Trial Review

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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] 291362 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EMDA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 302345 0
Anxiety 302346 0
Condition category
Condition code
Mental Health 301931 301931 0 0
Depression
Mental Health 301932 301932 0 0
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] 297386 0
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] 301356 0
Diagnosis of mood and/or anxiety disorder as measured by the SCID 5.
Timepoint [1] 301356 0
The SCID 5 was administered pre intervention and 6 weeks after intervention completion only
Primary outcome [2] 301373 0
Depression Anxiety Stress Scale
Timepoint [2] 301373 0
1-4 weeks pre intervention
1-3 weeks post intervention completion
6 weeks post intervention completion
12 weeks post intervention completion
Secondary outcome [1] 332404 0
Impact of Events Scale measuring impact of adverse event
Timepoint [1] 332404 0
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] 332481 0
Health of the Nation Outcomes Scale looking at health related impact of depression and anxiety
Timepoint [2] 332481 0
Pre intervention
Post intervention completion
Secondary outcome [3] 332482 0
Subjective Units of Distress (SUDS) looking at the impact of the adverse event
Timepoint [3] 332482 0
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] 332483 0
Vividness of Mental Imagery looking at the impact of the adverse event
Timepoint [4] 332483 0
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] 334776 0
Rathus Assertiveness Scale. Investigating the individual's assertiveness skills.
Timepoint [5] 334776 0
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?
No
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
45
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 7602 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 15501 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 295833 0
Hospital
Name [1] 295833 0
Hollywood Private Hospital
Country [1] 295833 0
Australia
Funding source category [2] 309961 0
Charities/Societies/Foundations
Name [2] 309961 0
EMDR Association of Australia
Country [2] 309961 0
Australia
Primary sponsor type
University
Name
Murdoch Universtiy
Address
South Street
Murdoch, WA 6150
Country
Australia
Secondary sponsor category [1] 294682 0
Hospital
Name [1] 294682 0
Hollywood Private Hospital
Address [1] 294682 0
Monash Ave
Nedlands, WA 6009
Country [1] 294682 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297115 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 297115 0
Ethics committee country [1] 297115 0
Australia
Date submitted for ethics approval [1] 297115 0
16/03/2017
Approval date [1] 297115 0
02/05/2017
Ethics approval number [1] 297115 0
2017/042
Ethics committee name [2] 297116 0
Hollywood Private Hospital
Ethics committee address [2] 297116 0
Ethics committee country [2] 297116 0
Australia
Date submitted for ethics approval [2] 297116 0
24/03/2017
Approval date [2] 297116 0
Ethics approval number [2] 297116 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73026 0
Ms Sarah Dominguez
Address 73026 0
School of Psychology and Exercise Science
Murdoch University
90 South Street
Murdoch, WA 6150
Country 73026 0
Australia
Phone 73026 0
+61422955340
Fax 73026 0
Email 73026 0
[email protected]
Contact person for public queries
Name 73027 0
Sarah Dominguez
Address 73027 0
School of Psychology and Exercise Science
Murdoch University
90 South Street
Murdoch, WA 6150
Country 73027 0
Australia
Phone 73027 0
+61422955340
Fax 73027 0
Email 73027 0
[email protected]
Contact person for scientific queries
Name 73028 0
Sarah Dominguez
Address 73028 0
School of Psychology and Exercise Science
Murdoch University
90 South Street
Murdoch, WA 6150
Country 73028 0
Australia
Phone 73028 0
+61422955340
Fax 73028 0
Email 73028 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
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
SourceTitleYear of PublicationDOI
EmbaseA randomized controlled trial examining the impact of individual trauma-focused therapy for individuals receiving group treatment for depression.2021https://dx.doi.org/10.1111/papt.12268
N.B. These documents automatically identified may not have been verified by the study sponsor.