Sertraline for Major Depression During the Year Following Traumatic Brain Injury: A Randomized Controlled Trial.

OBJECTIVE: Major depressive disorder (MDD) is common and associated with impaired functioning after traumatic brain injury (TBI). Few placebo-controlled antidepressant trials exist in this population. We evaluated the efficacy and tolerability of sertraline for MDD within 1 year of sustaining a TBI. SETTING: Level I trauma center. PARTICIPANTS: Adults with MDD within 1 year of hospitalization for complicated mild to severe TBI. DESIGN: Randomized, double-blind, placebo-controlled trial. MAIN MEASURES: Twelve-week treatment response on the 17-item Hamilton Depression Rating Scale. We also assessed symptom improvement and remission. RESULTS: We randomized 62 participants: 32% sustained a severe TBI, 68% had significant anxiety, 63% had a history of prior MDD, and 69% had a history of alcohol or drug dependence. Depression significantly improved from baseline to 12 weeks in both treatment groups (P < .001). There were no significant differences between the sertraline and placebo groups over 12 weeks on depression severity, response, or remission. The sertraline group had significant improvement on speed of information processing compared with the placebo group (P < .006). CONCLUSION: Sertraline monotherapy was not superior to placebo for MDD in people with post-acute complicated mild to severe TBI. Research is needed on the effectiveness of interventions that also address the significant psychosocial needs of this population.

Venlafaxine extended-release for depression following spinal cord injury: a randomized clinical trial.

IMPORTANCE: Depression is prevalent and associated with negative outcomes in individuals with spinal cord injury (SCI). Antidepressants are used routinely to treat depression, yet no placebo-controlled trials have been published in this population to our knowledge. OBJECTIVE: To determine the efficacy and tolerability of venlafaxine hydrochloride extended-release (XR) for major depressive disorder (MDD) or dysthymic disorder in persons with chronic SCI. DESIGN, SETTING, AND PARTICIPANTS: Multisite, randomized (1:1), double-blind, placebo-controlled Project to Improve Symptoms and Mood After SCI (PRISMS) trial. All research staff conducting screening, intervention, and outcome procedures were blinded to randomization status. We screened 2536 patients from outpatient clinics at 6 SCI treatment centers in the United States and randomized 133 participants into the trial. Participants were 18 to 64 years old and at least 1 month after SCI, with MDD or dysthymic disorder. Seventy-four percent of participants were male, and participants were on average 40 years old and 11 years after SCI. Forty-seven percent had cervical injuries, 53.4% had American Spinal Injury Association injury severity A (complete injury) SCI, 24.1% had at least 2 prior MDD episodes, and 99.2% had current MDD. Common comorbidities included chronic pain (93.9%), significant anxiety (57.1%), and history of substance dependence (44.4%). INTERVENTIONS: Twelve-week trial of venlafaxine XR vs placebo using a flexible-dose algorithm. MAIN OUTCOMES AND MEASURES: The Hamilton Depression Rating Scale (HAM-D 17-item version and Maier subscale, which focuses on core depression symptoms and excludes somatic symptoms) over 12 weeks. RESULTS: Mixed-effects models revealed a significant difference between the venlafaxine XR and placebo groups in improvement on the Maier subscale from baseline to 12 weeks (treatment effect, 1.6; 95% CI, 0.3-2.9; P = .02) but not on the HAM-D 17-item version (treatment effect, 1.0; 95% CI, -1.4 to 3.4; P = .42). Participants receiving venlafaxine XR reported significantly less SCI-related disability on the Sheehan Disability Scale at 12 weeks compared with placebo (treatment effect, 4.7; 95% CI, 1.5-7.8; P = .005). Blurred vision was the only significantly more common new or worsening adverse effect in the venlafaxine XR group compared with the placebo group over 12 weeks. CONCLUSIONS AND RELEVANCE: Venlafaxine XR was well tolerated by most patients and an effective antidepressant for decreasing core symptoms of depression and improving SCI-related disability. Further research is needed to determine the optimal treatment and measurement approaches for depression in chronic SCI. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00592384.

Nurses' knowledge of pain management for patients with combat-related traumatic brain injuries on rehabilitation units.

PURPOSE: The purpose of this project was to survey nurses' knowledge of pain management for patients with combat-related traumatic brain injuries (TBI). DESIGN/METHODS: A survey was used to collect data regarding nurses' knowledge of pain assessment and management for patients with combat-related TBI. Nurses were invited to participate in the study via email and provided with a link to the electronic survey. FINDINGS: Twenty-five surveys were returned (52% response rate). A total of 76% of nurse respondents perceived that TBI patients over report pain intensity. Only 40% of nurses were able to correctly identify the appropriate medication to treat migraine-type headache pain in TBI patients. CONCLUSION: This study identified gaps in knowledge regarding pain management for patients with combat related TBIs. CLINICAL RELEVANCE: Nurses need additional education regarding common pain syndromes, available treatments, and a better understanding of addiction in order to provide optimal care to these patients.

A randomized controlled trial of venlafaxine XR for major depressive disorder after spinal cord injury: Methods and lessons learned.

CONTEXT/OBJECTIVE: We describe the rationale, design, methods, and lessons learned conducting a treatment trial for major depressive disorder (MDD) or dysthymia in people with spinal cord injury (SCI). DESIGN: A multi-site, double-blind, randomized (1:1) placebo controlled trial of venlafaxine XR for MDD or dysthymia. Subjects were block randomized and stratified by site, lifetime history of substance dependence, and prior history of MDD. SETTING: Six SCI centers throughout the United States. PARTICIPANTS: Across participating centers, 2536 subjects were screened and 133 were enrolled into the trial. Subjects were 18-64 years old and at least 1 month post-SCI. Interventions Twelve-week trial of venlafaxine XR versus placebo using a flexible titration schedule. OUTCOME MEASURES: The primary outcome was improvement in depression severity at 12 weeks. The secondary outcome was improvement in pain. RESULTS: This article includes study methods, modifications prompted by a formative review process, preliminary data on the study sample and lessons learned. We describe common methodological and operational challenges conducting multi-site trials and how we addressed them. Challenges included study organization and decision making, staff training, obtaining human subjects approval, standardization of measurement and treatment, data and safety monitoring, subject screening and recruitment, unblinding and continuity of care, database management, and data analysis. CONCLUSIONS: The methodological and operational challenges we faced and the lessons we learned may provide useful information for researchers who aim to conduct clinical trials, especially in the area of medical treatment of depression in people with SCI.

Adverse events in cardiovascular-related training programs in people with spinal cord injury: a systematic review.

CONTEXT: There are anecdotal reports of adverse events (AEs) associated with exercise in people with spinal cord injury (SCI) and consequent concern by people with SCI and their providers about potential risks of exercise. Enumeration of specific events has never been performed and the extent of risk of exercise to people with SCI is not understood. OBJECTIVE: To systematically review published evidence to identify and enumerate reports of adverse events or AEs associated with training in persons with SCI. METHODS: Review was limited to peer-reviewed studies published in English from 1970 to 2011: (1) in adults with SCI, (2) evaluating training protocols consisting of repeated sessions over at least 4 weeks to maintain or improve cardiovascular health, (3) including volitional exercise modalities and functional electrical stimulation (FES)-enhanced exercise modalities, and (4) including a specific statement about AEs. Trained reviewers initially identified a total of 145 studies. After further screening, 38 studies were included in the review. Quality of evidence was evaluated using established procedures. RESULTS: There were no serious AEs reported. There were no common AEs reported across most types of interventions, except for musculoskeletal AEs related to FES walking. There were few AEs in volitional exercise studies. CONCLUSION: There is no evidence to suggest that cardiovascular exercise done according to guidelines and established safety precautions is harmful. To improve the strength of these conclusions, future publications should include definition of AEs, information about pre-intervention screening, and statements of the nature and extent of AEs.

Clinical assessment and management of obesity in individuals with spinal cord injury: a review.

BACKGROUND: Diagnosing and managing obesity in individuals with spinal cord injury (SCI) remain challenging. METHODS: Literature on the epidemiology, impact, and management of obesity in individuals with SCI was reviewed. FINDINGS: Although nearly 66% of individuals with SCI are either overweight or obese, little guidance is available to measure and monitor obesity in the clinical setting. The use of anthropometric indices and specific cut points available for able-bodied persons is limited by the body composition changes that follow SCI. Indices of upper body obesity warrant examination in SCI because they provide an index of central obesity, which is more closely linked to some obesity-related conditions than is overall obesity. Investigations into the sequelae of excess body fat and its distribution are also needed in SCI because past research in this area has been inconclusive. Although limited, evidence regarding obesity interventions in SCI may be promising. CONCLUSIONS: The best anthropometric tool to define obesity in the clinical setting remains unknown. SCI-specific assessment tools and a better understanding of the sequelae of excess body weight will lead to better targeting of prevention and treatment efforts. More research is needed on the individual components of a weight management program unique to SCI. Until then, providers are urged to use a team approach and draw on existing resources and applicable research in able-bodied individuals to facilitate weight management in individuals with SCI.

Measurement and description of physical activity in adult manual wheelchair users.

BACKGROUND: The purposes of this study were to (1) describe physical activity of adult manual wheelchair users as measured by wrist actigraphy and two self-report measures, (2) compare exercisers and nonexercisers on measures of physical activity, and (3) examine the relationships between three activity measures. METHODS: Fifty manual wheelchair users wore an activity monitor and completed a physical activity record for 7 days. At the completion of this period, a questionnaire that included the Physical Activity Scale for Individuals with Physical Disabilities, stage of exercise question, and demographic and health questions was completed. RESULTS: Mean daily hours spent in bed or asleep was 9.1, mean hours of light intensity activity was 12.5, mean hours of moderate intensity activity was 1.3, and mean hours of strenuous activity was 0.33. Thirty-eight percent did not report any strenuous activity, and 56% reported less than the 150 minutes weekly of moderate or strenuous activity required to meet public health guidelines. There was variability in both self-reported and objectively measured physical activity. Regular exercisers were not significantly different from nonexercisers on objective measures of physical activity. Measured physical movement was weakly correlated with recall of physical activity or exercise. CONCLUSION: Many wheelchair users do not meet public health guidelines for physical activity, but they are not a homogeneous group in intensity and frequency of physical activity. Multiple measurement methods can provide insights into the nature, intensity, and duration of physical activity that is more complex due to variations in abilities and ways of moving.

Correlates of physical activity in adults with mobility limitations.

This study identified the correlates of objectively and subjectively measured physical activity in adult wheelchair users. Fifty participants wore an activity monitor for a week and completed a questionnaire about factors associated with physical activity. Objectively measured activity correlated significantly with body mass index. Subjectively measured activity correlated significantly with age, stage of change, health, healthcare providers discussing exercise, and social support for exercise. Research on the effect of body mass index on activity in this population is needed. Intervention planners should plan programs that place emphasis on modifying the social environment (including healthcare providers) and removing attitudinal barriers.

Physical activity measurement in persons with chronic and disabling conditions: methods, strategies, and issues.

Measuring the physical activity of persons with chronic and disabling conditions presents complexities related to measuring instruments, the intensity of the activity being measured, the population being measured, and individual behavior and health status. They often have limitations in mobility that do not preclude physical activity but contribute to the complexity of measuring it, such as slow or altered gait, inability to walk, and the need for assistive devices. This article reviews currently available ways to measure physical activity, describes strengths and weaknesses of various measures, and provides examples of complexities in measuring physical activity in people who move differently.

There are a few things you did not ask about my pain: writing on the margins of a survey questionnaire.

This qualitative study is a secondary analysis of comments written on survey questionnaires about pain mailed to community-dwelling persons with spinal cord injury (SCI) or amputation. Narrative comments were added by 54.1% of 797 respondents. The purpose of this study was to determine the characteristics of those who wrote comments and to understand what was being communicated in their comments. A qualitative content analysis was used to identify the major themes, subthemes, and thematic categories in the unsolicited comments. The overarching theme was desiring dialogue with the researcher. Presenting themselves as experts on living with pain because of a chronic disabling condition, respondents described personal experiences of living with pain, coping with pain, and educating others about pain. Examining comments and narratives written in the margins of quantitative survey questionnaires can add value to and extend understanding of survey findings and implications.

Validity of the Patient Health Questionnaire-9 in assessing depression following traumatic brain injury.

OBJECTIVE: To test the validity and reliability of the Patient Health Questionnaire-9 (PHQ-9) for diagnosing major depressive disorder (MDD) among persons with traumatic brain injury (TBI). DESIGN: Prospective cohort study. SETTING: Level I trauma center. PARTICIPANTS: 135 adults within 1 year of complicated mild, moderate, or severe TBI. MAIN OUTCOME MEASURES: PHQ-9 Depression Scale, Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID). RESULTS: Using a screening criterion of at least 5 PHQ-9 symptoms present at least several days over the last 2 weeks (with one being depressed mood or anhedonia) maximizes sensitivity (0.93) and specificity (0.89) while providing a positive predictive value of 0.63 and a negative predictive value of 0.99 when compared to SCID diagnosis of MDD. Pearson's correlation between the PHQ-9 scores and other depression measures was 0.90 with the Hopkins Symptom Checklist depression subscale and 0.78 with the Hamilton Rating Scale for Depression. Test-retest reliability of the PHQ-9 was r = 0.76 and kappa = 0.46 when using the optimal screening method. CONCLUSIONS: The PHQ-9 is a valid and reliable screening tool for detecting MDD in persons with TBI.

Actigraphy as a measure of physical activity for wheelchair users with spinal cord injury.

BACKGROUND: Research has indicated that actigraphy is valid and reliable for measuring low levels of physical activity among ambulatory individuals, and that it may be a valid indicator of energy expenditure for wheelchair users in laboratory conditions, but there are no reports of its evaluation in free-living conditions. OBJECTIVE: To assess the suitability and validity of actigraphy as a measure of free-living physical activity for wheelchair users with spinal cord injury. METHODS: In a methodologic descriptive correlational study, measures of physical activity by an actigraph and a self-report physical activity record were obtained for six individuals in laboratory conditions and 22 individuals in free-living conditions during a 4-day period. At the completion of the home monitoring trial, all the participants completed a questionnaire about their experience wearing the monitor and maintaining the record. RESULTS: Mean activity counts by actigraphy during active tasks were significantly different from the counts during inactive tasks (p =.003). During home monitoring, the participants wore the monitor, on the average, 95% of the prescribed wearing time, rated it as very comfortable, and were willing to wear it again. Pearson correlation coefficients of activity counts with self-reported activity intensity varied from.30 to.77 (p <.01) for individual participants. The mean correlation across the sample was.60 (p <.01). Activity counts varied with reported activity, indicating concurrence between the two activity measurement methods. CONCLUSIONS: Actigraphy is suitable as a measurement of activity for people with spinal cord injury. This initial investigation suggests that it has concurrent validity with a self-report measure of activity intensity and frequency, as evidenced in this sample of wheelchair users in free-living conditions.

Physical activity and exercise in women's health.

Regular physical activity provides health benefits, including the reduction in risks of coronary heart disease, hypertension, type 2 diabetes mellitus, obesity, colon cancer, and premature mortality. Despite this information, most women are physically inactive. Research findings shed light on the gender differences in physiological responses to physical activity. Patterns and predictors of physical activity vary significantly by gender. Further study is needed of the benefits, barriers, and personally meaningful outcomes of physical activity for women, specifically including the frequently unspoken correlates of urinary incontinence, depression and mood disorders, and obesity.

Lifestyle physical activity for individuals with spinal cord injury: a pilot study.

PURPOSE: To evaluate the acceptability and feasibility of a lifestyle physical activity program for people with spinal cord injury (SCI). METHODS: Sixteen nonexercising adult volunteers with SCI participated in a single group pre-post-test of the "Be Active in Life Program" comprising stage-matched educational materials, home visit by a nurse, construction of a personal plan to increase activity, and four follow-up phone calls. Program acceptability, stage of change, barriers to health-promoting activities, abilities for health practices, health, depression, and muscle strength were rated. Physical activity was monitored using actigraphy and a self-report record. RESULTS: Participants rated the program positively, although some preferred a structured exercise approach. Eighty-one percent of participants progressed in stage of change and 60% increased physical activity. There were significant changes in motivational barriers, exercise self-efficacy, self-rated health, and muscle strength. DISCUSSION: Lifestyle physical activity is feasible and acceptable and could be effective in promoting greater physical activity among people with SCI.

Bodies in motion: monitoring daily activity and exercise with motion sensors in people with chronic pulmonary disease.

A primary goal of pulmonary rehabilitation is to improve health and life quality by encouraging participants to engage in exercise and to increase daily physical activity. The recent advent of motion sensors, including digital pedometers and accelerometers that measure motion as a continuous variable, have added precision to the measurement of free-living daily activity. Daily activity and exercise are variables of keen interest to proponents of the national health agenda, epidemiologists, clinical researchers, and rehabilitation interventionists. This paper summarizes issues related to conceptualizing and monitoring activity in the rehabilitation setting; reviews motion sensor methodology; compares motion-sensing devices; presents analysis issues and current and potential applications to the pulmonary rehabilitation setting; and gives practical applications and limitations.

Classification of chronic pain associated with spinal cord injuries.

OBJECTIVES: To determine interrater reliability of a classification system for chronic pain in persons with spinal cord injury (SCI) and to determine the frequency and characteristics of various pain types as categorized by this system. DESIGN: Independent categorization (based on questionnaires; for 15 persons, questionnaires plus personal interviews) by 2 investigators. SETTING: Community. PARTICIPANTS: A total of 163 individuals aged >or=18 years with SCI and pain. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Pain categories, Short-Form McGill Pain Questionnaire, and Chronic Pain Grade questionnaire. RESULTS: Among 41 (25%) questionnaires categorized independently by 2 investigators, strength of agreement in categorizing 68 pain problems was substantial (kappa=.68). For 15 persons whose pain was categorized in person by 2 investigators, strength of agreement was also substantial (kappa=.66). Among 163 survey respondents with pain, the most common worst pain was SCI pain (31.9%). Mean characteristic pain intensity +/- standard deviation for worst pain, regardless of type, was 61.02+/-18.5 on a scale from 0 to 100. On average, for worst pain, respondents reported moderate pain-related disability (43.70+/-29.4; scale range, 0-100). Although certain pain descriptors were more often associated with a specific type of pain, none was pathognomonic. CONCLUSIONS: Substantial interrater reliability was achieved in determining pain categories by use of responses to a questionnaire with a classification system based on presumed pathology. Adding interviews with patients increased our ability to classify pain but did not improve overall interrater reliability.

Blinding effectiveness and association of pretreatment expectations with pain improvement in a double-blind randomized controlled trial.

Patient, provider, and clinical investigator expectations concerning treatments are believed to play important roles in patient response. This study examined the association of patient and research nurse/physician pretreatment expectations of pain relief with actual pain relief, the accuracy of patient and research nurse guesses about patient medication assignment, and changes in research nurse and patient pain relief expectations over the course of a randomized double-blind trial of amitriptyline versus an active placebo for patients with chronic pain and spinal cord injuries (SCI). Patient expectations of pain relief with amitriptyline were associated significantly with actual pain decrease for patients in the amitriptyline, but not placebo, condition. Research nurse/physician expectations did not predict patient pain relief. Both patients and the research nurse were able to guess patient medication assignment at a rate significantly greater than chance. The research nurse's, but not the patients', expectations of pain relief with amitriptyline decreased significantly over the course of the study. These findings have implications for future randomized controlled trials. Fully double-blind conditions are very difficult to achieve, and it is informative to assess patient and research clinician expectations and guesses regarding medication assignment.

Catastrophizing is associated with pain intensity, psychological distress, and pain-related disability among individuals with chronic pain after spinal cord injury.

Little research has examined the role of patient cognitive and behavioral responses, including catastrophizing, in adjustment to chronic pain associated with spinal cord injury (SCI). The objective of this study was to examine the associations of catastrophizing and specific pain coping strategies with pain intensity, psychological distress, and pain-related disability among individuals with chronic pain and SCI, after controlling for important demographic and SCI-related variables that might affect outcomes. Participants in this study were 174 community residents with SCI and chronic pain who completed a mailed questionnaire that included the SF-36 Mental Health scale, Coping Strategies Questionnaire, and Graded Chronic Pain Scale. The pain coping and catastrophizing measures explained an additional 29% of the variance in pain intensity after adjusting for the demographic and SCI variables (P<0.001). The coping and catastrophizing scales accounted for an additional 30% of the variance in psychological distress (P<0.001) and 11% of the variance in pain-related disability (P<0.001), after controlling for pain intensity and demographic and SCI variables. Catastrophizing, but not any other single pain coping strategy, was consistently strongly and independently associated with the outcome measures. Potentially, the assessment and treatment of catastrophizing may reduce psychological distress and pain-related disability among individuals with chronic pain and SCI.

Treatments for chronic pain associated with spinal cord injuries: many are tried, few are helpful.

OBJECTIVE: The objective was to investigate, in two community samples of people with spinal cord injuries, the frequency of use of different pain treatments and the perceived helpfulness of these treatments. DESIGN AND SETTING: A postal survey was conducted in the community. PARTICIPANTS: The participants were 471 persons aged 18 years or older who had spinal cord injuries and pain. There were 2 separate samples (n = 308 and n = 163). OUTCOME MEASURES: The pain treatments used, the helpfulness of these treatments, and the Chronic Pain Grade questionnaire answers were assessed. RESULTS: Respondents reported multiple pain treatments (range of 0-14 and median of 4 in sample 1; range of 0-16 and median of 4 in sample 2). The most commonly reported treatments were oral medications and physical therapy. Medication types most commonly reported were nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and opioids. The treatments rated as most helpful were opioid medications, physical therapy, and diazepam therapy, and those rated as least helpful were spinal cord stimulation, counseling or psychotherapy, administration of acetaminophen, and administration of amitriptyline. Alternative treatments reported as most helpful were massage therapy and use of marijuana. Acupuncture was tried by many but was rated as only moderately helpful. CONCLUSIONS: This survey of two large samples of community-dwelling individuals with spinal cord injury-related chronic pain indicates that multiple pain treatments are tried but only a few are rated as more than somewhat helpful. Furthermore, the treatments that are most commonly reported are not always those that are rated as most helpful. The findings point to a number of potentially fruitful directions for future research.

Efficacy of amitriptyline for relief of pain in spinal cord injury: results of a randomized controlled trial.

Chronic pain in persons with spinal cord injury (SCI) is a difficult problem for which there is no simple method of treatment. Few randomized controlled trials of medications for pain in persons with SCI have been conducted. This study was designed to determine whether amitriptyline, a tricyclic antidepressant, is efficacious in relieving chronic pain and improving pain-related physical and psychosocial dysfunction in persons with SCI. Eighty-four participants with SCI and chronic pain were randomized to a 6-week trial of amitriptyline or an active placebo, benztropine mesylate. All pre- and post-treatment assessments were conducted by evaluators blind to the allocation. Regression analyses were conducted to examine whether there was a medication group effect on the primary (average pain intensity) and secondary outcome measures. No significant differences were found between the groups in pain intensity or pain-related disability post-treatment, in either intent-to-treat analyses or analyses of study completers. These findings do not support the use of amitriptyline in the treatment of chronic pain in this population, but we cannot rule out the possibility that certain subgroups may benefit.