ANZCTR - Registration

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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

Date results information 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]

Nil

Universal Trial Number (UTN)

Trial acronym

IREM

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Post-Traumatic Stress Disorder

Condition category

Condition code

Mental Health

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]

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]

Change in severity of PTSD symptoms as measured by the Clinician Assisted PTSD Scale (CAPS)

Timepoint [1]

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]

Impact of Events Scale – Revised (IES-R)

Timepoint [1]

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]

Beck Depression Inventory (BDI-II)

Timepoint [2]

Baseline, pre-treatment, after treatment, 8 weeks after treatment, and 1-year follow up (1-year after pre-treatment assessment).

Secondary outcome [3]

Post-Traumatic Cognitions Inventory (PTCI)

Timepoint [3]

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]

Trauma-Related Guilt Inventory (TRGI)

Timepoint [4]

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]

Trauma-Related Shame Inventory (TRSI)

Timepoint [5]

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]

Anger: Hostility scale from the Symptom Checklist-90-R (SCL-90-R)

Timepoint [6]

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]

WHO Disability Assessment Schedule 2.0 (WHODAS)

Timepoint [7]

Baseline, pre-treatment, after treatment, 8 weeks after treatment, and 1-year follow up (1-year after pre-treatment assessment).

Secondary outcome [8]

Vividness of memory (Imagery Interview), rated on a scale of 0-100

Timepoint [8]

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]

Level of distress of memory (Imagery Interview), rated on a scale of 0-100

Timepoint [9]

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]

Encapsulated belief of memory (Imagery Interview), rated on a scale of 0-100 for how true this belief is

Timepoint [10]

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]

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]

Will be incorporated into the start of treatment and post treatment assessments, approximately 30mins

Secondary outcome [12]

Qualitative Interview of treatment experience, approximately 2 hours

Timepoint [12]

Conducted after 8-week post treatment assessment

Secondary outcome [13]

Self-Expression and Control Scale (SECS)
Updated June 2016 to assess other symptoms associated with PTSD from childhood experiences.

Timepoint [13]

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]

Dissociative Experiences Scale-Taxon (DES-T)
Updated June 2016 to assess other symptoms associated with PTSD from childhood experiences.

Timepoint [14]

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]

Remoralization Questionnaire (RQ)
Updated June 2016 to assess other issues related to treatment and improvements in wellbeing.

Timepoint [15]

Baseline, pre-treatment, after treatment, 8 weeks after treatment, and 1-year follow up (1-year after pre-treatment assessment).

Secondary outcome [16]

Happiness question (HQ)
Updated June 2016 to assess other issues related to treatment and improvements in wellbeing.

Timepoint [16]

Baseline, pre-treatment, after treatment, 8 weeks after treatment, and 1-year follow up (1-year after pre-treatment assessment).

Secondary outcome [17]

Schema Mode Inventory (SMI)
Updated June 2016 to assess other issues related to treatment efficacy.

Timepoint [17]

Start of treatment, after treatment, 8 weeks after treatment.

Secondary outcome [18]

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]

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?

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)

Recruitment postcode(s) [1]

6008 - Subiaco

Recruitment outside Australia

Country [1]

Netherlands

State/province [1]

Maastricht

Country [2]

Netherlands

State/province [2]

Beverwijk

Country [3]

Netherlands

State/province [3]

Amsterdam

Country [4]

Netherlands

State/province [4]

Heerhugowaard

Country [5]

Netherlands

State/province [5]

Amstelveen

Country [6]

Germany

State/province [6]

Lubeck

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

EMDR Research Foundation

Address [1]

401 W. 15th Street, Suite 695
Austin, TX 78701

Country [1]

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]

Other

Name [1]

Sexual Assault Resource Centre

Address [1]

374 Bagot Road
Subiaco, Perth
Western Australia
6008

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

Maastricht University

Address [1]

Minderbroedersberg 4
6211 LK Maastricht

Country [1]

Netherlands

Other collaborator category [2]

University

Name [2]

University of Lubeck

Address [2]

Ratzeburger Allee 160
23538 Lubeck

Country [2]

Germany

Other collaborator category [3]

University

Name [3]

University of Amsterdam

Address [3]

Spui 21
1012 WX Amsterdam
The Netherlands

Country [3]

Netherlands

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee

Ethics committee address [1]

Division of Research and Development
Murdoch University
South Street
Murdoch WA 6160

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/04/2014

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

Government of Western Australian Department of Health

Ethics committee address [2]

Research Ethics and Governance
Women and Newborn Health Service
O Block, KEMH, Subiaco, WA 6008
T: (08) 6458 1667
E: [email protected]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

07/06/2015

Approval date [2]

07/07/2014

Ethics approval number [2]

2014067EW

Ethics committee name [3]

Maastricht University

Ethics committee address [3]

Bezoekadres
Universiteitssingel 40
6229 ER Maastricht

Ethics committee country [3]

Netherlands

Date submitted for ethics approval [3]

Approval date [3]

13/04/2014

Ethics approval number [3]

ECP-136

Ethics committee name [4]

University of Lubeck

Ethics committee address [4]

Ratzeburger Allee 160
23538 Lubeck

Ethics committee country [4]

Germany

Date submitted for ethics approval [4]

Approval date [4]

13/01/2015

Ethics approval number [4]

14-274

Ethics committee name [5]

University of Western Australia Ethics Office

Ethics committee address [5]

The University of Western Australia
M459, 35 Stirling Highway
Crawley WA 6009 Australia

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

26/02/2017

Approval date [5]

08/03/2017

Ethics approval number [5]

RA/4/1/8727

Summary

Brief summary

Comparing two treatment approaches, Imagery Rescripting (ImRs) and Eye Movement Desensitisation and Reprocessing (EMDR), for adults with PTSD related to childhood based trauma. ImRs is where the individual imagines a different ending to the trauma memory, so that the person can change the meaning of the event. EMDR uses a sequence of eye movements to help an individual to reprocess thoughts and feelings associated with trauma experiences.
This purpose of this research is to compare the effectiveness of these two approaches and to test if the element of the treatments that facilitate change is the same for both approaches.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/366124-Murdoch Approval Treatment of Childhood Trauma 2014 062.pdf

Attachments [2]

/AnzctrAttachments/366124-Amendment approval Lee 2014 062.pdf

Attachments [3]

/AnzctrAttachments/366124-Signed HREC approval letter.pdf

Attachments [4]

/AnzctrAttachments/366124-Signed RGO approval letter.pdf

Attachments [5]

/AnzctrAttachments/366124-Lubeck Approval.docx

Attachments [6]

/AnzctrAttachments/366124-Netherlands Ethics Approval.pdf (Ethics approval)

Contacts

Principal investigator

Name

Prof Arnoud Arntz

Address

University of Amsterdam
Spui 21
1012 WX Amsterdam
The Netherlands

Country

Netherlands

Phone

+31 (0)20 525 9111

Fax

[email protected]

Contact person for public queries

Name

Dr Christopher Lee

Address

University of Western Australia
35 Stirling Highway
Perth WA 6009
Australia

Country

Australia

Phone

+61 421 131 042

Fax

[email protected]

Contact person for scientific queries

Name

A/Prof Christopher Lee

Address

University of Western Australia
35 Stirling Highway
Perth WA 6009
Australia

Country

Australia

Phone

+61 421 131 042

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6759	Study protocol	Boterhoven 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
6760	Statistical 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

Source	Title	Year of Publication	DOI
Embase	Imagery rescripting and eye movement desensitisation and reprocessing for treatment of adults with childhood trauma-related post-traumatic stress disorder: IREM study design.	2017	https://dx.doi.org/10.1186/s12888-017-1330-2
Embase	Imagery rescripting and eye movement desensitisation and reprocessing as treatment for adults with post-traumatic stress disorder from childhood trauma: Randomised clinical trial.	2020	https://dx.doi.org/10.1192/bjp.2020.158
Embase	Patient and therapist perspectives on treatment for adults with ptsd from childhood trauma.	2021	https://dx.doi.org/10.3390/jcm10050954

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically