A randomized controlled trial of sertraline for the treatment of depression in persons with traumatic brain injury.

OBJECTIVE: To examine the efficacy of sertraline in the treatment of depression after traumatic brain injury (TBI). DESIGN: Double-blind, randomized controlled trial. SETTING: Research center at a major urban medical center. PARTICIPANTS: Subjects were a referred and volunteer sample of 52 participants with TBI, a diagnosis of major depression disorder (MDD), and a score on the Hamilton Rating Scale for Depression (HAM-D) of 18 or greater. The majority of the sample was male (58%), had less than 14 years of education (73%), had incomes below $20,000 (82%), and were from minority backgrounds (75%). Approximately one third of the sample had mild brain injuries, and two thirds had moderate to severe brain injuries. The mean age was 47+/-11, and the mean time since injury was 17+/-14 years. One participant withdrew from the study because of side effects. INTERVENTION: Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg) or placebo for 10 weeks. MAIN OUTCOME MEASURES: The HAM-D, the Beck Anxiety Inventory, and the Life-3 quality of life (QOL). RESULTS: No statistically significant differences were found at baseline between drug and placebo groups on baseline measures of depression (24.8+/-7.3 vs 27.7+/-7.0), anxiety (16.4+/-12.3 vs 24.0+/-14.9), or QOL (2.96+/-1.0 vs 2.9+/-0.9). The income level of those receiving placebo was significantly lower than those participants receiving medication. Analyses of covariance revealed significant changes from preintervention to posttreatment for all 3 outcome measures (P<.001) but no group effects. Random-effects modeling did not find any significant difference in patterns of scores of the outcome measures between the placebo and medication groups. CONCLUSIONS: Both groups showed improvements in mood, anxiety, and QOL, with 59% of the experimental group and 32% of the placebo group responding to the treatment, defined as a reduction of a person's HAM-D score by 50%.

Objective measurement of fatigue following traumatic brain injury.

OBJECTIVES: To quantify posttraumatic brain injury (post-TBI) mental fatigue objectively by documenting changes in performance on neuropsychological tests as a result of sustained mental effort and to examine the relationship between objectively measured mental fatigue and self-reported situational and day-to-day fatigue. PARTICIPANTS: The study included 202 community-dwelling individuals with mild-severe TBI and 73 noninjured controls. MEASURES: Measures included Cambridge Neuropsychological Test Automated Battery, Global Fatigue Index, and situational fatigue rating. METHOD: Subjects were administered a 30-minute computerized neuropsychological test battery 3 times. The second and third administrations of the battery were separated by approximately 2 hours of interviews and administration of self-report measures. RESULTS: The neuropsychological test scores were factor analyzed, yielding 3 subscales: speed, accuracy, and executive function. Situational fatigue and day-to-day fatigue were significantly higher in individual with TBI group than in individuals without TBI and were associated with speed subscale scores. Individuals with TBI evidenced a significant decline in performance on the accuracy subscale score. These declines in performance related to sustained mental effort were not associated with subjective fatigue in the TBI group. While practice effects on the speed and accuracy scores were observed in non-brain-injured individuals, they were not evidenced in individuals with TBI. CONCLUSIONS: Findings were largely consistent with previous literature and indicated that while subjective fatigue is associated with poor performance in individuals with TBI, it is not associated with objective decline in performance of mental tasks.

Fatigue after traumatic brain injury and its impact on participation and quality of life.

OBJECTIVES: To examine the relationships between post-TBI fatigue (PTBIF) and comorbid conditions, participation in activities, quality of life, and demographic and injury variables. PARTICIPANTS: 223 community-dwelling individuals with mild to severe TBI and 85 noninjured controls. MEASURES: Global Fatigue Index (GFI), Beck Depression Inventory (BDI-II), McGill Pain Questionnaire (MPQ), Pittsburgh Sleep Quality Inventory (PSQI), Participation Objective Participation Subjective (POPS), SF-36, Life-3. METHOD: Data were collected through interviews and administration of self-report measures as part of a study of PTBIF. RESULTS: Fatigue was more severe and prevalent in individuals with TBI, and more severe among women. It was not correlated with other demographic and injury variables. Once overlap in measurement instruments' content was removed, depression, pain, and sleep problems accounted for approximately 23% of the variance in fatigue in those with TBI compared to 58% of the variance in the control group. PTBIF was correlated with health-related quality of life and overall quality of life, but was not generally related to participation in major life activities. CONCLUSIONS: PTBIF has significant impact on well-being and quality of life and cannot be accounted for by comorbid conditions alone, suggesting that it is related to brain injury itself. It appears to be unrelated to demographic and injury variables other than gender. PTBIF does not limit the quantity and frequency of participation. Future research should focus on the relationship between fatigue and the quality of participation.