Abstract
BackgroundOver the last few decades, effective psychological treatments for posttraumatic stress disorder (PTSD) have been developed, but many patients are currently unable to access these treatments. There is initial evidence that therapist-assisted internet-based psychological treatments are effective for PTSD and may help increase access, but it remains unclear which of these treatments work best and are most acceptable to patients. This randomised controlled trial will compare a trauma-focussed and a nontrauma-focussed therapist-assisted cognitive behavioural Internet treatment for PTSD: Internet-delivered cognitive therapy for PTSD (iCT-PTSD) and internet-delivered stress management therapy (iStress-PTSD).Methods/designThe study is a single-blind, randomised controlled trial comparing iCT-PTSD, iStress-PTSD and a 13-week wait-list condition, with an embedded process study. Assessors of treatment outcome will be blinded to trial arm. Two hundred and seventeen participants who meet DSM-5 criteria for PTSD will be randomly allocated by a computer programme to iCT-PTSD, iStress-PTSD or wait-list at a 3:3:1 ratio. The primary assessment point is at 13 weeks, and further assessments are taken at 6, 26, 39 and 65 weeks. The primary outcome measure is the severity of PTSD symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5). Secondary measures of PTSD symptoms are the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the Impact of Event Scale-Revised (IES-R). Other symptoms and well-being will be assessed with the Patient Health Questionnaire (PHQ-9), Generalised Anxiety Disorder Scale (GAD-7), WHO (Five) Well-Being Index, Work and Social Adjustment Scale (WSAS), Endicott Quality of Life Scale (QoL), and Insomnia Sleep Index (ISI). Health economics analyses will consider quality of life, productivity, health resource utilisation, employment status and state benefits, and treatment delivery costs. Process analyses will investigate candidate mediators and moderators of outcome. Patient experience will be assessed by interview and questionnaire.DiscussionThis study will be the first to compare the efficacy of a trauma-focussed and nontrauma-focussed therapist-assisted online cognitive behavioural treatment for people with posttraumatic stress disorder.Trial registrationISRCTN16806208. Registered prospectively on 5 January 2018.
Highlights
The present study will compare a novel, traumafocussed therapist-assisted online psychological therapy and a comprehensive nontrauma-focussed therapistassisted online psychological therapy. Both treatments will be compared with a wait-list to control for the natural recovery that is sometimes seen in posttraumatic stress disorder (PTSD) samples
Whether internet-delivered Cognitive Therapy (iCT)-PTSD is cost-effective compared with internet-delivered Stress Management Therapy (iStress)-PTSD in terms of cost per participants with a clinical improvement in PTSD symptoms and costs per quality-adjusted life year (QALY) gained
While we expect that both treatments will lead to substantial improvement, the results will be informative about their relative benefit across outcomes, and their potential in increasing access to cognitive behaviour therapy for PTSD
Summary
This study will be the first to compare the efficacy of a trauma-focussed and nontrauma-focussed, therapistassisted, online cognitive behavioural treatment for people with PTSD. Possible advantages of online treatments include convenience for patients in that they can work on the treatment in a place and at a time that suits them and do not need to travel to therapy. They may worry less about possible stigma with an internet-based treatment. The results from this trial may help identify further ways to enhance treatment acceptability Another challenge is that while iStress-PTSD was chosen to represent a nontrauma-focussed treatment and focusses on general stress management skills to stressors in everyday life, it contains some traumarelated content.
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