CRITICALLY APPRAISED PAPER (CAP) Twamley, E. W., Jak, A. J., Delis, D. C., Bondi, M. W., & Lohr, J. B. (2014). Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) for Veterans with traumatic brain injury: Pilot randomized controlled trial. Journal of Rehabilitation Research & Development, 51(1), 59 69. https://doi.org/10.1682/jrrd.2013.01.0020 CLINICAL BOTTOM LINE Because the repercussions of traumatic brain injury (TBI) are extremely prevalent among veterans postwar, it is necessary to introduce them to cognitive compensatory strategies that enable them to reintegrate into society. This can be achieved with the help of a cognitive training program that includes education about the symptoms of TBI and concussions and introduction to vocational interventions that allow veterans to assimilate into the workforce. The authors of this study inferred that this intervention is all the more necessary given the absence of medications that could improve the cognitive impairments caused by TBI (p. 60). Hence, in this study they used a randomized controlled design to explore the effects of cognitive training as a rehabilitation technique. Cognitive training can focus on either restorative or compensatory techniques or may include a combination of both strategies. The intervention used in this study, Cognitive Symptom Management and Rehabilitation Therapy (CogSMART), was centered on compensatory strategies that resulted in significant improvements in postconcussive symptoms and prospective memory. Participants deemed the intervention advantageous and affirmed recommendation to other veterans. It is necessary to note that CogSMART needs to be replicated with a larger and more diverse sample to prove its effectiveness before widespread implementation. RESEARCH OBJECTIVE(S) To study the combined influence of CogSMART and a supported employment program for veterans experiencing cognitive deficits from mild to moderate TBI DESIGN TYPE AND LEVEL OF EVIDENCE Level I, randomized controlled trial (pilot study) PARTICIPANT SELECTION 1
How were participants recruited and selected to participate? Veterans who were currently receiving treatment at a Veterans Affairs health clinic were recruited for the study after written consent was obtained. All of them had received supported employment for a year prior. Inclusion criteria: Veterans Were currently unemployed and were involved in Operation Enduring Freedom or Operation Iraqi Freedom; Had a history of mild to moderate TBI with a loss of consciousness for less than 6 hours and had symptoms of posttraumatic amnesia for less than 7 days; Had documented impairment in at least one of the following neuropsychological areas: attention, processing speed, memory, learning, and executive functioning; and Were currently unemployed but stated an intention to get back into work. Exclusion criteria: Veterans who were involved in other intervention studies or who fulfilled the criteria for alcohol or substance abuse or dependence were excluded from participation. PARTICIPANT CHARACTERISTICS N= 34 #/ % Male: 32/(94%) #/ % Female: 2/(6%) Ethnicity: 76% were part of a racial or ethnic minority Disease/disability diagnosis: Cognitive deficits due to mild or moderate TBI INTERVENTION AND CONTROL GROUPS Group 1: Experimental group 2
Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? This group consisted of a supported employment program and CogSMART. The supported employment program was a practical, clientcentered, and evidence-based strategy that focused on accelerated community integration through work. CogSMART is a cognitive training program that focuses on education in compensatory approaches for prospective memory, learning, postconcussive symptoms, attention, and executive functions. 16 The participants could choose the employment setting, which could include coffee shops, career centers, libraries, or clinics. An employment specialist Two sessions per week: 1 hour per week for CogSMART, and one session per week for supported employment 12 weeks Group 2: Control group Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? Enhanced supported employment only 18 The employment location of participants choice ranged from libraries to coffee shops to career centers to clinics. A trained employment specialist Two visits per week 12 weeks INTERVENTION BIASES Contamination: YES The experimental group did not receive the intervention that the control group received. Co-intervention: 3
YES The participants did not receive any other intervention during the study. Timing of intervention: YES The intervention was given to both groups during the same time frame to prevent this bias. Site of intervention: YES Even though the services were offered at different locations chosen by the participants, this option was given to both groups, so bias was avoided. Use of different therapists to provide intervention: YES NO The intervention group and control group had different employment specialists. Baseline equality: YES The baseline scores on education level, ethnicity, IQ, gender, and nature and severity of the symptoms did not differ between the two groups. However, there was a 5-year difference in the mean age between the experimental and the control group. MEASURES AND OUTCOMES (Only on measures relevant to occupational therapy practice) Measure 1: Memory for Intentions Screening Test reliable (as reported in the article)? ( article)? Memory for Intentions Screening Test Prospective memory 4
Measure 2: Wechsler Adult Intelligence Scale in the Wechsler Adult Intelligence Scale (3rd ed.) Attention and working memory Measure 3: California Verbal Learning Test in the California Verbal Learning Test (2nd ed.) Verbal learning and memory Measure 4: Delis Kaplan Executive Function System Delis Kaplan Executive Function System Executive functioning 5
in the Measure 5: Wisconsin Card Sorting Test in the Wisconsin Card Sorting Test (64-card version) Reasoning and set switching Measure 6: Neurobehavioral Symptom Inventory in the Neurobehavioral Symptom Inventory Severity of postconcussive symptoms 6
Measure 7: Clinician-Administered PTSD Scale in the Clinician-Administered PTSD Scale Severity of PTSD symptoms Measure 8: Hamilton Depression Rating Scale in the Hamilton Depression Rating Scale Severity of depressive symptoms Measure 9: Quality of Life Interview Quality of Life Interview Brief Version Subjective judgment of global quality of life 7
in the MEASUREMENT BIASES Were the evaluators blind to treatment status? YES The research assistant was not made aware of the control and intervention groups at baseline assessment but was aware of which participants were in each group at reassessment. Was there recall or memory bias? YES NO Self-report measures that had the potential for recall bias were used. Other measurement biases: Participants who received the CogSMART and supported employment intervention were, on average, 5 years younger than participants in the control group, who received the enhanced supported employment. RESULTS There was a significant improvement in the postconcussive symptoms (p =.01) and prospective memory posttest assessment (p =.05) in the experimental group, which received CogSMART and supported employment, versus the control group, which received enhanced supported employment. There was a moderate effect size (d = 0.72) in prospective memory and a strong effect size (d = 0.97) in postconcussive symptoms. The experimental group showed a small to medium effect size improvement in the severity of psychiatric symptoms. There was no significant difference between the groups on quality of life, severity of psychiatric symptoms, work outcomes, or neuropsychological comparisons. The differences between the groups were not significant for reduction in the symptoms of PTSD, depression, or return to competitive work, as indicated by the low to medium effect size (d = 0.35). Was this study adequately powered (large enough to show a difference)? 8
YES This was a small pilot study with fewer than 20 participants in each group (experimental and control group) on completion of the study. Were the analysis methods appropriate? YES NO The authors performed an independent-samples t test to determine mean differences between the groups. Were statistics appropriately reported (in written or table format)? YES NO Tables were used for concise presentation of findings. Was participant dropout less than 20% in total sample and balanced between groups? YES NO A total of 16% of participants dropped out, and 32% of participants who did not complete the posttreatment assessment were also excluded. The experimental and control group had fewer than 20 participants per group. What are the overall study limitations? The small sample size limits the generalizability of the study. The high dropout rate (16%) and absence of posttreatment scores for 8 participants could have had an impact on the expected findings of the study. The difference in the mean ages of the two groups also could have skewed the results. Given the specific nature of the inclusion criteria, the findings of the study may be less generalizable to the adult population. CONCLUSION The veterans exposed to CogSMART perceived the psychoeducation aspect of the intervention to be advantageous. The intervention also led to an improvement in postconcussive symptoms and prospective memory. The results of this study are not applicable to people with severe TBI, those who are not veterans, and those who are not returning to work. This reduces the eligibility of the study to be generalized to a diverse population. Although the positive outcomes of CogSMART for prospective memory and postconcussive symptoms cannot be disregarded, it is imperative that more conclusive evidence be obtained before routine use of the intervention. Replicating the study with a larger sample size may lead to more definitive conclusions regarding its effectiveness. This work is based on the evidence-based literature review completed by Ruth George and Stacy Smallfield, DrOT, OTR/L, BCG, FAOTA, Washington University in St. Louis. CAP Worksheet adapted from Critical Review Form Quantitative Studies. Copyright 1998 by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, and M. Westmorland, McMaster University. Used with permission. For personal or educational use only. All other uses require permission from AOTA. Contact: www.copyright.com 9
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