ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

U1111-1158-6854

Trial acronym

SPRITE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Depression

Anxiety

Posttraumatic Stress Disorder

Injuries

Condition category

Condition code

Mental Health

Other mental health disorders

Mental Health

Depression

Mental Health

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]

Treatment: Other

Intervention code [2]

Behaviour

Intervention code [3]

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]

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]

Pre-treatment, Mid-treatment, Post treatment and at 6 month follow up

Primary outcome [2]

Severity of emotional disorder as measured by the Posttraumatic Stress Disorder Checklist, the Beck Anxiety Inventory, and the Beck Depression Inventory

Timepoint [2]

Pre-treatment, Mid- treatment, Post treatment and at 6 month follow up

Secondary outcome [1]

Perceived control over emotional experiences will be assessed using the Anxiety Control Questionnaire -Revised.

Timepoint [1]

Pre-treatment, Mid-treatment, Post-treatment and 6 month follow up.

Secondary outcome [2]

Use of strategies to avoid unpleasant emotions (experiential avoidance) as measured by the Brief Multi-dimensional Experiential Avoidance Questionnaire.

Timepoint [2]

Pre-treatment, Mid-treatment, Post-treatment and 6 month follow up.

Secondary outcome [3]

Disability as assessed by the World Health Organisation Disability Assessment Scale.

Timepoint [3]

Pre-treatment, Mid-treatment, Post-treatment and 6 month follow up.

Secondary outcome [4]

Quality of life as assessed using the Assessment of Quality of Life Questionnaire - 6D.

Timepoint [4]

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?

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]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [2]

The Alfred - Prahran

Recruitment postcode(s) [1]

3050 - Royal Melbourne Hospital

Recruitment postcode(s) [2]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health HREC

Ethics committee address [1]

Office for Research
Level 6 East, Main Building
300 Grattan Street
The Royal Melbourne Hospital  VIC  3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/07/2014

Approval date [1]

05/08/2014

Ethics approval number [1]

2014.097

Ethics committee name [2]

The Alfred Ethics Committee

Ethics committee address [2]

55 Commercial Rd, 
Melbourne VIC 3004

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

20/10/2017

Approval date [2]

13/11/2017

Ethics approval number [2]

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

A/Prof Meaghan O'Donnell

Address

Australian Centre for Posttraumatic Mental Health
Level 3 Alan Gilbert Building
161 Barry Street
Carlton
VIC
3053

Country

Australia

Phone

+ 61 3 9035 5599

Fax

mod@unimelb.edu.au

Contact person for public queries

Name

Sonia Terhaag

Address

Australian Centre for Posttraumatic Mental Health
Level 3 Alan Gilbert Building
161 Barry Street
Carlton
VIC
3053

Country

Australia

Phone

+ 61 3 9035 5599

Fax

sonia.terhaag@unimelb.edu.au

Contact person for scientific queries

Name

Sonia Terhaag

Address

Australian Centre for Posttraumatic Mental Health
Level 3 Alan Gilbert Building
161 Barry Street
Carlton
VIC
3053

Country

Australia

Phone

+ 61 3 9035 5599

Fax

sonia.terhaag@unimelb.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		O'Donnell, M. L., Lau, W., Chisholm, K., Agathos, ... [More Details]

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No additional documents have been identified.

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