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

Jonathan I Bisson Orcid Logo, 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 Orcid Logo, Paula Foscarini-Craggs, Shaun R S Harris, Mark Kelson, Karina Lovell, Maureen McKenna, Rachel McNamara, Claire Nollett, Tim Pickles, Rhys Williams-Thomas

BMJ, Start page: e069405

Swansea University Author: Deborah Fitzsimmons Orcid Logo

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DOI (Published version): 10.1136/bmj-2021-069405

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-inf...

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ISSN: 1756-1833
Published: BMJ 2022
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fullrecord <?xml version="1.0"?><rfc1807><datestamp>2022-07-15T17:42:20.1028917</datestamp><bib-version>v2</bib-version><id>60287</id><entry>2022-06-21</entry><title>Guided, internet based, cognitive behavioural therapy for post-traumatic stress disorder: pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID)</title><swanseaauthors><author><sid>e900d99a0977beccf607233b10c66b43</sid><ORCID>0000-0002-7286-8410</ORCID><firstname>Deborah</firstname><surname>Fitzsimmons</surname><name>Deborah Fitzsimmons</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2022-06-21</date><deptcode>PHAC</deptcode><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&#x2019;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 &#x2212;&#x221E; 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, &#x2212;&#x221E; to 6.00, P=0.15). Guided internet based CBT-TF was significantly (P&lt;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.</abstract><type>Journal Article</type><journal>BMJ</journal><volume/><journalNumber/><paginationStart>e069405</paginationStart><paginationEnd/><publisher>BMJ</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint/><issnElectronic>1756-1833</issnElectronic><keywords/><publishedDay>16</publishedDay><publishedMonth>6</publishedMonth><publishedYear>2022</publishedYear><publishedDate>2022-06-16</publishedDate><doi>10.1136/bmj-2021-069405</doi><url/><notes>Data sharing: The dataset is available from the corresponding author at bissonji@cardiff.ac.uk.</notes><college>COLLEGE NANME</college><department>Public Health</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>PHAC</DepartmentCode><institution>Swansea University</institution><apcterm/><funders>This project was funded by the UK National Institute for Health Research Health Technology Assessment (NIHR HTA) programme (project No 14/192/97).</funders><lastEdited>2022-07-15T17:42:20.1028917</lastEdited><Created>2022-06-21T09:01:03.7253563</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><order>2</order></author><author><firstname>Katherine</firstname><surname>Cullen</surname><order>3</order></author><author><firstname>Neil</firstname><surname>Kitchiner</surname><order>4</order></author><author><firstname>Catrin</firstname><surname>Lewis</surname><order>5</order></author><author><firstname>Neil P</firstname><surname>Roberts</surname><order>6</order></author><author><firstname>Natalie</firstname><surname>Simon</surname><order>7</order></author><author><firstname>Kim</firstname><surname>Smallman</surname><order>8</order></author><author><firstname>Katy</firstname><surname>Addison</surname><order>9</order></author><author><firstname>Vicky</firstname><surname>Bell</surname><order>10</order></author><author><firstname>Lucy</firstname><surname>Brookes-Howell</surname><order>11</order></author><author><firstname>Sarah</firstname><surname>Cosgrove</surname><order>12</order></author><author><firstname>Anke</firstname><surname>Ehlers</surname><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><order>15</order></author><author><firstname>Shaun R S</firstname><surname>Harris</surname><order>16</order></author><author><firstname>Mark</firstname><surname>Kelson</surname><order>17</order></author><author><firstname>Karina</firstname><surname>Lovell</surname><order>18</order></author><author><firstname>Maureen</firstname><surname>McKenna</surname><order>19</order></author><author><firstname>Rachel</firstname><surname>McNamara</surname><order>20</order></author><author><firstname>Claire</firstname><surname>Nollett</surname><order>21</order></author><author><firstname>Tim</firstname><surname>Pickles</surname><order>22</order></author><author><firstname>Rhys</firstname><surname>Williams-Thomas</surname><order>23</order></author></authors><documents><document><filename>60287__24617__5e6201d64197479ab89fa521dce4b617.pdf</filename><originalFilename>60287.pdf</originalFilename><uploaded>2022-07-15T17:08:37.5850236</uploaded><type>Output</type><contentLength>872715</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language><licence>http://creativecommons.org/licenses/by-nc/4.0/</licence></document></documents><OutputDurs/></rfc1807>
spelling 2022-07-15T17:42:20.1028917 v2 60287 2022-06-21 Guided, internet based, cognitive behavioural therapy for post-traumatic stress disorder: pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID) e900d99a0977beccf607233b10c66b43 0000-0002-7286-8410 Deborah Fitzsimmons Deborah Fitzsimmons true false 2022-06-21 PHAC 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. Journal Article BMJ e069405 BMJ 1756-1833 16 6 2022 2022-06-16 10.1136/bmj-2021-069405 Data sharing: The dataset is available from the corresponding author at bissonji@cardiff.ac.uk. COLLEGE NANME Public Health COLLEGE CODE PHAC Swansea University This project was funded by the UK National Institute for Health Research Health Technology Assessment (NIHR HTA) programme (project No 14/192/97). 2022-07-15T17:42:20.1028917 2022-06-21T09:01:03.7253563 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 2 Katherine Cullen 3 Neil Kitchiner 4 Catrin Lewis 5 Neil P Roberts 6 Natalie Simon 7 Kim Smallman 8 Katy Addison 9 Vicky Bell 10 Lucy Brookes-Howell 11 Sarah Cosgrove 12 Anke Ehlers 13 Deborah Fitzsimmons 0000-0002-7286-8410 14 Paula Foscarini-Craggs 15 Shaun R S Harris 16 Mark Kelson 17 Karina Lovell 18 Maureen McKenna 19 Rachel McNamara 20 Claire Nollett 21 Tim Pickles 22 Rhys Williams-Thomas 23 60287__24617__5e6201d64197479ab89fa521dce4b617.pdf 60287.pdf 2022-07-15T17:08:37.5850236 Output 872715 application/pdf Version of Record true This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license true eng http://creativecommons.org/licenses/by-nc/4.0/
title Guided, internet based, cognitive behavioural therapy for post-traumatic stress disorder: pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID)
spellingShingle Guided, internet based, cognitive behavioural therapy for post-traumatic stress disorder: pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID)
Deborah Fitzsimmons
title_short Guided, internet based, cognitive behavioural therapy for post-traumatic stress disorder: pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID)
title_full Guided, internet based, cognitive behavioural therapy for post-traumatic stress disorder: pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID)
title_fullStr Guided, internet based, cognitive behavioural therapy for post-traumatic stress disorder: pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID)
title_full_unstemmed Guided, internet based, cognitive behavioural therapy for post-traumatic stress disorder: pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID)
title_sort Guided, internet based, cognitive behavioural therapy for post-traumatic stress disorder: pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID)
author_id_str_mv e900d99a0977beccf607233b10c66b43
author_id_fullname_str_mv e900d99a0977beccf607233b10c66b43_***_Deborah Fitzsimmons
author Deborah Fitzsimmons
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 R S Harris
Mark Kelson
Karina Lovell
Maureen McKenna
Rachel McNamara
Claire Nollett
Tim Pickles
Rhys Williams-Thomas
format Journal article
container_title BMJ
container_start_page e069405
publishDate 2022
institution Swansea University
issn 1756-1833
doi_str_mv 10.1136/bmj-2021-069405
publisher BMJ
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
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
document_store_str 1
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description 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.
published_date 2022-06-16T04:18:16Z
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