A randomized controlled trial comparing a manual and computer version of CALM in VA community-based outpatient clinics

BACKGROUND: This study compared a computer and manual version of a tailored Coordinated Anxiety Learning and Management (VA CALM) protocol on provider fidelity to CBT and patient outcomes. METHODS: This study was a cluster randomized controlled trial. Providers (N = 32) were randomized to deliver VA CALM by computer or manual. Veteran patients (N = 135), treated by study providers, were recruited. The primary outcome was CBT fidelity, measured by rating audiotaped sessions. Secondary outcomes were Veterans’ general (BSI-18 GSI, SF-12) and disorder-specific (GAD-7, PCL-5, PHQ-9) outcomes assessed at baseline, three and six month follow-up. RESULTS: We found a large (d = 0.88) but not statistically significant difference in mean fidelity rating scores between conditions. Compared with the manual, participants with generalized anxiety disorder receiving VA CALM by computer reported lower GAD-7 scores at three (−5.88; 95% CI=−11.37, −0.39) and six month (−5.25; 95% CI=−10.29, −0.22) follow-ups (d = 0.37 to 0.55). Participants in the computer and manual conditions reported lower PHQ-9 (−3.11; 95% CI=−5.51, −0.71; −4.06; 95% CI=−7.22, −0.90, respectively) and BSI-18 GSI (0.78; 95% CI=0.68,0.90; 0.71; 95% CI=0.58, 0.87, respectively) scores from baseline to six month follow-up. We did not find statistically significant differences over time or between conditions on SF-12 or PCL-5 scores. LIMITATIONS: This study was underpowered to test the primary outcome. Small samples sizes in the disorder-specific subgroup analysis may limit the generalizability of findings. CONCLUSIONS: Neither modality proved to be superior on VA CALM fidelity. The computer version of VA CALM, compared to the manual, may provide modest benefit to Veterans with GAD.