Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000173796
Ethics application status
Approved
Date submitted
8/02/2013
Date registered
12/02/2013
Date last updated
30/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Assisting individuals struggling with grief.
Scientific title
Comparing the efficacy of Eye Movement Desensitization and Reprocessing (EMDR) Therapy and Cognitive Behavioural Therapy (CBT) in the treatment of grief, as measured by the Impact of Events Scale, Inventory of Complicated Grief and a behavioural questionnaire.
Secondary ID [1] 281878 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Grief 288260 0
Condition category
Condition code
Mental Health 288612 288612 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - Eye-Movement Desensitisation Reprocessing (EMDR) Treatment Condition.

Participants will receive seven treatment sessions, conducted on a weekly basis. The duration of all sessions will be 90 minutes each.

The first session will consist of an initial intake interview. The initial intake interview will provide some psychoeducation regarding EMDR and then focus on taking a brief client history. The purpose of the interview is two-fold: assessing the client’s suitability for EMDR and identifying key distressing memories to be focused on during treatment. Participants will be asked to rate the distress aroused by recalling the memory using the Subjective Units of Discomfort Scale (SUDS; Wolpe, 1991). The SUDS is an 11 point scale, whereby a 10 indicates the highest degree of distress and 0 indicated an absence of distress.

Before the conclusion of the intake session, participants will be taught a relaxation exercise, also known as a ‘safe place’ exercise and commonly used in EMDR. This exercise can be taught quite quickly and is used to assist participants in lowering their level of distress and becoming calm. If any participant remains highly distressed (indicated verbally by a SUDS score of 7 or more), an additional deep breathing exercise and repetition of the safe place exercise will be delivered. Both exercises will be taught by the attending psychologist. Participants will be prompted to use these exercises during therapy sessions when they show signs of distress and will be advised they are free to practice them on their own, between sessions as well.

Following the interview, the researchers will score the dissociative experiences scale (DES-II). As EMDR is not considered a suitable treatment in situations where the individual is still experiencing numbness, denial or dissociation, participants who exhibit these tendencies (according to researchers’ judgement) or score above 30 on the dissociative experiences scale (DES-II) will be excluded from the study.

The following six sessions of treatment will follow a scripted protocol for grieving individuals as set out by Luber (2009). To briefly describe one of the key elements of EMDR: desensitization involves the participant simultaneously focusing on a distressing memory and visually tracking the therapist’s finger, which is moved bilaterally in front of the participant’s eye in a precisely prescribed manner. The shifts of focus are continued until the person reports that their distress (as measured by SUDS scale levels of 0, 1 or 2) is reduced. Through this dual attention, as well as the installation of a positive belief afterwards, the distressing memories as well as any associated memories are systematically reprocessed and through exposure the participant is desensitised to the accompanying distress. Participants will be asked to complete the behavioural record each week between sessions for the duration of treatment. As adapted from Luber (2009), sessions two to seven will target the participants’ following areas of grief:
2) Actual events, including the loved one’s suffering or death
3) Intrusive images
4) Nightmare images (assessment measures re-administered following session)
5) Present triggers
6) Issues of personal responsibility, mortality or previous unresolved losses
7) Creating a future template, conclusion (assessment measures re-administered following session)

Arm 2 - Cognitive Behavioural Therapy (CBT) Treatment Condition

Participants will receive seven treatment sessions, conducted on a weekly basis. The duration of all sessions will be 90 minutes each. Each session will be administered one on one with a psychologist.

In short, CBT assists participants in understanding the relationships between their thoughts, feelings and behaviours and teaching them how to identify and change unhelpful thoughts, behaviours and feelings. It requires active participation on the part of the participant, including homework between sessions. Participants will be asked to complete the behavioural record each week between sessions for the duration of treatment. Treatment sessions will be adapted from a protocol set out by Rosner, Pfoh and Kotoucova (2011), covering the following components:

1. Administer measures; relaxation and safe place imagery; psychoeducation handout for homework
2. Psychoeducation on normal and complicated grief; introduction to complicated grief model; identification of dysfunctional thoughts
3. Rumination and guilt; emotions and perceptions
4. Worst moments: confrontation in sensu
5. Worst moments and identifications of “hot spots”; confrontation, cognitive restructuring and acceptance
6. Preparation and dialogical work for “walk to the grave”
7. Memento and future, New Life
Intervention code [1] 286438 0
Treatment: Other
Intervention code [2] 286502 0
Behaviour
Comparator / control treatment
Wait-list control. Once enrolled in the study all participants will be placed on a 7 week wait list wherein they will receive no treatment. At the conclusion of this period, they will be randomly allocated to one of two treatment conditions; EMDR or CBT.
Control group
Active

Outcomes
Primary outcome [1] 288768 0
Inventory of Complicated Grief (Prigerson et al., 1995)
Timepoint [1] 288768 0
Pre-treatment, after 4 treatment sessions, post-treatment and 3 months post-treatment follow-up.
Primary outcome [2] 288769 0
Impact of Events Scale (Horowitz, Wilner & Avarez, 1976)
Timepoint [2] 288769 0
Pre-treatment, after 4 treatment sessions, post-treatment and 3 months post-treatment follow-up.
Primary outcome [3] 288770 0
Behavioural Questionnaire (adapted from Sprang, 2001)
Timepoint [3] 288770 0
Pre-treatment, weekly intervals during the wait-list and treatment periods, 3 month post-treatment follow-up
Secondary outcome [1] 300937 0
Depression Anxiety Stress Scales (Lovibond & Lovibond, 1995)
Timepoint [1] 300937 0
Pre-treatment, after 4 treatment sessions, post-treatment, 3 month post-treatment follow-up
Secondary outcome [2] 300938 0
Quality of Life Scale (Flanagan, 1982)
Timepoint [2] 300938 0
Pre-treatment, after 4 treatment sessions, post-treatment, 3 month post-treatment follow-up

Eligibility
Key inclusion criteria
Participants must be over 18 years of age
Participants must report experiencing grief, relating to the death of somebody important to them.
The death must have occurred more than 6 months prior to enrolment in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Involvement in any legal matters pertaining to the death of the person the participant is grieving for (with the exception of will/estate matters).

Scores above 30 on the Dissociative Experiences Scale (DES-II).

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 randomisation table created by computer software
Masking / blinding
Open (masking not 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
Repeated measures and between measures Analyses of Varianve (ANOVAs) will be used to examine differences in outcomes measures (Impact of Event Scale, Inventory of Complicated Grief, Quality of Life Scale, Depression Anxiety Stress Scales) across time (pre-treatment, mid-treatment, and post-treatment) and condition (control, EMDR treatment and CBT treatment) respectively. Post-hoc comparisons will be conducted to explore any significant differences using paired sample t-tests (two tailed).

Similarly, repeated measures and between measures ANOVAs will be used to examine differences in behavioural outcomes (as measured by Behavioural Questionnaire) across time (each week for seven weeks) and condition (control, EMDR treatment and CBT treatment) respectively. Again, post-hoc comparisons will be conducted to explore any significant different using paired sample t-tests (two tailed).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/04/2013
Actual
15/04/2013
Date of last participant enrolment
Anticipated
27/09/2013
Actual
27/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 286663 0
Self funded/Unfunded
Name [1] 286663 0
N/A
Country [1] 286663 0
Primary sponsor type
University
Name
Murdoch University
Address
South St Murdoch
WA 6150
Country
Australia
Secondary sponsor category [1] 285492 0
None
Name [1] 285492 0
Address [1] 285492 0
Country [1] 285492 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288735 0
Human Research Ethics Committee, Murdoch University
Ethics committee address [1] 288735 0
Ethics committee country [1] 288735 0
Australia
Date submitted for ethics approval [1] 288735 0
15/02/2013
Approval date [1] 288735 0
08/03/2013
Ethics approval number [1] 288735 0
2013/022

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

Contacts
Principal investigator
Name 37530 0
Dr Christopher Lee
Address 37530 0
Room 2.038, Social Science Building, 90 South Street, Murdoch WA 6150
Country 37530 0
Australia
Phone 37530 0
+61 8 93606828
Fax 37530 0
Email 37530 0
[email protected]
Contact person for public queries
Name 37531 0
Prudence Cotter
Address 37531 0
29 Kweda Way, Nollamara WA 6061
Country 37531 0
Australia
Phone 37531 0
+61407992197
Fax 37531 0
Email 37531 0
[email protected]
Contact person for scientific queries
Name 37532 0
Larissa Morozow
Address 37532 0
4/150 Subiaco Rd, Subiaco WA 6008
Country 37532 0
Australia
Phone 37532 0
+61423616854
Fax 37532 0
Email 37532 0
[email protected]

No information has been provided regarding IPD availability


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.

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