Effects of early introduction of non-invasive positive pressure ventilation based on forced vital capacity rate of change: Variation across amyotrophic lateral sclerosis clinical phenotypes.

PURPOSE: Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease associated with high morbidity and mortality. We evaluated the ability of pulmonary function tests to predict disease progression by ALS clinical phenotypes, and the timing of the introduction of non-invasive positive pressure ventilation (NIPPV). MATERIALS AND METHODS: A cohort study was performed in all adult patients who fulfilled El Escorial criteria at a tertiary-care academic medical centre for veterans in the USA from 1 January 2010 to 31 December 2014. Eligible patients underwent sitting and supine forced vital capacity (FVC) and the FVC rate of change (RoC) per month was calculated. ALS Functional Rating Scale-Revised (ALSFRS-R) scores were collected. RESULTS: A total of 137 patients were included in our analysis. The average survival from ALS onset was 31.40 (±40.04) months. The general cohort median (IQR) RoC was -0.87 (-2.55 to 0.34)/-0.65 (-2.55 to 0.70) % per month (P = 0.81) of the sitting/supine FVC, respectively. However, mean monthly RoC varied among the ALS phenotypes, with higher variation among global ALS, where greater decline in RoC was noted. The average time from ALS onset to tracheostomy was 27.88 (±22.21) months. The average sitting/supine FVC RoC for subjects requiring tracheostomy was -2.86 (±3.77)/-3.63 (±3.75) at the time of tracheostomy, compared to -1.190 (±2.38)/-1.07 (±3.78) for those who did not require the procedure. Although NIPPV use did not result in statistically significant improvements in either the sitting or supine FVC %, it did slow the RoC decline of patients with global ALS phenotypes. CONCLUSIONS: Initiation of NIPPV based on decline in RoC rather than the absolute value of either sitting or supine FVC may result in early stabilisation of ALS patients' pulmonary deterioration for the global clinical phenotype, and thus may have the potential for prolonging survival until tracheostomy or death.

Efficacy of venlafaxine XR for the treatment of pain in patients with spinal cord injury and major depression: a randomized, controlled trial.

OBJECTIVES: To (1) determine the efficacy of venlafaxine XR for the treatment of pain (secondary aim) in individuals with spinal cord injury (SCI) enrolled in a randomized controlled trial (RCT) on the efficacy of venlafaxine XR for major depressive disorder (MDD) (primary aim); and (2) test the hypothesis that venlafaxine XR would be effective for both neuropathic and nociceptive pain. DESIGN: Multisite, double-blind, randomized (1:1) controlled trial with subjects block randomized and stratified by site, lifetime history of substance abuse, and prior history of MDD. SETTING: Six Departments of Physical Medicine and Rehabilitation in university-based medical schools. PARTICIPANTS: Individuals (N=123) with SCI and major depression between 18 and 64 years of age, at least 1 month post-SCI who also reported pain. INTERVENTION: Twelve-week trial of venlafaxine XR versus placebo using a flexible titration schedule. OUTCOME MEASURES: A 0-to-10 numeric rating scale for pain, pain interference items of the Brief Pain Inventory; 30% and 50% responders. RESULTS: The effect of venlafaxine XR on neuropathic pain was similar to that of placebo. However venlafaxine XR resulted in statistically significant and clinically meaningful reductions in nociceptive pain site intensity and interference even after controlling for anxiety, depression, and multiple pain sites within the same individual. For those who achieved a minimally effective dose of venlafaxine XR, some additional evidence of effectiveness was noted for those with mixed (both neuropathic and nociceptive) pain sites. CONCLUSIONS: Venlafaxine XR could complement current medications and procedures for treating pain after SCI and MDD that has nociceptive features. Its usefulness for treating central neuropathic pain is likely to be limited. Research is needed to replicate these findings and determine whether the antinociceptive effect of venlafaxine XR generalizes to persons with SCI pain without MDD.

Novel risk factors associated with current suicidal ideation and lifetime suicide attempts in individuals with spinal cord injury.

OBJECTIVE: To determine unique associations of suicidal ideation (SI) and lifetime suicide attempts (SAs) in individuals with spinal cord injury (SCI). DESIGN: Cross-sectional analysis. SETTING: Outpatient. PARTICIPANTS: Individuals with SCI (N=2533) who were 18 years or older with a history of traumatic SCI. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Any SI in the past 2 weeks (9-item Patient Health Questionnaire) and any lifetime SA. RESULTS: Three hundred twenty-three individuals (13.3%) reported SI in the past 2 weeks and 179 (7.4%) reported lifetime SA. After controlling for other factors, both lifetime SA and current SI were associated with study site and current level of depression. In addition, SA was associated with less education, younger age at injury, having current or past treatment of depression, and having bipolar disorder or schizophrenia. SI was associated with more years since injury and lifetime SA. Several psychological factors were associated with current SI and lifetime SAs, including lower environmental reward and less positive affect. In addition, control of one's community activities and spiritual well-being were associated with current SI. In bivariate comparisons, severity of SCI was also associated with the 47% of the SAs that occurred after injury. CONCLUSIONS: Several unique associations of SI and lifetime SA in individuals with SCI were identified, including level of environmental reward and control, spiritual well-being, and severity of SCI. These factors bear further investigation as prospective risk factors for suicidal behavior after SCI.

Predictors of participation enfranchisement after spinal cord injury: the mediating role of depression and moderating role of demographic and injury characteristics.

OBJECTIVES: (1) To examine the mediating effects of depressive symptoms on the relations between employment, grief, depression treatment, and participation enfranchisement after spinal cord injury (SCI); and (2) to examine the moderating role of demographic and injury characteristics, including sex, race, marital status, education, and injury level, and completeness on these relations. DESIGN: Cross-sectional survey as part of the Project to Improve Symptoms and Mood after SCI (PRISMS). SETTING: Rehabilitation facilities. PARTICIPANTS: Persons with SCI (N=522; average age, 42 y; 76% men; 64% white; 64% completed at least a high school education) enrolled from 2007 to 2011. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Participation enfranchisement. RESULTS: The final model fit the data relatively well (comparative fix index=.939; Tucker-Lewis Index=.894; root mean square error of approximation=.066; 90% confidence interval, .043-.089), explaining 32% of the variance in participation enfranchisement. Enfranchisement was positively related to employment and negatively related to depression. Grieving the loss of a loved one and the use of an antidepressant or psychotherapy were related to participation enfranchisement; these relations were mediated by depressive symptoms. Multigroup analyses supported the model's invariance across sex, marital status, severity of injury, and level of injury. CONCLUSIONS: Depression appears to mediate the influence of employment, grief, and depression treatments on participation enfranchisement after SCI. These relations are applicable regardless of sex, marital status, and injury completeness and level. These findings highlight efforts to improve the detection and treatment of depression in SCI rehabilitation programs that may enhance participation.

An exploration of modifiable risk factors for depression after spinal cord injury: which factors should we target?

OBJECTIVE: To identify modifiable risk factors for depression in people with spinal cord injury (SCI). DESIGN: Cross-sectional survey. SETTING: Outpatient and community settings. PARTICIPANTS: Community-residing people with SCI (N=244; 77% men, 61% white; mean age, 43.1y; 43% with tetraplegia) who were at least 1 month postinjury. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Depression severity (Patient Health Questionnaire-9 [PHQ-9]), physical activity (International Physical Activity Questionnaire [IPAQ]), pleasant and rewarding activities (Environment Rewards Observation Scale [EROS]), and self-efficacy to manage the effects of SCI (Modified Lorig Chronic Disease Self-Management Scale). RESULTS: Greater depression severity was associated with being 20 to 29 years of age, not completing high school, not working or attending school, and being ≤4 years post-SCI. After controlling for demographic and injury characteristics (adjusted R(2)=.13), lower EROS scores (change in adjusted R(2)=.34) and lower self-efficacy (change in R(2)=.13) were independent predictors of higher PHQ-9 scores. Contrary to predictions, physical activity as measured by the IPAQ did not predict depression severity. CONCLUSIONS: Our findings suggest that having fewer rewarding activities, and to a lesser extent, having less confidence in one's ability to manage the effects of SCI are independent predictors of greater depression severity after SCI. Interventions such as behavior activation, designed to increase rewarding activities, may represent an especially promising approach to treating depression in this population.

Relationship of psychology inpatient rehabilitation services and patient characteristics to outcomes following spinal cord injury: the SCIRehab project.

CONTEXT AND OBJECTIVE: To evaluate the effects of psychological interventions on rehabilitation outcomes, including residence and functional status at discharge, and residence, school attendance, or employment, and physical, social, occupational, and mobility aspects of participation 1 year after spinal cord injury (SCI). DESIGN: Prospective observational cohort study. SETTING: Six inpatient rehabilitation facilities in the United States. PARTICIPANTS: Inpatients with SCI 12 years of age and older. INTERVENTIONS: Usual rehabilitation care. OUTCOME MEASURES: Functional Independence Measure at rehabilitation discharge and 1-year injury anniversary; discharge destination and residence at 1-year anniversary; Craig Handicap Assessment and Reporting Technique, Diener Satisfaction with Life Scale, Patient Health Questionnaire, employment or school attendance, rehospitalization, and occurrence of a pressure ulcer at 1-year anniversary. RESULTS: More time in psycho-educational interventions was associated with better function, discharge to home, home residence at 1 year, and the absence of pressure ulcers at 1 year. More psychotherapeutic sessions focusing on processing emotions and/or locus of control were associated with poorer function at discharge and 1 year, less physical independence and community mobility, lower satisfaction with life, and the presence of pressure sores at 1 year. CONCLUSIONS: Psychological services are an important component of comprehensive medical rehabilitation and tailored to patient needs and readiness to benefit from rehabilitation. Services focused on remediating deficits tend to be associated with negative outcomes, while services intended to foster adjustment and growth tend to be associated with favorable outcomes. Further research is needed to determine the optimal type and timing of psychological services during inpatient rehabilitation based on individuals' strengths and vulnerabilities. Note: This is the sixth in this third series of SCIRehab articles.

A systematic review of how spinal cord injury impacts families.

PURPOSE/OBJECTIVE: This systematic review synthesizes the existing literature on the impact of spinal cord injury (SCI) on families, including parenting, marital relations, and caregivers' psychological adjustment. RESEARCH METHOD/DESIGN: Seven databases were searched for relevant peer-reviewed studies. Dissertations, chapters, editorials, and review articles were excluded. Sixty-six studies that examined SCI's impact on caregivers and families were included. RESULTS: The review included 55 quantitative studies, 10 qualitative studies, and one study that utilized both methodologies. Among the quantitative psychosocial adjustment studies, as well as the qualitative studies, lack of social support was associated with an increased sense of burden, stress, depression, anxiety, and poorer physical health in caregivers. In the family relationship studies (n = 7), few significant differences were found in family functioning. Marital relationship studies (n = 12) frequently examined intimacy (sex, partner affirmations, and emotional support) as an important facet for determining positive or negative outcomes when one partner had SCI. However, divorce rates appeared to increase over time postinjury. Though few studies investigated caregiver needs and interventions (n = 5), needs for social support and information were identified, and several interventions (e.g., family education, more social support, and problem-solving training) were beneficial for promoting caregivers' psychosocial adjustment. CONCLUSIONS: SCI significantly impacts caregivers' sense of burden and psychological distress, with major implications for family functioning and caregivers' physical, mental, and social health. These issues occurred internationally and endured over time. Findings indicated the need for focused interventions to support caregivers' psychosocial adjustment after SCI. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Depression after spinal cord injury: comorbidities, mental health service use, and adequacy of treatment.

OBJECTIVE: To provide data for depression rates and psychiatric comorbid conditions, mental health service use, and adequacy of depression treatment in depressed and nondepressed adults with spinal cord injury (SCI). DESIGN: Cross-sectional survey as part of the Project to Improve Symptoms and Mood after SCI (PRISMS). SETTING: Community setting. PARTICIPANTS: Community-residing people with traumatic SCI (N=947). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Patient Health Questionnaire-9 (PHQ-9) Depression Scale, psychiatric history questionnaire, Cornell Service Index (mental health service use), and current medication use. RESULTS: The prevalence of probable major depression (PHQ-9 score ≥10) was 23%. There was a high lifetime prevalence of other psychiatric conditions, particularly anxiety disorders. In depressed participants, 29% currently were receiving any antidepressant and 11% were receiving guideline-level antidepressant dose and duration, whereas 11% had been receiving any psychotherapy in the past 3 months and 6% had been receiving guideline-level psychotherapy in the past 3 months. Serotonergic antidepressants and individual psychotherapy were the most common types of treatment received, and there was a wide range of provider types and treatment settings. Demographic and clinical variables were not associated with receipt of mental health service or guideline-level care. CONCLUSIONS: Findings from this study document the low rate of mental health treatment for persons with SCI and probable major depression. These findings have implications for improving the effectiveness of depression treatment in people with SCI.

Improving measurement properties of the Patient Health Questionnaire-9 with rating scale analysis.

OBJECTIVE: The goal of this study was to explore the psychometric properties of the Patient Health Questionnaire-9 (PHQ-9; R. L. Spitzer, K. Kroenke, & J. B. W. Williams, 1999). METHOD: Factor analysis and Rasch rating scale analysis were used to examine the psychometric properties of the PHQ-9. The sample consisted of 202 adults with spinal cord injury (SCI). RESULTS: The PHQ-9 items appear to form a usefully unidimensional scale. One "double-barreled" item, "Moving or speaking so slowly that other people could have noticed or being so fidgety or restless that you've been moving around a lot more than usual," misfit the Rasch model. Category probability curves indicate respondent difficulty in distinguishing between the 2 intermediate rating scale categories: several days and more than half the days. Combining these categories eliminated this problem and resulted in all items fitting the measurement model. CONCLUSIONS: The measurement properties of the PHQ-9 can be improved by collapsing rating scale categories and by restructuring several double- and triple-barreled items. Adopting these changes may improve sensitivity in measuring depression after SCI.

Does attendance in SCI education courses impact health outcomes in acute rehabilitation?

OBJECTIVE: Though education about secondary complications following spinal cord injury (SCI) is a component of many rehabilitation programs, there is little research on their success in promoting healthier outcomes. This study examined 1) whether greater education course attendance was associated with improved health outcomes and quality of life and 2) whether completion of bladder management and skin care courses was associated with decreased incidence of urinary tract infections (UTIs) and pressure ulcers (PUs). DESIGN: Retrospective medical record review. SETTING AND PARTICIPANTS: Patients (N = 106) in a Veterans Administration (VA) SCI rehabilitation program who completed at least one education class from August 2008 to September 2012. METHODS AND OUTCOME MEASURES: Records were reviewed to determine the number of education courses completed and patients' responses to the Satisfaction with Life Survey (SWLS), the short form of the Craig Handicap and Assessment Reporting Technique (CHART-SF), and Short Form Health Survey (SF-8) at admission, discharge, and 90 days post-discharge. Records were reviewed to determine frequency of UTIs and PUs from admission to discharge and from discharge to 90-day follow-up. RESULTS: Regression analyses revealed no association between number of classes and self-reported health and quality of life. Skin care class attendance was associated with a decreased number of PUs. Greater overall attendance at education courses was unexpectedly associated with a higher number of UTIs from admission to discharge. CONCLUSION: Results of the study are mixed. Multiple factors appear to impact the success of education interventions. Future research is needed to clarify the best approach.

Gender differences in depression among veterans with spinal cord injury.

PURPOSE: Little is known about gender differences in depression among veterans with spinal cord injury (SCI). Accordingly, the main objectives of this study were (a) to examine demographic and clinical characteristics of veterans with SCI; (b) to investigate gender differences in lifetime depression and depressive symptom severity, including probable major depressive disorder (MDD); and (c) to identify contributory factors (e.g., pain, life satisfaction) for gender differences in depression. METHOD: An exploratory secondary analysis was performed on a cross-sectional data set (N = 1,047) from a longitudinal study of health and employment among veterans with SCI. Community-dwelling veterans (N = 135) included women (n = 45) case-matched 1:2 to men (n = 90) based on age, injury level, and time since injury. Group comparisons and regression analyses were used to explore gender differences. RESULTS: Veterans with SCI had significantly higher rates of lifetime depression as compared with the general population. Women, as compared with men, had higher rates of lifetime depression diagnosis and endorsed more depressive symptoms, as measured by the Quick Inventory of Depression Symptomatology-Self Report (QIDS-SR). Among women, satisfaction with life was a significant predictor of QIDS-SR scores. A similar pattern was seen among men, with the addition of bodily pain as a significant predictor. CONCLUSIONS: Given the relationship between depressive symptoms and life satisfaction for women, follow-up depression screenings among veterans with SCI should include quality of life assessments. Additionally, assessment of somatic symptoms, such as pain, in relation to depressive symptomatology is recommended, particularly among men. (PsycINFO Database Record

Assessment of the relationship of spiritual well-being to depression and quality of life for persons with spinal cord injury.

OBJECTIVE: This study sought to describe the association between spiritual well-being, demographic characteristics, quality of life (QOL) and depressive symptoms following spinal cord injury (SCI). We hypothesized QOL and depressed mood would both be explained by extent of spiritual well-being, and meaning-focused (M&P) spirituality would have a stronger impact than faith-focused spirituality. METHODS: 210 individuals with SCI were screened as part of a randomized control trial of venlafaxine XR for major depressive disorder (MDD). 204 completed all measures: Patient Health Questionniare-9 (PHQ-9) assessed depression, the FACIT-Sp assessed spiritual well-being, the Neuro-QOL PAWB scale assessed QOL, and the PANAS assessed affect. RESULTS: Approximately 26% had major depression. Bivariate correlations of scores on PAWB and PANAS and FACIT-Sp showed that all four scales had strong associations with those on PAWB (p < 0.0005). As hypothesized, both the M&P and Faith scales of the FACIT-Sp were significant predictors of QOL (ß = 0.544; p < 0.0005 and ß = 0.151; p = 0.004), though only the M&P scale was an independently significant predictor of likely MDD. CONCLUSION: The findings support that spirituality, as measured by the FACIT-Sp, is strongly associated with QOL and likelihood of MDD. Assessment of spirituality should be included along with more traditional psychological measurements to better inform treatment. Implications for Rehabilitation Spiritual beliefs can contribute to quality of life and may help moderate depressive symptoms that accompany chronic illness and disability, suggesting that rehabilitation professionals should address spirituality in working with their patients with spinal cord injury (SCI). While spiritual issues are often deferred to pastoral counselors during hospitalization, it is clear that addressing these is not the domain of one discipline and does not end upon inpatient discharge. In addressing spirituality, clinicians should tap the spiritual strengths present in their clients, whether meaning/peace-focused or religious, understanding that spirituality involves more than religiosity and also that having a sense of meaning and peace appears to be of great importance.

Rural Trauma Team Development Course decreases time to transfer for trauma patients.

BACKGROUND: The Rural Trauma Team Development Course (RTTDC) is designed to teach knowledge and skills for the initial assessment and stabilization of trauma patients in resource-limited environments. The effect of RTTDC training on transfers from nontrauma centers to definitive care has not been studied. We hypothesized that RTTDC training would decrease referring hospital emergency department (ED) length of stay (LOS), time to call for transfer, pretransfer computed tomography (CT) imaging rate, and mortality rate. METHODS: We conducted a pre/post analysis of trauma patients who were transferred from rural, nontrauma hospitals from 2012 to 2014. Patients from six rural hospitals that participated in an RTTDC course were compared with a control group of similar centers that did not participate in the course. Primary outcome evaluated was referring hospital ED LOS, which was estimated using a difference-in-differences regression model. Secondary outcomes were time to transfer call, pretransfer CT imaging rates, and mortality. RESULTS: Two hundred fifty-three patients were available for study (RTTDC group, n = 130; control group, n = 123). Demographics, CT imaging, and mortality rates were similar between the two groups. In the primary outcome, the RTTDC group experienced an overall 61-minute reduction in referring hospital LOS (p = 0.02) compared with the control group. The RTTDC group also showed a 41-minute reduction (p = 0.03) in time to call for transfer compared with controls. There were no differences in the secondary outcomes of pretransfer CT scanning rates or mortality. CONCLUSIONS: Rural Trauma Team Development Course training shortens ED LOS at rural, nontrauma hospitals by more than 1 hour without increasing mortality. Future educational and research efforts should focus on decreasing unnecessary imaging prior to transfer as well as opportunities to improve mortality rates. This study suggests an important role for RTTDC training in the care of rural trauma patients and may allow trauma centers to recapture the "golden hour" for transferred trauma patients. LEVEL OF EVIDENCE: Therapeutic/care management study, level III.

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.

Identifying depression severity risk factors in persons with traumatic spinal cord injury.

PURPOSE/OBJECTIVE: Examine the relationship between demographic characteristics, health-, and injury-related characteristics, and substance misuse across multiple levels of depression severity. RESEARCH METHOD/DESIGN: 204 persons with traumatic spinal cord injury (SCI) volunteered as part of screening efforts for a randomized controlled trial of venlafaxine extended release for major depressive disorder (MDD). Instruments included the Patient Health Questionnaire-9 (PHQ-9) depression scale, the Alcohol Use Disorders Identification Test (AUDIT), and the Substance Abuse in Vocational Rehabilitation-Screener (SAVR-S), which contains 3 subscales: drug misuse, alcohol misuse, and a subtle items scale. Each of the SAVR-S subscales contributes to an overall substance use disorder (SUD) outcome. Three proportional odds models were specified, varying the substance misuse measure included in each model. RESULTS: 44% individuals had no depression symptoms, 31% had mild symptoms, 16% had moderate symptoms, 6% had moderately severe symptoms, and 3% had severe depression symptoms. Alcohol misuse, as indicated by the AUDIT and the SAVR-S drug misuse subscale scores were significant predictors of depression symptom severity. The SAVR-S substance use disorder (SUD) screening outcome was the most predictive variable. Level of education was only significantly predictive of depression severity in the model using the AUDIT alcohol misuse indicator. CONCLUSIONS/IMPLICATIONS: Likely SUD as measured by the SAVR-S was most predictive of depression symptom severity in this sample of persons with traumatic SCI. Drug and alcohol screening are important for identifying individuals at risk for depression, but screening for both may be optimal. Further research is needed on risk and protective factors for depression, including psychosocial characteristics.

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.