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.DiscussionThis 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.
Highlights
There is good evidence that trauma-focused therapies for Post-Traumatic Stress Disorder are effective
Following Guided Self-Help (GSH), Post-Traumatic Stress Disorder (PTSD) sufferers’ symptoms improved by over 50% and over 40% with an average of 149 min of therapist input; effect sizes that compare favourably with those found for therapist-delivered Trauma focused psychological therapy (TFPT)
Outcomes 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) [38] at 16 weeks post-randomisation
Summary
There is good evidence that trauma-focused therapies for Post-Traumatic Stress Disorder are effective. They are not always feasible to deliver due a shortage of trained therapists and demands on the patient. Post-Traumatic Stress Disorder (PTSD) is a common mental disorder that may develop following exposure to exceptionally threatening or horrifying events. Evidence suggests that the most effective approaches are trauma focused cognitive behavioural therapy (TFCBT), including trauma focused cognitive therapy, and eye movement desensitization and reprocessing therapy (EMDR) [11]. EMDR is a psychological therapy that involves exposure to unwanted and distressing memories whilst focusing on a bilateral stimulation. TFCBT protocols vary in the focus on exposure or cognitive interventions and differ slightly in the number of treatment sessions that are recommended.
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