Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022 Jun 16:377:e069405.
doi: 10.1136/bmj-2021-069405.

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

Jonathan I Bisson  1 , Cono Ariti  2 , Katherine Cullen  3 , Neil Kitchiner  4   5 , Catrin Lewis  4 , Neil P Roberts  4   5 , Natalie Simon  4 , Kim Smallman  2 , Katy Addison  2 , Vicky Bell  6 , Lucy Brookes-Howell  2 , Sarah Cosgrove  4 , Anke Ehlers  7 , Deborah Fitzsimmons  3 , Paula Foscarini-Craggs  2 , Shaun R S Harris  3 , Mark Kelson  8 , Karina Lovell  6 , Maureen McKenna  9 , Rachel McNamara  2 , Claire Nollett  2 , Tim Pickles  2 , Rhys Williams-Thomas  2
Affiliations
Randomized Controlled Trial

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

Jonathan I Bisson et al. BMJ. .

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 non-inferiority 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 CBT-TF 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 CAPS-5 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.

Conclusions: 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.

PubMed Disclaimer

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at https://www.icmje.org/disclosure-of-interest/ and declare: support from the NIHR HTA programme and the Welsh Government, through Health and Care Research Wales, for the submitted work; the Spring programme was developed by and is owned by Cardiff University and, if commercialised, Cardiff University would benefit, as would authors JIB, NK, CL, and NPR; AE is an originator of cognitive therapy for PTSD and occasionally receives an honorarium for workshops on cognitive therapy for PTSD; MK receives consulting fees from eCorys Consulting and support for institutional travel from the Alan Turing Institute; no other relationships or activities that could appear to have influenced the submitted work.

Figures

Fig 1
Fig 1
Consolidated Standards of Reporting Trials (CONSORT) flow diagram of population selection for the RAPID trial. Participants were randomised to receive guided self-help (GSH) internet based cognitive behavioural therapy with a trauma focus (CBT-TF) or face-to-face CBT-TF. PTSD=post-traumatic stress disorder; CAPS-5=Clinician Administered PTSD Scale for DSM-5 (diagnosis of PTSD based on criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, DSM-5)
Fig 2
Fig 2
Precipitating traumatic events in post-traumatic stress disorder
Fig 3
Fig 3
Primary outcome: non-inferiority analyses for Clinician Administered Post-Traumatic Stress Disorder Scale for DSM-5 (CAPS-5) at 16 weeks (diagnosis of PTSD based on criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, DSM-5) in the two groups: guided self-help (GSH) group (internet based cognitive behavioural therapy with a trauma focus (CBT-TF)) and face-to-face CBT-TF group
Fig 4
Fig 4
Adjusted mean Clinician Administered Post-Traumatic Stress Disorder Scale for DSM-5 (CAPS-5) scores over time in the two groups (diagnosis of PTSD based on criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, DSM-5)
Fig 5
Fig 5
Non-inferiority analyses for Clinician Administered Post-Traumatic Stress Disorder Scale for DSM-5 (CAPS-5) at 52 weeks (diagnosis of PTSD based on criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, DSM-5) in the two groups: guided self-help (GSH) group (internet based cognitive behavioural therapy with a trauma focus (CBT-TF)) and face-to-face CBT-TF group
See this image and copyright information in PMC

References

    1. American Psychiatric Association . Diagnostic and statistical manual of mental disorders. 5th ed. Author, 2013.
    1. World Health Organization. International classification of diseases for mortality and morbidity statistics (11th revision). https://icd.who.int/en
    1. McManus S, Bebbington PE, Jenkins R, et al. Mental health and wellbeing in England: The adult psychiatric morbidity survey 2014: NHS Digital 2016.
    1. Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry 1995;52:1048-60. 10.1001/archpsyc.1995.03950240066012 - DOI - PubMed
    1. Brady KT, Killeen TK, Brewerton T, Lucerini S. Comorbidity of psychiatric disorders and posttraumatic stress disorder. J Clin Psychiatry 2000;61(Suppl 7):22-32. - PubMed

Publication types