None listed
Conditions
Brief summary
Traumatic events, such as serious injury, interpersonal assault or natural disaster have a high lifetime incidence. In the aftermath of such an event, individuals may develop emotional disorders (e.g., posttraumatic stress disorder, Anxiety Disorders or Depressive disorders). Many trauma survivors develop multiple emotional disorders and can therefore present for treatment with complex difficulties. This demands psychological interventions that are flexible and applicable across disorder types. Such approaches, termed 'transdiagnostic treatments', have been developed for use across emotional disorders. The aim of this project is to conduct the first randomised controlled trial testing the efficacy of the early delivery of a psychological treatment known as the 'Unified Protocol for Transdiagnostic Treatment of Emotional Disorders' in (i) reducing the prevalence and severity of emotional disorders and (ii) lowering disability and raising quality of life in a sample of severe injury survivors. Based on our earlier work, a two stepped screening process will identify patients eligible for the treatment component of the study. The first step is to screen 1650 injury patients for ‘risk’ of developing an emotional disorder during their acute hospitalisation stage using the Posttrauma Adjustment Screen. The second step is to reassess patients identified as ‘ at risk’ (n= 900) four weeks after injury to assess for emotional disorders meeting diagnostic criteria using the Mini International Neuropsychiatric Interview. Of these, we expect the sample will comprise 115 participants who meet diagnostic threshold for at least one anxiety disorder, major depressive disorder or PTSD four weeks after they have sustained a traumatic injury and who take up the offer of treatment. These participants will be randomly allocated to either an (a) Treatment (Unified Protocol early intervention/UPEI) or (b) Control (usual care – UC) group. The treatment condition will consist of 10-14 weekly therapy sessions using the 'Unified Protocol for Transdiagnostic Treatment of Emotional Disorders' with a trained clinician. Participants will be assessed using self report questionnaires to determine types of emotional disorders and severity of symptoms at: (a) pre treatment, (b) mid treatment, (c) post treatment and (d) six months follow up. Quality of life, disability, perceived control and problematic emotion regulation strategies will also be measured at all three time points.
Interventions
This study involves two elements: Screening and Intervention.
In order to identify participants who are experiencing emotional disorders and who will benefit from the treatment, a two stage screening process will be carried out. Injury survivors will first be screened face to face 1 week post injury using the Posttrauma Adjustment Scale in order to identify those who are at risk of developing emotional disorders. This will be carried out during their admission to the trauma service. Participan
This study involves two elements: Screening and Intervention. In order to identify participants who are experiencing emotional disorders and who will benefit from the treatment, a two stage screening process will be carried out. Injury survivors will first be screened face to face 1 week post injury using the Posttrauma Adjustment Scale in order to identify those who are at risk of developing emotional disorders. This will be carried out during their admission to the trauma service. Participants identified as 'at risk' will then be screened again over the telephone at 4 weeks post injury using the MINI Neuropsychiatric Inteview 6.0 to determine whether they meet criteria for one or more emotional disorders. Those who meet this criteria will then proceed to the intervention phase of the study. The active treatment in the intervention phase is 'The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders' (UP). The UP is a psychological intervention which targets the shared underlying processes of emotional disorders, such as cognitive distortions, emotional avoidance, maladaptive emotion driven behaviours and emotional dysregulation. It is a face to face therapy delivered by a trained clinician over 10-14 weekly 60 minute sessions. The number of weeks of face to face therapy is dependent on the clinician's assessment of the patient's needs and how many aspects of the protocol are relevant to their clinical presentation. The treatment has 8 modules and the protocol allows for flexibility in the number of sessions taken to complete each module to accommodate differences in patient presentation.
Sponsors
The 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 70 Years
Healthy volunteers
No
Inclusion criteria
SCREENING a) A patient with traumatic physical injury that requires an admission of at least 24 hours to the trauma service. b) No brain injury or only mild Traumatic Brain Injury c) Age between 18 and 70 years. d) A reasonable comprehension of English (defined by proficiency to read and understand the participant information sheet and consent form) TREATMENT a) All inclusion criteria as stated overall in the study, plus: b) Depression, Anxiety or PTSD MINI scores that exceed the symptom threshold. c) Participant accepts invitation for therapy
Exclusion criteria
a) Death b) Age at or > 70 c) Age < 18 d) Non traumatic injury – defined as patients with an injury that is minor and caused by a non-traumatic event. This includes minor injury sustained by the following mechanisms of injury: - Falling from a non-height (e.g., tripping, slipping, fainting) - Domestic accidents (accidents that occur around the home) - Contact sport e) Non direct admission (e.g., secondary admission for injuries subsequent to initial injury) f) Satellite admission – in some cases patients are kept in wards for observation, usually because their injuries are relatively minor. Those in observation wards are not included in the study. g) Brain injury is greater than mild (ie. moderate or severe TBI) h) Actively suicidal or injury is a result of deliberate self harm i) Substance dependence j) History of or a current psychotic disorder k) Other non traumatic event l) Non English speaker m) Non Victorian/Non permanent resident or visitor to Victoria (e.g., tourist) n) Homelessness/Itinerant o) Admission <24 hours p) On hospital ward at or > 28 days. q) Cognitive impairment r) Under police guard s) Weekend discharges – patients discharged over the weekend who could not be admitted to the study.
Outcome results
None listed