Early-stage randomised controlled trial of therapist-supported online cognitive therapy for post-traumatic stress disorder in young people.

Abstract

BACKGROUND: Effective face-to-face treatments for Post-Traumatic Stress Disorder (PTSD) are available, but most young people with PTSD do not receive effective treatment. Therapist-supported online Cognitive Therapy has the potential to improve accessibility of effective treatment. This early-stage trial gathered data on the feasibility, acceptability, and initial signal of clinical efficacy of a novel online Cognitive Therapy program for young people with PTSD. METHODS: A two-arm, parallel-groups, single-blind, early-stage feasibility RCT compared online Cognitive Therapy to a waitlList condition. Participants were N = 31 adolescents (12-17 years-old) with a diagnosis of PTSD, randomised in a 1:1 ratio using minimisation. Thresholds for progression to a larger trial were set a priori for recruitment rate, data completeness, and the initial signal of clinical efficacy. The primary clinical outcome was PTSD diagnosis at 16 weeks post-randomisation. Secondary clinical outcomes were continuous measures of PTSD, depression, and anxiety at 16 weeks; and at 38 weeks in the online Cognitive Therapy arm. RESULTS: All pre-determined feasibility thresholds for progression to a larger trial were met. We recruited to target at a rate of 1-2 participants/month. No patient dropped out of therapy; 94% of all participants were retained at 16 weeks. At 16-weeks, the intention-to-treat (ITT) effect adjusted odds ratio was 0.20 (95% CI, 0.02, 1.42), indicating that the odds of meeting PTSD caseness after online therapy were 80% lower than after the waitlist (10/16 participants met PTSD caseness after therapy compared to 11/13 after WL). Effect-size estimates for all secondary clinical outcomes were large-moderate; improvements were sustained 38 weeks after online Cognitive Therapy. CONCLUSIONS: Therapist-supported online Cognitive Therapy for PTSD is acceptable to young people and has potential for meaningful and sustained clinical effects. A larger trial appears feasible to deliver. Further work is needed to refine the intervention and its delivery and to evaluate it in a larger confirmatory trial.