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

Nollett, Claire ORCID: https://orcid.org/0000-0001-6676-4933, Lewis, Catrin ORCID: https://orcid.org/0000-0002-3818-9377, Kitchiner, Neil ORCID: https://orcid.org/0000-0003-0499-9520, Roberts, Neil, Addison, Katherine, Brookes-Howell, Lucy ORCID: https://orcid.org/0000-0002-8263-7130, Cosgrove, Sarah, Cullen, Katherine, Ehlers, Anke, Heke, Sarah, Kelson, Mark ORCID: https://orcid.org/0000-0001-7744-3780, Lovell, Karina, Madden, Kim ORCID: https://orcid.org/0000-0002-9283-8120, McEwan, Kirsten, McNamara, Rachel ORCID: https://orcid.org/0000-0002-7280-1611, Phillips, Ceri, Pickles, Timothy ORCID: https://orcid.org/0000-0001-7743-0234, Simon, Natalie and Bisson, Jonathan ORCID: https://orcid.org/0000-0001-5170-1243 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 18 (1) , 77. 10.1186/s12888-018-1665-3

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Abstract

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.

Item Type:	Article
Date Type:	Published Online
Status:	Published
Schools:	Medicine
Publisher:	BioMed Central
ISSN:	1471-244X
Funders:	National Institute for Health Research (NIHR)
Date of First Compliant Deposit:	6 April 2018
Date of Acceptance:	14 March 2018
Last Modified:	06 Nov 2024 15:03
URI:	https://orca.cardiff.ac.uk/id/eprint/110552

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