None listed
Conditions
Brief summary
The current study will investigate the feasibility and effectiveness of a stepped care approach for treating posttraumatic stress disorder (PTSD) in adults. Stepped care is defined as a hierarchy of evidence-based therapies where clients can be matched to an intervention level that suits their current needs. In an open trial, participants will initially complete a self-guided PTSD program online (This Way Up, developed by the Clinical Research Unit for Anxiety and Depression, CRUfAD, St Vincent’s Hospital, Sydney) that involves modest clinician involvement. Participants who show risk of disengagement and/or dropout, or do not make significant clinical gains will be offered traditional, one-to-one, PTSD treatment (Cognitive Processing Therapy) via telehealth. Outcome measures will be assessed at pre- and post-treatment and at a 3-month follow-up. Primary outcomes are PTSD (diagnosis, good end-state achievement, severity reduction) and treatment retention. Important secondary outcomes include comorbid conditions, quality of life, feasibility (i.e., ease of delivery), acceptability as rated by clients, and cost effectiveness. It is hypothesised that this approach will be both accessible and cost-effective as we predict that most clients will achieve good end state functioning without needing to be "stepped-up" to CPT.
Interventions
In an open trial, the study aims to test the feasibility and effectiveness of a stepped-care approach to treating posttraumatic stress disorder (PTSD) in adults, using online and telehealth technology. Following a comprehensive clinical, pre-treatment assessment (T1) via an online video call (90 minutes) and Qualtrics questionnaire (60 minutes), all participants undertake Step 1 of the intervention. Step 1: This Way Up (TWU) TWU is an eight-week online cognitive-behavioural treatment program developed by the Clinical Research Unit for Anxiety and Depression (CRUfAD) at St Vincent’s Hospital in Sydney. Each week, participants will complete a self-guided 60-minute lesson in their own time. The lessons are delivered as comic-book stories and cover psychoeducation around PTSD, coping skills, cognitive therapy (i.e., teaching more adaptive ways to evaluate and interpret situations) and written and real-life exposure (e.g., a trauma account). In addition, participants complete homework exercises for one to three hours each week to practice the skills taught in lesson. To monitor progress and problem solve any issues, participants will consult with a therapist by video call for 15 minutes after each lesson is completed. At the completion of TWU, and at a matched time point for those who are 'stepped-up' early, participants complete a post-treatment assessment (T2) via an online video call (45 minutes) and Qualtrics questionnaire (60 minutes). Step 2: Cognitive Processing Therapy (CPT) Following the pragmatic trial design, participants are 'stepped-up' to CPT if (a) there is non-response in the first 5 sessions (i.e., no reliable change on PTSD self-report), (b) they fail to engage (e.g., complete session 1, but don’t progress immediately to session 2), (c) they complete TWU, but with minimal or moderate response (all assessed via reliability of change index analysed in conjunction with clinical cut-offs on the PCL-5), or (d) clinical issues arise that indicate more intensive therapy is required (e.g., reliable increase in symptoms associated with marked distress that does not remit by subsequent session). CPT is an evidence-based cognitive behavioural therapy for PTSD developed by Resick, Monsoon and Chard (2016). In the current study, participants will be offered up to 15 weekly, 60-minute sessions on a one-to-one basis via online video call. CPT duration is estimated between 8 to 15 weeks depending on client's individual needs. Initial sessions provide a rationale for the approach, and psychoeducation about PTSD. Participants are asked to write an impact statement about how the trauma has impacted their life and beliefs about their self, others and the world. Subsequent sessions then focus upon learning to identify and label thoughts and feelings, and challenging unhelpful automatic thoughts through Socratic questioning. Therapist works with the participant to develop strategies for generating more useful and helpful thinking patterns. The final sessions focus on maladaptive beliefs surrounding safety, trust, power, esteem, intimacy (domains that are often impacted by PTSD). Before the final session of CPT, participants write a new impact statement which typically reflects treatments gains, and relapse prevention is discussed. Following CPT, participants complete a post-treatment assessment (T3) via an online video call (45 minutes) and Qualtrics questionnaire (60 minutes). At this time point we will also assess those who only completed TWU as a comparator. Approximately 9 months after enrolment into the study, all participants will be assessed again via an online video call and Qualtrics questionnaire (this will reflect a 3-month follow-up for those who needed CPT, and a matched time interval for those who completed TWU only). Additional funding success permitting, we would also like to include a 6-month follow-up. To ensure diagnostic reliability, all diagnostic interviews and therapy sessions will be video/audiotaped and will be coded by a research assistant to ensure that the therapist is adhering to the components of each treatment session. By adopting this design the proposed research conforms to the gold standard for conducting treatment outcome research with traumatised samples (Foa & Meadows, 1997), and ensures the methodological rigour of the proposed project. Assessors who have no knowledge of the participants or stage or treatment reached will be used at post and three-month follow up assessments. Therapists involved are either registered psychologists or currently undertaking clinical psychology training or have recently completed this training and undertaking a placement in the Flinders University Posttraumatic Stress Research Unit. All therapists will have training in the TWU and CPT protocol. Therapists will receive weekly supervision from Professor Nixon.
Sponsors
Study design
Eligibility
Inclusion criteria
All participants must have been directly or indirectly exposed to a Criterion A trauma, as defined by the DSM-5 and meet diagnostic criteria for PTSD (APA, 2013). Due to the online nature of the study, participants must have regular and secure access to a computer with a webcam and enough internet data to support video calls with a therapist.
Exclusion criteria
Exclusion criteria for the study include scoring a sub-threshold level of PTSD as indicated by a cut off of 30 or below on the PCL-5 (as recommended by Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013). Additional exclusion criteria include illiteracy, current uncontrolled psychosis or substance dependence, and/or significant cognitive impairment. These criteria are on the basis that individuals need to have a sufficient level of functioning to be able to participate in therapy. Further, individuals with a significant risk of harm (e.g., in a current abusive relationship or suicidality with intent) will be excluded as it is recommended that they engage in treatment to help minimise these risks before receiving treatment for PTSD.