Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000872639
Ethics application status
Approved
Date submitted
31/07/2014
Date registered
14/08/2014
Date last updated
14/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Early Psychological Interventions for Post Traumatic Stress post Burn Injury
Scientific title
A Randomised Control Trial of Eye Movement Desensitisation and Reprocessing (EMDR) for Post-Traumatic Stress Following Burn Injury
Secondary ID [1] 285086 0
Nil Known
Universal Trial Number (UTN)
U1111-1159-8067
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Traumatic Stress Disorder (PTSD) 292619 0
Depression 292620 0
Anxiety 292621 0
Adjustment and quality of life 292622 0
Burn Injury 292710 0
Condition category
Condition code
Mental Health 292938 292938 0 0
Anxiety
Mental Health 292939 292939 0 0
Depression
Injuries and Accidents 293017 293017 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eye Movement Desensitisation and Reprocessing (EMDR), which is a psychotherapy for trauma. Each participant in the 'intervention/EMDR group' will recieve 3 one hourly sessions of EMDR 2 weeks after injury. Sessions are administered once weekly for 3 weeks. Bilateral eye stimulation involves the participant moving their eyes sideways, following the therapists finger back and forth.

Session One: Introduction & Stabilisation
1) The EMDR is administered within 3 sessions, as per the A-TIP protocol and ‘processing’ is confined to the recent traumatic event.
2) The patient is asked to give a brief chronological narrative of the whole traumatic experience and then asked to rate their level of disturbance, which is referred to as SUD (subjective units of distress: 0 is no disturbance and 10 is maximum disturbance). The patient’s negative cognition associated with the event as well as their positive/adaptive belief is elicited and both are rated using the VoC scale (validity of cognition: 1 being totally false and 7 being totally true).
3) Patients are taught some basic relaxation and self-soothing strategies, to assure safety and containment as well as to adequately assess patients’ readiness for processing. Patients must have the ability to both tolerate their disturbance and regulate their responses. If this is not the case, more stabilisation work may need to be done before bilateral stimulation is introduced. Safe/calm place, container and breathing exercises will be used for this. These are evidence based exercises used to help patients feel or regain a sense of safety and reduce arousal and anxiety.
4) Patients are then asked to ‘walk through’ the story with continuous BLS (bilateral stimulation). This involves patients talking about their traumatic experience from beginning to end while having the bilateral eye stimulation. During bilateral eye stimulation the patient's eyes are made to move sideways following the therapists fingers that move continously from side to side.
5) Debrief & closure. Options for next session are discussed and if necessary affect management skills for stabilisation are revised.

Session Two: Processing the disturbance
1) The ‘worst part of the incident’ is assessed, including image that represents the event, sensory component, negative and positive belief, VoC: 1-7, emotions, SUD (0-10) and body location of disturbance. This is then processed using BLS until SUD are as low as possible. This is followed by the installation of the positive belief until the VoC is as high as possible. This is repeated for other disturbing aspects/fragments of the trauma, either in chronological or by level of disturbance.
2) Debrief and closure. Affect management skills if required.

Session Three: Reevaluation& Future Action Planning
1) Patients are re-evaluated, both globally, in terms of any changes, dreams, startle responses and triggers that may have arisen, and specifically in terms of the previous ‘targets’ processed. Any new or remaining disturbances are processed as in session two.
2) Patients are asked to imagine potential future aspects similar to the traumatic event and asked to hold their positive belief with that situation. The VoC is checked and then BLS is applied until the VoC moves to an adaptive level.
3) Exit interview and closure
Intervention code [1] 289931 0
Prevention
Intervention code [2] 290027 0
Treatment: Other
Comparator / control treatment
Participants in the 'control/standard care group' will recieve 3 hours of supportive counselling. This will be administered once weekly for 3 weeks.

Supportive Counselling Intervention:

Session One:
1) Explanation of 3 session contact for supportive counselling.
2) Provide psycho-education re PTS and normal trauma reactions/what to expect
3) Explore patients concerns, coping and social supports.
4) Patients are taught some basic relaxation and self-soothing strategies, to help them manage their current post traumatic symptoms, assure safety and containment. Safe/calm place, container and breathing exercises will be used for this.

Session Two:
1 Exploration of patients’ ongoing concerns, allowing patients to reflect on how they have coped and made meaning of traumatic experiences.
2 More affect/stress management skills as required.

Session Three:
3 Exploration of patients’ ongoing concerns, allowing patients to reflect on how they have coped and made meaning of traumatic experiences.
4 More affect/stress management skills as required.
5 Debrief and closure: Participants, who remain symptomatic, will be offered the 3 sessions of EMDR. This will be explained as part of the debriefing and closure and arrangements for recruitment into the cross over group made if indicated.
Control group
Active

Outcomes
Primary outcome [1] 292798 0
Diagnosis of PTSD
The Clinician Administered PTSD Scale (CAPS), which is the gold standard for diagnosing PTSD will be administered to all participants.

The Impact of Event Scale -Revised (IES-R), which measures post traumatic symptoms will also be used.
Timepoint [1] 292798 0
The CAPS will be administered 3 months post injury and the IES-R before and after each intervention as well as at the 3 month mark.
Primary outcome [2] 292799 0
Depression
The Depression Anxiety and Stress Schedule (DASS), a valid and reliable measure for symptoms of depression, anxiety and stress will be used to assess this outcome.
Timepoint [2] 292799 0
3 months post injury
Primary outcome [3] 292802 0
Anxiety
The Depression Anxiety and Stress Schedule (DASS), a valid and reliable measure for symptoms of depression, anxiety and stress will be used to assess this outcome.
Timepoint [3] 292802 0
3 months post injury
Secondary outcome [1] 309701 0
Adjustment and quality of life
The Burns Specific Health Scale Brief (BSHS-B) measures quality of life post burn injury
Timepoint [1] 309701 0
The BSHS-B will be administered 12 months post injury to allow time for rehabilitation and some adjustment before measuring quality of life.

Eligibility
Key inclusion criteria
All burns patients admitted to the Severe Burns Injury Unit at Royal Nortrh Shore Hospital, Sydney will be eligible to participate in the first (screening) phase of this study. Of these patients, those with moderate to high levels of uncomplicated post-traumatic stress symptoms at 2-4 weeks post injury will be offered participation in the second/treatment phase of this study. Moderate to high levels of post-traumatic stress symptoms will be defined as an Impact of Event Scale Revised (IES-R) score equal or greater than 26.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients younger than 18 years of age.
2. Medical or psychiatric issue that impairs the ability of the participant to give informed consent.
3. Patients with high levels of dissociation (DES score >40)
4. Patients suffering from acute grief reactions
5. Patients at risk of self-harm who cannot assure their safety.
6. Patients who remain in an unsafe environment/current abusive relationship.
7. Patients with complex chronic trauma histories that are unresolved (discernible signs of ongoing traumatic disorganization of reasoning, discourse and behaviour)
8. Patients that are required to give evidence or statements to the police or in a court of law.
9. Patients with self-inflicted burns

Patients younger than 18 years of age and those with issues that impair the ability to give informed consent will be excluded as their capacity for informed consent will be affected.

Patients with current and ongoing severe substance abuse, high levels of dissociation (DES score >40), those suffering from an acute grief reaction as well as patients with complex chronic trauma histories that are unresolved (discernible signs of ongoing traumatic disorganization of reasoning, discourse and behaviour) will also be excluded as this would require longer term support and stabilisation before being able to address the current (burn related) trauma safely.

Also patients at risk of self-harm who cannot assure their safety, those who remain in an unsafe environment/current abusive relationship and patients with a previous PTSD diagnosis will be excluded as these are contraindications for early EMDR intervention

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)
The participant will be enrolled into the study after the informed written consent process has been completed and the participant has met all inclusion criteria and none of the exclusion criteria. The participant will receive a study enrolment number and this will be documented in the participant’s medical record and on all study documents. Ms Kwiet will allocate patient study numbers but Dr McLean will be responsible for randomization from a random numbers protocol.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer sofware and operated off site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
n/a
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Effect size, measured as Cohen’s d from similar published studies of early intervention is very strong (d==1.0). Allowing for a possible lower effect size in this medically unwell group of 1.0 >d >0.9 with power of 0.8 and significance set at an alpha of 0.05 (two-tailed) with a minimum sample size of 17-20 in each group for an independent samples t-test. Dependent testing usually yields a higher power, because the interconnection between data points of different measurements are kept and is relevant here in the repeated measures design This suggests that even smaller samples with a lower effect size may be able to be analysed.
(http://www.psychometrica.de/effect_size.html#transform) Given however the unwell nature of our sample group, high attrition rate of patients with PTSD and need for covariate analysis, we plan to over recruit, but for statistical significance require 20 in each group or 40 in total.
Statistical analysis will require comparison of pre- and post-measures within subjects and between groups. It is planned to analyse the data using M/ANCOVA techniques with the independent variables as the treatment type (EMDR vs optimised standard care and the dependent variable of post-traumatic stress (PTS). Important covariates that may be analysed will include total body surface area (TBSA), burn site, gender and age. Analyse at the 3 month mark will examine the effect of the interventions on the prevalence of post-traumatic stress disorder (PTSD), depressive and anxiety symptoms and quality of life. Logistic regression models will be used to establish models of factors predicting risk and outcome over time.

Qualitative analysis on the interviews on the experience of recovery and rehabilitation and treatment will proceed via thematic analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/08/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2797 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 8490 0
2065 - Royal North Shore Hospital

Funding & Sponsors
Funding source category [1] 289692 0
Government body
Name [1] 289692 0
The NSW Institute of Psychiatry
Country [1] 289692 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Royal North Shore Hospital
Pacific Highway
St Leonards,
NSW 2065
Country
Australia
Secondary sponsor category [1] 288387 0
University
Name [1] 288387 0
The University of Sydney
Address [1] 288387 0
The University of Sydney,
City Road
NSW 2006
Country [1] 288387 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291436 0
Human Research Ethics Committee of Northern Sydney Central Coast Health (ECOO132)
Ethics committee address [1] 291436 0
Ethics committee country [1] 291436 0
Australia
Date submitted for ethics approval [1] 291436 0
31/03/2014
Approval date [1] 291436 0
15/07/2014
Ethics approval number [1] 291436 0
HREC/14/HAWKE/79

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 141 141 0 0
/AnzctrAttachments/366825-Protocol_U1111_1159_8067.docx
Attachments [2] 143 143 0 0
/AnzctrAttachments/366825-Letter - HREC FINAL approval - HREC Exec meeting OOS 14 July 2014 - RESP 14 57.PDF
Attachments [3] 144 144 0 0
/AnzctrAttachments/366825-PISCF_screening.docx
Attachments [4] 145 145 0 0
/AnzctrAttachments/366825-PISCF_RCT.docx

Contacts
Principal investigator
Name 50358 0
A/Prof Loyola McLean
Address 50358 0
Consultation Liaison Psychiatry
Royal North Shore Hospital
St Leonards, NSW 2065
Country 50358 0
Australia
Phone 50358 0
61 2 99267111
Fax 50358 0
Email 50358 0
[email protected]
Contact person for public queries
Name 50359 0
Julia Kwiet
Address 50359 0
Department of Social Work
Building 30
Royal North Shore Hospital
St Leonards, NSW, 2065
Country 50359 0
Australia
Phone 50359 0
61 2 9462 9477
Fax 50359 0
61 2 9463 1020
Email 50359 0
[email protected]
Contact person for scientific queries
Name 50360 0
Loyola McLean
Address 50360 0
Consultation Liaison Psychiatry
Royal North Shore Hospital
St Leonards, NSW 2065
Country 50360 0
Australia
Phone 50360 0
61 2 9926 7111
Fax 50360 0
Email 50360 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
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