Scheduled telephone intervention for traumatic brain injury: a multicenter randomized controlled trial

Bell KR, Brockway JA, Hart T, Whyte J, Sherer M, Fraser RT, Temkin NR, Dikmen SS. Scheduled telephone intervention for traumatic brain injury: a multicenter randomized controlled trial.

Objective

To evaluate the effect of a Scheduled Telephone Intervention (STI) compared with usual care (UC) on function, health/emotional status, community/work activities, and well-being at 1 and 2 years after traumatic brain injury (TBI).

Design

Two group, randomized controlled trial.

Setting

Telephone contacts with subjects recruited in inpatient rehabilitation.

Participants

Eligible subjects (N=433) with TBI (age>16y) were randomly assigned to STI plus UC (n=210) or UC (n=223) at discharge. STI subjects (n=169) completed the outcome at year 1 (118 at year 2) and 174 UC subjects at year 1 (123 at year 2).

Interventions

STI subjects received calls at 2 and 4 weeks and 2, 3, 5, 7, 9, 12, 15, 18, and 21 months consisting of brief training in problem solving, education, or referral.

Main Outcome Measures

A composite outcome at 1 year was the primary endpoint. Analysis on intent-to-treat basis used linear regression adjusted for site, Glasgow Coma Scale, race/ethnicity, age, FIM, sex, and Disability Rating Scale (DRS). Secondary analyses were conducted on individual and composite measures (FIM, DRS, community participation indicators, Glasgow Outcome Scale [Extended], Short Form-12 Health Survey, Brief Symptom Inventory-18, EuroQOL, and modified Perceived Quality of Life).

Results

No significant differences were noted between the groups at years 1 or 2 for primary (P=.987 regression for year 1, P=.983 for year 2) or secondary analyses.

Conclusions

This study failed to replicate the findings of a previous single center study of telephone-based counseling. While telephone mediated treatment has shown promise in other studies, this model of flexible counseling in problem solving and education for varied problems was not effective over and above usual care.     

A randomized controlled trial of botulinum toxin on lower limb spasticity following acute acquired severe brain injury

OBJECTIVE: To determine whether serial casting combined with botulinum toxin reduces the development of calf contracture after severe head injury. DESIGN: A double-blind placebo-controlled trial of three parallel treatments for lower limb spasticity. SETTING: Acute general hospital in the UK. SUBJECTS: Adults aged 17-70 years admitted to hospital following a severe brain INTERVENTIONS: Current physical treatment (group I), lower leg casting plus injections with either saline (group II), or with botulinum toxin (group III) into gastrocnemius and soleus muscles. MEASURES: Limit of ankle dorsiflexion at entry and exit after up to 12 weeks, the Glasgow Outcome Scale (GOS) and Modified Ashworth Scale (MAS). RESULTS: Two hundred and fifty-three patients were screened and 35 were entered into the trial. Three patients died and four failed to complete the trial. Eighty-eight per cent of those entering the randomized part of the study developed spasticity within 14 days of their injury and the mean range of improvement in the angle of passive ankle dorsiflexion was 4.59 degrees in controls, 11.69 degrees in cast and saline and 13.59 degrees in cast and botulinum toxin. There were significant improvements in the MAS scores in actively treated groups, but not in controls. Cast and botulinum toxin patients also demonstrated a significant improvement in the GOS. CONCLUSIONS: Active intervention with casting prevents talipes equinovarus deformities in patients losing ankle movement following severe brain injury. Casting alone in these patients is sufficient; the role of additional botulinum toxin needs further investigation, but is safe in these patients.     

A natural setting behavior management program for persons with acquired brain injury: a randomized controlled trial

OBJECTIVE: To investigate the efficacy of a behavior management program delivered in the natural community setting for persons with brain injury and their caregivers. DESIGN: Three-group randomized controlled trial. SETTING: Homes and other community settings. PARTICIPANTS: Thirty-seven persons with traumatic and other acquired brain injury and their caregivers. INTERVENTIONS: Natural Setting Behavior Management (NSBM) involving education and individualized behavior modification program versus education only versus control group. MAIN OUTCOME MEASURES: Changes in frequency of targeted problematic behaviors. Subscale in Questionnaire on Resources and Stress, Maslach Burnout Inventory, and the Neurobehavioral Functioning Inventory. RESULTS: While no significant effects were detected at termination of education only (P<.075) or of NSBM (P<.56), significant treatment effects were found at the main outcome point 3 months after termination of services (P<.002). Rates of disruptive or aggressive behaviors declined significantly in the NSBM group. Differences in caregiver-rated stress, burden, and aggression were not statistically significant. CONCLUSIONS: A program of caregiver education and individualized behavior management in natural settings can decrease the frequency of disruptive behavioral challenges. Larger studies are needed to clarify the duration and intensity of education and individualized treatment required to diminish behavioral challenges and to understand relationships with general stress and burden experienced by caregivers.     

高容量血液滤过改善重型颅脑损伤患者脑功能的多中心随机对照研究

目的探讨高容量血液滤过（HVHF）对重型颅脑损伤患者颅内压、内环境、脑氧代谢及脑保护作用的影响。 方法采用随机数字表法将114例重型颅脑损伤患者分为常规组和HVHF组,每组各57例。常规组予以甘露醇0.5 g/kg静脉滴注,每6小时1次,连续治疗7 d;HVHF组在常规组的基础上72 h内予以超滤量为60 mL·kg^-1·h^-1的HVHF治疗,持续72 h。记录两组患者的一般资料,治疗前及治疗24 h、72 h、7 d后的颅内压,颈内静脉血氧饱和度（SjvO₂）,血清Na⁺浓度,平均动脉压,机械通气时间及ICU住院时间。 结果两组患者各时间点颅内压、血清Na⁺及SjvO₂表达水平比较,差异均有统计学意义（F= 8.159、3.770、2.787,P < 0.001、= 0.011、0.040）;而平均动脉压比较,差异无统计学意义（F= 0.755,P= 0.520）。进一步两两比较发现,常规组患者治疗7 d后颅内压较同组治疗前显著降低（P < 0.05）;HVHF组患者治疗72 h及7 d后颅内压均较同组治疗前和常规组同时间点显著降低（P均< 0.05）;常规组患者治疗72 h及7 d后血清Na⁺和SjvO₂表达水平均较同组治疗前显著升高（P均< 0.05）;HVHF组患者治疗24 h、72 h及7 d后血清Na⁺表达水平均较常规组同时间点显著降低（P均< 0.05）,治疗72 h及7 d后SjvO₂表达水平均较同组治疗前和常规组同时间点显著升高（P均< 0.05）。两组患者机械通气时间[（13.5 ± 3.3）d vs.（12.5 ± 2.6）d]和住ICU时间[（18 ± 6）d vs.（16 ± 5）d]比较,差异均无统计学意义（t = 1.797、1.599,P = 0.075、0.113）。 结论HVHF可有效改善重型颅脑损伤患者颅内压及脑代谢水平,具有脑保护和稳定内环境的作用。     

Arm ability training for stroke and traumatic brain injury patients with mild arm paresis: a single-blind, randomized, controlled trial.

OBJECTIVE: To test the efficacy of the arm ability training (AAT) on a sample of patients with central arm paresis after traumatic brain injury (TBI) or stroke. DESIGN: Single-blind, randomized, controlled trial. SETTING: Inpatient rehabilitation center. PATIENTS: Consecutive sample of 74 patients of whom 60 (45 with stroke, 15 with TBI) completed the study; 37 patients received a 1-year follow-up. INTERVENTION: Daily AAT with (n = 20) or without (n = 20) knowledge of results, or no AAT (n = 20) during a 3-week intervention period. MAIN OUTCOME MEASURES: Summary time scores of the Test Evaluant les Membres superieurs des Personnes Agees (TEMPA)-a test of upper extremity function with daily function-like activities (focal disability)-and kinematic analysis of aimed movements. RESULTS: Patients with AAT realized superior improvement as compared with controls. Mean improvement in the time needed to perform (1) all TEMPA tasks was 41.4 versus 12.8 seconds (p =.0012); (2) unilateral TEMPA tasks, 16.5 versus 4.2 seconds (p =.0036); and (3) the ballistic component of aimed movements, 96 versus 20ms (p =.0115). Knowledge of result did not substantially modify these effects. A functional benefit existed at 1-year follow-up. CONCLUSION: The AAT reduces focal disability among stroke and TBI patients with mild central arm paresis.     

Evaluating a psychosocial intervention for men with prostate cancer and their partners: Outcomes and lessons learned from a randomized controlled trial

AimThis study evaluated the process and outcome of a psychosocial intervention for men with prostate cancer and their partners. As more men survive prostate cancer, they and their partners need help and support to help them cope with the physical and psychosocial effects of the disease and treatment. There is a lack of psychosocial interventions for men with prostate cancer and their partners.MethodsA randomized controlled trial was conducted with 34 participants to measure the effects of the intervention on selected psychosocial outcomes, post-intervention and at one month’ follow-up. The nine-week program (CONNECT) consisted of three group and two telephone sessions. It focused on symptom management, sexual dysfunction, uncertainty management, positive thinking and couple communication. The outcomes, measured by validated tools were: self-efficacy, quality of life, symptom distress, communication, uncertainty and illness benefits.ResultsThe men in the intervention group did better on two outcomes (communication and support) than controls. Partners in the intervention group did better than controls on most outcomes. Less participants than expected participated in the trial. The reasons for non-participation included partners not wishing to participate, men not interested in group work, and not understanding the core purpose of the intervention. The cost of training facilitators and for delivering the intervention appeared to be low.ConclusionThe knowledge generated from this study will be beneficial for all those grappling with the challenges of developing, implementing and evaluating complex psychosocial interventions. This study has also highlighted the difficulties in recruiting men and their partners in clinical trials.     

Effects of methylphenidate on attention deficits after traumatic brain injury: a multidimensional, randomized, controlled trial

OBJECTIVE: To evaluate the effects of methylphenidate on a variety of aspects of attention, ranging from laboratory-based impairment measures to caregiver ratings and work productivity, in individuals after traumatic brain injury. DESIGN: A total of 34 adults with moderate to severe traumatic brain injury and attention complaints in the postacute phase of recovery were enrolled in a 6-wk, double-blind, placebo-controlled, repeated crossover study of methylphenidate, administered in a dose of 0.3 mg/kg/dose, twice a day. A wide range of attentional measures was gathered weekly, including computerized and paper-and-pencil tests of attention, videotaped records of individual work in a distracting environment, real-time observational scoring of attentiveness in a classroom environment, and caregiver and clinician rating scales of attentiveness. Participants also attempted to guess their drug condition each week. Data from the first ten participants were used for pilot purposes, to develop attentional factors for composite scoring, and to identify attentional dimensions suggestive of a treatment effect for independent replication. The remaining 24 participants' results were used to confirm potential treatment effects seen in the pilot sample, using Wilcoxon's signed-ranks test on composite factor scores and individual variables. RESULTS: A total of 54 dependent variables were reduced to 13 composite factors and 13 remaining individual variables. Of the 13 attentional factors, five showed suggestive treatment effects in the pilot sample. Of these, three showed statistically significant treatment effects in the replication sample: speed of information processing (effect sizes, -0.06 to 0.48; P < 0.001), attentiveness during individual work tasks (effect sizes, 0.15-0.62; P = 0.01), and caregiver ratings of attention (effect sizes, 0.44-0.50; P = 0.01). Of the individual variables, four showed suggestive treatment effects in the pilot sample, but only one showed significant treatment effects in the replication sample: reaction time before errors in the Sustained Attention to Response Task (effect size, 0.20; P = 0.03). No treatment-related improvement was seen in divided attention, sustained attention, or susceptibility to distraction. None of the variables showed suggestive or definite negative treatment effects. Effect sizes for those performance measures positively affected by methylphenidate were in the small to medium range and included both impairment and activity level measures. Improvements in processing speed did not seem to come at the expense of accuracy. CONCLUSIONS: Methylphenidate, at 0.3 mg/kg/dose, given twice a day to individuals with attentional complaints after traumatic brain injury, seems to have clinically significant positive effects on speed of processing, caregiver ratings of attention, and some aspects of on-task behavior in naturalistic tasks. Further research is needed to identify the optimal dose and to extend these findings to less carefully selected individuals.     

A cognitive-behavioral group intervention as prevention for persistent neck and back pain in a non-patient population: a randomized controlled trial

Given the demand for interventions that may prevent the development of persistent musculoskeletal pain problems, we investigated the effects of a cognitive-behavioral program in a group of non-patients with neck or back pain symptoms. Two hundred and fifty-three people selected from a population study were invited to participate. These people had experienced four or more episodes of relatively intense spinal pain during the past year but had not been out of work more than 30 days. Participants were randomly assigned to either a cognitive-behavioral group intervention or a treatment as usual comparison group. The experimental group received a standardized six-session program, provided by a trained therapist according to a manual. A significant overall analysis at the 1-year follow-up showed that the cognitive-behavioral group produced better results on 26 of the 33 outcome variables. Group comparisons indicated that the cognitive-behavioral group, relative to the comparison group, had significantly better results with regard to fear-avoidance beliefs, number of pain-free days, as well as the key variable of sick leave. Participation in the cognitive behavioral group reduced the risk for long-term sick leave during the follow-up by threefold. Thus, despite the strong natural recovery rate for back pain, the cognitive-behavioral intervention produced a significant preventive effect with regard to disability.     

Telephone-delivered cognitive behavioral therapy for veterans with chronic pain following traumatic brain injury: Rationale and study protocol for a randomized controlled trial study

Background and objectivesChronic pain is a highly prevalent and potentially disabling condition in Veterans who have had a traumatic brain injury (TBI) and access to non-pharmacological pain treatments such as cognitive behavioral therapy is limited and variable. The purpose of this randomized controlled trial (RCT) is to evaluate the efficacy of a telephone-delivered cognitive behavioral therapy (T-CBT) for pain in Veterans with a history of TBI.MethodsVeterans with a history of TBI and chronic pain of at least six months duration (N = 160) will be randomized to either T-CBT or a telephone-delivered pain psychoeducational active control condition (T-Ed). The eight-week T-CBT intervention builds on other efficacious CBT interventions for chronic pain in the general population but is novel in that it is conducted via telephone and adapted for Veterans with a history of TBI. Outcome variables will be collected pre, mid-, and post-treatment, and 6 months following randomization (follow-up).Projected outcomesIn addition to evaluating the effects of the interventions on pain intensity (primary outcome), this study will determine their effects on pain interference, sleep, depression, and life satisfaction. We will also examine potential moderators of treatment outcomes such as cognition, PTSD, and alcohol and drug use. This non-pharmacologic one-on-one therapeutic intervention has the potential to reduce pain and pain-related dysfunction, improve access to care, and reduce barriers associated with geography, finances, and stigma, without the negative effects on physical and cognitive performance and potential for addiction as seen with some pharmacologic treatments for pain.This trial is registered at ClinicalTrials.gov, protocol NCT01768650     

Botulinum toxin in upper limb spasticity after acquired brain injury: a randomized trial comparing dilution techniques

OBJECTIVE: To compare the efficacy of two different volume preparations of the same dose of botulinum toxin-A in relieving spasticity in wrist and finger flexors secondary to acquired brain injury. DESIGN: Thirteen adult patients who had modified Ashworth scale scores of 3 for both wrist and finger flexors were included in this randomized, controlled trial. Wrist and finger flexors were each injected. Blinded modified Ashworth scale ratings of wrist and finger flexor spasticity were measured. RESULTS: Spasticity in both muscles decreased significantly in both treatment groups. However, the high-volume and low-volume groups did not differ significantly in spasticity reduction. CONCLUSIONS: Because this preliminary study found no difference in spasticity reduction between high- and low-volume preparations of a 60-unit dose of botulinum toxin-A, a larger-sample study seems warranted to compare the efficacy of high-volume and low-volume preparations.     

Supportive intervention for fatigue in patients undergoing chemotherapy: a randomized controlled trial

This study evaluated a supportive intervention for fatigue in patients undergoing chemotherapy. One hundred three chemotherapy-naïve patients were recruited, stratified by treatment regimen, and randomly allocated to intervention or usual care. The intervention was conducted over three months. Recipients were provided with an investigator-designed information pack and Fatigue Diary that they completed during the week following each treatment. Additionally, support nurses visited them monthly at home. They assessed fatigue, provided psychological support, and coached participants in self-care. The intervention group reported significantly less fatigue (P < 0.05), lower associated distress (P < 0.05), and less impact of fatigue on valued pastimes (P < 0.05) than the control group. Further, they reported significantly less anxiety (P < 0.05) and depression (P < 0.05) and displayed more adaptive coping (P < 0.05). The intervention enabled patients to adapt to living with fatigue and contributed to their psychological/emotional well-being and ability to cope with their illness and treatment.     

Comparison of lorazepam and zopiclone for insomnia in patients with stroke and brain injury: a randomized, crossover, double-blinded trial

OBJECTIVES: To determine if lorazepam or zopiclone is more effective in providing a restful night of sleep and to assess the effects of these medications on cognition. DESIGN: A randomized, double-blinded, crossover trial was performed at a tertiary care rehabilitation inpatient unit in a teaching hospital. A total of 18 brain-injured and stroke patients, aged 20-78 yrs, were administered lorazepam, 0.5-1.0 mg, orally at bedtime as needed for 7 days and zopiclone, 3.75-7.5 mg, orally at bedtime as needed for 7 days. Total sleep time and characteristics of sleep were measured. Effects on cognition were also measured using the Folstein Mini Mental Status Exam. RESULTS: There was no difference in average sleep duration or in subjective measures of sleep. Cognition as assessed by the Mini Mental Status Exam revealed no difference in the zopiclone arm compared with the lorazepam arm. CONCLUSION: Zopiclone is equally effective as lorazepam in the treatment of insomnia in stroke and brain-injured patients.     

Effects of psychosocial group rehabilitation on social functioning, loneliness and well-being of lonely, older people: randomized controlled trial

Title. Effects of psychosocial group rehabilitation on social functioning, loneliness and well‐being of lonely, older people: randomized controlled trial. Aim. This paper is a report of a study to explore the effects of psychosocial group nursing intervention on older people’s feelings of loneliness, social activity and psychological well‐being. Background. Older people’s loneliness is associated with low quality of life, and impaired health, increased use of health and social services and increased mortality. Previous intervention studies have achieved quite modest results. Method. A randomized controlled trial was conducted between 2003 and 2006 using a group intervention aimed at empowering older people, and promoting peer support and social integration. A total of 235 people (>74 years) suffering from loneliness met 12 times with professional leaders in groups. The UCLA Loneliness Scale and Lubben’s Social Network Scale were used at entry, after 3 and 6 months. Psychological well‐being was charted using a six‐dimensional questionnaire at baseline and 12 months later. Findings. A statistically significantly larger proportion of intervention group participants had found new friends during the follow‐up year (45% vs. 32%, P = 0·048), and 40% of intervention group participants continued their group meetings for 1 year. However, no differences were found in loneliness or social networks between the groups. Psychological well‐being score improved statistically significantly in the intervention groups [+0·11, 95% confidence interval (CI): +0·04 to +0·13], compared with the controls (+0·01, 95% CI: ?0·05 to +0·07, P = 0·045). Feeling needed was statistically significantly more common in the intervention groups (66%) than in controls (49%, P = 0·019). Conclusion. New sensitive measurements of loneliness and social isolation are needed to measure fluctuations in feelings of loneliness and in social isolation.     

Longitudinal effects of coping on outcome in a randomized controlled trial of a group intervention for HIV-positive adults with AIDS-related bereavement

This study examined the longitudinal effects of coping on outcome one year following completion of a randomized, controlled trial of a group coping intervention for AIDS-related bereavement. Bereaved HIV-positive participants (N = 267) were administered measures of grief, psychiatric distress, quality of life, and coping at baseline, post-intervention, and at 4-, 8-, and 12-month follow-ups. Coping strategies directly impacted all outcome variables for both study conditions. Additionally, the coping intervention moderated the relationship between avoidant coping and the longitudinal course of grief and psychiatric distress, resulting in greater reductions in grief and distress for intervention participants after accounting for avoidant coping strategies.     

Positive behaviour support for adults with acquired brain injury and challenging behaviour: A randomised controlled trial

BackgroundChallenging behaviours are common and disabling consequences of acquired brain injury (ABI), causing stress for close-others and disrupting community integration. Positive Behaviour Support (PBS) interventions have support from case studies as a means of reducing these behaviours, but controlled trials are lacking.ObjectivesThis study aimed to evaluate, with a randomised waitlist-controlled trial, the efficacy of a 12-month PBS intervention, termed PBS+PLUS, in reducing challenging behaviours after ABI.MethodsParticipants included 49 individuals with ABI (PBS+PLUS Intervention and Waitlist Treatment-as-usual groups) and their close-others. The design was a randomised waitlist-controlled trial with 12-month follow-up. PBS+PLUS involved setting collaborative goals toward a more meaningful life with the individual with ABI and addressing barriers to achieving these, including challenging behaviours, through skill-building, restructuring environments and executive strategies. The primary outcome measure was the Overt Behaviour Scale (OBS). The Challenging Behaviour Self-Efficacy Scale (CBSES) was a secondary outcome, assessing close-others’ self-efficacy in addressing challenging behaviour. Measures were completed at baseline and every 4 months. Data analyses involved mixed-effects and negative binomial regressions examining change over time by group.ResultsThe PBS+PLUS Intervention group included 24 participants and the Waitlist group 25 participants. On the OBS, the Intervention group showed a significant reduction in challenging behaviour over the 12-month intervention. However, the Waitlist group showed similar improvement on the OBS over the 12-month waitlist period. The Waitlist group was not denied an intervention from other providers during this period. Gains continued for 8 months post-intervention. The PBS+PLUS intervention resulted in significantly greater gains in close-others’ confidence in addressing challenging behaviours on the CBSES, relative to those in the Waitlist group, who showed no such gains.ConclusionsAlthough we cannot say this intervention is more effective than any other, the study did show that PBS+PLUS can result in significant and sustained reductions in challenging behaviour in individuals with severe ABI and increased confidence of close-others in addressing these difficult behaviours.Australian New Zealand Clinical Trials Registry#ACTRN12616001704482     

Ambulation training with and without partial weightbearing after traumatic brain injury: results of a randomized, controlled trial

OBJECTIVE: To test the hypothesis that 8 wks of partial weight-bearing gait retraining improves functional ambulation to a greater extent than traditional physical therapy in individuals after traumatic brain injury. DESIGN: A randomized, open-label, controlled, cohort study was conducted at two inpatient university-based rehabilitation hospitals. A total of 38 adults with a primary diagnosis of traumatic brain injury and significant gait abnormalities received either 8 wks of standard physical therapy or physical therapy supplemented with partial weight-bearing gait training twice weekly. RESULTS: Significant (P < 0.05) improvements were detected in both groups on Functional Ambulation Category, Standing Balance Scale, Rivermead Mobility Index, and FIM. However, no differences were found between the treatment groups. CONCLUSIONS: Results did not support the hypothesis that 8 wks of partial weight-bearing gait retraining improves functional ambulation to a greater extent than traditional physical therapy in individuals after traumatic brain injury based on common clinical measures.