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. 2018 Mar 27;18(1):77.
doi: 10.1186/s12888-018-1665-3.

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

Claire Nollett  1 , Catrin Lewis  2 , Neil Kitchiner  2   3 , Neil Roberts  2   3 , Katy Addison  4 , Lucy Brookes-Howell  5 , Sarah Cosgrove  6 , Katherine Cullen  7 , Anke Ehlers  8 , Sarah Heke  9   10 , Mark Kelson  11 , Karina Lovell  12 , Kim Madden  5 , Kirsten McEwan  13 , Rachel McNamara  4 , Ceri Phillips  7 , Timothy Pickles  4 , Natalie Simon  2 , Jonathan Bisson  14
Affiliations

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

Claire Nollett et al. BMC Psychiatry. .

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.

Trial registration: ISRCTN13697710 registered on 20/12/2016.

Keywords: Guided self-help; Internet; Intervention; Online; PTSD; Post-traumatic stress disorder; Protocol; RCT; Randomised controlled trial; Trauma focused.

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Conflict of interest statement

Ethics approval and consent to participate

The protocol Version 3.0 was approved by Wales Research Ethics Committee Panel 3 (17/WA/0008) on 14th November 2017. All participants will give written informed consent prior to taking part in the baseline assessment.

Consent for publication

Not applicable

Competing interests

CL, NK, NR and JB are members of the research team that developed Spring. The IP for Spring is owned by Cardiff University and, were Spring to be commercialised, royalties would be payable to the authors in line with Cardiff University’s rules.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Spring Screenshot. A screenshot, taken from Step 1, showing the actors whose PTSD case histories are followed throughout the intervention. The Toolkit can be seen at the bottom of the webpage
Fig. 2
Fig. 2
Participant Timeline. Participant activity throughout the trial
See this image and copyright information in PMC

References

    1. American Psychiatric Association, Diagnostic and statistical manual of mental disorders (DSM-5®). Washington DC: American Psychiatric Pub; 2013.
    1. World Health Organization, The ICD-10 classification of mental and behavioural disorders: clinical descriptions and diagnostic guidelines. 1992: Geneva: World Health Organization.
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    1. Kessler RC, et al. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995;52(12):1048–1060. - PubMed
    1. Kachadourian LK, Pilver CE, Potenza MN. Trauma, PTSD, and binge and hazardous drinking among women and men: findings from a national study. J Psychiatr Res. 2014;55:35–43. - PMC - PubMed

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