Early-stage randomised controlled trial of therapist-supported online cognitive therapy for post-traumatic stress disorder in young people.
Smith P., Ehlers A., Carr E., Clark DM., Dalgleish T., Forbes G., Goldsmith K., Griffiths H., Gupta M., King D., Miles S., Plant DT., Smith A., Steward J., Yule W., Meiser-Stedman R.
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.