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Course 200: Brain injury: The Effect of Telephone Counseling in Reducing Symptoms After Mild Traumatic Brain Injury: A Randomized Trial
ACADEMY ANNUAL ASSEMBLY ABSTRACTS
Friday, November 21, 2008 4:15 PM–5:45 PM Convention Center–Room 31 Stroke/TBI Research and Clinical Pearls Course 200 Brain Injury The Effect of Telephone Counseling in Reducing Symptoms After Mild Traumatic Brain Injury: A Randomized Trial. Kathleen R. Bell, MD (Univ of WA, Seattle, WA); Sureyya Dikmen, PhD; Peter Esselman, MD; Jeanne Hoffman, PhD; Janet M. Powell, PhD; Nancy Temkin, PhD. Disclosure: K.R. Bell, Allergan, consulting fees or other remuneration; S. Dikmen, none; P. Esselman, none; J. Hoffman, none; J.M. Powell, none; N. Temkin, none. Objective: To determine whether focused, scheduled telephone counseling during the first 3 months after mild traumatic brain injury (MTBI) decreases symptoms and improves functioning at 6 months. Design: 2-group, parallel, randomized clinical trial with outcome assessed by a blinded examiner at 6 months after injury. Setting: Emergency departments of Harborview Medical Center and University of Washington Medical Center. Participants: 366 of 389 eligible subjects age 16 or older with MTBI enrolled between February 2004 and February 2006 with an 85% follow-up completion rate. Interventions: 5 telephone calls, individualized for patient concerns and scripted to address education, reassurance, and reactivation. Main Outcome Measures: 2 composites, 1 relating to posttraumatic symptoms that developed or worsened after injury and their impact on functioning and the other related to general health status. Results: The group assigned to receive telephone counseling had a significantly better outcome for symptoms (6.6 difference in adjusted mean symptom score, 95% confidence interval [CI], 1.2–12.0), but there was no difference in general health outcome (1.5 difference in adjusted mean functional score, 95% CI, ⫺2.2–5.2). A smaller proportion of the treatment group had each individual symptom in the 2 weeks prior to assessment. Similarly, a smaller proportion assigned to the treatment group had daily functioning negatively impacted by symptoms with the largest differences in impact on work, leisure activities, memory and concentration, and financial independence. Conclusions: Telephone counseling with a focus on symptom management was successful in reducing the development of chronic symptoms after MTBI. Key Words: Brain injuries; Post-concussion syndrome; Rehabilitation.
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were not depressed at the time of study initiation. Main Outcome Measures: Hamilton Depression Rating Scale administered at intervals during the year; Depression Scale of the Neurobehavioral Functioning Inventory administered 3, 6, and 12 months after injury. Results: Based on intent-to-treat and efficacy subset analyses, those receiving placebo exhibited significantly greater depression symptoms than those receiving sertraline during the first 3 months after injury while receiving placebo or drug (10% of placebo group achieving a score of ⱖ6 on the HDRS, 0% of the sertraline group; P⬍.023.). There was no significant difference in depressive symptoms during the remainder of the year between the 2 groups. Conclusions: Sertraline is effective in diminishing depressive symptoms even among those not clinically depressed while the medication is being taken. However, the results do not support the idea that administration early in recovery diminishes depressive symptoms after the drug is stopped. There is no basis from this study to assume that sertraline administered early in recovery after TBI, when neurotransmitter functioning is often altered, has ongoing effects on the serotonin system after sertraline is discontinued. Key Words: Depression; Rehabilitation; Traumatic brain injury.
Course 200 Brain Injury Effect of Early Sertraline Administration on Emotional Status Following Traumatic Brain Injury. Tom Novack, PhD (University of Alabama at Birmingham, Birmingham, AL); James Banos, PhD; Robert Brunner, MD; Jay Meythaler, MD; Sharon G. Renfroe, RN, MSN, CRNP. Disclosure: T. Novack, none; J. Banos, none; R. Brunner, none; J. Meythaler, none; S.G. Renfroe, none. Objective: Assess the prophylactic efficacy of sertraline administered in the first 3 months after moderate to severe traumatic brain injury (TBI) in reducing the incidence of depression in the first year after injury. Design: Double-blinded randomized control trial. Setting: Academic medical center. Participants: 99 subjects randomized to placebo (n⫽50) or sertraline 50mg (n⫽49). There were no group differences in age, sex, education, or severity of injury. Interventions: Subjects were enrolled an average of 21 days after injury (none ⬎8wk) followed by oral administration of placebo/drug for 3 months. Subjects Arch Phys Med Rehabil Vol 89, November 2008
Friday, November 21, 2008 4:15 PM–5:45 PM Convention Center–Room 31 Stroke/TBI Research and Clinical Pearls Course 200 Brain Injury The Effect of Telephone Counseling in Reducing Symptoms After Mild Traumatic Brain Injury: A Randomized Trial. Kathleen R. Bell, MD (Univ of WA, Seattle, WA); Sureyya Dikmen, PhD; Peter Esselman, MD; Jeanne Hoffman, PhD; Janet M. Powell, PhD; Nancy Temkin, PhD. Disclosure: K.R. Bell, Allergan, consulting fees or other remuneration; S. Dikmen, none; P. Esselman, none; J. Hoffman, none; J.M. Powell, none; N. Temkin, none. Objective: To determine whether focused, scheduled telephone counseling during the first 3 months after mild traumatic brain injury (MTBI) decreases symptoms and improves functioning at 6 months. Design: 2-group, parallel, randomized clinical trial with outcome assessed by a blinded examiner at 6 months after injury. Setting: Emergency departments of Harborview Medical Center and University of Washington Medical Center. Participants: 366 of 389 eligible subjects age 16 or older with MTBI enrolled between February 2004 and February 2006 with an 85% follow-up completion rate. Interventions: 5 telephone calls, individualized for patient concerns and scripted to address education, reassurance, and reactivation. Main Outcome Measures: 2 composites, 1 relating to posttraumatic symptoms that developed or worsened after injury and their impact on functioning and the other related to general health status. Results: The group assigned to receive telephone counseling had a significantly better outcome for symptoms (6.6 difference in adjusted mean symptom score, 95% confidence interval [CI], 1.2–12.0), but there was no difference in general health outcome (1.5 difference in adjusted mean functional score, 95% CI, ⫺2.2–5.2). A smaller proportion of the treatment group had each individual symptom in the 2 weeks prior to assessment. Similarly, a smaller proportion assigned to the treatment group had daily functioning negatively impacted by symptoms with the largest differences in impact on work, leisure activities, memory and concentration, and financial independence. Conclusions: Telephone counseling with a focus on symptom management was successful in reducing the development of chronic symptoms after MTBI. Key Words: Brain injuries; Post-concussion syndrome; Rehabilitation.
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were not depressed at the time of study initiation. Main Outcome Measures: Hamilton Depression Rating Scale administered at intervals during the year; Depression Scale of the Neurobehavioral Functioning Inventory administered 3, 6, and 12 months after injury. Results: Based on intent-to-treat and efficacy subset analyses, those receiving placebo exhibited significantly greater depression symptoms than those receiving sertraline during the first 3 months after injury while receiving placebo or drug (10% of placebo group achieving a score of ⱖ6 on the HDRS, 0% of the sertraline group; P⬍.023.). There was no significant difference in depressive symptoms during the remainder of the year between the 2 groups. Conclusions: Sertraline is effective in diminishing depressive symptoms even among those not clinically depressed while the medication is being taken. However, the results do not support the idea that administration early in recovery diminishes depressive symptoms after the drug is stopped. There is no basis from this study to assume that sertraline administered early in recovery after TBI, when neurotransmitter functioning is often altered, has ongoing effects on the serotonin system after sertraline is discontinued. Key Words: Depression; Rehabilitation; Traumatic brain injury.
Course 200 Brain Injury Effect of Early Sertraline Administration on Emotional Status Following Traumatic Brain Injury. Tom Novack, PhD (University of Alabama at Birmingham, Birmingham, AL); James Banos, PhD; Robert Brunner, MD; Jay Meythaler, MD; Sharon G. Renfroe, RN, MSN, CRNP. Disclosure: T. Novack, none; J. Banos, none; R. Brunner, none; J. Meythaler, none; S.G. Renfroe, none. Objective: Assess the prophylactic efficacy of sertraline administered in the first 3 months after moderate to severe traumatic brain injury (TBI) in reducing the incidence of depression in the first year after injury. Design: Double-blinded randomized control trial. Setting: Academic medical center. Participants: 99 subjects randomized to placebo (n⫽50) or sertraline 50mg (n⫽49). There were no group differences in age, sex, education, or severity of injury. Interventions: Subjects were enrolled an average of 21 days after injury (none ⬎8wk) followed by oral administration of placebo/drug for 3 months. Subjects Arch Phys Med Rehabil Vol 89, November 2008