Evidence map›Paper›PMID 29580220›Full record

ArticleBMC psychiatry2018

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, Catrin Lewis, Neil Kitchiner, Neil Roberts, Katy Addison, Lucy Brookes-Howell, Sarah Cosgrove, Katherine Cullen, Anke Ehlers, Sarah Heke and 9 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC psychiatry, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Review
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Claire NollettCentre for Trials Research, Cardiff University, 4th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK. nollettcl@cardiff.ac.uk.ORCID 0000-0001-6676-4933
Catrin LewisDivision of Psychological Medicine and Clinical Neurosciences, Cardiff University School of Medicine, Haydn Ellis Building, Maindy Road, Cardiff, CF24 4HQ, UK.
Neil KitchinerDivision of Psychological Medicine and Clinical Neurosciences, Cardiff University School of Medicine, Haydn Ellis Building, Maindy Road, Cardiff, CF24 4HQ, UK.
Neil RobertsDivision of Psychological Medicine and Clinical Neurosciences, Cardiff University School of Medicine, Haydn Ellis Building, Maindy Road, Cardiff, CF24 4HQ, UK.
Katy AddisonCentre for Trials Research, Cardiff University, 4th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
Lucy Brookes-HowellCentre for Trials Research, Cardiff University, 7th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
Sarah CosgroveIndependent Public and Patient Involvement (PPI) representative, Cardiff, UK.
Katherine CullenSwansea Centre for Health Economics, College of Human and Health Sciences, Swansea University, Singleton Park, Swansea, SA2 8PP, UK.
Anke EhlersDepartment of Experimental Psychology, Oxford Centre for Anxiety Disorders and Trauma, Paradise Square, Oxford, OX1 1TW, UK.
Sarah HekeGrenfell Emotional Health and Wellbeing service, Central and Northwest London (CNWL) NHS Trust, St Charles Hospital, Exmoor Street, London, UK.
Mark KelsonDepartment of Mathematics, Laver Building, University of Exeter, Exeter, EX4 4QRE, UK.
Karina LovellDivision of Nursing, Midwifery & Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Room 6.322a, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, UK.
Kim MaddenCentre for Trials Research, Cardiff University, 7th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
Kirsten McEwanDepartment of Psychology, University of Derby, Kedleston Road, Derby, DE22 1GB, UK.
Rachel McNamaraCentre for Trials Research, Cardiff University, 4th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
Ceri PhillipsSwansea Centre for Health Economics, College of Human and Health Sciences, Swansea University, Singleton Park, Swansea, SA2 8PP, UK.
Timothy PicklesCentre for Trials Research, Cardiff University, 4th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
Natalie SimonDivision of Psychological Medicine and Clinical Neurosciences, Cardiff University School of Medicine, Haydn Ellis Building, Maindy Road, Cardiff, CF24 4HQ, UK.
Jonathan BissonDivision of Psychological Medicine and Clinical Neurosciences, Cardiff University School of Medicine, Haydn Ellis Building, Maindy Road, Cardiff, CF24 4HQ, UK. bissonji@cardiff.ac.uk.

Funding

Department of Health HTA/14/192/97Health Technology Assessment Programme 14/192/97Wellcome Trust 200796/Z/16/Z
6 · The paper itself

Abstract

backgroundThere 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.

methodsThe 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 registrationISRCTN13697710 registered on 20/12/2016.

Indexed as

Cognitive Behavioral TherapyPsychiatric RehabilitationSelf CareStress Disorders, Post-TraumaticWounds and InjuriesAdultEquivalence Trials as TopicFemaleHumansMaleMulticenter Studies as TopicPilot ProjectsPragmatic Clinical Trials as TopicProgram EvaluationQuality of LifeRandomized Controlled Trials as TopicGuided self-helpInternetInterventionOnlinePost-traumatic stress disorderProtocolPTSDRandomised controlled trialRCTTrauma focused

Identifiers

PMID29580220
PMCPMC5870753

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.