Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000611224
Ethics application status
Approved
Date submitted
31/03/2018
Date registered
19/04/2018
Date last updated
3/04/2019
Date data sharing statement initially provided
25/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of the effectiveness of Experiential Awareness Therapy for the treatment of Eating Disorders
Scientific title
A pilot trial of the effectiveness of Experiential Awareness Therapy for Eating Disorders
Secondary ID [1] 294441 0
nil known
Universal Trial Number (UTN)
U1111-1211-3411
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating Disorders 307191 0
Condition category
Condition code
Mental Health 306302 306302 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experiential Awareness Therapy is a manualised group therapy for people with eating disorders. Sessions comprise of studying course material, group discussions, experiential contemplation/meditation, calm-abiding meditation and gentle movement-based exercises. Facilitators will promote participant Reflective Functioning through explicit mentalising as theoretically taken from Mentalising Based Therapy. Emotional processing will be promoted by participants being guided to embody emotions and understanding the personal relevance of the emotion as taken from Emotion Focused Therapy. Where appropriate maladaptive schema will be challenged as taken from Emotion Focused Therapy and Mentalising Based Therapy. Session content will be structured around a Mahayana understand of the Four Noble Truths, see below for session content.
Session Content
1- Overview This section will give participants an in-depth overview of the conceptualisation of the aetiology and maintaining factors of ED,
2- Self-compassion Participants are guided to engender a sense of self-compassion, and explore the adverse effects of holding harmful feeling towards oneself
3-Valid cognition/emotion Participants are taught skills to critically evaluate their perceptions, beliefs and resultant emotions. Participants will be aided to understand the purpose of emotions and therefore premise for increasing emotional awareness.
4- Suffering Participants are guided to contemplate and understand the suffering involved with ED. Participants will gain an awareness and acceptance of this existential condition. This intervention aims to increase motivation and challenge the ego-syntonic nature of ED.
5- Fixation Participants explore the role fixation on weight and shape plays in ED maintenance.
6- Self vs person Participants explore sense of self as a construct. Highlighting the psychological benefits of experiencing themselves as a ‘whole person’
7-Cause and effect In-depth exploration of causes and conditions that maintain ED
8- Recovery Participants are challenged regarding the belief that ED is advantageous to sense of self-worth, and as a component of their identity. ED is instead contemplated as a compounded phenomena arising from causes and conditions in their life that arose, and are subject to change.
9- Path to recovery Participants discuss application of skills learned in the course. Participants are guided to understand how to apply these skills in systematic, sustainable manner to work towards recovery
10- Compassion Participants are guided on how to utilise an ‘other regarding’ attitude skilfully. Support and guidance is further given for applying the ‘path’ to recovery

Participants will be given activities to complete between therapy sessions. Activities given to participants to undertake between sessions include meditation, gentle movement based activities, self-soothing activities (when distressed), and mindfulness to become aware of psychological functioning in relation eating disordered pathology.
Participant adherence to the intervention will be monitored via an attendance checklist and a self-report record book of daily usage/ practicing of skills taught in the intervention. The facilitating psychologist adherence will be monitored through all therapy sessions being audio recorded and 20% of sessions being reviewed by an independent party for fidelity to the manual.
The intervention will be conducted by a registered psychologist with expertise in eating disorder treatment. The psychologist is a registered member of Australian Psychological Society and Australian Health Practitioner Regulation Agency.
Experiential Awareness Therapy is a 10 session manualised group therapy, ran over ten weeks. Each session runs for 2 hours.
Sessions will be delivered in person to groups of approximately 10 participants. Sessions will be delivered within a private therapy space.
Intervention code [1] 300732 0
Behaviour
Comparator / control treatment
Cognitive Behaviour Therapy – Enhanced is a manualised group therapy. The intervention will utilise 10 sessions taken from the Overcoming Disordered Eating manual for Cognitive Behaviour Therapy – Enhanced, The intervention will be run over 10 weeks. Each session will be 2 hours long. Session will be conducted in person, with 10 participants. Sessions will include an introduction and clarification of subject material, facilitation of worksheets to support individual understanding of personal relevance of material and group discussion. The facilitator will additionally challenge maladaptive schema, in line with Cognitive Behaviour Therapy – Enhanced therapeutic principles. Session content is as follows
Session Content
1-What is an ED This module provides an overview of what eating disorders are, their impact, and the role of dieting and healthy weight
2- How Ready am I to Change? This module explores preparedness to change disordered eating behaviours, and also outlines some of the treatment options for eating disorders.
3- How ED are Maintained This module outlines some of the factors which maintain disordered eating and create a vicious cycle.
4- Self-Monitoring This module explains the importance of self-monitoring of eating behaviours, and provides a food log worksheet.
5-Regular Eating and Weighing This module provides a rationale for regular eating and weighing, along with guidelines and worksheets.
6-Binge Eating, Purging, and Driven Exercise This module explains the role of binge eating, purging, and driven exercise, and how these behaviours maintain disordered eating in a vicious cycle.
7-Mood and Disordered Eating This module explores the way emotions and difficulty handling moods can affect disordered eating behaviours, along with strategies to manage moods.
8-Dietary Rules This module explores the role of dietary restriction and rules in maintaining disordered eating, along with guidelines for normal eating.
9-Progress Review and Barrier to Change This module helps you to review your progress through the modules so far and to identify any potential barriers to progress.
10-Over evaluation of Weight and Shape In this module we will explore in more detail how people with eating disorders place an unusually high value on controlling their eating, weight and/or shape, and how they judge their self-worth accordingly.
Participants will complete homework between therapy sessions. Homework will be based on session content, utilising methodology from CBT.
Participant adherence to the intervention will be monitored via an attendance checklist. The facilitating psychologist adherence will be monitored through all therapy sessions being audio recorded and 20% of sessions being reviewed by an independent party for fidelity to the manual.
The intervention will be conducted by a registered psychologist with expertise in eating disorder treatment. The psychologist is a registered member of Australian Psychological Society and Australian Health Practitioner Regulation Agency.
Control group
Active

Outcomes
Primary outcome [1] 305308 0
A change in eating disorder symptomology as measured in the Eating Disorder Examination - Questionnaire
Timepoint [1] 305308 0
Measures will be taken at baseline, on completion of the intervention (primary endpoint) and 3 months follow up
Primary outcome [2] 305309 0
A change in Reflective Functioning (RF). This primary outcome will be measured as a composite factor.
Toronto Alexithymia Scale-20 will be utilised as a generally measure of RF,
Cognitive fusion Questionnaire will be utilised to measure the 'psychic-equivalence' aspect of RF.
Multiscale Dissociation Inventory will be utiliised to measure the 'pretend mode aspect' of RF.
Timepoint [2] 305309 0
Measures will be taken at baseline, on completion of the intervention (primary endpoint) and 3 months follow up
Primary outcome [3] 305310 0
A change in emotional regulation (ER) will be measured as a composite factor
Difficulties in Emotional Regulation Scale will be utilised as a generally measure of ER
Differentiation of Self Inventory will be utilised to measure hyperactivating and deactivating aspects of ER.
Timepoint [3] 305310 0
Measures will be taken at baseline, on completion of the intervention (primary endpoint) and 3 months follow up
Secondary outcome [1] 344819 0
A change in psycho-social functioning will be measured as a composite factor.
Depression Anxiety Stress Scale will be utilised to measure psychological functioning
Social Adaptation Self-evaluation Scale will be utilised to measure social functioning
Timepoint [1] 344819 0
Measures will be taken at baseline, on completion of the intervention and 3 months follow up

Eligibility
Key inclusion criteria
Participants will be required to meet a minimal of a subthreshold rating of disorder eating (EDE-Q),
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Applicants with a Body Mass Index of under 16 and those suffering from a psychotic disorder will be excluded

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)
The researcher who allocates participants to trial or control is independent from the researcher who determines eligibility. Participants applications will be placed in numbered sealed opaque envelope
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?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
T-tests will be conducted on pre and post measures and between measures. For an assumption of power .80, P<.05 for a sample n=30, effective size of d=.55 must be found in outcome measures. Effects sizes d=.55 are commonly reported in ED trials.
The amount of time practicing skills will be turned in categorical data. An ANOVA will be conducted to determine if there are difference in outcomes based on level of practice. A post-hoc test, Tukey’s honestly significant difference test, will be conducted if any significant differences occur.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2019
Actual
Date of last participant enrolment
Anticipated
31/03/2020
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 299070 0
University
Name [1] 299070 0
University of Melbourne
Country [1] 299070 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 298309 0
None
Name [1] 298309 0
Address [1] 298309 0
Country [1] 298309 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300004 0
University of Melbourne Human ethics advisory group
Ethics committee address [1] 300004 0
Ethics committee country [1] 300004 0
Australia
Date submitted for ethics approval [1] 300004 0
30/04/2018
Approval date [1] 300004 0
31/10/2018
Ethics approval number [1] 300004 0
1749363.1

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

Contacts
Principal investigator
Name 82234 0
Mr Jasper Eames
Address 82234 0
University of Melbourne,
50 Flemington Street, Flemington Victoria 3031 Australia
Country 82234 0
Australia
Phone 82234 0
+61 437665465
Fax 82234 0
Email 82234 0
[email protected]
Contact person for public queries
Name 82235 0
Jasper Eames
Address 82235 0
University of Melbourne
50 Flemington Street, Flemington Victoria 3031 Australia
Country 82235 0
Australia
Phone 82235 0
+61 437665465
Fax 82235 0
Email 82235 0
[email protected]
Contact person for scientific queries
Name 82236 0
Jasper Eames
Address 82236 0
University of Melbourne
50 Flemington Street, Flemington Victoria 3031 Australia
Country 82236 0
Australia
Phone 82236 0
+61 437665465
Fax 82236 0
Email 82236 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


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
No additional documents have been identified.