Guided, internet based, cognitive behavioural therapy for post-traumatic stress disorder: pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID).

Abstract
Objective
To determine if guided internet based cognitive
behavioural therapy with a trauma focus (CBT-TF) is
non-inferior to individual face-to-face CBT-TF for mild
to moderate post-traumatic stress disorder (PTSD) to
one traumatic event.
Design
Pragmatic, multicentre, randomised controlled noninferiority trial (RAPID).
Setting
Primary and secondary mental health settings across
the UK’s NHS.
Participants
196 adults with a primary diagnosis of mild to
moderate PTSD were randomised in a 1:1 ratio to
one of two interventions, with 82% retention at 16
weeks and 71% retention at 52 weeks. 19 participants
and 10 therapists were purposively sampled and
interviewed for evaluation of the process.
Interventions
Up to 12 face-to-face, manual based, individual CBTTF sessions, each lasting 60-90 minutes; or guided
internet based CBT-TF with an eight step online
programme, with up to three hours of contact with
a therapist and four brief telephone calls or email
contacts between sessions.
Main outcome measures
Primary outcome was the Clinician Administered
PTSD Scale for DSM-5 (CAPS-5) at 16 weeks after
randomisation (diagnosis of PTSD based on the
criteria of the Diagnostic and Statistical Manual of
Mental Disorders, fifth edition, DSM-5). Secondary
outcomes included severity of PTSD symptoms at 52
weeks, and functioning, symptoms of depression and
anxiety, use of alcohol, and perceived social support
at 16 and 52 weeks after randomisation.
Results
Non-inferiority was found at the primary endpoint
of 16 weeks on the CAPS-5 (mean difference 1.01,
one sided 95% confidence interval −∞ to 3.90,
non-inferiority P=0.012). Improvements in CAPS5 score of more than 60% in the two groups were
maintained at 52 weeks, but the non-inferiority results
were inconclusive in favour of face-to-face CBT-TF at
this time point (3.20, −∞ to 6.00, P=0.15). Guided
internet based CBT-TF was significantly (P<0.001)
cheaper than face-to-face CBT-TF and seemed to
be acceptable and well tolerated by participants.
The main themes of the qualitative analysis were
facilitators and barriers to engagement with guided
internet based CBT-TF, treatment outcomes, and
considerations for its future implementation.
Co nclusions
Guided internet based CBT-TF for mild to moderate
PTSD to one traumatic event was non-inferior
to individual face-to-face CBT-TF and should be
considered a first line treatment for people with this
condition.
Trial registration
ISRCTN13697710.