Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000632291p
Ethics application status
Not yet submitted
Date submitted
11/04/2018
Date registered
20/04/2018
Date last updated
20/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An exploration of the feasibility of an attachment based intervention for Eating Disorders
Scientific title
A feasibility trial of Experiential Awareness Therapy for Eating Disorders
Secondary ID [1] 294493 0
nil known
Universal Trial Number (UTN)
U1111-1211-7542
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating Disorders 307264 0
Condition category
Condition code
Mental Health 306382 306382 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 contain an in-depth overview of the conceptualisation of the aetiology and maintaining factors of ED, with supporting science, for facilitators
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 to 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] 300791 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305480 0
Is course material relevant/meaningful to Eating Disorder recovery
Findings will based on thematic analysis of: a recorded group discussion at the end of the intervention, trends seen in quantitative results (Eating Disorder Examination Questionnaire ), participants semi-structured qualitative weekly logs, and facilitating psychologist observations
Timepoint [1] 305480 0
This outcome will be assessed at the end of the course of treatment (primary time point)
Primary outcome [2] 305481 0
Is the intervention engaging/salient
Findings will based on thematic analysis of: a recorded group discussion at the end of the intervention, trends seen in quantitative results (Client Motivation for Therapy Scale ), participants semi-structured qualitative weekly logs, and facilitating psychologist observations
Timepoint [2] 305481 0
This outcome will be assessed at the end of the course of treatment (primary time point)
Primary outcome [3] 305483 0
Have participants experienced meaningful psychological change post intervention.
Findings will based on thematic analysis of: a recorded group discussion at the end of the intervention, trends seen in quantitative results (Depression Anxiety Stress Scale; Social adaptation self-evaluation scale), participants semi-structured qualitative weekly logs , and facilitating psychologist observations
Timepoint [3] 305483 0
This outcome will be assessed at the end of the course of treatment (primary time point)
Secondary outcome [1] 345388 0
Has there been a change in Reflective Functioning
Findings will based on thematic analysis of: a recorded group discussion at the end of the intervention, trends seen in quantitative results (Cognitive fusion Questionnaire; Toronto Alexithymia Scale-20; Multiscale Dissociation Inventory), participants semi-structured qualitative weekly logs and facilitating psychologist observations
Timepoint [1] 345388 0
This outcome will be assessed at the end of the course of treatment
Secondary outcome [2] 345389 0
Has there been a change in Emotional Regulation
Findings will based on thematic analysis of: a recorded group discussion at the end of the intervention, trends seen in quantitative results (Differentiation of Self Inventory; Difficulties in Emotional Regulation Scale), participants semi-structured qualitative weekly logs, and facilitating psychologist observations
Timepoint [2] 345389 0
This outcome will be assessed at the end of the course of treatment
Secondary outcome [3] 345390 0
Has there been a change in core- schema related to over identification of self with perceived appearance.
Findings will based on thematic analysis of: a recorded group discussion at the end of the intervention, trends seen in quantitative results (Attachment Style Questionnaire), participants semi-structured qualitative weekly logs, and facilitating psychologist observations
Timepoint [3] 345390 0
This outcome will be assessed at the end of the course of treatment

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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
A semi structured discourse analysis to gauge the interventions effectiveness will be conducted post feasibility trial. Discussion questions will be formulated from quantitative results, participants logs, and facilitating psychologist observations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/09/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 299117 0
University
Name [1] 299117 0
University of Melbourne
Country [1] 299117 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 298376 0
None
Name [1] 298376 0
Address [1] 298376 0
Country [1] 298376 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 300051 0
University of Melbourne Human ethics advisory group
Ethics committee address [1] 300051 0
Ethics committee country [1] 300051 0
Australia
Date submitted for ethics approval [1] 300051 0
30/04/2018
Approval date [1] 300051 0
Ethics approval number [1] 300051 0

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

Contacts
Principal investigator
Name 82394 0
Mr Jasper Eames
Address 82394 0
University of Melbourne,
50 Flemington Street, Flemington Victoria 3031 Australia
Country 82394 0
Australia
Phone 82394 0
+61 437665465
Fax 82394 0
Email 82394 0
[email protected]
Contact person for public queries
Name 82395 0
Jasper Eames
Address 82395 0
University of Melbourne,
50 Flemington Street, Flemington Victoria 3031 Australia
Country 82395 0
Australia
Phone 82395 0
+61 437665465
Fax 82395 0
Email 82395 0
[email protected]
Contact person for scientific queries
Name 82396 0
Jasper Eames
Address 82396 0
University of Melbourne,
50 Flemington Street, Flemington Victoria 3031 Australia
Country 82396 0
Australia
Phone 82396 0
+61 437665465
Fax 82396 0
Email 82396 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.

Documents added automatically
No additional documents have been identified.