A pragmatic randomized controlled trial of cognitive therapy for post-traumatic stress disorder in children and adolescents exposed to multiple traumatic stressors: the DECRYPT trial.

Trauma-focused cognitive-behavioral therapies (TF-CBTs) are efficacious in children and adolescents with post-traumatic stress disorder (PTSD). However, there is limited evidence in youth exposed to multiple traumas, especially in real-world settings. This paper reports on a pragmatic randomized controlled trial (RCT) evaluating whether one form of TF-CBT, cognitive therapy for PTSD (CT-PTSD), was effective for PTSD following multiple trauma exposure in 8-17 year-olds attending UK mental health services, relative to treatment-as-usual (TAU). Youth with PTSD (N=120) following multiple traumas were randomly allocated to receive CT-PTSD or TAU. At baseline, complex PTSD diagnosis was common (55.0% of cases), and a large proportion of youth had comorbid mental disorders. The primary outcome was the score on the Child Revised Impact of Event Scale, 8-item version (CRIES-8) at post-treatment. Secondary outcomes included the CRIES-8 score at 11 months post-randomization, and several measures of PTSD, anxiety, depression, suicidal ideation, affect regulation, irritability, and general functioning at post-treatment and 11 months post-randomization. CT-PTSD was not found to be significantly superior to TAU on the CRIES-8 at post-treatment (adjusted difference: -3.80, 95% CI: -7.56 to -0.06, p=0.095; Hedges' g=-0.37, 95% CI: -0.78 to 0.03), but it was superior to TAU when patients who had received TF-CBT were excluded from that arm (adjusted difference: -4.60, 95% CI: -8.36 to -0.81, p=0.047; g=-0.46, 95% CI: -0.89 to -0.04). CT-PTSD was also superior to TAU on the CRIES-8 at 11 months (adjusted difference: -5.38, 95% CI: -8.88 to -1.87, p=0.003; g=-0.46, 95% CI: -0.90 to -0.02), and in a mixed-effect model incorporating all time points (p=0.007). Evidence of superiority for CT-PTSD was observed on parent-reported emotional difficulties at post-treatment and 11 months; and on child-reported total anxiety and depression, total anxiety, panic and separation anxiety, and parent-reported affect dysregulation and irritability at 11 months. Treatment withdrawal rate was low. Despite high baseline levels of comorbidity and impairment not seen in previous trials, CT-PTSD was not associated with significant deterioration or adverse events. This pragmatic trial is likely to contribute to the optimization of psychological intervention in youth with PTSD following multiple traumas, accompanied by severe comorbid mental disorders, in routine settings.