None listed
Conditions
Brief summary
Currently, Prolonged Exposure (PE) therapy is considered the gold-standard treatment for PTSD. Emerging evidence suggests that the Unified Protocol (UP) may offer an alternative treatment option. Research indicates that UP may work in a slightly different way than PE, prompting further exploration into which factors influence treatment outcomes. In this trial, participants will complete assessments to gather a holistic picture of their symptoms and PTSD presentation, after which they will be randomly allocated to either the Unified Protocol (UP) or Prolonged Exposure (PE) therapy which are delivered in a massed format. Ultimately, the goal of this research is to improve the matching of individuals to the PTSD treatment that will be most effective for them based on the factors uncovered in the assessments.
Interventions
The study aims to understand biopsychosocial markers of treatment response to better match patients to evidence-based psychological interventions which address the presence and severity of PTSD.
It investigates massed Unified Protocol (UP), a transdiagnostic non-trauma focused cognitive behavioural therapy. UP is a manualised psychological treatment consisting of ten, 80-minute individual sessions delivered by a trained clinician. The UP has eight modules which cover: (1) goal setting/maintainin
The study aims to understand biopsychosocial markers of treatment response to better match patients to evidence-based psychological interventions which address the presence and severity of PTSD. It investigates massed Unified Protocol (UP), a transdiagnostic non-trauma focused cognitive behavioural therapy. UP is a manualised psychological treatment consisting of ten, 80-minute individual sessions delivered by a trained clinician. The UP has eight modules which cover: (1) goal setting/maintaining motivation, (2) psychoeducation about emotions, (3) mindful emotional awareness, (4) cognitive flexibility, (5) emotion driven behaviours, (6) interoceptive exposures, (7) emotion exposures, and (8) relapse prevention. Consistent with the delivery of massed UP as in other trials (e.g., Sherrill et al., 2024), instead of having weekly sessions, the sessions will be condensed into a more limited time-frame (i.e., daily for two weeks). The UP treatment will be delivered face-to-face at the Phoenix Traumatic Stress Research Clinic at the Royal Melbourne Hospital (Royal Park) or via telehealth using videoconferencing. To maintain fidelity to the UP treatment protocol, we hold monthly dedicated UP supervision with an expert UP supervisor. We also audio record 10% of our treatment sessions (allocated randomly), which are evaluated for fidelity.
Sponsors
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
1. Aged 18+ 2. English comprehension at a level to make informed consent 3. Meeting diagnostic threshold for PTSD after a traumatic experience (experienced at any time point in their life) 4. Able to commit the time to the intensive nature of treatment delivery 5. 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
Exclusion criteria
1. Cognitive impairment, including from serious traumatic brain injury 2. Current psychosis, mania or active suicidality and/or other serious risk issue 3. Severe alcohol or substance use disorders 4. Currently undergoing active psychological treatment for a mental health condition
Outcome results
None listed