Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) for veterans with traumatic brain injury: Pilot randomized controlled trial (Twamley et al. 2014)
Twamley, E., Jak, A., Delis, D., Bondi, M., & Lohr, J. (2014). Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) for veterans with traumatic brain injury: Pilot randomized controlled trial. Journal of Rehabilitation Research and Development, 51(1), 59-70.
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- The study’s objective was to examine the impact of adding Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) to standard supported employment programming for veterans with a history of traumatic brain injury (TBI) and persistent related postconcussive symptoms.
- Veterans were referred to the program and completed a series of baseline neurocognitive and neuropsychological assessments to determine eligibility. Eligible veterans were randomly assigned to either the CogSMART treatment group, which received supported employment, enhanced by CogSMART sessions, or to a control group that did not participate in CogSMART sessions.
- The study found that veterans in the CogSMART group demonstrated statistically significant reductions in postconcussive symptoms and improvements in prospective memory functioning. Although a higher proportion of the treatment group entered competitive employment within 14 weeks of starting the program—50 percent compared to 26 percent in the control group—the difference was not statistically significant.
- The quality of causal evidence presented in this study is low because it is a randomized controlled trial with high or unknown attrition and no control variables included in the analysis. This means we are not confident that the estimated effects are attributable to CogSMART. Other factors are likely to have contributed.
CogSMART was developed from a review of prior cognitive training studies and used targeted rehabilitative techniques with demonstrated efficacy in populations with severe TBI, psychiatric disorders, and memory deficits related to neurologic pathology. This study focused on veterans with mild to moderate TBI to explore whether such techniques could have similar positive impacts in this population, leading to improved employability and mental health. CogSMART sessions included psychoeducation and cognitive training. Psychoeducation focused on postconcussive symptoms and management techniques such as stress reduction, sleep hygiene, and other lifestyle management strategies. Cognitive training included multi-modal compensatory interventions such as habit learning, acronym use, list making, conversational skills, alarms, calendars, problem-solving systems, and smartphone use to improve prospective memory, attention, learning, and executive functioning.
The treatment consisted of one year of standard supported employment programming, with one added treatment visit per week (lasting one hour) to receive the manualized CogSMART treatment during the first 12 weeks of the supported employment program. The supported employment program was a one-hour session each week emphasizing assisted rapid job searching for community-based employment opportunities that aligned with veterans’ interests and preferences. Both supported employment services and CogSMART were delivered by the same employment specialist.
Features of the Study
The study was designed as a randomized controlled trial. Veterans were referred to the supported employment program by the Veterans Administration (VA) San Diego Healthcare System Wellness, Vocational Enrichment Clinic, Polytrauma Clinic, and Neuropsychological Assessment Unit. To be eligible for the study, veterans had to (1) be Operation Iraqi Freedom or Operation Enduring Freedom veterans, (2) have a history of mild to moderate TBI (with added amnesia and loss-of-consciousness criteria), (3) have a documented impairment at least 1 standard deviation below the mean in at least one neuropsychological area, and (4) be unemployed but seeking to return to work. Veterans qualifying for other special substance abuse–related programs or who were participating in other studies were not accepted for the study. Eligible veterans completed a series of baseline neurocognitive and neuropsychological assessments and provided additional demographic and medical history data during the intake period.
Fifty veterans met the inclusion criteria for the study and were randomly assigned to either the treatment group, which received supported employment plus CogSMART for one year, or the control group. Members of the control group received one year of supported employment services plus one added session per week of “enhanced supported employment” to ensure comparable amounts of time and contact with the employment specialists as those in the CogSMART group. Activities completed as part of the enhanced supported employment session were not described in the report.
Study data included neuropsychological measures collected at baseline and three-month follow up; these were administered by a research assistant, blinded to treatment assignment, using standardized procedures. Employment-related data were collected weekly from study participants. The authors estimated impacts by comparing the differences of treatment and control group members on outcomes of interest.
- Statistically significant improvements were noted in postconcussive symptoms and prospective memory performance after three months, when participants had concluded the 12-week treatment period of the one-year supported employment program.
- Although a higher proportion of the treatment group entered competitive employment within 14 weeks of starting the program—50 percent compared with 26 percent in the control group—this difference was not statistically significant (p = 0.15).
Considerations for Interpreting the Findings
Of the 50 veterans randomly assigned to treatment and control groups, outcomes were reported for only 16 in the treatment group and 18 in the control group. The authors did not state how many veterans had initially been assigned to each of the groups. If the groups were initially the same size, that implies that the study has high attrition according to CLEAR guidelines, which means the study cannot receive a high causal evidence rating. Random assignment studies with high attrition can receive a moderate causal evidence rating if they include statistical controls specified for each topic area. However, this study did not include any statistical controls, which means it cannot receive a moderate causal evidence rating.
In addition, the study did not report what records were used to assess competitive employment after 14 weeks and did not describe whether this employment was full-time, part-time, or in the preferred job arenas of the veterans in treatment.
Causal Evidence Rating
The quality of causal evidence presented in this study is low because it is a randomized controlled trial with high or unknown attrition and no control variables included in the analysis. This means we are not confident that the estimated effects are attributable to CogSMART. Other factors are likely to have contributed.