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Trial registered on ANZCTR


Registration number
ACTRN12614000750684
Ethics application status
Approved
Date submitted
6/05/2014
Date registered
16/07/2014
Date last updated
5/02/2020
Date data sharing statement initially provided
5/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of Childhood Trauma: What Works Best in Reducing Trauma Symptoms for People Who Experienced a Traumatic Event in Childhood
Scientific title
International multi-centre RCT comparing the effectiveness of Imagery Rescripting and Eye Movement Desensitisation and Reprocessing as treatment for adults with Post-Traumatic Stress Disorder (PTSD) related to childhood trauma in reducing severity of PTSD symptoms and improving quality of life
Secondary ID [1] 284424 0
Nil
Universal Trial Number (UTN)
Trial acronym
IREM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-Traumatic Stress Disorder 291626 0
Condition category
Condition code
Mental Health 292005 292005 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparing the effectiveness of Imagery Rescripting (ImRs) and Eye Movement Desensitization and Reprocessing (EMDR) as treatment of childhood-trauma related PTSD in adults
ImRs: ImRs is a technique where an individual imagines a different course of the trauma events that helps to satisfy the needs of the person. This in turn leads to a change in the meaning of the events. ImRs is considered especially suited for events of an interpersonal nature where an individuals trust of others was violated, where there is an inappropriate degree of level responsibility for the event, and where core needs of dependency and safety were threatened.
EMDR: A psychotherapeutic treatment approach which uses a sequence of eye movements to facilitate emotional-cognitive processing of disturbing experiences. EMDR asks individuals to recall their trauma experience into their minds while at the same time tracking the back and forth movements of the therapist's finger. The effect of this treatment process is it helps to alleviate lingering effects of the trauma, allowing the individual to reprocess the traumatic experience, and to develop more adaptive coping skills.
The research will follow the treatment protocol for each of these treatments. Random allocation using random number tables controlled by central researcher in Holland. Participants will receive a maximum of 12, 90 minute sessions twice a week in either ImRs or EMDR. Individual treatment sessions will be with a registered psychologist or psychiatrist.
Intervention code [1] 289651 0
Treatment: Other
Comparator / control treatment
An estimated natural wait list of 6 weeks for treatment. At the conclusion of the wait time each participant will be offered ImRs or EMDR.
Control group
Active

Outcomes
Primary outcome [1] 291896 0
Change in severity of PTSD symptoms as measured by the Clinician Assisted PTSD Scale (CAPS)
Timepoint [1] 291896 0
Change in PTSD symptom severity shortly after the intervention phase (assessed at 8-week post treatment follow up), compared to severity of PTSD symptoms at the pre-treatment phase.
Secondary outcome [1] 307761 0
Impact of Events Scale – Revised (IES-R)
Timepoint [1] 307761 0
IES-R at every treatment session (x 12 sessions) as well as baseline, pre-treatment, after treatment, 8 weeks after treatment, and 1-year follow up (1-year after pre-treatment assessment). IES-R from session 7 will be used as mid-treatment assessment.
Secondary outcome [2] 309237 0
Beck Depression Inventory (BDI-II)
Timepoint [2] 309237 0
Baseline, pre-treatment, after treatment, 8 weeks after treatment, and 1-year follow up (1-year after pre-treatment assessment).
Secondary outcome [3] 309238 0
Post-Traumatic Cognitions Inventory (PTCI)
Timepoint [3] 309238 0
Baseline, pre-treatment, mid treatment, after treatment, 8 weeks after treatment, and 1-year follow up (1-year after pre-treatment assessment).
Secondary outcome [4] 309239 0
Trauma-Related Guilt Inventory (TRGI)
Timepoint [4] 309239 0
Baseline, pre-treatment, mid treatment, after treatment, 8 weeks after treatment, and 1-year follow up (1-year after pre-treatment assessment).
Secondary outcome [5] 309240 0
Trauma-Related Shame Inventory (TRSI)
Timepoint [5] 309240 0
Baseline, pre-treatment, mid treatment, after treatment, 8 weeks after treatment, and 1-year follow up (1-year after pre-treatment assessment).
Secondary outcome [6] 309241 0
Anger: Hostility scale from the Symptom Checklist-90-R (SCL-90-R)
Timepoint [6] 309241 0
Baseline, pre-treatment, mid treatment, after treatment, 8 weeks after treatment, and 1-year follow up (1-year after pre-treatment assessment).
Secondary outcome [7] 309242 0
WHO Disability Assessment Schedule 2.0 (WHODAS)
Timepoint [7] 309242 0
Baseline, pre-treatment, after treatment, 8 weeks after treatment, and 1-year follow up (1-year after pre-treatment assessment).
Secondary outcome [8] 309243 0
Vividness of memory (Imagery Interview), rated on a scale of 0-100
Timepoint [8] 309243 0
Baseline, pre-treatment, mid treatment, after treatment, 8 weeks after treatment, and 1-year follow up (1-year after pre-treatment assessment).
Secondary outcome [9] 309244 0
Level of distress of memory (Imagery Interview), rated on a scale of 0-100
Timepoint [9] 309244 0
Baseline, pre-treatment, mid treatment, after treatment, 8 weeks after treatment, and 1-year follow up (1-year after pre-treatment assessment).
Secondary outcome [10] 309245 0
Encapsulated belief of memory (Imagery Interview), rated on a scale of 0-100 for how true this belief is
Timepoint [10] 309245 0
Baseline, pre-treatment, mid treatment, after treatment, 8 weeks after treatment, and 1-year follow up (1-year after pre-treatment assessment).
Secondary outcome [11] 309246 0
To explore if a memory of a single trauma event is more specific and consistent than memories of repeated traumas - participants to write an account of an index trauma or multiple traumas that constitute the index trauma pre and post treatment. They will also complete a control task where they are asked to give an account of a single or repeated event i.e. birthday, that they have the clearest memory of.
Timepoint [11] 309246 0
Will be incorporated into the start of treatment and post treatment assessments, approximately 30mins
Secondary outcome [12] 309247 0
Qualitative Interview of treatment experience, approximately 2 hours
Timepoint [12] 309247 0
Conducted after 8-week post treatment assessment
Secondary outcome [13] 327481 0
Self-Expression and Control Scale (SECS)
Updated June 2016 to assess other symptoms associated with PTSD from childhood experiences.
Timepoint [13] 327481 0
Baseline, pre-treatment, mid treatment, after treatment, 8 weeks after treatment, and 1-year follow up (1-year after pre-treatment assessment).
Secondary outcome [14] 327482 0
Dissociative Experiences Scale-Taxon (DES-T)
Updated June 2016 to assess other symptoms associated with PTSD from childhood experiences.
Timepoint [14] 327482 0
Baseline, pre-treatment, mid treatment, after treatment, 8 weeks after treatment, and 1-year follow up (1-year after pre-treatment assessment).
Secondary outcome [15] 327483 0
Remoralization Questionnaire (RQ)
Updated June 2016 to assess other issues related to treatment and improvements in wellbeing.
Timepoint [15] 327483 0
Baseline, pre-treatment, after treatment, 8 weeks after treatment, and 1-year follow up (1-year after pre-treatment assessment).
Secondary outcome [16] 327484 0
Happiness question (HQ)
Updated June 2016 to assess other issues related to treatment and improvements in wellbeing.
Timepoint [16] 327484 0
Baseline, pre-treatment, after treatment, 8 weeks after treatment, and 1-year follow up (1-year after pre-treatment assessment).
Secondary outcome [17] 327485 0
Schema Mode Inventory (SMI)
Updated June 2016 to assess other issues related to treatment efficacy.
Timepoint [17] 327485 0
Start of treatment, after treatment, 8 weeks after treatment.
Secondary outcome [18] 327486 0
Medication Use
This will be assessed by asking individuals at each assessment and treatment session what medication they are taking for psychological complaints and if there have been any changes.
It was noticed that this was missing from original ANZCTR registration, however was in the original protocol.
Timepoint [18] 327486 0
Every treatment session (x 12) and at each assessment: baseline, pre-treatment, after treatment, 8 weeks after treatment and 1 year post treatment (1-year after pre-treatment assessment). Mid-treatment medication use will be assessed at session 7.

Eligibility
Key inclusion criteria
DSM-IV diagnosis of PTSD, as assessed with the SCID-II or MINI
PTSD as main complaint
PTSD diagnosis lasting for 3 months or more
Trauma that occurred prior to the age of 16 years old and participant agrees that this is the main focus of treatment
If recent trauma - happened more than 6 months ago
Aged between 18 and 70 years old
Able to understand, read, and write country of participation language (Dutch, German or English)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute PTSD
DSM-IV diagnosed alcohol or drug dependence
Benzodiazepine use (participant can participate if they stop benzodiazepine and they have been abstinent for at least 2 weeks)
Comorbid psychotic disorder
DSM-IV Bipolar disorder, type 1
Acute suicide risk
IQ of 80 or less
Scheduled to begin another form of PTSD treatment
PTSD focused treatment within the past 3 months
Participants should not start/continue any form of psychological therapy or medication during the screening, treatment, and waitlist stage (up to 8 weeks post-treatment assessment)
Changes in medication within last 3 months
Not able to plan 12 x 90 minutes treatment sessions twice a week within 6-8 weeks

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)
Once a site has identified a potential participant and completed consent. An independent central research assistant will randomize participants to condition after checking all inclusion and exclusion criteria. Due to the nature of the trial blinding of the therapist or participants is not possible.
All assessments will be carried out by a research assistant who is blind to treatment condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to one of the treatment conditions based on block randomization, to guarantee a balance between conditions per site and over time, and stratified for gender, so that gender distribution is controlled per arm per site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed regression analysis taken all available data into account will be used to analyse the data. For diagnostic outcome mixed logistic regression analysis will be used, for skewed distributions mixed gamma regression, for medication use Poisson or negative binomial regression.
With a sample size of N=128 the study is powered at 80% to detect a medium effect size of Cohen’s d = .5 at a two-tailed significance level of .05. To replace early dropouts (estimated 10%) the sample size is increased to N=142. Actual power will be higher because of the use of mixed regression (taking all available data into account) and use of covariates that reduce standard error.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/07/2014
Actual
8/10/2014
Date of last participant enrolment
Anticipated
18/12/2017
Actual
18/06/2018
Date of last data collection
Anticipated
18/12/2018
Actual
7/06/2019
Sample size
Target
142
Accrual to date
Final
155
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 7985 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 5997 0
Netherlands
State/province [1] 5997 0
Maastricht
Country [2] 8196 0
Netherlands
State/province [2] 8196 0
Beverwijk
Country [3] 8197 0
Netherlands
State/province [3] 8197 0
Amsterdam
Country [4] 8198 0
Netherlands
State/province [4] 8198 0
Heerhugowaard
Country [5] 8199 0
Netherlands
State/province [5] 8199 0
Amstelveen
Country [6] 8201 0
Germany
State/province [6] 8201 0
Lubeck

Funding & Sponsors
Funding source category [1] 289075 0
Charities/Societies/Foundations
Name [1] 289075 0
EMDR Research Foundation
Country [1] 289075 0
United States of America
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway
Perth WA 6009
Australia
Country
Australia
Secondary sponsor category [1] 287736 0
Other
Name [1] 287736 0
Sexual Assault Resource Centre
Address [1] 287736 0
374 Bagot Road
Subiaco, Perth
Western Australia
6008
Country [1] 287736 0
Australia
Other collaborator category [1] 277918 0
University
Name [1] 277918 0
Maastricht University
Address [1] 277918 0
Minderbroedersberg 4
6211 LK Maastricht
Country [1] 277918 0
Netherlands
Other collaborator category [2] 277919 0
University
Name [2] 277919 0
University of Lubeck
Address [2] 277919 0
Ratzeburger Allee 160
23538 Lubeck
Country [2] 277919 0
Germany
Other collaborator category [3] 279207 0
University
Name [3] 279207 0
University of Amsterdam
Address [3] 279207 0
Spui 21
1012 WX Amsterdam
The Netherlands
Country [3] 279207 0
Netherlands

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290867 0
Human Research Ethics Committee
Ethics committee address [1] 290867 0
Ethics committee country [1] 290867 0
Australia
Date submitted for ethics approval [1] 290867 0
11/04/2014
Approval date [1] 290867 0
Ethics approval number [1] 290867 0
Ethics committee name [2] 295903 0
Government of Western Australian Department of Health
Ethics committee address [2] 295903 0
Ethics committee country [2] 295903 0
Australia
Date submitted for ethics approval [2] 295903 0
07/06/2015
Approval date [2] 295903 0
07/07/2014
Ethics approval number [2] 295903 0
2014067EW
Ethics committee name [3] 295904 0
Maastricht University
Ethics committee address [3] 295904 0
Ethics committee country [3] 295904 0
Netherlands
Date submitted for ethics approval [3] 295904 0
Approval date [3] 295904 0
13/04/2014
Ethics approval number [3] 295904 0
ECP-136
Ethics committee name [4] 295905 0
University of Lubeck
Ethics committee address [4] 295905 0
Ethics committee country [4] 295905 0
Germany
Date submitted for ethics approval [4] 295905 0
Approval date [4] 295905 0
13/01/2015
Ethics approval number [4] 295905 0
14-274
Ethics committee name [5] 305287 0
University of Western Australia Ethics Office
Ethics committee address [5] 305287 0
Ethics committee country [5] 305287 0
Australia
Date submitted for ethics approval [5] 305287 0
26/02/2017
Approval date [5] 305287 0
08/03/2017
Ethics approval number [5] 305287 0
RA/4/1/8727

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1085 1085 0 0
/AnzctrAttachments/366124-Murdoch Approval Treatment of Childhood Trauma 2014 062.pdf
Attachments [2] 1086 1086 0 0
/AnzctrAttachments/366124-Amendment approval Lee 2014 062.pdf
Attachments [3] 1087 1087 0 0
/AnzctrAttachments/366124-Signed HREC approval letter.pdf
Attachments [4] 1088 1088 0 0
/AnzctrAttachments/366124-Signed RGO approval letter.pdf
Attachments [5] 1089 1089 0 0
/AnzctrAttachments/366124-Lubeck Approval.docx
Attachments [6] 1090 1090 0 0
/AnzctrAttachments/366124-Netherlands Ethics Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 47554 0
Prof Arnoud Arntz
Address 47554 0
University of Amsterdam
Spui 21
1012 WX Amsterdam
The Netherlands
Country 47554 0
Netherlands
Phone 47554 0
+31 (0)20 525 9111
Fax 47554 0
Email 47554 0
[email protected]
Contact person for public queries
Name 47555 0
Christopher Lee
Address 47555 0
University of Western Australia
35 Stirling Highway
Perth WA 6009
Australia
Country 47555 0
Australia
Phone 47555 0
+61 421 131 042
Fax 47555 0
Email 47555 0
[email protected]
Contact person for scientific queries
Name 47556 0
Christopher Lee
Address 47556 0
University of Western Australia
35 Stirling Highway
Perth WA 6009
Australia
Country 47556 0
Australia
Phone 47556 0
+61 421 131 042
Fax 47556 0
Email 47556 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6759Study protocolBoterhoven de Haan KL, Lee CW, Fassbinder E, et al. Imagery rescripting and eye movement desensitisation and reprocessing for treatment of adults with childhood trauma-related post-traumatic stress disorder: IREM study design. BMC Psychiatry. 2017;17(1):165.https://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-017-1330-2  366124-(Uploaded-29-01-2020-16-11-37)-Study-related document.pdf
6760Statistical analysis plan https://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-017-1330-2  366124-(Uploaded-29-01-2020-16-13-14)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImagery rescripting and eye movement desensitisation and reprocessing for treatment of adults with childhood trauma-related post-traumatic stress disorder: IREM study design.2017https://dx.doi.org/10.1186/s12888-017-1330-2
EmbaseImagery rescripting and eye movement desensitisation and reprocessing as treatment for adults with post-traumatic stress disorder from childhood trauma: Randomised clinical trial.2020https://dx.doi.org/10.1192/bjp.2020.158
EmbasePatient and therapist perspectives on treatment for adults with ptsd from childhood trauma.2021https://dx.doi.org/10.3390/jcm10050954
N.B. These documents automatically identified may not have been verified by the study sponsor.