METHODS: We report 12-month post-treatment data from a single-blind, active-controlled trial (October 2017-August 2019) where 327 Myanmar refugees in Malaysia were assigned to either six sessions of IAT (n = 164) or cognitive behavioral treatment (CBT) (n = 163). Primary outcomes were posttraumatic stress disorder (PTSD), depression, anxiety, and persistent complex bereavement disorder (PCBD) symptom scores at treatment end and 12-month post-treatment. Secondary outcome was functional impairment.
RESULTS: 282 (86.2%) participants were retained at 12-month follow-up. For both groups, large treatment effects for common mental disorders (CMD) symptoms were maintained at 12-month post-treatment compared to baseline (d = 0.75-1.13). Although participants in IAT had greater symptom reductions and larger effect sizes than CBT participants for all CMDs at treatment end, there were no significant differences between treatment arms at 12-month post-treatment for PTSD [mean difference: -0.9, 95% CI (-2.5 to 0.6), p = 0.25], depression [mean difference: 0.1, 95% CI (-0.6 to 0.7), p = 0.89), anxiety [mean difference: -0.4, 95% CI (-1.4 to 0.6), p = 0.46], and PCBD [mean difference: -0.6, 95% CI (-3.1 to 1.9), p = 0.65]. CBT participants showed greater improvement in functioning than IAT participants at 12-month post-treatment [mean difference: -2.5, 95% CI (-4.7 to -0.3], p = 0.03]. No adverse effects were recorded for either therapy.
CONCLUSIONS: Both IAT and CBT showed sustained treatment gains for CMD symptoms amongst refugees over the 12-month period.
METHODS AND FINDINGS: We conducted a single-blind RCT (October 2017 -May 2019) with Chin (39.3%), Kachin (15.7%), and Rohingya (45%) refugees living in Kuala Lumpur, Malaysia. The trial included 170 participants receiving six 45-minute weekly sessions of IAT (97.6% retention, 4 lost to follow-up) and 161 receiving a multicomponent CBT also involving six 45-minute weekly sessions (96.8% retention, 5 lost to follow-up). Participants (mean age: 30.8 years, SD = 9.6) had experienced and/or witnessed an average 10.1 types (SD = 5.9, range = 1-27) of traumatic events. We applied a single-blind design in which independent assessors of pre- and posttreatment indices were masked in relation to participants' treatment allocation status. Primary outcomes were symptom scores of Post Traumatic Stress Disorder (PTSD), Complex PTSD (CPTSD), Major Depressive Disorder (MDD), the 5 scales of the Adaptive Stress Index (ASI), and a measure of resilience (the Connor-Davidson Resilience Scale [CDRS]). Compared to CBT, an intention-to-treat analysis (n = 331) at 6-week posttreatment follow-up demonstrated greater reductions in the IAT arm for all common mental disorder (CMD) symptoms and ASI domains except for ASI-3 (injustice), as well as increases in the resilience scores. Adjusted average treatment effects assessing the differences in posttreatment scores between IAT and CBT (with baseline scores as covariates) were -0.08 (95% CI: -0.14 to -0.02, p = 0.012) for PTSD, -0.07 (95% CI: -0.14 to -0.01) for CPTSD, -0.07 for MDD (95% CI: -0.13 to -0.01, p = 0.025), 0.16 for CDRS (95% CI: 0.06-0.026, p ≤ 0.001), -0.12 (95% CI: -0.20 to -0.03, p ≤ 0.001) for ASI-1 (safety/security), -0.10 for ASI-2 (traumatic losses; 95% CI: -0.18 to -0.02, p = 0.02), -0.03 for ASI-3 (injustice; (95% CI: -0.11 to 0.06, p = 0.513), -0.12 for ASI-4 (role/identity disruptions; 95% CI: -0.21 to -0.04, p ≤ 0.001), and -0.18 for ASI-5 (existential meaning; 95% CI: -0.19 to -0.05, p ≤ 0.001). Compared to CBT, the IAT group had larger effect sizes for all indices (except for resilience) including PTSD (IAT, d = 0.93 versus CBT, d = 0.87), CPTSD (d = 1.27 versus d = 1.02), MDD (d = 1.4 versus d = 1.11), ASI-1 (d = 1.1 versus d = 0.85), ASI-2 (d = 0.81 versus d = 0.66), ASI-3 (d = 0.49 versus d = 0.42), ASI-4 (d = 0.86 versus d = 0.67), and ASI-5 (d = 0.72 versus d = 0.53). No adverse events were recorded for either therapy. Limitations include a possible allegiance effect (the authors inadvertently conveying disproportionate enthusiasm for IAT in training and supervision), cross-over effects (counsellors applying elements of one therapy in delivering the other), and the brief period of follow-up.
CONCLUSIONS: Compared to CBT, IAT showed superiority in improving mental health symptoms and adaptative stress from baseline to 6-week posttreatment. The differences in scores between IAT and CBT were modest and future studies conducted by independent research teams need to confirm the findings.
TRIAL REGISTRATION: The study is registered under Australian New Zealand Clinical Trials Registry (ANZCTR) (http://www.anzctr.org.au/). The trial registration number is: ACTRN12617001452381.