after traumatic brain injury.

OBJECTIVE: Examine considerations and perceived barriers to return to driving, and their association with psychosocial outcomes among adults with traumatic brain injury (TBI) who were not driving. METHODS: 174 adults with moderate-to-severe TBI enrolled in the TBI Model System participated in this cross-sectional study. All participants were drivers prior to their TBI. Outcome measures included the Barriers to Driving Questionnaire, Disability Rating Scale, Patient Health Questionnaire-9, General Anxiety Disorder-7, and Satisfaction With Life Scale. Descriptive analyses examined considerations and barriers to driving, including differences associated with demographic characteristics. Moderation analyses investigated the extent to which disability moderated the relationship between barriers and psychosocial outcomes. RESULTS: Social barriers were the most strongly endorsed domain, whereas physical barriers were endorsed least. The profile of endorsements differed for men and women, and for Black and White participants, on both theoretical considerations in returning to drive and experiences of barriers in doing so. Disability level moderated the relationship between barriers to driving and depression and life satisfaction, but not anxiety. CONCLUSION: The experience of barriers to driving is differentially associated with psychosocial outcomes among nondriving adults with TBI. Adults with low disability appear to be at risk for distress, even compared to other nondrivers.

Factors Associated With High and Low Life Satisfaction 10 Years After Traumatic Brain Injury.

OBJECTIVE: To identify correlates of life satisfaction at 10 years after moderate to severe traumatic brain injury (TBI) using an extreme phenotyping approach. DESIGN: Effect sizes were calculated in this observational cohort study to estimate relationships of 10-year postinjury extremely high, extremely low, and moderate life satisfaction with (1) pre-injury demographics, injury-related factors, and functional characteristics at inpatient rehabilitation admission and discharge; and (2) postinjury demographics and clinical and functional measures at 10 years postinjury. SETTING: Multicenter longitudinal database study. PARTICIPANTS: People identified from the National Institute on Disability, Independent Living, and Rehabilitation Research TBI Database with life satisfaction data at 10 years post TBI (N=4800). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Satisfaction With Life Scale. RESULTS: Although few pre-injury factors or clinical and functional factors shortly after injury were associated with 10-year life satisfaction groups, the following 10-year postinjury factors were associated with extremely high vs extremely low life satisfaction group membership: greater independent functioning, less disability, more frequent community participation, being employed, and having fewer depressive and anxiety symptoms. Those with extremely high life satisfaction were distinctly different from those with moderate and extremely low satisfaction. Extremely high life satisfaction was underrepresented among non-Hispanic Black persons relative to non-Hispanic White persons. Relationships between life satisfaction and independent functioning, disability, and participation were attenuated among non-Hispanic Black persons. CONCLUSIONS: Extreme phenotyping analysis complements existing knowledge regarding life satisfaction after moderate to severe TBI and may inform acute and postacute clinical service delivery by comparing extremely high and extremely low life satisfaction subgroups. Findings suggest little association among personal, clinical, and functional characteristics early post TBI and life satisfaction 10 years later. Contemporaneous correlates of extremely high life satisfaction exist at 10 years post TBI, although the positive relationship of these variables to life satisfaction may be attenuated for non-Hispanic Black persons.

Anxiety Trajectories the First 10 Years After a Traumatic Brain Injury (TBI): A TBI Model Systems Study.

OBJECTIVE: Determine anxiety trajectories and predictors up to 10 years posttraumatic brain injury (TBI). DESIGN: Prospective longitudinal, observational study. SETTING: Inpatient rehabilitation centers. PARTICIPANTS: 2836 participants with moderate to severe TBI enrolled in the TBI Model Systems National Database who had ≥2 anxiety data collection points (N=2836). MAIN OUTCOME MEASURE: Generalized Anxiety Disorder-7 (GAD-7) at 1, 2, 5, and 10-year follow-ups. RESULTS: Linear mixed models showed higher GAD-7 scores were associated with Black race (P<.001), public insurance (P<.001), pre-injury mental health treatment (P<.001), 2 additional TBIs with loss of consciousness (P=.003), violent injury (P=.047), and more years post-TBI (P=.023). An interaction between follow-up year and age was also related to GAD-7 scores (P=.006). A latent class mixed model identified 3 anxiety trajectories: low-stable (n=2195), high-increasing (n=289), and high-decreasing (n=352). The high-increasing and high-decreasing groups had mild or higher GAD-7 scores up to 10 years. Compared to the low-stable group, the high-decreasing group was more likely to be Black (OR=2.25), have public insurance (OR=2.13), have had pre-injury mental health treatment (OR=1.77), and have had 2 prior TBIs (OR=3.16). CONCLUSIONS: A substantial minority of participants had anxiety symptoms that either increased (10%) or decreased (13%) over 10 years but never decreased below mild anxiety. Risk factors of anxiety included indicators of socioeconomic disadvantage (public insurance) and racial inequities (Black race) as well as having had pre-injury mental health treatment and 2 prior TBIs. Awareness of these risk factors may lead to identifying and proactively referring susceptible individuals to mental health services.

Relations Among Suicidal Ideation, Depressive Symptoms, and Functional Independence During the 10 Years After Traumatic Brain Injury: A Model Systems Study.

OBJECTIVE: To investigate relative causality in relations among suicidal ideation (SI), depressive symptoms, and functional independence over the first 10 years after traumatic brain injury (TBI). DESIGN: Prospective longitudinal design with data collected through the Traumatic Brain Injury Model Systems (TBIMS) network at acute rehabilitation hospitalization as well as 1, 2, 5, and 10 years after injury. SETTING: United States Level I/II trauma centers and inpatient rehabilitation centers with telephone follow-up. PARTICIPANTS: Individuals enrolled into the TBIMS National Database (N=9539) with at least 1 SI score at any follow-up data collection (72.1% male; mean age, 39.39y). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Patient Health Questionnaire-9 and FIM at years 1, 2, 5, and 10 post injury. RESULTS: A cross-lagged panel structural equation model, which is meant to indirectly infer causality through longitudinal correlational data, suggested that SI, depressive symptoms, and functional independence each significantly predicted themselves over time. Within the model, bivariate correlations among variables were all significant within each time point. Between years 1 and 2 and between years 2 and 5, depressive symptoms had a larger effect on SI than SI had on depressive symptoms. Between years 5 and 10, there was reciprocal causality between the 2 variables. Functional independence more strongly predicted depressive symptoms than the reverse between years 1 and 2 as well as years 2 and 5, but its unique effects on SI over time were extremely marginal or absent after controlling for depressive symptoms. CONCLUSIONS: A primary goal for rehabilitation and mental health providers should be to monitor and address elevated symptoms of depression as quickly as possible before they translate into SI, particularly for individuals with TBI who have reduced functional independence. Doing so may be a key to breaking the connection between low functional independence and SI.

Identifying group-based patterns of suicidal ideation over the first 10 years after moderate-to-severe TBI.

OBJECTIVE: To identify group-based patterns in suicidal ideation (SI) over the first 10 years after traumatic brain injury (TBI). METHODS: Participants included 9539 individuals in the TBI Model Systems National Database who responded to Patient Health Questionnaire-9 Item 9 assessing SI at 1, 2, 5, and/or 10 years post-injury. A k-means cluster analysis was conducted to determine group-based patterns of SI, and pre-injury variables were compared with ANOVAs and chi-square tests. RESULTS: SI and attempts decreased over time. Four group-based patterns emerged: Low, increasing, moderate, and decreasing SI. The low SI group comprised 89% of the sample, had the highest pre-injury employment, fewer mental health vulnerabilities, least severe injuries, and were oldest. The increasing SI group had the most severe TBIs, were youngest, and disproportionately Black or Asian/Pacific Islander. CONCLUSION: These findings reinforce the importance of mental health and suicide risk assessment during chronic recovery from TBI.

Return to Driving After Moderate-to-Severe Traumatic Brain Injury: A Traumatic Brain Injury Model System Study.

OBJECTIVE: Describe who is able to return to driving (RTD) after moderate-to-severe traumatic brain injury (TBI), when this occurs, who maintains that activity, and the association with outcome. DESIGN: Cross-sectional descriptive study. SETTING: Eight follow-up sites of the TBI Model Systems (TBIMS) program. PARTICIPANTS: 618 participants enrolled in the TBIMS and 88 caregivers (N=706). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: A survey was completed from 1-30 years postinjury focusing on RTD. Descriptors included demographic information, injury severity, and current employment status. Outcome was assessed at the time of the interview, including depression, quality of life, functional status, and community participation. RESULTS: Of 706 respondents, 78% (N = 552) RTD, but 14% (N = 77) of these did not maintain that activity. Of those who RTD, 43% (N = 192) did so within 6 months of the injury and 92% did so within 24 months postinjury. The percentage of people driving after TBI did not differ significantly based on age at time of injury or follow-up. There were significant differences between drivers and nondrivers with respect to severity of injury, seizures, race, education, employment, rural vs urban setting, marital status, and family income. We performed a multivariate logistic regression to examine the association between driving status and demographic variables, adjusting for other variables in the model. The strongest associations were with current employment, family income, race, seizures, and severity of injury. Driving was associated with greater community participation, better functional outcomes, fewer symptoms of depression, and greater life satisfaction. CONCLUSIONS: Over a span of 30 years, three-quarters of people experiencing moderate-to-severe TBI return to driving a personal vehicle, although not everyone maintains this activity. Employment, race, family income, and seizures are strongly associated with RTD.

A tele-health intervention to increase physical fitness in people with spinal cord injury and cardiometabolic disease or risk factors: a pilot randomized controlled trial.

STUDY DESIGN: Clinical trial. OBJECTIVES: We used a single-blind parallel-group design to test the feasibility and preliminary efficacy of a telehealth-based physical activity counseling intervention to increase physical fitness in people with SCI. SETTING: Seattle, Washington, United States. METHODS: We recruited under-active, manual wheelchair-using adults at least 1-year post-SCI who had at least two cardiometabolic risk factors/diseases. Participants underwent baseline tests of peak cardiorespiratory fitness; lipids, glucose and insulin; muscle and fat mass; self-reported physical activity, depression, pain and other factors. Participants were assigned 1:1 to treatment vs. usual care (UC) control conditions via concealed computerized randomization. Treatment was delivered via telephone and adapted from the 16-session Diabetes Prevention Program. All baseline tests were repeated at 6 months. Prespecified feasibility goals were to recruit at least nine participants/quarter and retain 85% with complete fitness testing at 6 months. Prespecified efficacy goals were to demonstrate at least a medium treatment effect size (0.50) on fitness, self-reported physical activity, and other outcomes. RESULTS: Seven participants were randomized to treatment, 8 to UC over 15 months. Maximum recruitment was only 5.4 participants/quarter. Thirteen (87%) of participants were retained. The effects of treatment on fitness and most cardiometabolic risk factors did not meet expectations, whereas the effects on self-reported physical activity, depression, and pain did meet expectations. CONCLUSIONS: The study did not meet key efficacy and feasibility objectives, yet there were some promising effects on self-report measures and lessons to be learned for designing future trials.

Driving patterns, confidence, and perception of abilities following moderate to severe traumatic brain injury: a TBI model system study.

OBJECTIVE: Describe driving patterns following moderate-to-severe traumatic brain injury (TBI). Participants: Adults (N = 438) with TBI that required inpatient acute rehabilitation who had resumed driving. DESIGN: Cross-sectional, observational design. SETTING: Eight TBI Model System sites. MAIN MEASURES: A driving survey was completed at phone follow-up. RESULTS: Most respondents reported driving daily, although 41% reported driving less than before their injury. Driving patterns were primarily associated with employment, family income, sex, residence, and time since injury, but not injury severity. Confidence in driving was high for most participants and was associated with a perception that the TBI had not diminished driving ability. Lower confidence and perceived loss of ability were associated with altered driving patterns. CONCLUSION: Most people with moderate-to-severe TBI resume driving but perhaps not at pre-injury or normal levels compared to healthy drivers. Some driving situations are restricted. The relationship between low confidence/perceived loss of ability and driving patterns/restrictions suggests people with TBI are exhibiting some degree of caution consistent with those perceptions. Careful assessment of driving skills and monitoring during early stages of RTD is warranted, particularly for younger, male, and/or single drivers who express higher levels of confidence.

Equivalency of the diagnostic accuracy of the PHQ-8 and PHQ-9: a systematic review and individual participant data meta-analysis.

BACKGROUND: Item 9 of the Patient Health Questionnaire-9 (PHQ-9) queries about thoughts of death and self-harm, but not suicidality. Although it is sometimes used to assess suicide risk, most positive responses are not associated with suicidality. The PHQ-8, which omits Item 9, is thus increasingly used in research. We assessed equivalency of total score correlations and the diagnostic accuracy to detect major depression of the PHQ-8 and PHQ-9. METHODS: We conducted an individual patient data meta-analysis. We fit bivariate random-effects models to assess diagnostic accuracy. RESULTS: 16 742 participants (2097 major depression cases) from 54 studies were included. The correlation between PHQ-8 and PHQ-9 scores was 0.996 (95% confidence interval 0.996 to 0.996). The standard cutoff score of 10 for the PHQ-9 maximized sensitivity + specificity for the PHQ-8 among studies that used a semi-structured diagnostic interview reference standard (N = 27). At cutoff 10, the PHQ-8 was less sensitive by 0.02 (-0.06 to 0.00) and more specific by 0.01 (0.00 to 0.01) among those studies (N = 27), with similar results for studies that used other types of interviews (N = 27). For all 54 primary studies combined, across all cutoffs, the PHQ-8 was less sensitive than the PHQ-9 by 0.00 to 0.05 (0.03 at cutoff 10), and specificity was within 0.01 for all cutoffs (0.00 to 0.01). CONCLUSIONS: PHQ-8 and PHQ-9 total scores were similar. Sensitivity may be minimally reduced with the PHQ-8, but specificity is similar.