ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000693325

Ethics application status

Approved

Date submitted

13/03/2017

Date registered

15/05/2017

Date last updated

20/10/2021

Date data sharing statement initially provided

20/10/2021

Date results provided

20/10/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Investigating the impact of treating adverse memories on individuals with depression and anxiety

Scientific title

The effect of individual Eye Movement Desensitisation and Reprocessing (EMDR) sessions on symptom change for people with depression and/or anxiety receiving Cognitive Behavioural Therapy (CBT).

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

EMDA

Linked study record

Health condition

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

Depression

Anxiety

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

All participants will receive a ten session group evidence based CBT psychological intervention for 75 minutes over two weeks. In addition three treatment conditions will be randomly assigned. The group work is undertaken in the mornings over this time and the individual treatment sessions would take place over the two weeks of the group program in the afternoon.

Arm 1. Three individual 90 minute sessions utilising eye movement desensitisation and reprocessing (EMDR). EMDR is an evidence based psychological intervention for posttraumatic stress disorder. EMDR asks the individual to focus on a distressing past event while engaging in another task (usually bilateral eye movements). This dual processing enhances the individual's capacity to process the memory, resulting in decreased distress and more distance from the target memory. The initial EMDR session would entail giving information on the intervention, establishing a safe place via imagery and identifying memories that would be targeting in subsequent session. The second and third session would involve processing identified memories as per EMDR procedure.

Arm 2. Three individual 90 minute sessions utilising Cognitive Behavioural Therapy (CBT). CBT is an evidence based practice that is widely used in the treatment of psychological disorders. CBT supports an individual to identify and alter unhelpful thoughts, feelings and behaviours. Sessions would focus on assertive communication, looking at the individuals beliefs around assertiveness and supporting them to practice more assertive behaviour

Arm 3. Treatment as usual/ Delayed treatment. Participation in the group program with no additional individual sessions. however will be offered individual sessions following their six week follow up assessment.

All treatment sessions will be delivered by the researchers who are in their second year of their clinical masters and who are trained in both interventions.

The first cohort (2-4 participants) to be administered the assessments and intervention are treated as a trial and as such their data will not be included in the data analysis.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The CBT group will be utilised as the active control group.
Treatment as usual/delayed treatment will also be utilised as a no treatment group.

Control group

Active

Outcomes

Primary outcome [1]

Diagnosis of mood and/or anxiety disorder as measured by the SCID 5.

Timepoint [1]

The SCID 5 was administered pre intervention and 6 weeks after intervention completion only

Primary outcome [2]

Depression Anxiety Stress Scale

Timepoint [2]

1-4 weeks pre intervention
1-3 weeks post intervention completion
6 weeks post intervention completion
12 weeks post intervention completion

Secondary outcome [1]

Impact of Events Scale measuring impact of adverse event

Timepoint [1]

Utilised with the EMDR group only
In first intervention session
1-3 weeks post intervention completion
6 weeks post intervention completion
12 weeks post intervention completion

Secondary outcome [2]

Health of the Nation Outcomes Scale looking at health related impact of depression and anxiety

Timepoint [2]

Pre intervention
Post intervention completion

Secondary outcome [3]

Subjective Units of Distress (SUDS) looking at the impact of the adverse event

Timepoint [3]

Utilised with the EMDR group only
Assessed in each individual therapy session.
1-3 weeks post intervention
6 weeks post intervention completion
12 weeks post intervention completion

Secondary outcome [4]

Vividness of Mental Imagery looking at the impact of the adverse event

Timepoint [4]

Utilised with the EMDR group only
Assessed in each individual therapy session.
1-3 weeks post intervention completion
6 weeks post intervention completion
12 weeks post intervention completion

Secondary outcome [5]

Rathus Assertiveness Scale. Investigating the individual's assertiveness skills.

Timepoint [5]

Utilised with the CBT group only
Assessed in each individual therapy session.
1-3 weeks post intervention completion
6 weeks post intervention completion
12 weeks post intervention completion

Eligibility

Key inclusion criteria

Participation in the Hollywood Clinic Mood and Anxiety Management Program.

Minimum age

18 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients who have been assessed to be at a high risk of suicide.

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)

Central randomisation using computer software

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a computer program

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

The first cohort (2-4 participants) to be administered the assessments and intervention are treated as a trial and as such their data will not be included in the data analysis.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

This is a planned sample size limited by the time schedule and group program that the participants are being recruited from. Despite these limitations, it was initially estimated that a sample size of 20-30 could be obtained, however this was revised in July 2017 and increased to 45 participants.. Although a larger sample size is desirable, studies looking at similar variables have reached significant conclusions with sample sizes from 16 to 21 participants (Hase et al., 2015; Hoffman et al., 2014 Schubert et al., 2016).

A Repeated Measures Analysis of Variance (ANOVA) will be used to investigate effects of treatment (EMDR; CBT and TAU) over time (pre-treatment, post-treatment and follow-up).

On completion of the study we decided to run an analysis on all participants and a sub sample of those who met MDE criteria on intake.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

20/05/2017

Actual

15/06/2017

Date of last participant enrolment

Anticipated

Actual

15/10/2018

Date of last data collection

Anticipated

Actual

15/01/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Hollywood Private Hospital - Nedlands

Recruitment postcode(s) [1]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Hollywood Private Hospital

Address [1]

Monash Ave
Nedlands WA. 2009

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

EMDR Association of Australia

Address [2]

21 Scott Street,
South Fremantle WA 6162.
This is also the address of the organisation and is already publicly available

Country [2]

Australia

Primary sponsor type

University

Name

Murdoch Universtiy

Address

South Street
Murdoch, WA 6150

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Hollywood Private Hospital

Address [1]

Monash Ave
Nedlands, WA 6009

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Murdoch University Human Research Ethics Committee

Ethics committee address [1]

Murdoch University
90 South Street,
Murdoch.  WA 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/03/2017

Approval date [1]

02/05/2017

Ethics approval number [1]

2017/042

Ethics committee name [2]

Hollywood Private Hospital

Ethics committee address [2]

Monash Avenue
Nedlands WA 6009

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

24/03/2017

Approval date [2]

Ethics approval number [2]

Summary

Brief summary

Research has repeatedly identified that stressful life events and childhood adversities are associated with increased risk of psychological disorders.  For example, individuals who were maltreated as children are  approximately twice as likely to develop recurrent or persistent depression than individuals who had not experienced maltreatment.  Additional studies have also found a high association between childhood maltreatment and anxiety disorders.

Eye Movement Desensitisation and Reprocessing (EMDR) is an evidence based psychological intervention utilised to treat symptoms of post traumatic stress disorder (PTSD).  EMDR also has empirical support for treating comorbid symptoms of depression and anxiety in individuals with PTSD. By targeting early adverse experiences, therapists can work with clients, with a primary diagnosis other than post-traumatic stress disorder, to significantly improve treatment outcomes.   Exploratory studies examining the impact of EMDR for clients experiencing depression and/or anxiety, indicate emerging evidence regarding the utility of these methods in improving treatment outcomes and decreasing relapse rates. However, studies in this area are scarce and the majority of studies identified have limitations including small sample sizes and lacking other key aspects of experimental design.  

The aim of this study is to build on the evidence to improve treatment outcomes for people with depression and anxiety.  All participants will be partaking in a two week, outpatient group CBT based intervention for depression and anxiety. Participants will be randomly allocated to one of three treatment conditions, receiving either three 90 minute individual EMDR sessions; three 90 minute individual CBT sessions or treatment as usual (TAU)/delayed treatment.  Psychological symptoms will be measured prior to treatment, at the completion of treatment, and at six and twelve week follow up sessions.  The TAU group will be offered individual therapy following their six-week assessment.
It is proposed that the addition of a EMDR targeting adverse childhood experiences will increase positive outcomes of treatment post treatment and at follow up.

Trial website

Trial related presentations / publications

Dominguez, S., Drummond, P., Gouldthorp, B., Janson, D., & Lee, C. W. (2020). A randomised controlled trial examining the impact of individual trauma-focused therapy for individuals receiving group treatment for depression. Psychology and Psychotherapy: Theory, Research and Practice.

Public notes

Contacts

Principal investigator

Name

Ms Sarah Dominguez

Address

School of Psychology and Exercise Science
Murdoch University
90 South Street
Murdoch, WA 6150

Country

Australia

Phone

+61422955340

Fax

sarah.k.dominguez@gmail.com

Contact person for public queries

Name

Sarah Dominguez

Address

School of Psychology and Exercise Science
Murdoch University
90 South Street
Murdoch, WA 6150

Country

Australia

Phone

+61422955340

Fax

sarah.k.dominguez@gmail.com

Contact person for scientific queries

Name

Sarah Dominguez

Address

School of Psychology and Exercise Science
Murdoch University
90 South Street
Murdoch, WA 6150

Country

Australia

Phone

+61422955340

Fax

sarah.k.dominguez@gmail.com

Data sharing statement

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

No/undecided IPD sharing reason/comment

To ensure anonymity and confidentiality is maintained individual data will not be shared.

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

Source	Title	Year of Publication	DOI
Embase	A randomized controlled trial examining the impact of individual trauma-focused therapy for individuals receiving group treatment for depression.	2021	https://dx.doi.org/10.1111/papt.12268

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

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