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Trial registered on ANZCTR


Registration number
ACTRN12618000683235
Ethics application status
Approved
Date submitted
16/04/2018
Date registered
26/04/2018
Date last updated
14/06/2019
Date data sharing statement initially provided
14/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Eye Movement Desensitisation and Re-programming (EMDR) therapy for the treatment of posttraumatic stress disorder in people with serious mental illness within forensic and rehabilitation services
Scientific title
Single blind randomised controlled trial comparing the efficacy and safety of Eye Movement Desensitisation and Re-programming therapy versus waitlist for the treatment of posttraumatic stress disorder in people with serious mental illness within forensic and rehabilitation services
Secondary ID [1] 294277 0
None
Universal Trial Number (UTN)
U1111-1210-5143
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 306968 0
Condition category
Condition code
Mental Health 306061 306061 0 0
Schizophrenia
Mental Health 306062 306062 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eye Movement Desensitization and Reprocessing (EMDR) is a psychotherapeutic treatment based on an information processing model of trauma to alleviate the distress associated with traumatic memories. During EMDR the client is instructed to attend to the traumatic event in brief doses while simultaneously tracking the therapist’s fingers with their eyes. The bilateral brain stimulation is thought to activate the brain’s information processing pathways, enabling more adaptive associations to be made. Over time this leads to processing of traumatic events into long-term memory. As a result, people are able to recall the traumatic event/s but are no longer so distressed by them; affective distress is relieved, negative beliefs are reformulated, and physiological arousal is reduced.

The therapy will constitute 9 sessions of therapy with weekly sessions of one hour in length, the first session being a joint case conceptualisation agreed by therapist and participant, the next 8 sessions being active therapy.

EMDR is well established as an effective treatment with a strong evidence base. EMDR and Trauma focused CBT are the two therapies recommended by the NICE Guidelines and the World Health Organisation for the treatment of PTSD, with a course of eight to 12 individual sessions being the most common forms of treatment. EMDR’s use in the treatment of PTSD use is supported by a wide range of practice guidelines and meta-analyses.

We will monitor our participant's views on acceptability of the intervention using the Treatment Acceptability/Adherence Scale. We will also record attendance on checklists.

EMDR practitioners will attend monthly supervision with senior experts who will assess fidelity to the intervention.
Intervention code [1] 300570 0
Treatment: Other
Intervention code [2] 300678 0
Rehabilitation
Comparator / control treatment
Participants randomised to the control group will be put on a waitlist. After outcome measure collection at 6 months they will be offered EMDR.

Participants in both conditions—EMDR and waiting list—will receive TAU, consisting of antipsychotic medication, and multidisciplinary treatment by psychiatrists, psychologists, social workers, occupational therapists and input from keyworkers, spiritual and cultural workers. Psychotic illness are treated by a multidisciplinary approach in accordance with the Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for the management of schizophrenia and related disorders.



Control group
Active

Outcomes
Primary outcome [1] 305092 0
The Clinician Administered PTSD Scale (CAPS) will be used to measure change between PTSD symptoms from prior to randomisation to immediately post treatment and at 6 month follow up. The CAPS assesses the presence or absence of PTSD diagnosis and the frequency and intensity of the clinician's rated PTSD symptoms.

The primary outcome is mean CAPS score.
Timepoint [1] 305092 0
1. Baseline
2. At week ten (i.e after completion of EMDR in the active treatment group) (Primary timepoint)
2. At 6 months follow up
Primary outcome [2] 305231 0
The Adverse Events Questionnaire is a self-designed checklist that will establish treatment safety. In ten questions the patient is asked to report any experiences they have had over the last two months of self-harm, suicide attempt, deliberately hurting another person, excessive use of alcohol, excessive use of drugs, having needed help because of a crisis, moving back to a higher level of security within the services or any reoffending.
Timepoint [2] 305231 0
1. Baseline
2. At week ten (i.e after completion of EMDR in the active treatment group) (Primary timepoint)
2. At 6 months follow up
Primary outcome [3] 305642 0
PTSD symtpomatology as measured by the Trauma Symptom Inventory
Timepoint [3] 305642 0
1. Baseline
2. At week ten (i.e after completion of EMDR in the active treatment group) (Primary timepoint)
2. At 6 months follow up
Secondary outcome [1] 344138 0
Self reported PTSD as assessed by the Posttraumatic Stress Symptom Scale Self-Report (PSS-SR), which assesses self-reported frequency of PTSD symptoms.
Timepoint [1] 344138 0
1. Baseline
2. At week ten (i.e after completion of EMDR in the active treatment group)
2. At 6 months follow up
Secondary outcome [2] 345652 0
Mean depression score as measured by BDI-II
Timepoint [2] 345652 0
1. Baseline
2. At week ten (i.e after completion of EMDR in the active treatment group)
2. At 6 months follow up
Secondary outcome [3] 345653 0
Psychotic symptoms as measured median scores on the the PSYRATS delusions and hallucinations subscales (composite secondary outcome).
Timepoint [3] 345653 0
1. Baseline
2. At week ten (i.e after completion of EMDR in the active treatment group)
2. At 6 months follow up
Secondary outcome [4] 345654 0
Level of social functioning as measured by the Social Functioning Scale
Timepoint [4] 345654 0
11. Baseline
2. At week ten (i.e after completion of EMDR in the active treatment group)
2. At 6 months follow up
Secondary outcome [5] 345655 0
Levels of disability as measured by the WHODAS II
Timepoint [5] 345655 0
1. Baseline
2. At week ten (i.e after completion of EMDR in the active treatment group) (
2. At 6 months follow up
Secondary outcome [6] 345656 0
Self esteem score as measured by the Rosenberg self esteem scale
Timepoint [6] 345656 0
1. Baseline
2. At week ten (i.e after completion of EMDR in the active treatment group)
2. At 6 months follow up
Secondary outcome [7] 345657 0
Traumatic sequelae as measured by the trauma symptom inventory.
Timepoint [7] 345657 0
1. Baseline
2. At week ten (i.e after completion of EMDR in the active treatment group)
2. At 6 months follow up

Eligibility
Key inclusion criteria
a) age between 18 and 65 years;
b) a lifetime history of a psychotic disorder or a mood disorder with psychotic features
c) meeting diagnostic criteria for PTSD (Clinician Administered PTSD Scale (CAPS)).
d) current patient of the forensic and rehabilitation mental health services
e) competent to provide informed consent
f) likely to remain in the area for the 6 month trial duration (i.e if a prisoner, release date > 6 months away; if a special patient, special patient discharge > 6 months away)
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) high suicidality, operationalised as the combination of having a high suicidality score on the M.I.N.I. with the last suicide attempt within the past six months and a depression score on the Beck Depression Inventory-II (BDI-II) of 35 or higher;
b) mental state considered by the treating psychiatrist as too unstable to participate in the trial (participants may have chronic low grade symptoms, but cannot be acutely psychotic)
c) inability to speak English

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)
The randomisation process will be managed centrally and independently by the Capital and Coast District Health Board research office. Once participants have been recruited the central office will be supplied with the participant details and undertake computerized randomisation, with the allocation sequence concealed from those assigning participants to intervention groups, until the moment of assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation process will be managed centrally and independently by the District Randomisation methods will involve an independent computerized process with with a 1:1 allocation using random block sizes.

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
The power is based on information from investigations in related, but not identical, clinical groups to those planned to participate in this trial.

In a RCT investigating EMDR in mental health outpatients with psychosis and PTSD the post-treatment CAPS score for EMDR was 40.3, n=55 compared with 56.5, n=47 for waitlist, a difference of 16 points. The baseline mean (SD) CAPS score for these trial participants was 69.9 (16.2).

A 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change, and so we feel that a difference of 16 points on the CAPS in clinically significant, and is likely to represent the difference between severe and moderate symptoms, or moderate and mild (subthreshold) symptoms.

To detect a change of 16 points with an SD of 16 points using a t-test and based on equal proportions of participants randomised to each group with a two-sided type I error rate of 0.05 and power of 0.8 needs 15 participants per arm.

We estimate attrition could be as much as 30% although this is likely to be a conservative estimate as a meta-analysis reports that the drop-out rate for trauma focused interventions is around 18% and our previous research of non-pharmacological interventions in this patient group has found participants to be engaged with low drop-out rates (<10%). A conservative estimate of drop-out is reasonable because the studies in the meta-analysis were over shorter timeframes, and we anticipate some participants may have been discharged, changed address and be lost to follow up at the six month mark. Based on the 30% drop-out rate the trial would need to recruit 23 participants per arm.

An important consideration is that we are uncertain if the SD of the outcome variable will be as previously reported. To this end we will initially plan to recruit 2 x 8 participants in order to estimate the SD as the number of participants gives reasonable precision for this estimation. This will also enable us to determine preliminary efficacy, safety and acceptability data, before moving if this analysis is acceptable to a larger multisite trial (phase III). Key elements that will determine if a larger trial is not feasible is if the SD is much larger than anticipated, if 30% of participants or more report important adverse effects; or if 30% or more of participants do not find the intervention acceptable.

Baseline differences in demographic and clinical characteristics between the EMDR and control group will be analysed using chi-squared test or Fisher's exact tests when one or more expected count is less than five, t tests, and analysis of variance.

Descriptive statistics will provide data summaries.

Continuous variables will be analyzed on an intention-to-treat basis with linear mixed models. Baseline scores will be included as covariates, time as a categorical variable, and treatment condition as a fixed effect. The intercept will be treated as a random effect.

Dichotomous outcomes will be analysed with logistic generalized estimating equation analyses with exchangeable correlation structure.

A biostatistician is part of the research team.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9669 0
New Zealand
State/province [1] 9669 0
Wellington

Funding & Sponsors
Funding source category [1] 298915 0
Government body
Name [1] 298915 0
Capital and Coast District Health Board
Address [1] 298915 0
Riddiford St, Newtown, Wellington 6021
Country [1] 298915 0
New Zealand
Funding source category [2] 303045 0
Charities/Societies/Foundations
Name [2] 303045 0
The EMDR Foundation
Address [2] 303045 0
207 E Ohio St #430, Chicago, IL 60611, USA
Country [2] 303045 0
United States of America
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 298143 0
None
Name [1] 298143 0
Address [1] 298143 0
Country [1] 298143 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299857 0
Health and Disability Ethics Committee
Ethics committee address [1] 299857 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 299857 0
New Zealand
Date submitted for ethics approval [1] 299857 0
15/03/2018
Approval date [1] 299857 0
10/04/2018
Ethics approval number [1] 299857 0
18/CEN/48

Summary
Brief summary
This is a single blind randomised controlled trial to compare Eye Movement Desensitisation and Reprocessing Therapy (EMDR) versus treatment as usual for people with post traumatic stress disorder within a forensic and rehabilitation long stay setting.

Eye Movement Desensitization and Reprocessing (EMDR) is a psychotherapy treatment based on information processing model of trauma (Adaptive Information Processing model) to alleviate the distress associated with traumatic memories.
During EMDR the client is instructed to attend to the traumatic event for brief periods while simultaneously tracking the therapist’s fingers with their eyes or alternating right and left hand taps. The bilateral brain stimulation is thought to activate the brain’s information processing pathways, enabling more adaptive associations to be made. Over time this leads to processing of traumatic events into long-term memory. As a result, people are able to recall the traumatic event/s but are no longer as distressed by them; affective distress is relieved, negative beliefs are reformulated, and physiological arousal is reduced.

EMDR is well established as an effective treatment with a strong evidence base. EMDR and Trauma focused CBT are the two therapies recommended by the NICE Guidelines, and the World Health Organisation for the treatment of PTSD. EMDR’s use in the treatment of PTSD use is supported by a wide range of practice guidelines and meta-analyses. However it has not been assessed in a forensic setting, a population with well established high morbidity from PTSD.

The primary research questions are:
Does outcome data suggest efficacy of EMDR for the treatment of PTSD compared to waitlist in a psychiatric forensic and rehabilitation population with Serious Mental Illness (SMI)?
Does outcome data suggest safety of EMDR for the treatment of PTSD compared to waitlist in a psychiatric forensic and rehabilitation population with SMI?

The secondary research question is:
What are the participant experiences of participants receiving EMDR in this setting?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81786 0
Dr Susanna Every-Palmer
Address 81786 0
C/o Papatuanuku
Ratonga rua-o-porirua,
Capital and Coast District Health Board
PO box 50-233,
Porirua 5240
Country 81786 0
New Zealand
Phone 81786 0
+64 21 76 76 75
Fax 81786 0
Email 81786 0
susanna.every-palmer@ccdhb.org.nz
Contact person for public queries
Name 81787 0
Dr Susanna Every-Palmer
Address 81787 0
C/o Papatuanuku
Ratonga rua-o-porirua,
Capital and Coast District Health Board
PO box 50-233,
Porirua 5240
Country 81787 0
New Zealand
Phone 81787 0
+64 21 76 76 75
Fax 81787 0
Email 81787 0
susanna.every-palmer@ccdhb.org.nz
Contact person for scientific queries
Name 81788 0
Dr Susanna Every-Palmer
Address 81788 0
C/o Papatuanuku
Ratonga rua-o-porirua,
Capital and Coast District Health Board
PO box 50-233,
Porirua 5240
Country 81788 0
New Zealand
Phone 81788 0
+64 21 76 76 75
Fax 81788 0
Email 81788 0
susanna.every-palmer@ccdhb.org.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Clinical study report
Ethical approval
Summary results
No Results