Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000647831p
Ethics application status
Not yet submitted
Date submitted
2/04/2021
Date registered
31/05/2021
Date last updated
31/05/2021
Date data sharing statement initially provided
31/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Case Series Trial on the effect of an Adaptation of Memory Reconsolidation Therapy on disease severity in Adults with Bulimia Nervosa and Posttraumatic Stress Disorder
Scientific title
A Case Series Trial on the effect of an Adaptation of Memory Reconsolidation Therapy on disease severity in Adults with Bulimia Nervosa and Posttraumatic Stress Disorder
Secondary ID [1] 303871 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bulimia Nervosa 321442 0
Posttraumatic Stress Disorder 321443 0
Condition category
Condition code
Mental Health 319203 319203 0 0
Eating disorders
Mental Health 319204 319204 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be conducted at the Queensland University of Technology Psychology and Counselling Clinic. Participants who appear to meet criteria for the study and express interest in participating will be further screened in a 60-minute face-to-face interview with a Master of Clinical Psychology student who will be trained in conducting a structured clinical interview (SCID-5RV) and will be supervised by the Research Project Supervisor, who is an experienced Clinical Psychologist.

The participants will each be monitored over a four-week baseline period. During these weeks, the participants will be asked to complete the Treatment Outcome Package (TOP) Questionnaire as well as report the frequency of binge and purge episodes in the previous week. We anticipate that this will take 10 minutes to complete each week. This four week period is to receive a baseline estimate of functioning only, and is thus not being used as a control.

Treatment will involve 12-16 x 90-minute sessions conducted weekly. The number of sessions required for each participant will be determined by the therapist based upon the progress of the participant. The therapy will be delivered by the Principal Researcher (a post-graduate Clinical Psychology student registered with the Psychology Board of Australia). Following the final treatment session, and at three-month follow-up participants will be asked to complete all the initial battery of questionnaires again.

Treatment Outline.
Phase One: Psychoeducation based upon Metacognitive Therapy (2-3 sessions)
• Psychoeducation around the function of emotions
o This will include an explanation of the metacognitive model where bingeing and purging are considered coping strategies to manage unbearable distress. Some patients may be afraid they will be unable to cope if they no longer binge, purge, or use compensatory behaviours
o It will also involve discussion about the positive function of emotions (including negative emotions), exploration of unhelpful beliefs about emotions and Socratic Questioning to help the participant consider alternative perspectives regarding their unhelpful beliefs about emotions.
o Participants will be trained in detached mindfulness and encouraged to become more mindful of their emotions as part of a behavioural experiment to test the validity of their unhelpful beliefs about emotions.

Phase Two: Memory Reconsolidation (~10-12 treatment sessions)
• A fear hierarchy will be developed by ranking the traumatic events that link to the PTSD according to the level of distress they envisage experience when they recall these events. The therapist and participant will start the Memory Reconsolidation Therapy protocol using memory of the lowest ranked traumatic event and then progress up the fear hierarchy after the successful extinction of the current traumatic memory being addressed.
• The client’s mental state during the week will be reviewed, as a measure of progress. Also, the therapist will be sensitive to the risk of self-harm. If the client has already engaged in an MRT session, any primary or secondary emotions associated with the last fear memory during the week will be explored. If there is still an ongoing primary fear response associated with the last memory, then the therapist may consider redoing MRT on this memory before going up the next step of the hierarchy. If there are ongoing secondary emotions associated with the last fear memory, then part of the session may be spent using cognitive strategies to help the client gain a shift in his/her maladaptive interpretations by considering the trauma from a post-traumatic growth perspective.
a. The client will be asked to recall the traumatic memory on the current step of the fear hierarchy.
a. The client will be encouraged to close her/his eyes to intensify the extinction process (by minimising distractions) if they feel safe to do so.
b. The client will initially be asked to imagine being in a real or an imaginary safe place. The goal is to a) get a baseline of the client’s imagination – to gauge whether their imagery during the exposure is OK compared with baseline, b) relax them to help resistance to recall, c) train them in inducing the relaxation so they can use this to reduce any distress after recall.
c. The client will then be asked to describe the scene of the traumatic memory as clearly as he/she can. This recollection will be kept no longer than 3-5 minutes, as the goal is only to activate the memory and not to start the extinction process.
d. Once the memory is activated, the client will be asked to return to the safe place imagined before the recall.
b. The client will be engaged in a detached mindfulness exercise for approximately 20 minutes.
c. After 20 minutes the client will be asked to close her/his eyes and return to the safe place experienced earlier.
d. The client will then be invited to recall the same traumatic event they recalled 20 minutes prior. The therapist will ask the client to describe the image out loud in the present tense and in first person, as though it were happening now.
e. Questions will be asked, including what the client can see, hear smell, feel and sense in their body. The vividness of each experience will be heighted by asking the client to focus on aspects of the memory and focus on how vivid it was.
f. According to their emotional needs, the client may then change the imagined situation into less aversive mental images. The positive effects of this approach are enhanced if clients play an active role in the new script (i.e., patients imagine themselves enacting the change), compared to a more passive approach where patients imagine third parties (e.g., the therapist) helping in the imagined situation (Arntz, 2012; Siegesleitner et al., 2020).
g. At various times throughout this process, the client will be asked to rate his/her subjective units of distress (SUDS) on a scale of 0 to 10.
h. These steps will be repeated until the client experiences a significant reduction in SUDS – ideally towards 1 or 2 out of 10.
i. Once the client reports a significant reduction in SUDS, then the client will be asked to move his/her attention back to the safe place imagery.
j. The experience of the client will be explored towards the end of the session.
k. Any secondary emotions (e.g. anger, sadness, guilt) that arose from the experience will be explored from a post-traumatic growth perspective (e.g. emotions normalised and validated and then the client encouraged to consider what they have learned from experiencing the trauma).
l. The client will be encouraged to keep calm and relaxed during the next 4-5 hours (i.e., up to 6 hours after the initial recall).

Phase Three: Final Session
a. The clients mental state during the week will be reviewed. This will be used as a measure of progress.
b. Summarise
i. The formulation of the presenting problem and the role of fear memories in the experience of BN and PTSD.
ii. The rationale for exposure therapy and the focus on reducing the primary emotion of fear.
iii. The client’s progress up the fear hierarchy
c. Summarise the client’s current mental state and discuss/negotiate if the client needs any further treatment and what the options are for referrals.
d. Ask the client to report on their understanding of any strategies that they can continue to apply to manage secondary emotions.
e. Ask the client to discuss their experiences with the process of the therapy and what they have learned from the experience.
f. Address any unresolved issues.
g. End the sessions and praise the client for his/her progress and recognise the gains made.
Intervention code [1] 320176 0
Treatment: Other
Intervention code [2] 320437 0
Behaviour
Comparator / control treatment
The same intervention is being applied to all participants. Thus, there will be no control group/comparator treatment within this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327072 0
Eating Disorder Examination Questionnaire (EDE-Q; Christopher G Fairburn & Sarah J Beglin, 1994)
Timepoint [1] 327072 0
Baseline, post-treatment (i.e., immediately after final treatment session) and three-month follow up
Primary outcome [2] 327073 0
Posttraumatic Stress Disorder Checklist for the DSM-5 (PCL-5; Weathers et al., 2013)
Timepoint [2] 327073 0
Baseline, post-treatment (i.e., immediately after final treatment session) and three-month follow up
Secondary outcome [1] 393680 0
Beliefs About Emotions Questionnaire (BAEQ; Manser et al., 2012)
Timepoint [1] 393680 0
Baseline, post-treatment (i.e., immediately after final treatment session) and three-month follow up
Secondary outcome [2] 393681 0
The Posttraumatic Cognitions Inventory (PTCI; Foa et al., 1999)
Timepoint [2] 393681 0
Baseline, post-treatment (i.e., immediately after final treatment session) and three-month follow up
Secondary outcome [3] 393682 0
Self-reported frequency of: Objective binge eating episodes. The question will be administered as a self-report questionnaire based upon the Eating Disorder Examination Questionnaire).
The questions to asses binge eating will include: Over the past 7 days, how many times have you eaten what other people would regard as an unusually large amount of food (given the circumstances)?
On how many of these times did you have a sense of having lost control over your eating (at the time that you were eating)?
Over the past 7 days, on how many DAYS have such episodes of overeating occurred (i.e., you have eaten an unusually large amount of food and have had a sense of loss of control at the time)?
Timepoint [3] 393682 0
After every treatment session
Secondary outcome [4] 394878 0
Self report frequency of: Self-induced vomiting
The question will be administered as a self-report questionnaire based upon the Eating Disorder Examination Questionnaire).
The question to assess self-induced vomiting will include: Over the past 7 days, how many times have you made yourself sick (vomit) as a means of controlling your shape or weight?
Timepoint [4] 394878 0
After every treatment session
Secondary outcome [5] 394879 0
Self report frequency of: Laxative misuse
The question will be administered as a self-report questionnaire based upon the Eating Disorder Examination Questionnaire).
The question to assess laxative misuse will include: Over the past 7 days, how many times have you taken laxatives as a means of controlling your shape or weight?
Timepoint [5] 394879 0
After every treatment session
Secondary outcome [6] 394880 0
Self-report frequency of: Exercise as a means of controlling shape or weight
The question will be administered as a self-report questionnaire based upon the Eating Disorder Examination Questionnaire).
The question to assess exercise will include: Over the past 7 days, how many times have you exercised in a “driven” or “compulsive” way as a means of controlling your weight, shape or amount of fat, or to burn off calories?
Timepoint [6] 394880 0
After every treatment session

Eligibility
Key inclusion criteria
18-65 years of age
Diagnosis of co-morbid Bulimia Nervosa and Posttraumatic Stress Disorder
Medical Stability, as determined by a General Practitioner.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychosis
Intellectual Disability or any evidence of cognitive impairment that would interfere with the course of treatment.
Bipolar Disorder
Alcohol Use Disorder and/or Substance Use Disorder
Anorexia Nervosa
Pregnancy
High Suicide Risk

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Clinically significant change will be assessed on all outcome measures using Jacobson and Traux’s (1991) Reliable Change Index (RCI) approach. RCI will be calculated using the Christensen (1986) formula:

RCI = (X2 – X1)/Sdiff,

X1 represents a participants pre-test score, X2 represents the same participants post-test score, and Sdiff is the standard error of the difference between the two scores. Sdiff is calculated from the standard error of measurement (SE) as follows:

Sdiff = v2(SE)
SE = S1v(1-r)

Where S1 = standard deviation (SD) of the normal population and r = test-retest reliability of the outcome measure. A RCI>1.96 will indicate that the degree of change is statistically reliable and not the result of measurement error. When published data for normal populations of the outcome measures are not available, clinical cut-offs will be calculated using the M and Sd information from the normal population and experimental treatment group as follows:

C = S1 M2 + S2M`/S1 + S2

Where S1 = experimental treatment group SD, M2 = normal population M, S2 = normal population SD, and M1 = experimental treatment group M.

Non-parametric Wilcoxon signed-rank tests will be used on all outcome measures to compare pre-treatment ranks at 0 weeks to posttreatment ranks at post-treatment.

In addition, the weekly self-ratings will be graphed to show changes in symptoms during the course of therapy.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/08/2021
Actual
Date of last participant enrolment
Anticipated
1/08/2022
Actual
Date of last data collection
Anticipated
28/10/2022
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 308265 0
University
Name [1] 308265 0
Queensland University of Technology
Country [1] 308265 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
44 Musk Avenue, Kelvin Grove Queensland 4059
Country
Australia
Secondary sponsor category [1] 309057 0
None
Name [1] 309057 0
Address [1] 309057 0
Country [1] 309057 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 308243 0
Queensland University of Technology University Human Research Ethics Committee (UHREC)
Ethics committee address [1] 308243 0
Ethics committee country [1] 308243 0
Australia
Date submitted for ethics approval [1] 308243 0
18/06/2021
Approval date [1] 308243 0
Ethics approval number [1] 308243 0

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

Contacts
Principal investigator
Name 110046 0
Ms Gemma Frost
Address 110046 0
Queensland University of Technology, 44 Musk Avenue, Kelvin Grove Queensland 4059
Country 110046 0
Australia
Phone 110046 0
+61 419970534
Fax 110046 0
Email 110046 0
[email protected]
Contact person for public queries
Name 110047 0
Gemma Frost
Address 110047 0
Queensland University of Technology, 44 Musk Avenue, Kelvin Grove Queensland 4059
Country 110047 0
Australia
Phone 110047 0
+61 7 3138 0999
Fax 110047 0
Email 110047 0
[email protected]
Contact person for scientific queries
Name 110048 0
Gemma Frost
Address 110048 0
Queensland University of Technology, 44 Musk Avenue, Kelvin Grove Queensland 4059
Country 110048 0
Australia
Phone 110048 0
+61 7 3138 0999
Fax 110048 0
Email 110048 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
Due to the small sample size, detailed questionnaires and data it is possible that the participants could be identified from the raw data. Thus, the data will not be made publicly available on a data repository, to protect the identify of the clients.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11266Study protocol  [email protected] 381747-(Uploaded-29-05-2021-08-34-58)-Study-related document.docx
11267Ethical approval  [email protected]
11268Informed consent form  [email protected] 381747-(Uploaded-01-05-2021-09-48-59)-Study-related document.docx



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.