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

Autor: Lucy Brookes-Howell, Katherine Addison, Anke Ehlers, Claire Nollett, Neil J Kitchiner, Timothy Pickles, Jonathan Ian Bisson, Sarah Cosgrove, Natalie Simon, Ceri Phillips, Katherine Cullen, Rachel McNamara, Mark Kelson, Neil P. Roberts, Kim Madden, Kirsten McEwan, Catrin Lewis, Karina Lovell, Sarah Heke
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Male
Clinician Administered PTSD Scale
Psychological intervention
Pilot Projects
law.invention
Stress Disorders
Post-Traumatic
Study Protocol
0302 clinical medicine
Randomized controlled trial
law
lcsh:Psychiatry
Protocol
Online
Randomized Controlled Trials as Topic
Randomised controlled trial
Traumatic stress
PTSD
Psychiatry and Mental health
Treatment Outcome
Anxiety
Female
medicine.symptom
RCT
Adult
medicine.medical_specialty
lcsh:RC435-571
Intervention
Psychiatric Rehabilitation
03 medical and health sciences
Social support
Quality of life (healthcare)
Guided self-help
Intervention (counseling)
Pragmatic Clinical Trials as Topic
medicine
Humans
Internet
Cognitive Behavioral Therapy
Post-traumatic stress disorder
business.industry
Trauma focused
030227 psychiatry
Self Care
Quality of Life
Physical therapy
Wounds and Injuries
business
030217 neurology & neurosurgery
Program Evaluation
Zdroj: Nollett, C, Lewis, C, Kitchiner, N, Roberts, N, Addison, K, Brookes-Howell, L, Cosgrove, S, Cullen, K, Ehlers, A, Heke, S, Kelson, M, Lovell, K, Madden, K, McEwan, K, McNamara, R, Phillips, C, Pickles, T, Simon, N & Bisson, J 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, vol. 18, no. 1, 77 . https://doi.org/10.1186/s12888-018-1665-3
BMC Psychiatry, Vol 18, Iss 1, Pp 1-14 (2018)
BMC Psychiatry
ISSN: 1471-244X
Popis: 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.
Databáze: OpenAIRE
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