Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000249752p
Ethics application status
Submitted, not yet approved
Date submitted
1/02/2022
Date registered
11/02/2022
Date last updated
28/03/2022
Date data sharing statement initially provided
11/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual Eye Movement Desensitisation and Reprocessing (EMDR) trial in Australian Veterans with Posttraumatic Stress Disorder (PTSD)
Scientific title
A randomised, controlled trial of the efficacy and safety of Eye Movement Desensitisation and Reprocessing via telehealth compared with in person in Australian veterans with Posttraumatic Stress Disorder
Secondary ID [1] 306309 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder 325065 0
Condition category
Condition code
Mental Health 322500 322500 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eye Movement Desensitisation and Reprocessing therapy (EMDR) is a form of psychological exposure therapy for the treatment of Posttraumatic Stress Disorder (PTSD). Targeted memories are identified and the patient attends to those memories while simultaneously focusing on an external lateral stimulation, typically involving eye movements. EMDR follows a standardised treatment protocol that proceeds in five phases over 8-12 weekly sessions:
1. Initial phase in which targets are identified for EMDR processing (90 minutes)
2. Safety planning phase and strategies for coping with emotional distress (90 minutes)
3. Active treatment phase in which EMDR practitioner utilises bilateral stimulation techniques and assesses response using the Subjective Units of Distress Scale (SUDS) (four to eight 60-90 minute sessions)
4. Closure phase and commencement of a log for the following week to document any material that may arise (60 minutes)
5. Re-evaluation phase to examine progress (60 minutes)

The standard treatment protocol has been adapted to a virtual format by a number of commercial providers. The intervention for this is study is the delivery of EMDR via telehealth using a commercial online platform that allows a therapist to control bilateral stimulation. An EMDR trained therapist will deliver EMDR using the standard EMDR protocol, with eye movements stimulated by following circles moving across the screen.

Adherence will be monitored by weekly attendance at sessions.
Intervention code [1] 322761 0
Treatment: Other
Comparator / control treatment
The control for this study is the delivery of EMDR in person using the standard EMDR protocol proceeding in five phases over 8-12 weekly sessions at the National Centre for Veterans' Healthcare (NCVH):
1. Initial phase in which targets are identified for EMDR processing (90 minutes)
2. Safety planning phase and strategies for coping with emotional distress (90 minutes)
3. Active treatment phase in which EMDR practitioner utilises bilateral stimulation techniques and assesses response using SUDS (four to eight 60-90 minute sessions)
4. Closure phase and commencement of a log for the following week to document any material that may arise (60 minutes)
5. Re-evaluation phase to examine progress (60 minutes)

Adherence will be monitored by weekly attendance at sessions.
Control group
Active

Outcomes
Primary outcome [1] 330317 0
The primary objective of the trial will be to compare changes in PTSD symptom severity using the PTSD Checklist for DSM5 (PCL-5) in veterans randomized to either EMDR delivered via telehealth or in person
Timepoint [1] 330317 0
For an 8 week course of EMDR, participants will complete a PCL-5 at enrolment, then weeks 2, 4, 6, and 8 during therapy. This will continue post-intervention by telephone at weeks 14, 20, 26, and 32.
Secondary outcome [1] 405779 0
Compare changes in quality of life (QOL) using the veteran version of the Short Form-36 (VR-36) in veterans randomized to either EMDR delivered via telehealth or in person
Timepoint [1] 405779 0
For an 8 week course of EMDR, participants will complete a VR-36 at enrolment, then weeks 2, 4, 6, and 8 during therapy. This will continue post-intervention by telephone at weeks 14, 20, 26, and 32.
Secondary outcome [2] 405780 0
Compare functional disability using the Global Assessment of Function (GAF) in veterans randomized to either EMDR delivered via telehealth or in person
Timepoint [2] 405780 0
For an 8 week course of EMDR, participants will complete a GAF at enrolment, then weeks 2, 4, 6, and 8 during therapy. This will continue post-intervention by telephone at weeks 14, 20, 26, and 32.
Secondary outcome [3] 405781 0
Adverse events associated with EMDR include increased level of distress, increased anger, worsening of nightmares and sleep, increased anxiety symptoms, worsening of negative cognitions, deterioration of relationships, and increased alcohol or substance use. Serious adverse events include admissions to mental health units, increased suicidality and suicidal behaviour, and deliberate self-harm; death can result from suicidal behaviour.

Serious adverse outcomes and SUDS at the end of a session will be compared in veterans randomized to either EMDR delivered via telehealth or in person.
Timepoint [3] 405781 0
For an 8 week course of EMDR, serious adverse outcomes and end of session SUDS will be measured at enrolment, then weeks 2, 4, 6, and 8 during therapy. This will continue post-intervention by telephone at weeks 14, 20, 26, and 32.

Eligibility
Key inclusion criteria
1. Australian veterans attending the National Centre for Veterans' Healthcare (NCVH)
2. Department of Veterans’ Affairs (DVA) accepted clinical diagnosis of PTSD, which have been confirmed by NCVH clinicians administering and trained in the Structured Clinical Interview for DSM 5 (SCID-5)
3. Suitable for treatment with EMDR
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. No prior treatment with EMDR
2. No history of acquired brain injury from any cause, which may increase the risk of developing PTSD but the impact of acquired brain injury on treatment for PTSD with EMDR is currently unknown
3. No active alcohol, benzodiazepine, or illicit substance use, which are common comorbidities among patients with PTSD but are generally considered relative contraindications for EMDR on the basis of their effects on long term potentiation

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation based on sex, military service branch, and combat exposure
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
Safety/efficacy
Statistical methods / analysis
Data will be analysed using the intention to treat principle by including patients who withdraw or exit from the study. For the purposes of statistical analysis, treatment will consist of a minimum of three sessions in order to include at least one active phase of treatment. Statistical significance will be defined as p < 0.05.

Kaplan-Meier event-free survival analysis curves using right-censoring will be used to analyse PCL-5, SF-35V, and GAF scores based on 25% and 50% improvements in scores. Differences between groups assessed using log-rank tests. Cox proportional hazards regression used to control for differences in demographics and clinical characteristics.

Categorical data will be compared using Fisher’s exact test and interval data will be compared using Mann-Whitney’s U test. The following six clinical features will be modelled for the primary outcome using regression analysis: sex, current age, military service branch (including special forces experience), combat exposure, exposure to moral injury, and duration since trauma exposure.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/05/2022
Actual
Date of last participant enrolment
Anticipated
8/03/2024
Actual
Date of last data collection
Anticipated
7/06/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21614 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 36540 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 310654 0
Hospital
Name [1] 310654 0
Concord Repatriation General Hospital
Country [1] 310654 0
Australia
Primary sponsor type
Hospital
Name
Concord Repatriation General Hospital
Address
Hospital Rd
Concord
NSW 2139
Country
Australia
Secondary sponsor category [1] 311896 0
None
Name [1] 311896 0
Address [1] 311896 0
Country [1] 311896 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310248 0
Sydney Local Health District Human Research Ethics Committee - Concord Repatriation General Hospital
Ethics committee address [1] 310248 0
Hospital Rd
Concord
NSW 2139
Ethics committee country [1] 310248 0
Australia
Date submitted for ethics approval [1] 310248 0
01/02/2022
Approval date [1] 310248 0
Ethics approval number [1] 310248 0

Summary
Brief summary
PTSD can be a debilitating syndrome of prolonged stress reactions that may develop after either direct or indirect exposure to a traumatic event. It is a significant issue among veterans with up to one in four veterans experiencing PTSD in their lifetime.

Treatment usually involves psychotherapy and pharmacotherapy. EMDR and trauma-focused cognitive behavioural therapy (CBT) are both widely used and equally effective therapies. EMDR involves attention to the past, present, and future with a focus on disturbing memories and related events. Targeted memories are identified and the patient attends to those memories while simultaneously focusing on an external lateral stimulation, typically involving eye movements.

The COVID-19 pandemic has significantly altered the way in which mental health intervention has been delivered and telehealth has been rapidly implemented throughout Australia. A number of companies have adapted EMDR to telehealth, but the evidence base remains limited. From a clinical perspective, the capacity to deliver EMDR via telehealth provides an opportunity to provide access to rural and remote patients, as well as enabling preparedness for future pandemics.

This trial will aim to investigate whether EMDR via telehealth to veterans with PTSD provides similar safety and efficacy outcomes to delivering EMDR in person.
Trial website
Trial related presentations / publications
Public notes
EMDR is a form of exposure therapy, and thereby can destabilise a patient’s mental state. Safety planning is integral to the delivery of EMDR whether via telehealth or in person, and distress coping strategies are developed and practiced with patients as part of the preparation for EMDR. Despite this preparation work, adverse effects of EMDR may occur.

Contacts
Principal investigator
Name 116998 0
Dr David Graham
Address 116998 0
National Centre for Veterans' Healthcare
Concord Repatriation General Hospital
Hospital Rd
Concord
NSW 2139
Country 116998 0
Australia
Phone 116998 0
+61 2 9767 8671
Fax 116998 0
Email 116998 0
david.graham1@health.nsw.gov.au
Contact person for public queries
Name 116999 0
Dr David Graham
Address 116999 0
National Centre for Veterans' Healthcare
Concord Repatriation General Hospital
Hospital Rd
Concord
NSW 2139
Country 116999 0
Australia
Phone 116999 0
+61 2 9767 8671
Fax 116999 0
Email 116999 0
david.graham1@health.nsw.gov.au
Contact person for scientific queries
Name 117000 0
Dr David Graham
Address 117000 0
National Centre for Veterans' Healthcare
Concord Repatriation General Hospital
Hospital Rd
Concord
NSW 2139
Country 117000 0
Australia
Phone 117000 0
+61 2 9767 8671
Fax 117000 0
Email 117000 0
david.graham1@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only aggregated data based on de-identified data will be made available to ensure participant privacy


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14892Study protocol    383485-(Uploaded-01-02-2022-17-21-43)-Study-related document.docx
14893Ethical approval    Not yet available



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.