None listed
Conditions
Brief summary
In a randomised controlled trial (including 3- and 6-month follow-up), the current study will investigate the efficacy of a stepped care approach for treating PTSD in adults. The key research question is whether an online stepped care approach can clinically improve PTSD at a comparable rate to traditional high-intensity PTSD treatment, Cognitive Processing Therapy (CPT) delivered via video call. . The study will also examine potential predictors of clients’ response to low- versus higher-intensity therapy (e.g., PTSD severity, co-morbidity with other psychological disorders, and therapeutic alliance). The feasibility of online stepped care will be evaluated by comparing cost-effectiveness, ease of delivery, and acceptability of the treatments as rated by clients. Overall, it is hypothesised that stepped care would be comparable over time to CPT in terms of posttraumatic stress severity (primary outcome), depression severity, quality of life, and acceptability as rated by clients. Stepped care is predicted to have equivalent PTSD severity reductions to CPT as assessed by a standardised diagnostic interview instrument (CAPS-5) to CPT at 6-months post-treatment. However, Stepped care is predicted to cost significantly less that CPT in terms of the amount of therapist time required and economic evaluation of quality of adjusted life years.
Interventions
In a randomised control trial, the study aims to test the feasibility and effectiveness of a stepped care approach to treating posttraumatic stress disorder (PTSD) in adults that initially uses an intervention delivered online with modest clinician involvement, in comparison to a standard treatment approach (Cognitive Processing Therapy; CPT). Following a comprehensive clinical, pre-treatment assessment via an online video call (90 minutes) and Qualtrics questionnaire (60 minutes), participants will be randomly allocated into either a Stepped condition or CPT. All participants in the Stepped condition 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, particpants complete a post-treatment assessment via an online video call (45 minutes) and Qualtrics questionnaire (60 minutes). Particpants who are 'stepped-up' before completing 7 sessions of TWU will only complete the 2-week version of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) via online video call before starting CPT. Step 2: Cognitive Processing Therapy (CPT) 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 (see Resick, Monson and Chard, 2016). In the current study, participants will be offered up to 18 weekly, 60-minute sessions on a one-to-one basis via online video call. CPT duration is estimated between 8 to 18 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. At the completion of CPT, participants complete another post-treatment assessment via an online video call (45 minutes) and Qualtrics questionnaire (60 minutes). Following therapy, regardless of treatment dose, participants complete a 3- and 6-month follow-up assessment via an online video call (45 minutes) and Qualtrics questionnaire (60 minutes). 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, currently undertaking clinical psychology training or have recently completed this training and undertaking a placement in the Flinders University Posttraumatic Stress Clinic. 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 or sub-threshold PTSD (APA, 2013). In the current study sub-threshold PTSD is defined as meeting 3 of 4 Criteria B-E, in addition to meeting Criteria F-H on the CAPS-5. 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-clinical 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 requiring supervised medical withdrawal, 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.