Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000239965
Ethics application status
Approved
Date submitted
28/02/2011
Date registered
4/03/2011
Date last updated
18/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness and underlying mechanisms of eye movement desensitisation and reprocessing (EMDR) for posttraumatic stress disorder in Timor Leste.
Scientific title
The effectiveness and underlying mechanisms of eye movement desensitisation and reprocessing (EMDR) for posttraumatic stress disorder in Timor Leste.
Secondary ID [1] 259694 0
Nil Known
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 261268 0
Condition category
Condition code
Mental Health 259420 259420 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a trial with one experimental treatment condition where, following an initial assessment session in which participants are also taught basic calming techniques, each participant serves as their own 2-week wait list control then engages EMDR therapy for treatment of symptoms consistent with PTSD. The minimal calming intervention includes teaching calm breathing, safe place, and identifying coping resources. EMDR therapy will utilise eye-movements as the dual attention task during desensitisation of trauma memories. EMDR therapy will follow the standard EMDR protocol outlined by Shapiro (2001). EMDR therapy is administered in 60-90 minute individual sessions on alternate days with one of 2 EMDR therapists and a translator over 17 days. Participants will receive a maximum of 10 active treatment sessions. The duration of the study for any participant will conclude after a 3 month follow-up assessment following the end of therapy, resulting in a participation duration of approximately 4 months.
Intervention code [1] 264122 0
Treatment: Other
Comparator / control treatment
Wait list controlled. The duration of the waitlist period for each participant is 2 weeks.
Experimental conditions: (1) EMDR-with eye movements whereby participants act as their own control.
There is not a seperate control group.
Note: The wiatlist control consisted of a minimal stabilization intervention. Whereby, following the initial asessment, and prior to the two week waitlist period, basic calming techniques were taught to each participant (safe place and calm breathing). Participants supports and coping resources were also identified. Att he end of the initial assessment it took approximately 20mins to teach calming techniques, and participants were encouraged to use the techniques should they feel distressed during the waitlist period.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262229 0
Symptoms consistent with PTSD is measured with the Harvard Trauma Questionnaire (HTQ: a version translated to Tetun/Indonesian).
Timepoint [1] 262229 0
Administered at 2 weeks pre-treatment, pre-treatment, 2 weeks post-treatment, and at 3-months post-treatment.
Secondary outcome [1] 273358 0
Depression is measured by using the Hopkins Symptom Checklist (HSCL - 25)
Timepoint [1] 273358 0
Administered at 2 weeks pre-treatment, pre-treatment, 2 weeks post-treatment, and at 3-months post-treatment.
Secondary outcome [2] 273359 0
Anxiety, symptoms of general anxiety is measured by using the Hopkins Symptom Checklist (HSCL - 25).
Timepoint [2] 273359 0
Administered at 2 weeks pre-treatment, pre-treatment, 2 weeks post-treatment, and at 3-months post-treatment.
Secondary outcome [3] 273360 0
The distress related to the memory of the event targeted for processing is measured by the within session process measure of Subject Units of distress (SUDS).
Timepoint [3] 273360 0
Administered during all desensitisation sessions, 2 weeks post treatment, and at 3-months post-treatment.
Secondary outcome [4] 273382 0
Psychophysiological changes within session and across treatment.
Timepoint [4] 273382 0
Within the first and last active treatment session ongoing measures of heart rate (HR), heart rate variability (HRV), skin conductance (SC), and respiration rate (RR) will be recorded.

Eligibility
Key inclusion criteria
(1) Exposure to traumatic events in Timor Leste.
(2) The traumatic event occured at least 3 months prior to study entry.
(3) Has symptoms consistent with PTSD.
(4) Timorese resident.
(5) Males and females.
(6) Willingness to participate in the study (informed consent procedure).
(7) The participant has a level of stability and support or is linked with a Timorese NGO health service.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Deaf, Blind, or a history of serious eye disease.
(2) The participant is in an ongoing threatening situation.
(3) Suicidal intent.
(4) Problematic substance 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 Timorese males and females attending a NGO health service in Timor Leste. Following an initial face-to-face assessment interview to assess trauma history and current symptoms consistent with PTSD, and at the end of the assessment participants are also taught 2 calming techniques and their coping resources are identified, participants will then be placed on a 2 week wait list for EMDR treatment. Post-treatment and 3 month follow-up assessment will be conducted by a second Timorese health worker/contact person involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants were allocated to EMDR therapy after thier 2 week wait list period.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/04/2011
Actual
7/04/2011
Date of last participant enrolment
Anticipated
Actual
28/05/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 3242 0
Timor-Leste
State/province [1] 3242 0
Dili

Funding & Sponsors
Funding source category [1] 258579 0
Charities/Societies/Foundations
Name [1] 258579 0
EMDRIA (EMDR International Association)
Country [1] 258579 0
United States of America
Funding source category [2] 289466 0
Charities/Societies/Foundations
Name [2] 289466 0
Anxiety Disorders Foundation (ADF)
Country [2] 289466 0
Australia
Primary sponsor type
University
Name
Murdoch University - School of Psychology
Address
90 South Street
Murdoch, W.A. 6150
Country
Australia
Secondary sponsor category [1] 288662 0
None
Name [1] 288662 0
Address [1] 288662 0
Country [1] 288662 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260566 0
Murdoch University Human Research Ethics Commitee
Ethics committee address [1] 260566 0
Ethics committee country [1] 260566 0
Australia
Date submitted for ethics approval [1] 260566 0
Approval date [1] 260566 0
17/02/2011
Ethics approval number [1] 260566 0
2011/013
Ethics committee name [2] 291223 0
The Cabinet of HEalth Research and Development
Ethics committee address [2] 291223 0
Ethics committee country [2] 291223 0
Timor-Leste
Date submitted for ethics approval [2] 291223 0
05/04/2011
Approval date [2] 291223 0
05/04/2011
Ethics approval number [2] 291223 0
ref: MS-CHRD/IV/2011/21

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

Contacts
Principal investigator
Name 32283 0
Dr Christopher Lee
Address 32283 0
Murdoch University
90 South Street
Murdoch WA 6150
Country 32283 0
Australia
Phone 32283 0
+61 (08) 9360 6000
Fax 32283 0
Email 32283 0
[email protected]
Contact person for public queries
Name 15530 0
Sarah Schubert
Address 15530 0
School of Psychology,
Murdoch University
90 South St
Murdoch, W.A. 6150
Country 15530 0
Australia
Phone 15530 0
+61 (0)408 483460
Fax 15530 0
Email 15530 0
[email protected]
Contact person for scientific queries
Name 6458 0
Sarah Schubert
Address 6458 0
School of Psychology,
Murdoch University
90 South St
Murdoch, W.A. 6150
Country 6458 0
Australia
Phone 6458 0
+61 (0)408 483460
Fax 6458 0
Email 6458 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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