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Trial registered on ANZCTR


Registration number
ACTRN12616001302448
Ethics application status
Approved
Date submitted
19/08/2016
Date registered
16/09/2016
Date last updated
17/06/2019
Date data sharing statement initially provided
17/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Rapid Exposure Supporting Trauma Recovery - RESTORE
Scientific title
Optimising mental health and quality of life for Australia’s military personnel and veterans with PTSD.
Secondary ID [1] 289144 0
Nil known
Universal Trial Number (UTN)
Trial acronym
RESTORE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder 298657 0
Condition category
Condition code
Mental Health 298719 298719 0 0
Anxiety
Mental Health 299872 299872 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prolonged exposure (PE) is the gold standard evidence based treatment for PTSD. It involves helping the person address the traumatic memories and avoided situations in a supportive, controlled and safe environment, in order to reduce the associated fear and modify interpretations of the event that are impeding recovery.

Standard PE (SPE) requires weekly treatment for 10 weeks, which can pose a barrier to treatment uptake for some military personnel (for whom 10-week windows of availability between training activities, deployments and postings may be rare), as well as for veterans and other civilian populations (for whom life demands and stressors may make attendance difficult).

Intensive PE (IPE) delivers the same intervention over 10 working days within a two week period, rather than weekly over 10 weeks.

In this study we seek to test whether IPE is as effective as the 10-week SPE model.

Both IPE and SPE sessions will be conducted individually with participants by psychologists. SPE consists of 10 weekly sessions of 90 minute, face-to-face manualised standard PE therapy with the therapist, and associated homework tasks. The IPE intervention is identical to SPE but delivered intensively over the course of two weeks, with a 90 minute session with the psychologist each morning, followed by homework tasks each afternoon. Homework is of approximately 2 hours duration, with tasks including gradually engaging in avoided situations, in imagination and in real-life. Participants do this in a gradual manner, while learning to manage the associated anxiety. Therapists will keep a session attendance log for each individual participant. Participants will keep a homework log which will be reviewed with their therapist at the beginning of each session.
Intervention code [1] 294661 0
Treatment: Other
Intervention code [2] 295692 0
Behaviour
Comparator / control treatment
Standard Prolonged Exposure (SPE) therapy: Prolonged exposure treatment provided in the standard treatment schedule of weekly, individual face-to-face manualised 90 minute therapy sessions with a psychologist, and associated homework tasks over a 10 week period.
Control group
Active

Outcomes
Primary outcome [1] 298199 0
Severity of PTSD symptomatology, as measured by the Clinician Administered PTSD Scale for DMS-5 (CAPS-5)
Timepoint [1] 298199 0
Pre-treatment, 4 weeks, 12 weeks and 12 months post-treatment commencement
Primary outcome [2] 298200 0
Severity of self-reported PTSD symptomatology, as measured by the Posttraumatic Check List for DSM-5 (PCL-5)
Timepoint [2] 298200 0
Pre-treatment, 4 weeks, 12 weeks and 12 months post-treatment commencement
Secondary outcome [1] 323479 0
Severity of comorbid anxiety as measured by the anxiety sub-scale of the Hospital Anxiety and Depression Scale (HADS).
Timepoint [1] 323479 0
Pre-treatment, 4 weeks, 12 weeks and 12 months post-treatment commencement
Secondary outcome [2] 326976 0
Severity of comorbid depression as measured by the depression sub-scale of the Hospital Anxiety and Depression Scale (HADS).
Timepoint [2] 326976 0
Pre-treatment, 4 weeks, 12 weeks and 12 months post-treatment commencement
Secondary outcome [3] 326977 0
Severity of anger, as measured by the Dimensions of Anger Reactions-5 (DAR-5).
Timepoint [3] 326977 0
Pre-treatment, 4 weeks, 12 weeks and 12 months post-treatment commencement
Secondary outcome [4] 326978 0
Disability as assessed by the World Health Organization Disability and Assessment Schedule 2.0 (WHODAS 2.0)
Timepoint [4] 326978 0
Pre-treatment, 4 weeks, 12 weeks and 12 months post-treatment commencement
Secondary outcome [5] 327141 0
Quality of life, as assessed by the Assessment of Quality of Life Scale (AQoL-6D)
Timepoint [5] 327141 0
Pre-treatment, 4 weeks, 12 weeks and 12 months post-treatment commencement
Secondary outcome [6] 327142 0
Physiological arousal in response to imaginal exposure, as assessed by skin conductance responses obtained on finger electrodes.
Timepoint [6] 327142 0
During imaginal exposure component of therapy, conducted in sessions 3 - 10.

Eligibility
Key inclusion criteria
1. Veteran, ex-serving or currently serving member of the Australian Defence Force (ADF)
2. A diagnosis of PTSD as assessed by the CAPS-5, of a minimum duration of at least three months, which is related to a military trauma
3. Able to commit to the study treatment schedule
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current psychosis, mania or active suicidality
2. Current severe alcohol or substance use disorder
3. Currently receiving other psychological therapy and unwilling/unable to pause

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 will occur following the determination of eligibility by the study assessor, coordinated at a central administration site by the project manager and conducted according to a computer generated randomisation list provided by an independent researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated permuted block randomisation
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
Sample size is determined for detecting non-inferiority of the primary endpoint, CAPS score, where non-inferiority is to be declared if the upper endpoint of the 95% confidence interval for the difference in mean change scores from baseline to 12 months between IPE and SPE (adjusted for baseline) is less than 7 CAPS points. The margin of 7 CAPS points is determined as being the maximum non-clinically significant change. With a between-subject SD of 15.6 points and a baseline-to-12 month correlation in CAPS scores of 0.32, a total of 172 patients are required to detect non-inferiority with 80% power when IPE is truly non-inferior. The false positive error rate (i.e. falsely declaring non-inferiority) with this design is at most 2.5%. Allowing for 10-15% loss to follow up at 12 months, the sample size increases to 200 patients.

Analyses will follow the intention to treat principle. Baseline characteristics of the IPE and SPE groups will be tabulated using appropriate summary statistics. Analyses of the (quantitative) outcome measures at each of the follow up time points will be performed using linear regression with change from baseline as the dependent variable, treatment group as the covariate of interest, and adjusting for the baseline value of the outcome measure and the stratification variables used in the randomisation. Results will be presented as adjusted differences in mean change from baseline in each outcome measure compared between IPE and SPE groups, together with 95% confidence intervals and p-values. Data from patients lost to follow up will be imputed using multiple imputation methods using as much post-baseline auxiliary information as available in the imputation models. Supplementary ‘as treated’ and ‘per protocol’ analyses will be performed to account for lack of treatment adherence.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 293527 0
Government body
Name [1] 293527 0
National Health and Medical Research Council Partnership Grant
Address [1] 293527 0
Level 1,
16 Marcus Clarke Street
Canberra ACT 2601

Country [1] 293527 0
Australia
Funding source category [2] 293528 0
Government body
Name [2] 293528 0
Australian Government Department of Defence
Address [2] 293528 0
PO Box 7911
Canberra BC ACT 2610
Country [2] 293528 0
Australia
Funding source category [3] 293531 0
Government body
Name [3] 293531 0
Australian Government Department of Veterans' Affairs
Address [3] 293531 0
GPO Box 9998
Canberra ACT 2601
Country [3] 293531 0
Australia
Primary sponsor type
Other
Name
Phoenix Australia - Centre for Posttraumatic Mental Health
Address
Level 3
Alan Gilbert Building
161 Barry St
Carlton, VIC 3053
Country
Australia
Secondary sponsor category [1] 292349 0
None
Name [1] 292349 0
Address [1] 292349 0
Country [1] 292349 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294967 0
Department of Veterans' Affairs Human Research Ethics Committee
Ethics committee address [1] 294967 0
Department of Veterans' Affairs
GPO BOx 9998
Canberra ACT 2601
Ethics committee country [1] 294967 0
Australia
Date submitted for ethics approval [1] 294967 0
19/02/2016
Approval date [1] 294967 0
01/03/2016
Ethics approval number [1] 294967 0
E016/009
Ethics committee name [2] 295072 0
Australian Defence Human Research Ethics Committee
Ethics committee address [2] 295072 0
PO Box 7911
Canberra BC
ACT 2600
Ethics committee country [2] 295072 0
Australia
Date submitted for ethics approval [2] 295072 0
02/02/2016
Approval date [2] 295072 0
07/09/2016
Ethics approval number [2] 295072 0
818-16

Summary
Brief summary
One of the most effective treatments for PTSD is prolonged exposure (PE). In this treatment, the person is helped to gradually address the difficult memories and avoided situations in a supportive and controlled fashion. PE is delivered by qualified therapists in sessions that are held once a week for 10 weeks. For some people, this can pose a barrier – it may be difficult to get time off work or to make other arrangements for family commitments. Allocating 10 weeks for treatment can also be difficult for serving members. There is now some early evidence that we may be able to get equivalent results by providing the same number of sessions on a daily basis in just two weeks. In this study we seek to test whether the intensive approach is as effective as the 10-week model. If so, it has the potential to increase how accessible and acceptable this evidence based treatment is to veterans, serving members, civilians and their families. Using a randomised controlled trial design, we will therefore compare the effectiveness of the standard and intensive versions of PE in the treatment of PTSD in veterans and serving members.

Eligible veterans and currently serving Defence members who meet criteria for PTSD will be randomly allocated to either standard PE (SPE; 10 weekly 90-minute sessions or intensive PE (IPE; 10 daily 90-minute sessions). Participants will be assess pre-treatment and at 4 weeks, 12 weeks and 12 months post-treatment commencement. We hypothesise that IPE will be as effective as SPE in reducing the severity of PTSD symptoms at post-treatment and 12 month follow-up.
Trial website
http://phoenixaustralia.org/RESTORE
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65634 0
Prof David Forbes
Address 65634 0
Phoenix Australia - Centre for Posttraumatic Mental Health
University of Melbourne, Department of Psychiatry
Level 3, Alan Gilbert Building
161 Barry St,
Carlton VIC 3053
Country 65634 0
Australia
Phone 65634 0
+ 61 3 9035 5599
Fax 65634 0
Email 65634 0
dforbes@unimelb.edu.au
Contact person for public queries
Name 65635 0
Prof David Forbes
Address 65635 0
Phoenix Australia - Centre for Posttraumatic Mental Health
University of Melbourne, Department of Psychiatry
Level 3, Alan Gilbert Building
161 Barry St,
Carlton VIC 3053
Country 65635 0
Australia
Phone 65635 0
+ 61 3 9035 5599
Fax 65635 0
+ 61 3 9035 5455
Email 65635 0
phoenix-clinical@unimelb.edu.au
Contact person for scientific queries
Name 65636 0
Prof David Forbes
Address 65636 0
Phoenix Australia - Centre for Posttraumatic Mental Health
University of Melbourne, Department of Psychiatry
Level 3, Alan Gilbert Building
161 Barry St,
Carlton VIC 3053
Country 65636 0
Australia
Phone 65636 0
+ 61 3 9035 5599
Fax 65636 0
Email 65636 0
dforbes@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this stage there is no plan to make IPD publicly available. Given we are close to the conclusion of our trial and the majority of our participants have already signed their informed consent forms, which did not include notification about making IPD public, it is unlikely that we will be able to do this for this trial.
What supporting documents are/will be available?
No other documents available
Summary results
No Results