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Trial registered on ANZCTR


Registration number
ACTRN12614000823673
Ethics application status
Approved
Date submitted
15/07/2014
Date registered
1/08/2014
Date last updated
10/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Screening and Promoting Recovery after Injury by Treating Early
Scientific title
A Randomised Controlled Trial to Test the Efficacy of the Early Delivery of the 'Unified Protocol for Transdiagnostic Treatment of Emotional Disorders' in Reducing Emotional Disorders following Injury
Secondary ID [1] 284891 0
Nil
Universal Trial Number (UTN)
U1111-1158-6854
Trial acronym
SPRITE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 292341 0
Anxiety 292342 0
Posttraumatic Stress Disorder 292343 0
Injuries 292644 0
Condition category
Condition code
Mental Health 292670 292670 0 0
Other mental health disorders
Mental Health 292671 292671 0 0
Depression
Mental Health 292672 292672 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289704 0
Treatment: Other
Intervention code [2] 289866 0
Behaviour
Intervention code [3] 289942 0
Early detection / Screening
Comparator / control treatment
Treatment as usual.

Participants in the control condition will be managed by their GP as usual and are free to pursue other treatments if they wish.
Control group
Active

Outcomes
Primary outcome [1] 292515 0
Presence of major depression, an anxiety disorder or posttraumatic stress disorder as assessed using the MINI international neuropsychiatric interview. A dichotomous variable indicating the presence or absence of any emotional disorder will be created and serve as the primary outcome measure.
Timepoint [1] 292515 0
Pre-treatment, Mid-treatment, Post treatment and at 6 month follow up
Primary outcome [2] 292516 0
Severity of emotional disorder as measured by the Posttraumatic Stress Disorder Checklist, the Beck Anxiety Inventory, and the Beck Depression Inventory
Timepoint [2] 292516 0
Pre-treatment, Mid- treatment, Post treatment and at 6 month follow up
Secondary outcome [1] 309131 0
Perceived control over emotional experiences will be assessed using the Anxiety Control Questionnaire -Revised.
Timepoint [1] 309131 0
Pre-treatment, Mid-treatment, Post-treatment and 6 month follow up.
Secondary outcome [2] 309559 0
Use of strategies to avoid unpleasant emotions (experiential avoidance) as measured by the Brief Multi-dimensional Experiential Avoidance Questionnaire.
Timepoint [2] 309559 0
Pre-treatment, Mid-treatment, Post-treatment and 6 month follow up.
Secondary outcome [3] 309560 0
Disability as assessed by the World Health Organisation Disability Assessment Scale.
Timepoint [3] 309560 0
Pre-treatment, Mid-treatment, Post-treatment and 6 month follow up.
Secondary outcome [4] 309561 0
Quality of life as assessed using the Assessment of Quality of Life Questionnaire - 6D.
Timepoint [4] 309561 0
Pre-treatment, Mid-treatment, Post-treatment and 6 month follow up.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to treatment condition will be conducted by a researcher who is independent to the study. The trial manager will provide a list of eligible participants and the independent researcher will then inform the trial manager of the allocated treatment conditions. Only the trial manager and treating clinicians will be aware of the participant conditions. All assessments from this point will be conducted by a research assistant who is blind to the treatment conditions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to either the treatment or control condition using a computer generated randomisation schedule (stratified by age and gender), using permuted blocks of random sizes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Hypothesis 1: The primary hypothesis (individuals receiving UP-EI will be more likely to lose their diagnoses than UC) will be examined by calculating an odds ratio effect size (with 95% confidence interval) between the two conditions for the number of individuals who no longer meet diagnostic criteria for any disorder at the post-treatment and 6 month follow-up assessments. Hypotheses 2-4: In order to assess the effect of treatment on (a) depression, anxiety, and PTSD, (b) temperament and emotion regulation, and (c) disability and quality of life, a series of conditional latent growth curve models will be estimated whereby slope factors are regressed onto a dummy code variable representing treatment condition (UC = 0, UP-EI = 1). Separate LGM will be conducted for each outcome, examining changes across both the acute treatment phase and follow-up period. For these models, the intercept of the LGM will be centred on the pre-treatment assessment (i.e., first slope loading fixed to 0). The mean and variance of the slope factor in these models will reflect the total change in, and individual differences in change in, each outcome. In addition, for hypothesis 3, we will conduct a series of parallel process LGM to examine how changes in temperament and emotion regulation relate to changes in the primary symptom severity outcomes (depression, anxiety, and PTSD).

SPSS sample power calculations based on treatment response in our previous trials suggest a sample size of n = 94 is required to detect a 35 point difference in the proportion of participants who meet diagnostic criteria for at least one disorder at follow-up (i.e., 30% of UP-EI and 65% of UC retain diagnosis), with power set at 80% and p set at .01. Monte Carlo simulations conducted in Mplus 7.11 indicated that a sample size of n = 94 would also provide sufficient power for examining hypotheses 2-4.

A total of 1650 will be recruited into the study. Since the study involves a 2 stage screening process, this is then anticipated to lead to 115 people being eligible for the treatment phase of the study, thus meeting our target sample of 115 for this phase.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2014
Actual
5/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1650
Accrual to date
779
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2695 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 2696 0
The Alfred - Prahran
Recruitment postcode(s) [1] 8396 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [2] 8397 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 289524 0
Government body
Name [1] 289524 0
NHMRC
Country [1] 289524 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The Australian Centre for Posttraumatic Mental Health
Level 3 Alan Gilbert Building
161 Barry Street
Carlton
VIC
3053
Country
Australia
Secondary sponsor category [1] 288292 0
None
Name [1] 288292 0
Address [1] 288292 0
Country [1] 288292 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291345 0
Melbourne Health HREC
Ethics committee address [1] 291345 0
Office for Research
Level 6 East, Main Building
300 Grattan Street
The Royal Melbourne Hospital VIC 3050
Ethics committee country [1] 291345 0
Australia
Date submitted for ethics approval [1] 291345 0
09/07/2014
Approval date [1] 291345 0
05/08/2014
Ethics approval number [1] 291345 0
2014.097
Ethics committee name [2] 300346 0
The Alfred Ethics Committee
Ethics committee address [2] 300346 0
55 Commercial Rd,
Melbourne VIC 3004
Ethics committee country [2] 300346 0
Australia
Date submitted for ethics approval [2] 300346 0
20/10/2017
Approval date [2] 300346 0
13/11/2017
Ethics approval number [2] 300346 0
27/17

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49566 0
A/Prof Meaghan O'Donnell
Address 49566 0
Australian Centre for Posttraumatic Mental Health
Level 3 Alan Gilbert Building
161 Barry Street
Carlton
VIC
3053
Country 49566 0
Australia
Phone 49566 0
+ 61 3 9035 5599
Fax 49566 0
Email 49566 0
[email protected]
Contact person for public queries
Name 49567 0
Sonia Terhaag
Address 49567 0
Australian Centre for Posttraumatic Mental Health
Level 3 Alan Gilbert Building
161 Barry Street
Carlton
VIC
3053
Country 49567 0
Australia
Phone 49567 0
+ 61 3 9035 5599
Fax 49567 0
Email 49567 0
[email protected]
Contact person for scientific queries
Name 49568 0
Sonia Terhaag
Address 49568 0
Australian Centre for Posttraumatic Mental Health
Level 3 Alan Gilbert Building
161 Barry Street
Carlton
VIC
3053
Country 49568 0
Australia
Phone 49568 0
+ 61 3 9035 5599
Fax 49568 0
Email 49568 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4485Study results articleYes O'Donnell, M. L., Lau, W., Chisholm, K., Agathos, ... [More Details]

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