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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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.</abstract><type>Other</type><journal>Health Technology Assessment</journal><volume>27</volume><journalNumber>26</journalNumber><paginationStart>1</paginationStart><paginationEnd>141</paginationEnd><publisher>National Institute for Health and Care Research</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>1366-5278</issnPrint><issnElectronic>2046-4924</issnElectronic><keywords>Randomised controlled trial, guided self-help, cognitive behavioural therapy, post-traumatic stress disorder</keywords><publishedDay>30</publishedDay><publishedMonth>11</publishedMonth><publishedYear>2023</publishedYear><publishedDate>2023-11-30</publishedDate><doi>10.3310/ytqw8336</doi><url>http://dx.doi.org/10.3310/ytqw8336</url><notes>Report with a plain language summary and a scientific summary.</notes><college>COLLEGE NANME</college><department>Health and Social Care School</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>HSOC</DepartmentCode><institution>Swansea University</institution><apcterm>Other</apcterm><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).</funders><projectreference/><lastEdited>2024-07-15T11:40:26.4019780</lastEdited><Created>2023-11-22T17:30:20.4201422</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">School of Health and Social Care - Public Health</level></path><authors><author><firstname>Jonathan I</firstname><surname>Bisson</surname><orcid>0000-0001-5170-1243</orcid><order>1</order></author><author><firstname>Cono</firstname><surname>Ariti</surname><orcid>0000-0001-7615-0935</orcid><order>2</order></author><author><firstname>Katherine</firstname><surname>Cullen</surname><orcid>0000-0002-3704-4598</orcid><order>3</order></author><author><firstname>Neil</firstname><surname>Kitchiner</surname><orcid>0000-0003-0499-9520</orcid><order>4</order></author><author><firstname>Catrin</firstname><surname>Lewis</surname><orcid>0000-0002-3818-9377</orcid><order>5</order></author><author><firstname>Neil P</firstname><surname>Roberts</surname><orcid>0000-0002-6277-0102</orcid><order>6</order></author><author><firstname>Natalie</firstname><surname>Simon</surname><orcid>0000-0001-5712-9460</orcid><order>7</order></author><author><firstname>Kim</firstname><surname>Smallman</surname><orcid>0000-0002-9283-8120</orcid><order>8</order></author><author><firstname>Katy</firstname><surname>Addison</surname><orcid>0000-0002-5388-6437</orcid><order>9</order></author><author><firstname>Vicky</firstname><surname>Bell</surname><orcid>0000-0002-2405-0673</orcid><order>10</order></author><author><firstname>Lucy</firstname><surname>Brookes-Howell</surname><orcid>0000-0002-8263-7130</orcid><order>11</order></author><author><firstname>Sarah</firstname><surname>Cosgrove</surname><orcid>0000-0001-8816-5878</orcid><order>12</order></author><author><firstname>Anke</firstname><surname>Ehlers</surname><orcid>0000-0002-8742-0192</orcid><order>13</order></author><author><firstname>Deborah</firstname><surname>Fitzsimmons</surname><orcid>0000-0002-7286-8410</orcid><order>14</order></author><author><firstname>Paula</firstname><surname>Foscarini-Craggs</surname><orcid>0000-0001-9511-696x</orcid><order>15</order></author><author><firstname>Shaun</firstname><surname>Harris</surname><orcid>0000-0001-7724-6621</orcid><order>16</order></author><author><firstname>Mark</firstname><surname>Kelson</surname><orcid>0000-0001-7744-3780</orcid><order>17</order></author><author><firstname>Karina</firstname><surname>Lovell</surname><orcid>0000-0001-8821-895x</orcid><order>18</order></author><author><firstname>Maureen</firstname><surname>McKenna</surname><orcid>0000-0002-3477-1626</orcid><order>19</order></author><author><firstname>Rachel</firstname><surname>McNamara</surname><orcid>0000-0002-7280-1611</orcid><order>20</order></author><author><firstname>Claire</firstname><surname>Nollett</surname><orcid>0000-0001-6676-4933</orcid><order>21</order></author><author><firstname>Tim</firstname><surname>Pickles</surname><orcid>0000-0001-7743-0234</orcid><order>22</order></author><author><firstname>Rhys</firstname><surname>Williams-Thomas</surname><orcid>0000-0002-1779-3460</orcid><order>23</order></author></authors><documents><document><filename>65076__29265__b1433f4375f647909d0a18ab36adc61e.pdf</filename><originalFilename>65076.VOR.pdf</originalFilename><uploaded>2023-12-13T15:48:24.1981630</uploaded><type>Output</type><contentLength>3559231</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>Copyright © 2023 Bisson et al. 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spelling	v2 65076 2023-11-22 Pragmatic randomised controlled trial of guided self-help versus individual cognitive behavioural therapy with a trauma focus for post-traumatic stress disorder (RAPID) 9ddf9fac6330356b51fbb9f38fd6081f 0000-0002-3704-4598 Katherine Cullen Katherine Cullen true false e900d99a0977beccf607233b10c66b43 0000-0002-7286-8410 Deborah Fitzsimmons Deborah Fitzsimmons true false 10b1bd08dbad1f2681ff1e527af9f9a3 0000-0001-7724-6621 Shaun Harris Shaun Harris true false 2023-11-22 HSOC 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. Other Health Technology Assessment 27 26 1 141 National Institute for Health and Care Research 1366-5278 2046-4924 Randomised controlled trial, guided self-help, cognitive behavioural therapy, post-traumatic stress disorder 30 11 2023 2023-11-30 10.3310/ytqw8336 http://dx.doi.org/10.3310/ytqw8336 Report with a plain language summary and a scientific summary. COLLEGE NANME Health and Social Care School COLLEGE CODE HSOC Swansea University Other This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/192/97). 2024-07-15T11:40:26.4019780 2023-11-22T17:30:20.4201422 Faculty of Medicine, Health and Life Sciences School of Health and Social Care - Public Health Jonathan I Bisson 0000-0001-5170-1243 1 Cono Ariti 0000-0001-7615-0935 2 Katherine Cullen 0000-0002-3704-4598 3 Neil Kitchiner 0000-0003-0499-9520 4 Catrin Lewis 0000-0002-3818-9377 5 Neil P Roberts 0000-0002-6277-0102 6 Natalie Simon 0000-0001-5712-9460 7 Kim Smallman 0000-0002-9283-8120 8 Katy Addison 0000-0002-5388-6437 9 Vicky Bell 0000-0002-2405-0673 10 Lucy Brookes-Howell 0000-0002-8263-7130 11 Sarah Cosgrove 0000-0001-8816-5878 12 Anke Ehlers 0000-0002-8742-0192 13 Deborah Fitzsimmons 0000-0002-7286-8410 14 Paula Foscarini-Craggs 0000-0001-9511-696x 15 Shaun Harris 0000-0001-7724-6621 16 Mark Kelson 0000-0001-7744-3780 17 Karina Lovell 0000-0001-8821-895x 18 Maureen McKenna 0000-0002-3477-1626 19 Rachel McNamara 0000-0002-7280-1611 20 Claire Nollett 0000-0001-6676-4933 21 Tim Pickles 0000-0001-7743-0234 22 Rhys Williams-Thomas 0000-0002-1779-3460 23 65076__29265__b1433f4375f647909d0a18ab36adc61e.pdf 65076.VOR.pdf 2023-12-13T15:48:24.1981630 Output 3559231 application/pdf Version of Record true Copyright © 2023 Bisson et al. Distributed under the terms of a Creative Commons Attribution 4.0 International License (CC BY 4.0). true eng https://creativecommons.org/licenses/by/4.0/
title	Pragmatic randomised controlled trial of guided self-help versus individual cognitive behavioural therapy with a trauma focus for post-traumatic stress disorder (RAPID)
spellingShingle	Pragmatic randomised controlled trial of guided self-help versus individual cognitive behavioural therapy with a trauma focus for post-traumatic stress disorder (RAPID) Katherine Cullen Deborah Fitzsimmons Shaun Harris
title_short	Pragmatic randomised controlled trial of guided self-help versus individual cognitive behavioural therapy with a trauma focus for post-traumatic stress disorder (RAPID)
title_full	Pragmatic randomised controlled trial of guided self-help versus individual cognitive behavioural therapy with a trauma focus for post-traumatic stress disorder (RAPID)
title_fullStr	Pragmatic randomised controlled trial of guided self-help versus individual cognitive behavioural therapy with a trauma focus for post-traumatic stress disorder (RAPID)
title_full_unstemmed	Pragmatic randomised controlled trial of guided self-help versus individual cognitive behavioural therapy with a trauma focus for post-traumatic stress disorder (RAPID)
title_sort	Pragmatic randomised controlled trial of guided self-help versus individual cognitive behavioural therapy with a trauma focus for post-traumatic stress disorder (RAPID)
author_id_str_mv	9ddf9fac6330356b51fbb9f38fd6081f e900d99a0977beccf607233b10c66b43 10b1bd08dbad1f2681ff1e527af9f9a3
author_id_fullname_str_mv	9ddf9fac6330356b51fbb9f38fd6081f_*_Katherine Cullen e900d99a0977beccf607233b10c66b43__Deborah Fitzsimmons 10b1bd08dbad1f2681ff1e527af9f9a3_**_Shaun Harris
author	Katherine Cullen Deborah Fitzsimmons Shaun Harris
author2	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
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container_title	Health Technology Assessment
container_volume	27
container_issue	26
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publishDate	2023
institution	Swansea University
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doi_str_mv	10.3310/ytqw8336
publisher	National Institute for Health and Care Research
college_str	Faculty of Medicine, Health and Life Sciences
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hierarchy_top_title	Faculty of Medicine, Health and Life Sciences
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hierarchy_parent_title	Faculty of Medicine, Health and Life Sciences
department_str	School of Health and Social Care - Public Health{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}School of Health and Social Care - Public Health
url	http://dx.doi.org/10.3310/ytqw8336
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description	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.
published_date	2023-11-30T11:40:25Z
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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)

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