None listed
Conditions
Brief summary
After exposure to a traumatic or stressful event, some people develop emotional disorders such as posttraumatic stress disorder (PTSD). Trauma-focussed psychological interventions, such as the gold standard Prolonged Exposure (PE) are empirically supported, first-line treatments for PTSD. However, non-response and drop-out rates are high with PE and many mental health clinicians do not use trauma-focussed treatments to treat PTSD. Using a randomised controlled trial design, this project aims to evaluate the efficacy of a non-trauma focussed transdiagnostic intervention called the Unified Protocol (UP) which targets features associated with PTSD including emotional dysregulation and cognitive distortions, compared to the gold-standard prolonged exposure (PE) therapy for the treatment of PTSD. Eligible participants will be randomly allocated to 10 weekly 90 minute sessions of UP or PE with pre-treatment, post-treatment and 6-month follow-up assessments. We hypothesise that UP and PE will be equally effective in treating PTSD.
Interventions
The IMPACT trial is a non-inferiority Randomised Controlled Trial (RCT) that is comparing a non-trauma focussed transdiagnostic treatment known as the Unified Protocol (UP) (Barlow et al., 2017), to gold-standard Prolonged Exposure (PE) (Foa et al., 2007), for participants with PTSD. The UP therapy involves targeting shared features that are said to underlie emotional disorders such as cognitive distortions, emotional avoidance, maladaptive emotion driven behaviours, and emotional dysregulation.
The IMPACT trial is a non-inferiority Randomised Controlled Trial (RCT) that is comparing a non-trauma focussed transdiagnostic treatment known as the Unified Protocol (UP) (Barlow et al., 2017), to gold-standard Prolonged Exposure (PE) (Foa et al., 2007), for participants with PTSD. The UP therapy involves targeting shared features that are said to underlie emotional disorders such as cognitive distortions, emotional avoidance, maladaptive emotion driven behaviours, and emotional dysregulation. The manualised transdiagnostic UP treatment originally involved 10 weekly 90 minute face to face or telehealth sessions delivered to the individual by a trained clinician. The UP treatment will be delivered face-to-face at the Phoenix Traumatic Stress Research Clinic at the Royal Melbourne Hospital (Royal Park), via outreach (in participants home), or via telehealth using videoconferencing.
Sponsors
Phoenix Australia, Centre for Posttraumatic Mental Health, Department of Psychiatry, University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(a) 18 years old and over (b) Meeting diagnostic threshold for PTSD on the MINI 7 (PTSD module) after experiencing a traumatic event (at any time-point in their life) (c) Provision of consent to partake in therapy (d) English comprehension at a level to make informed consent (e) If on psychotropic medication, on a stable dose for the last 4 weeks, and not intending to change for the duration of the treatment phase. (f) For telehealth modality only: ability to reliably participate in telehealth treatment delivery, including appropriate technology for videoconferencing
Exclusion criteria
(a) Cognitive impairment (b) Active mania or psychosis or suicidal ideation or other active risk (c) Severe alcohol or substance use disorder (d) Currently undergoing psychological treatment as assessed against a checklist of known psychological interventions.
Outcome results
None listed