Pragmatic randomised controlled trial of guided self-help versus individual cognitive behavioural therapy with a trauma focus for post-traumatic stress disorder (RAPID)

Bisson, Jonathan I; Ariti, Cono; Cullen, Katherine; Kitchiner, Neil; Lewis, Catrin; Roberts, Neil P; Simon, Natalie; Smallman, Kim; Addison, Katy; Bell, Vicky; Brookes-Howell, Lucy; Cosgrove, Sarah; Ehlers, Anke; Fitzsimmons, Deborah; Foscarini-Craggs, Paula; Harris, Shaun; Kelson, Mark; Lovell, Karina; McKenna, Maureen; McNamara, Rachel; Nollett, Claire; Pickles, Tim; Williams-Thomas, Rhys

doi:10.3310/ytqw8336

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Pragmatic randomised controlled trial of guided self-help versus individual cognitive behavioural therapy with a trauma focus for post-traumatic stress disorder (RAPID)

Jonathan I Bisson

, Cono Ariti

, Katherine Cullen

, Neil Kitchiner

, Catrin Lewis

, Neil P Roberts

, Natalie Simon

, Kim Smallman

, Katy Addison

, Vicky Bell

, Lucy Brookes-Howell

, Sarah Cosgrove

, Anke Ehlers

, Deborah Fitzsimmons

, Paula Foscarini-Craggs

, Shaun Harris

, Mark Kelson

, Karina Lovell

, Maureen McKenna

, Rachel McNamara

, Claire Nollett

, Tim Pickles

, Rhys Williams-Thomas

Health Technology Assessment, Volume: 27, Issue: 26, Pages: 1 - 141

Swansea University Authors: Katherine Cullen , Deborah Fitzsimmons , Shaun Harris

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DOI (Published version): 10.3310/ytqw8336

Abstract

Background: Guided self-help has been shown to be effective for other mental conditions and, if effective for post-traumatic stress disorder, would offer a time-efficient and accessible treatment option, with the potential to reduce waiting times and costs. Objective: To determine if trauma-focused...

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Published in:	Health Technology Assessment
ISSN:	1366-5278 2046-4924
Published:	National Institute for Health and Care Research 2023
Online Access:	Check full text
URI:	https://cronfa.swan.ac.uk/Record/cronfa65076
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Abstract:	Background: Guided self-help has been shown to be effective for other mental conditions and, if effective for post-traumatic stress disorder, would offer a time-efficient and accessible treatment option, with the potential to reduce waiting times and costs. Objective: To determine if trauma-focused guided self-help is non-inferior to individual, face-to-face cognitive-behavioural therapy with a trauma focus for mild to moderate post-traumatic stress disorder to a single traumatic event. Design: Multicentre pragmatic randomised controlled non-inferiority trial with economic evaluation to determine cost-effectiveness and nested process evaluation to assess fidelity and adherence, dose and factors that influence outcome (including context, acceptability, facilitators and barriers, measured qualitatively). Participants were randomised in a 1 : 1 ratio. The primary analysis was intention to treat using multilevel analysis of covariance. Setting: Primary and secondary mental health settings across the United Kingdom’s National Health Service. Participants: One hundred and ninety-six adults with a primary diagnosis of mild to moderate post-traumatic stress disorder were randomised with 82% retention at 16 weeks and 71% at 52 weeks. Nineteen participants and ten therapists were interviewed for the process evaluation. Interventions: Up to 12 face-to-face, manualised, individual cognitive-behavioural therapy with a trauma focus sessions, each lasting 60–90 minutes, or to guided self-help using Spring, an eight-step online guided self-help programme based on cognitive-behavioural therapy with a trauma focus, with up to five face-to-face meetings of up to 3 hours in total and four brief telephone calls or e-mail contacts between sessions. Main outcome measures: Primary outcome: the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, at 16 weeks post-randomisation. Secondary outcomes: included severity of post-traumatic stress disorder symptoms at 52 weeks, and functioning, symptoms of depression, symptoms of anxiety, alcohol use and perceived social support at both 16 and 52 weeks post-randomisation. Those assessing outcomes were blinded to group assignment. Results: Non-inferiority was demonstrated at the primary end point of 16 weeks on the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [mean difference 1.01 (one-sided 95% CI −∞ to 3.90, non-inferiority p = 0.012)]. Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, score improvements of over 60% in both groups were maintained at 52 weeks but the non-inferiority results were inconclusive in favour of cognitive-behavioural therapy with a trauma focus at this timepoint [mean difference 3.20 (one-sided 95% confidence interval −∞ to 6.00, non-inferiority p = 0.15)]. Guided self-help using Spring was not shown to be more cost-effective than face-to-face cognitive-behavioural therapy with a trauma focus although there was no significant difference in accruing quality-adjusted life-years, incremental quality-adjusted life-years −0.04 (95% confidence interval −0.10 to 0.01) and guided self-help using Spring was significantly cheaper to deliver [£277 (95% confidence interval £253 to £301) vs. £729 (95% CI £671 to £788)]. Guided self-help using Spring appeared to be acceptable and well tolerated by participants. No important adverse events or side effects were identified. Limitations: The results are not generalisable to people with post-traumatic stress disorder to more than one traumatic event. Conclusions: Guided self-help using Spring for mild to moderate post-traumatic stress disorder to a single traumatic event appears to be non-inferior to individual face-to-face cognitive-behavioural therapy with a trauma focus and the results suggest it should be considered a first-line treatment for people with this condition. Future work: Work is now needed to determine how best to effectively disseminate and implement guided self-help using Spring at scale. Trial registration: This trial is registered as ISRCTN13697710.
Item Description:	Report with a plain language summary and a scientific summary.
Keywords:	Randomised controlled trial, guided self-help, cognitive behavioural therapy, post-traumatic stress disorder
College:	Faculty of Medicine, Health and Life Sciences
Funders:	This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/192/97).
Issue:	26
Start Page:	1
End Page:	141

Pragmatic randomised controlled trial of guided self-help versus individual cognitive behavioural therapy with a trauma focus for post-traumatic stress disorder (RAPID)

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