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Trial registered on ANZCTR


Registration number
ACTRN12617000316303
Ethics application status
Approved
Date submitted
7/02/2017
Date registered
28/02/2017
Date last updated
17/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness and acceptance of eye movement desensitisation and reprocessing (EMDR) from a remote Aboriginal Australian community perspective.
Scientific title
The effectiveness and acceptance of an ecologically adapted eye movement desensitisation and reprocessing (EMDR) standard protocol to treat post traumatic symptoms with remote Aboriginal Australian adults.
Secondary ID [1] 291039 0
Nil known
Universal Trial Number (UTN)
U1111-1192-2556
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post traumatic stress disorder 301830 0
Condition category
Condition code
Mental Health 301508 301508 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial has one experimental treatment condition, where EMDR treatment is compared to a two-week wait period, where participants serve as their own control.

Participants complete an initial assessment session (including identifying single or multiple trauma memories to target with EMDR) and diagnostic assessment session (to identify symptoms and diagnosis of PTSD) after which they are taught basic calming techniques. The basic calming techniques are taught for ethical reasons as participants will be discussing trauma memories, however in themselves do not constitute an intervention. Brief calming techniques include calm breathing (breathing in, 2, 3, 4, pause, out, 2, 3, 4) and safe place, which invites participants to picture a place (real or imagined) which invokes a sense of calm and safety. The safe place image is amplified by identifying sensory elements associated with the place and the place is given a name for later cueing if the participant is feeling distressed. Existing family/social supports and internal coping resources will also be identified, and participants provided a brochure with the brief calming techniques and a list of their own supports and resources should they feel distressed in the wait period.

Participants then complete a two week wit period serving as their own control.

Participants then engage in EMDR therapy for treatment of PTSD symptoms. Participants will receive up to 10, individual, face-to-face, 90minute active EMDR treatment sessions on a biweekly basis. EMDR therapy will follow the eight-phase EMDR standard protocol outlined by Shapiro (2001), with additional local cultural considerations developed with the community with the primary researcher for this study (Y. Eriksen). During assessment, participants identified distressing trauma memory/ies to target with EMDR. For each memory during EMDR therapy, participants will be asked to identify the image that represents the most traumatic or distressing part of the experience and how vivid the image is; their associated negative cognition, emotions, body sensations and how strong they are; and their preferred positive cognition. The participant will be invited to focus on the memory image and associated negative thoughts and body sensations and at the same time follow the therapist fingers with their eyes. Eye-movements will be used as the dual attention task during EMDR desensitisation of trauma memories. In between sets of eye movements (approximately 24-35 saccades each set) participants will be asked to describe thoughts, feelings or body sensations that arise. Processing each memory will continue until associated participant distress has reduced, their positive cognition has strengthened and no, or little residual body sensations remains when recalling the original memory. One or more memories may be targeted each session based on timing and participant inclination. The total number of EMDR sessions will be based on participant individual needs. EMDR therapy will be considered complete when the participant does not feel distress when recalling the target trauma memory/ies identified during assessment (up to 10 sessions). Sessions may take place in the building of the participants workplace program, NGO health service, participants workplace, home or a community venue as appropriate.

Assessment and EMDR therapy sessions will be administered by a registered psychologist with Level II EMDR training and four years experience with the participating community. Assessment at three months follow up will be completed by an independent professional trained in psychology and provided assessment training specific to this study by the primary researcher. The duration of the study for any participant will conclude after a three-month follow-up assessment after the completion of therapy, resulting in a total participation duration of approximately 5 months.

All sessions will be video recorded with participant consent. Video recordings of all PTSD assessment sessions will be reviewed by a PhD level registered psychologist for inter-rater reliability. During the course of the trial, a sample of 12 EMDR treatment session video recordings will be assessed for treatment fidelity by an accredited EMDR consultant using a treatment fidelity checklist provided during EMDR training. Two EMDR consultants will provide fortnightly consultation to the treating psychologist during field work to ensure rigorous adherence to the treatment protocol throughout the trial.
Intervention code [1] 297012 0
Treatment: Other
Comparator / control treatment
This trial has one experimental treatment condition, where EMDR treatment is compared to a two-week wait period, where participants serve as their own control. Accordingly, participants symptom change during the treatment period will be compared to symptom change during an equivalent wait period.
Experimental condition: EMDR-with eye movements
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300902 0
Change in symptoms consistent with PTSD as measured with scores of the Impact of Event Scale–Revised (IES-R; Weiss, 2004, 2007)
Timepoint [1] 300902 0
Administered at Baseline (2 weeks pre-treatment), pre-treatment, every EMDR treatment session, 2 weeks post-treatment, and at 3-months post-treatment.
Primary outcome [2] 300903 0
Change in diagnosis of PTSD using the Clinician Administered PTSD scale for DSM-5 (CAPS-5; Weathers, Blake, Schnurr, Marx, & Keane, 2013)
Timepoint [2] 300903 0
Administered at Baseline (2 weeks pre-treatment) and 3-months post-treatment.
Primary outcome [3] 301038 0
Change in the presence of criteria symptoms of PTSD (intrusions, avoidance, cognition/mood, arousal/reactivity) as measured using scores from the Clinician Administered PTSD scale for DSM-5 (CAPS-5; Weathers, Blake, Schnurr, Marx, & Keane, 2013)
Timepoint [3] 301038 0
Administered at Baseline (2 weeks pre-treatment) and 3-months post-treatment.
Secondary outcome [1] 331158 0
Change in depression scores as measured using the modified Primary Health Questionnaire-9 (MPHQ-9; Esler et al., 2007; 2008).
Timepoint [1] 331158 0
Administered at Baseline (2 weeks pre-treatment), pre-treatment, every EMDR treatment session, 2 weeks post-treatment, and at 3-months post-treatment.
Secondary outcome [2] 331159 0
Change in distress related to the memory of the event targeted for processing as measured by the within session process measure of Subjective Units of Distress scale (SUDs; Wolpe, 1990)
Timepoint [2] 331159 0
Administered during every EMDR treatment session, 2 weeks post-treatment, and at 3-months post-treatment.
Secondary outcome [3] 331160 0
Change in vividness of the image related to the memory of the event targeted for processing as measured by The vividness scale (VVS; Schubert, Lee, & Drummond, 2011; van den Hout et al., 2011).
Timepoint [3] 331160 0
Administered during every EMDR treatment session, 2 weeks post-treatment, and at 3-months post-treatment.
Secondary outcome [4] 331347 0
Change in client self-defined and self-reported outcome measure (CPOM) as described by McLeod (2010), identified individually with each client for the study. (Please note there may be one or multiple CPOMs per client depending on the individual, however the primary, or most desired CPOM identified by the participant will be used in analysis).
Timepoint [4] 331347 0
Administered at Baseline (2 weeks pre-treatment), pre-treatment, every EMDR treatment session, 2 weeks post-treatment, and at 3-months post-treatment.

Eligibility
Key inclusion criteria
1) Exposure to traumatic event/s.
2) The traumatic event/s occurred at least 3 months prior to study entry.
3) Has symptoms consistent with PTSD.
4) Males and females.
5) Identifies as of Aboriginal and/or Torres Strait Islander descent.
6) Willingness to participate in the study (informed consent procedure).
7) The participant has a level of stability and support and/or is linked with a local health service.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Deaf, blind, or a history of serious eye disease (e.g detached retina), or epilepsy.
2) The participant is in an ongoing threatening situation.
3) Current benzodiazepine use.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be treatment seeking males and females attending a work assistance program and/or NGO health service in a remote QLD Aboriginal community. Participants may also respond to print or radio advertisement in community.

Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants will be allocated to EMDR therapy after their two-week wait period.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Whilst blinding is not possible within the single group assignment, assessment at 3-months post-treatment (CAPS-5, IES-R, mPHQ-9, CPOM and qualitative questions) will be completed by an independent clinician/researcher.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 20 is required to achieve an effect size of .35 at alpha .05.
Diagnosis of PTSD and criteria symptoms of PTSD (CAPS5) will be described for the sample at baseline, with changes described at follow up. Baseline, pre-, post- and follow-up treatment changes in primary psychometric variables (posttraumatic symptoms/IES-R; depression/MPHQ-9) will be examined using multivariate repeated measure Analysis of Variance (ANOVAs) to incorporate time (baseline, pre-, post- and follow-up treatment) with two within subjects variables (IES-R, MPHQ-9). Significant effects will be investigated using univariate ANOVAs with a priori planned contrasts to delineate treatment effects.
Analysis of reliably and clinically significant change will be assessed for the IES-R and MPHQ using methods recommended by Jacobson and Traux (1991). Pre-, post-, and follow up changes in secondary measures (subjective units of distress/SUDs; Vividness/VVS; Client's personal outcome measure/CPOM) will be examined using ANOVAs incorporating time (before and after memory processing, post-treatment and follow-up) with three within subjects variables (SUDs, VVS, CPOM). Significant effects will be investigated using univariate ANOVAs with a priori planned contrasts to delineate treatment effects.
If data is missing at post-treatment or follow up, analysis will use intent to treat data with the last observation carried forward.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/03/2017
Actual
16/03/2017
Date of last participant enrolment
Anticipated
30/05/2017
Actual
Date of last data collection
Anticipated
27/10/2017
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 15198 0
4830 - Doomadgee

Funding & Sponsors
Funding source category [1] 295463 0
Government body
Name [1] 295463 0
Australian Government Research Training Program Scholarship
Country [1] 295463 0
Australia
Funding source category [2] 295465 0
Commercial sector/Industry
Name [2] 295465 0
MyPathway
Country [2] 295465 0
Australia
Funding source category [3] 295466 0
Charities/Societies/Foundations
Name [3] 295466 0
EMDR Research Foundation
Country [3] 295466 0
United States of America
Funding source category [4] 295467 0
Other
Name [4] 295467 0
EMDR Association of Australia
Country [4] 295467 0
Australia
Primary sponsor type
University
Name
Charles Sturt University
Address
School of Psychology
Locked Bag 588
Boorooma Street
Wagga Wagga, NSW 2678
Country
Australia
Secondary sponsor category [1] 294288 0
None
Name [1] 294288 0
Address [1] 294288 0
Country [1] 294288 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296798 0
Charles Sturt University Human Research Ethics Committee
Ethics committee address [1] 296798 0
Ethics committee country [1] 296798 0
Australia
Date submitted for ethics approval [1] 296798 0
20/01/2017
Approval date [1] 296798 0
15/03/2017
Ethics approval number [1] 296798 0
H17030

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72086 0
Dr Gene Hodgins
Address 72086 0
Charles Sturt University
School of Psychology
Locked Bag 588
Wagga Wagga, NSW 2650
Country 72086 0
Australia
Phone 72086 0
+61(0)269332746
Fax 72086 0
Email 72086 0
ghodgins@csu.edu.au
Contact person for public queries
Name 72087 0
Yvette Eriksen
Address 72087 0
Charles Sturt University
School of Psychology
Locked Bag 588
Wagga Wagga, NSW 2650
Country 72087 0
Australia
Phone 72087 0
+61(0)419343006
Fax 72087 0
Email 72087 0
yeriksen@csu.edu.au
Contact person for scientific queries
Name 72088 0
Yvette Eriksen
Address 72088 0
Charles Sturt University
School of Psychology
Locked Bag 588
Wagga Wagga, NSW 2650
Country 72088 0
Australia
Phone 72088 0
+61(0)419343006
Fax 72088 0
Email 72088 0
yeriksen@csu.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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.