Title |
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
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Published in |
BMC Psychiatry, March 2018
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DOI | 10.1186/s12888-018-1665-3 |
Pubmed ID | |
Authors |
Claire Nollett, Catrin Lewis, Neil Kitchiner, Neil Roberts, Katy Addison, Lucy Brookes-Howell, Sarah Cosgrove, Katherine Cullen, Anke Ehlers, Sarah Heke, Mark Kelson, Karina Lovell, Kim Madden, Kirsten McEwan, Rachel McNamara, Ceri Phillips, Timothy Pickles, Natalie Simon, Jonathan Bisson |
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. 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. 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. ISRCTN13697710 registered on 20/12/2016. |
X Demographics
Geographical breakdown
Country | Count | As % |
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United Kingdom | 13 | 93% |
Unknown | 1 | 7% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 10 | 71% |
Scientists | 3 | 21% |
Practitioners (doctors, other healthcare professionals) | 1 | 7% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 229 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 33 | 14% |
Student > Master | 26 | 11% |
Student > Ph. D. Student | 25 | 11% |
Student > Doctoral Student | 16 | 7% |
Student > Bachelor | 16 | 7% |
Other | 34 | 15% |
Unknown | 79 | 34% |
Readers by discipline | Count | As % |
---|---|---|
Psychology | 54 | 24% |
Medicine and Dentistry | 31 | 14% |
Nursing and Health Professions | 19 | 8% |
Neuroscience | 7 | 3% |
Social Sciences | 4 | 2% |
Other | 22 | 10% |
Unknown | 92 | 40% |