Pragmatic Randomised controlled trial of a trauma-focused guided self-help Programme versus InDividual trauma-focused cognitive behavioural therapy for post-traumatic stress disorder (RAPID): trial protocol.

Journal article


Nollett, Claire, Lewis, Catrin, Kitchiner, Neil, Roberts, Neil, Addison, Katy, Brookes-Howell, Lucy, Cosgrove, Sarah, Cullen, Katherine, Ehlers, Anke, Heke, Sarah, Kelson, Mark, Lovell, Karina, Madden, Kim, McEwan, Kirsten, McNamara, Rachel, Philips, Ceri, Pickles, Timothy, Simon, Natalie and Bisson, Jonathan 2018. Pragmatic Randomised controlled trial of a trauma-focused guided self-help Programme versus InDividual trauma-focused cognitive behavioural therapy for post-traumatic stress disorder (RAPID): trial protocol. BMC Psychiatry. https://doi.org/10.1186/s12888-018-1665-3
AuthorsNollett, Claire, Lewis, Catrin, Kitchiner, Neil, Roberts, Neil, Addison, Katy, Brookes-Howell, Lucy, Cosgrove, Sarah, Cullen, Katherine, Ehlers, Anke, Heke, Sarah, Kelson, Mark, Lovell, Karina, Madden, Kim, McEwan, Kirsten, McNamara, Rachel, Philips, Ceri, Pickles, Timothy, Simon, Natalie and Bisson, Jonathan
Abstract

Abstract Background: There is good evidence that trauma-focused therapies for Post-Traumatic Stress Disorder are effective. However, they are not always feasible to deliver due a shortage of trained therapists and demands on the patient. An online trauma-focused Guided Self-Help (GSH) programme which could overcome these barriers has shown promise in a pilot study. This study will be the first to evaluate GSH against standard face-to-face therapy to assess its suitability for use in the NHS. Methods: The study is a large-scale multi-centre pragmatic randomised controlled non-inferiority trial, with assessors masked to treatment allocation. One hundred and ninety-two participants will be randomly allocated to receive either face-to-face trauma-focused cognitive behaviour therapy (TFCBT) or trauma-focused online guided self-help (GSH). The primary outcome will be the severity of symptoms of PTSD over the previous week as measured by the Clinician Administered PTSD Scale for DSM5 (CAPS-5) at 16 weeks post-randomisation. Secondary outcome measures include PTSD symptoms over the previous month as measured by the CAPS-5 at 52 weeks plus the Impact of Event Scale – revised (IES-R), Work and Social Adjustment Scale (WSAS), Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorder-7 (GAD-7), Alcohol Use Disorders Test (AUDIT-O), Multidimensional Scale for Perceived Social Support (MSPSS), short Post-Traumatic Cognitions Inventory (PTCI), Insomnia Severity Index (ISI) and General Self Efficacy Scale (GSES) measured at 16 and 52 weeks post-randomisation. Changes in health-related quality of life will be measured by the EQ-5D and the level of healthcare resource utilisation for health economic analysis will be determined by an amended version of the Client Socio-Demographic and Service Receipt Inventory European Version. The Client Satisfaction Questionnaire (CSQ) will be collected at 16 weeks post-randomisation to evaluate treatment satisfaction. Discussion: This study will be the first to compare online GSH with usual face-to-face therapy for PTSD. The strengths are that it will test a rigorously developed intervention in a real world setting to inform NHS commissioning. The potential challenges of delivering such a pragmatic study may include participant recruitment, retention and adherence, therapist retention, and fidelity of intervention delivery.

KeywordsPost traumatic stress; Randomised controlled trials; Guided self-help; Trauma; Interventions; Internet intervention; Protocols
Year2018
JournalBMC Psychiatry
PublisherSpringer Nature
ISSN1471244X
Digital Object Identifier (DOI)https://doi.org/10.1186/s12888-018-1665-3
Web address (URL)http://hdl.handle.net/10545/622839
hdl:10545/622839
Publication dates27 Mar 2018
Publication process dates
Deposited27 Jul 2018, 13:55
ContributorsCardiff University, Swansea University, Oxford Centre for Anxiety Disorders and Trauma, Central and Northwest London NHS Trust, University of Exeter, University of Manchester and University of Derby
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Compassion motivations: Distinguishing submissive compassion from genuine compassion and its association with shame, submissive behavior, depression, anxiety and stress
Catarino, Francisca, Gilbert, Paul, McEwan, Kirsten and Baião, Rita 2014. Compassion motivations: Distinguishing submissive compassion from genuine compassion and its association with shame, submissive behavior, depression, anxiety and stress. Journal of Social and Clinical Psychology. https://doi.org/10.1521/jscp.2014.33.5.399
Forms of self-criticising/attacking & self-reassuring scale: Psychometric properties and normative study
Baião, Rita, Gilbert, Paul, McEwan, Kirsten and Carvalho, Sérgio 2014. Forms of self-criticising/attacking & self-reassuring scale: Psychometric properties and normative study. Psychology and Psychotherapy: Theory, Research and Practice. https://doi.org/10.1111/papt.12049
Fears of negative emotions in relation to fears of happiness, compassion, alexithymia and psychopathology in a depressed population: A preliminary study
Gilbert, Paul, McEwan, Kirsten, Catarino, Francisca and Baião, Rita 2014. Fears of negative emotions in relation to fears of happiness, compassion, alexithymia and psychopathology in a depressed population: A preliminary study. Journal of Depression and Anxiety. https://doi.org/10.4172/2167-1044.S2-004
Fears of compassion in a depressed population: Implication for psychotherapy
Gilbert, Paul, McEwan, Kirsten, Catarino, Francisca and Baião, Rita 2014. Fears of compassion in a depressed population: Implication for psychotherapy. Journal of Depression and Anxiety. https://doi.org/10.4172/2167-1044.S2-003
The physiological and emotional effects of touch: Assessing a hand-massage intervention with high self-critics
Maratos, Frances A., Duarte, Joana, Barnes, Christopher, McEwan, Kirsten, Sheffield, David and Gilbert, Paul 2017. The physiological and emotional effects of touch: Assessing a hand-massage intervention with high self-critics. Psychiatry Research. 250, pp. 221-227. https://doi.org/10.1016/j.psychres.2017.01.066
Joy and calm: how an evolutionary functional model of affect regulation informs positive emotions in nature
Richardson, Miles, McEwan, Kirsten, Maratos, Frances A. and Sheffield, David 2016. Joy and calm: how an evolutionary functional model of affect regulation informs positive emotions in nature. Evolutionary Psychological Science. https://doi.org/10.1007/s40806-016-0065-5
Do therapeutic imagery practices affect physiological and emotional indicators of threat in high self-critics?
Duarte, Joana, McEwan, Kirsten, Barnes, Christopher, Gilbert, Paul and Maratos, Frances A. 2015. Do therapeutic imagery practices affect physiological and emotional indicators of threat in high self-critics? Psychology and Psychotherapy: Theory, Research and Practice. https://doi.org/10.1111/papt.12043
An exploration of the processing of compassionate and critical faces
McEwan, Kirsten 2012. An exploration of the processing of compassionate and critical faces. Thesis
Facial expressions depicting compassionate and critical emotions: the development and validation of a new emotional face stimulus set
McEwan, Kirsten, Gilbert, Paul, Dandeneau, Stephane, Lipka, Sigrid, Maratos, Frances A., Paterson, Kevin B. and Baldwin, Mark 2014. Facial expressions depicting compassionate and critical emotions: the development and validation of a new emotional face stimulus set. PLos ONE. https://doi.org/10.1371/journal.pone.0088783