A comparison of Internet-based Cognitive Behavioural Therapy for Posttraumatic Stress Disorder with and without exposure: A randomized controlled trial

INTERVENTION: Participants will be conducted in two phases with 2 parallel groups in each phase (total sample size = 128. Each phase n=64 contains the following groups: Group 1: Clinician‐guided iCBT including exposure (n = 32). Receive access to an internet‐based CBT (iCBT) program with clinician‐guidance. Group 2: Clinician‐guided iCBT minus exposure (n = 32). Receive access to the above iCBT program with clinician‐guidance without the exposure component. (NB: There is no waiting list control condition in this study) Evidence from face to face treatment trials suggests that PTSD can be successfully treated without an exposure component To date, there is no research evaluating the benefits of exposure within an Internet‐based cognitive behavioural treatment for PTSD. Exposure requires engagement with avoided situations, objects and memories. For example: it is common for people with PTSD to avoid places that remind them of their trauma even though such places are safe. Exposure involves a gradual introduction to such places that is done in a step‐wise manner so that participants don’t become overwhelmed. A similar procedure is recommended for memories and objects. However, exposure places burden on participants in terms of time and energy. We propose to compare iCBT for PTSD with and without exposure by testing a group that follows an established iCBT protocol with an exposure component versus the same protocol without the exposure component. Phase 1 will be conducted over 8 weeks and will involve the treatment of 2 groups (iCBT with exposure & iCBT without exposure). Phase 2 will commence during week 7 of the trial (as the Phase 1 groups are finishing treatment) and will involve the commencement of treatment for 2 new groups who will receive the identical treatments (iCBT with exposure & iCBT without exposure) but will involve new participants. All participants will report experiencing symptoms of Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM‐IV) criteria for posttraumatic stress disorder (PTSD). Participants in the iCBT with exposure group will complete 6 lessons of Internet based treatment about management of symptoms of PTSD. One lesson will be completed every 7‐10 days over 8 weeks. Participants in the iCBT without exposure group will complete 4 lessons of of Internet based treatment about management of symptoms of PTSD using the same protocol with 2 lessons about exposure removed. One lesson will be completed every 7 to 14 days over 8 weeks. Each lesson will take about 15 minutes to complete. Participants will also have access to summaries of each lesson, and will read anonymous stories about other people with PTSD, taking a further 20 minutes per summary. Participants in both groups will also receive automatic email and weekly reminder phone calls by a clinical psychologist. The duration of the reminder emails/phone calls is expected to be 15‐20 minutes per week. The duration of the program is 8 weeks, but participants will be contacted 3 and 12 months post program and asked to complete follow‐up questionnaires. Study questionnaires will be administered at application, pre‐treatment, post‐treatment, and at 3‐months post‐treatment. These will take about 20‐30 minutes to complete. The treatment materials are based on our previous Internet treatment protocols, which apply cognitive behavioural techniques. CONDITION: Posttraumatic stress disorder PRIMARY OUTCOME: PTSD is measured by the Posttraumatic Stress Disorder Symptom Scale (PSS‐I) Coffey SF, Gudmundsdottir B, Beck JG, Palyo SA, Miller L. Screening for PTSD in motor vehicle accident survivors using the PSS‐SR and IES. Journal of Traumatic Stress 2006;19:119–128. Weiss, D. S., & Marmar, C. R. (1996). The Impact of Event Scale ‐ Revised. In J. Wilson & T. M. Keane (Eds.), Assessing psychological trauma and PTSD (pp. 399‐411). New York: Guilford. SECONDARY OUTCOME: Anxiety is measured by the Generalised Anxiety Disorder 7 Item Scale (GAD‐7) Disability is measured by the Sheehan Disability Scale (SDS) Health status is measured by the EuroQol‐5D (EQ‐5D) Neuroticism is measured by using the NEO‐Five Factor Inventory (NEO‐FFI) Neuroticism scale PTSD is measured by the PTSD Checklist ‐ Civilian version (PCL‐C) Service use is measured by the Service Use Questionnaire (SEQ) Symptoms and severity of depression is measured by the Patient Health Questionnaire‐9 (PHQ‐9) INCLUSION CRITERIA: ‐ PTSD symptoms above a recommended clinical cutoff (A score of 27 or above on the Impact of Events Scale‐ Revised (Weiss & Marmar, 1996) as recommended by Coffey et al. (2006) ‐ Internet access + printer access ‐ Australian resident ‐ Males and females