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Trial registered on ANZCTR


Registration number
ACTRN12611000843954
Ethics application status
Approved
Date submitted
3/08/2011
Date registered
10/08/2011
Date last updated
16/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating changes in hippocampal volume and regional cerebral perfusion and therapeutic and system related outcomes following the treatment of Post Traumatic Stress Disorder with Eye Movement Desensitization Reprocessing and exposure therapy: a pilot study.
Scientific title
Investigating changes in hippocampal volume and regional cerebral perfusion and therapeutic and system related outcomes (including symptom reduction and effects of participants experience of therapy on treatment efficacy, daily functioning and quality of life) following the treatment of Post Traumatic Stress Disorder with eye movement desensitization and reprocessing (EMDR) and prolonged exposure therapy: a pilot study.
Secondary ID [1] 262768 0
Nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Traumatic Stress Disorder - PTSD is an anxiety disorder that can develop after exposure to any distressing event, this event may involve the threat of death to oneself or to someone else, or to one's own or someone else's physical, sexual, or psychological integrity, overwhelming the individual's ability to cope. Typical symptoms for PTSD include re-experiencing the original trauma (s) through flashbacks or nightmares, avoidance of stimuli associated with the trauma, and increased arousal - such as difficulty falling or staying asleep, anger and hyper vigilance. 270478 0
Condition category
Condition code
Mental Health 270635 270635 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EMDR is a form of psychotherapy that was developed by Francine Shapiro to resolve the development of trauma-related disorders caused by exposure to distressing events. The theory suggests when distressing experiences occur they may overwhelm usual cognitive and neurological coping mechanisms. The memory and associated stimuli of the event are inadequately processed, and are dysfunction-ally stored in an isolated memory network. The goal of EMDR therapy is to process these distressing memories, using dual attention stimuli (by way of bilateral stimulation (e.g. eye movements, tones or tapping) while triggering a physiological state that facilitates information processing, therefore reducing the distress and allowing the client to develop more adaptive coping mechanisms. Following a 6 week period, after the individual assessment, where participants receive MRI and PET scans and act as their own control group; participants in the EMDR intervention group will receive 2 x 90 minute sessions per week for 6 weeks, administered in one-on-one individualized sessions by trained therapists.
Intervention code [1] 267111 0
Treatment: Other
Comparator / control treatment
Exposure therapy is an internationally recognized treatment modality for PTSD. This technique requires individuals to confront the distressing memory until its arousal-provoking properties are decreased through a process of habituation. Following a 6 week period, after the individual assessment, where participants receive MRI and PET scans and act as their own control group; participants in the exposure therapy intervention group will receive 2 x 90 minute sessions per week for 6 weeks, administered in one-on-one individualized sessions by trained therapists.
Control group
Active

Outcomes
Primary outcome [1] 269363 0
Mean PTSD checklist - civilian: 17 item self-report measure of DSM IV symptoms of PTSD. To be used as a screening tool and to monitor change following treatment.
Timepoint [1] 269363 0
Pre-treatment - 6 weeks prior to treatment; Baseline - The beginning of treatment; post-treatment - at the conclusion of treatment; 6 week follow-up - 6 weeks following the conclusion of treatment; 6 month follow-up - 6 months following the conclusion of treatment and 12 month follow-up - 12 months following the conclusion of treatment.
Primary outcome [2] 269364 0
Mean Depression Anxiety and Stress Scale scores (DASS) - 42 item self-report measure of depression, anxiety and stress symptoms often co-morbid with PTSD symptoms.
Timepoint [2] 269364 0
Baseline - The beginning of treatment; post-treatment - at the conclusion of treatment; 6 week follow-up - 6 weeks following the conclusion of treatment; 6 month follow-up - 6 months following the conclusion of treatment and 12 month follow-up - 12 months following the conclusion of treatment.
Primary outcome [3] 269365 0
PET and MRI results measuring hippocampal volumes.
Timepoint [3] 269365 0
Pre-treatment - within the 6 week period prior to treatment beginning and Post-treatment - at the conclusion of treatment.
Secondary outcome [1] 279456 0
Subjective Units of Distress - used as a monitoring tool throughout the treatment period.
Timepoint [1] 279456 0
Assessed at the end of each EMDR treatment session.
Secondary outcome [2] 279457 0
Mean scores on the Impact of Events Scale (IES) = 15 item self-report inventory which reflects DSM-IV criteria for PTSD and levels of distress.
Timepoint [2] 279457 0
Used at the beginning of each treatment session when a new distressing memory is being targeted; and at the end of each treatment session.
Secondary outcome [3] 287557 0
Qualitative individual interviews - questions specific to the participants experience of therapy, daily functioning and quality of life. Themes will be extracted from the transcribed interviews and analyzed using content analysis. Triangulation of data will include comparisons of experience of therapy and symptom reduction results and quality of life changes will be triangulated with the WHOQOL-BREF results.
Timepoint [3] 287557 0
Post-treatment; 6 week follow-up; 6 month follow-up and 12 month follow-up.

Eligibility
Key inclusion criteria
Currently diagnosable with PTSD (via assessment interview and CAPS form 2); willing to engage in psychological treatment; consenting to neuroimaging and audio-taped interviews.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current drug or alcohol dependence; diabetes; currently pregnant or breast feeding; past history of psychotic illness; previously diagnosed organic brain disorder; evidence of diagnosable cluster B Personality Disorder (via SCID II); currently on Psychotropic based medications; unable to cope with confined spaces or needles; any metal implants.

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)
Participants will be contacted off the wait-list of the Posttraumatic Stress Unit at Fremantle Hospital and the Murdoch University Psychology Clinic. A screening telephone call will assess whether the participant meets criteria for the study and is willing to attend an assessment interview to assess possible admission. The PTSD checklist, SCID II personality questionnaire and Dissociative Experience scale is completed to assess admissibility. Following an assessment interview (using the CAPS form 2 to assess PTSD criteria) and signed consent, participants complete pre-treatment inventory and MRI / PET scans. Following a six week wait, where participants act as their own control group, participants attend their initial intervention appointment; prior to entering the therapy room the therapist contacts the primary supervisor who informs them of the treatment type, randomly allocated through computer software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software will be used to randomly allocate participants to 1 of 2 treatment groups (EMDR or exposure therapy)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A comparative outcomes study; the between subjects design will compare 2 treatment groups; a within subjects design will compare each participant over 5 data collection points. Each participant will act as their own control.

This study will be a mixed methods design using both quantitative and qualitative data. Triangulation of quantitative and qualitative data will be used where possible. Content analysis will be used to analyze the qualitative data.

The time frame will allow a longitudinal analysis to compare treatment efficacy, participants perceptions of the treatment experience, quality of life and daily functioning changes over time.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269597 0
University
Name [1] 269597 0
School of Psychiatry and Clinical Neurosciences University of WA
Country [1] 269597 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
Murdoch University
South Street
Murdoch WA 6164
Country
Australia
Secondary sponsor category [1] 266631 0
University
Name [1] 266631 0
University of WA
Address [1] 266631 0
University of WA
35 Stirling Highway
CRAWLEY WA 6009
Country [1] 266631 0
Australia
Other collaborator category [1] 252173 0
Hospital
Name [1] 252173 0
Fremantle Hospital
Address [1] 252173 0
Alma Street
Fremantle WA 6160
Country [1] 252173 0
Australia
Other collaborator category [2] 252174 0
Hospital
Name [2] 252174 0
Sir Charles Gairdner Hospital
Address [2] 252174 0
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS WA 6009
Country [2] 252174 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269549 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 269549 0
Murdoch University
South Street
MURDOCH WA 6164
Ethics committee country [1] 269549 0
Australia
Date submitted for ethics approval [1] 269549 0
02/08/2011
Approval date [1] 269549 0
Ethics approval number [1] 269549 0
Ethics committee name [2] 269550 0
South Metropolitan Area Health Services Human Research Ethics Commitee
Ethics committee address [2] 269550 0
Alma Street
Fremantle WA 6160
Ethics committee country [2] 269550 0
Australia
Date submitted for ethics approval [2] 269550 0
01/07/2011
Approval date [2] 269550 0
Ethics approval number [2] 269550 0

Summary
Brief summary
Eye Movement Desensitisation and Reprogramming (EMDR) and exposure therapy are well established first line psychological treatments for Post-Traumatic Stress Disorder (PTSD)(Boudewyns et al., 1993; Boudewyns & Hyer, 1996; Edmond & Rubin, 2004; Lee et al., 2002; Montgomery & Ayllon, 1994; Power et al., 2002; Vaughan et al., 1994; Van Etten & Taylor, 1998). There have been few studies to date exploring changes in brain functioning following treatment in EMDR, which has left the underlying question of 'what is the mechanism by which the two therapies acheive their therapeutic effects' unresolved. Evidence as to what neurological changes occur as a result of treatment may help vindicate the efficacy of treatment modalities and aid understanding of treatment function. Positron Emission Tomography (PET) scanning enables research into changes in activation of different parts of the brain by measuring regional cerebral perfusion (blood flow), providing insight into this question by measuring brain activity. Magnetic Resonance Imaging (MRI) will enable accurate interpretation of the PET/CT scans and will aim to replicate or refute findings from a recent study that suggests effective treatment of PTSD is associated with an increase in hippocampal volume (Bossini et al., 2011). This project aims to also explore the therapeutic efficacy of EMDR and exposure therapy (in terms of symptom reduction), and the significance of the participant's experience of therapy; the impact of this experience on therapeutic efficacy and on the participant's quality of life and levels of functioning. Although there is an abundance of data evaluating the effectiveness of EMDR and prolonged exposure therapy in relation to symptom reduction (see refrences above), there are very few studies investigating participant's experience of therapy and the significance of this experience in their recovery both short and longer term; and only three major qualitative studies published on EMDR (Di Giorgio, Arnkoff, Glass, Lyhus & Walter, 2004; Edmond, Sloan & McCarty, 2004 and Ricci, Clayton and Shapiro, 2006). It was reported that due to the unusual nature of EMDR with the eye movements, exploration of participant's experiences of treatment was relevant, furthermore qualitative methods were felt to be the logical approach to gaining insight into these questions (Edmond, Sloan & McCarty, 2004).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32972 0
Address 32972 0
Country 32972 0
Phone 32972 0
Fax 32972 0
Email 32972 0
Contact person for public queries
Name 16219 0
Dr Chris Lee
Address 16219 0
Murdoch University
School of Psychology, Division of Health Sciences
South Street
MURDOCH WA 6164
Country 16219 0
Australia
Phone 16219 0
+61 8 93606828
Fax 16219 0
Email 16219 0
[email protected]
Contact person for scientific queries
Name 7147 0
Tracy McGuire
Address 7147 0
Murdoch University
School of Psychology, Division of Health Sciences
South Street
MURDOCH WA 6164
Country 7147 0
Australia
Phone 7147 0
+61 8 93606000
Fax 7147 0
Email 7147 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

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