negative consequences, or exacerbation of a concomitant condition (e.g., posttraumatic stress disorder). None of the trials reported data about any serious adverse events, including acts of aggression, suicide, or death.
Several of the trials that evaluated multi-modal/comprehensive therapy assessed measures such as anxiety and depression that theoretically could be improved or worsened with some forms of CRT (Ruff and Niemann 1990; Salazar et al. 2000; Tiersky et al. 2005; Vanderploeg et al. 2008). Ruff and Niemann’s (1990) small trial included 24 patients with chronic, moderate-severe traumatic brain injury (TBI). The trial compared a multi-modal, structured cognitive outpatient retraining program with therapy focusing on psychosocial functioning and activities of daily living (ADLs). Although the investigators had hypothesized increased emotional distress with cognitive rehabilitation, they found neither group perceived any changes in emotional or psychosocial functioning, though individuals in the second group tended to rate themselves more obstreperous after treatment. Salazar et al. (2000) and colleagues’1 single-center trial of patients with TBI in the subacute phase reported increased numbers of patients with major depression (19 at baseline, 27 at 1-year follow-up) and generalized anxiety (10 at baseline, 20 at 1-year follow up) among the 53 active-duty military personnel with moderate-severe TBI randomized to home rehabilitation with telephone support. No such increases were seen among the 67 individuals randomized to intensive in-hospital rehabilitation (depression 18 at baseline and 16 at follow up; anxiety 9 at baseline and follow-up). Incomplete follow-up at 1 year (34 of 53 home rehabilitation patients and 42 of 67 in-hospital rehabilitation patients) and possible differential surveillance and ascertainment limit the interpretation of these findings. Tiersky et al.’s (2005) small, single-blind trial found that individuals with mild TBI in the chronic phase who were randomized to neuro-psychologic rehabilitation reported less anxiety and depression (measured with SCL-90R) at 3 months than those randomized to a waitlist group. Vanderploeg et al.’s (2008) multi-center trial involving veterans with moderate-severe TBI in the subacute phase who were treated in acute inpatient rehabilitation programs reported no differences in worry, depression, or irritability at 1 year between groups randomized to cognitive didactic versus functional-experiential rehabilitation.
RCTs that evaluated single modality interventions most often used modality-specific outcomes and did not assess outcomes that could have detected any psycho-emotional distress related to the rehabilitation therapy. Only the Salazar trial reported estimated costs of CRT. The additional rehabilitation cost estimated for each patient in the intensive in-hospital group
1 The committee reviewed Salazar et al. 2000, with Braverman et al. 1999 and Warden et al. 2000.