Early Psychological Interventions for Post Traumatic Stress post Burn Injury

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000872639
• Date of registration: 14/08/2014
• Prospective Registration: Yes
• Primary sponsor: Royal North Shore Hospital
• 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
• Date of first enrolment: 18/08/2014
• Target sample size: 40
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12614000872639.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;

Countries of recruitment

Australia

Contacts

• Name: Mrs Julia Kwiet

• Name: A/Prof Loyola McLean

Key inclusion & exclusion criteria

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.
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


Age minimum: 18 Years
Age maximum: 100 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Mental Health - Depression

Post Traumatic Stress Disorder (PTSD);Depression;Anxiety;Adjustment and quality of life;Burn Injury;
Post Traumatic Stress Disorder (PTSD)
Depression
Anxiety
Adjustment and quality of life
Burn Injury

Mental Health - Anxiety

Injuries and Accidents - Burns

Intervention(s)

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

Primary Outcome(s)

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.[3 months post injury ]

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.[3 months post injury ]

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.[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.]

Secondary Outcome(s)

Adjustment and quality of life
The Burns Specific Health Scale Brief (BSHS-B) measures quality of life post burn injury[The BSHS-B will be administered 12 months post injury to allow time for rehabilitation and some adjustment before measuring quality of life. ]

Secondary ID(s)

Nil Known

Source(s) of Monetary Support

The NSW Institute of Psychiatry

Secondary Sponsor(s)

The University of Sydney

Ethics review

Status: Approved
Approval date:
Contact:

Human Research Ethics Committee of Northern Sydney Central Coast Health (ECOO132)