Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000192886p
Ethics application status
Submitted, not yet approved
Date submitted
28/11/2020
Date registered
23/02/2021
Date last updated
23/02/2021
Date data sharing statement initially provided
23/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Meta-Emotion Therapy for Bulimia Nervosa
Scientific title
Evaluating the Effectiveness of Meta-Emotion Therapy for Bulimia Nervosa
Secondary ID [1] 302892 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bulimia Nervosa 319895 0
Condition category
Condition code
Mental Health 317831 317831 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Meta-Emotion Therapy is an individual form of therapy utilizing various psychological techniques (e.g., psycho-education, self-monitoring task, detached mindfulness task, Socratic questioning, behavioral experiments, and short videos). The treatment will involve 16 weekly 1 hour sessions. The treatment will be conducted one-on-one by a Provisional Psychologist. This therapist is a postgraduate psychology student who has undertaken clinical psychology training including training in the area of MET. The therapist will be working as a therapist in the QUT Clinic as part of their thesis requirements. This therapist will have weekly supervision sessions with a Registered Clinical Psychologist. This treatment focuses on meta-cognitions about emotions (eg. “Strong negative emotions mean something uncontrollable is happening and therefore I need to focus and perseverate on my negative thoughts to protect me from losing control of my eating because if I lose control of my eating I become fat and worthless”). A summary of the content covered during the treatment is as follows: Psycho-education on binge eating, purging and risks, Socialise patient to the language of MET, Create mini-formulation, Introduce self-monitoring task, Review formulation, and self-monitoring, Introduce rationale for detached mindfulness task, Introduce the role of attentional bias, Attentional Training Technique, Continue to review formulation and treatment plan, Focus on negative beliefs about emotions and their role based on the formulation, Identify the patient’s negative beliefs about emotions, Challenge negative meta-beliefs towards emotions using Socratic questioning, Challenge negative meta-beliefs towards emotions using Socratic questioning, Explore and challenge positive beliefs about cognitive coping strategies, Behavioural Experiments, Reviewing and implementing strategies and Relapse prevention.
Intervention code [1] 319177 0
Behaviour
Intervention code [2] 319566 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326086 0
Symptoms of Bulimia Nervosa will be measured by the Eating Disorder Examination Questionnaire (EDE-Q)
Timepoint [1] 326086 0
Pre-treatment, post-treatment and 1-month follow-up outcome measure
Primary outcome [2] 326087 0
Bingeing and purging behaviours will be measured via questions adopted from the Eating Disorder Examination Questionnaire (EDE-Q). Questions will be altered to reflect symptoms in the past 7 days as opposed to 28 days.
Timepoint [2] 326087 0
The participants will be asked to complete weekly questions three times prior to the start of therapy in order to determine a baseline, as well as prior to the start of each therapy session and a week after the last therapy session.
Secondary outcome [1] 390085 0
Depression symptoms will be measured via the Patient Health Questionnaire (PHQ).
Timepoint [1] 390085 0
Pre-treatment, post-treatment and 1-month follow-up outcome measure.
Secondary outcome [2] 390086 0
Anxiety symptoms will be measured via the Generalized Anxiety Disorder Questionnaire (GAD-7).
Timepoint [2] 390086 0
Pre-treatment, post-treatment and 1-month follow-up outcome measure.
Secondary outcome [3] 390087 0
Ability to identify and describe emotions will be measured via the Perth Alexithymia Questionnaire (PAQ).
Timepoint [3] 390087 0
Pre-treatment, post-treatment and 1-month follow-up outcome measure.
Secondary outcome [4] 390088 0
Beliefs about one's emotions will be measured via the Emotions Beliefs Questionnaire (EBQ).
Timepoint [4] 390088 0
Pre-treatment, post-treatment and 1-month follow-up outcome measure.
Secondary outcome [5] 390089 0
Beliefs about one's emotions will be measured via the Beliefs About Emotions Questionnaire (BAEQ).
Timepoint [5] 390089 0
Pre-treatment, post-treatment and 1-month follow-up outcome measure.

Eligibility
Key inclusion criteria
Meets diagnosis of Bulimia Nervosa as per Diagnostic and Statistical Manual of Mental Disorders 5.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusionary criteria included current psychosis, high suicide risk, intellectual disability, drug or alcohol abuse, current treatment for obesity, the presence of Anorexia Nervosa and pregnancy.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Non-regression approach has been Percentage of Non-Overlapping Data,
A percentage of data points exceeding the median of the baseline phase,
A reliable change index will be calculated for each participant on each measure, comparing baseline with post-treatment scores and baseline with scores at follow-up

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 307315 0
University
Name [1] 307315 0
Queensland University of Technology
Country [1] 307315 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
149 Victoria Park Rd, Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 307952 0
None
Name [1] 307952 0
Address [1] 307952 0
Country [1] 307952 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307406 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [1] 307406 0
OREI - Office of Research Ethics and Integrity
GPO Box 2434, Brisbane, QLD 4000.
Ethics committee country [1] 307406 0
Australia
Date submitted for ethics approval [1] 307406 0
12/01/2021
Approval date [1] 307406 0
Ethics approval number [1] 307406 0

Summary
Brief summary
The aim is to build on previous findings and gain some preliminary evidence to the effectiveness of MET within the BN population. Furthermore, it is important to gain feedback on therapy content, process and dosage in order to prepare for future clinical studies. It is hypothesised that the MET intervention will improve participants’ BN as evidenced by primary measure scores, as well as the secondary measure scores.
This study employed a single-case multiple baseline design with commencement of the intervention staggered for each participant. Participants intend to include six adults. Following pre-treatment telephone screening, participants will be screened in an initial assessment interview and to ensure a diagnosis of BN consistent with DSM-5 criteria. Participants will also be administered a Structured Clinical Interview for DSM-5 (SCID) (First, 2015) to ascertain that inclusion and exclusion criteria were met. Participants will be referred to another service for treatment if exclusion criteria is met. Following the initial interview, participants will then complete the outcome measures. Participants will also need to be assessed by a general practitioner to identify any physical conditions that precluded full participation and to ensure that their electrolyte levels are all within a safe range.
Participants will complete 16 sessions of MET treatment on a weekly basis with each session lasting approximately one hour in duration. The therapist will be a registered provisional psychologist currently undertaking a Masters of Clinical Psychology at QUT. All sessions will be video/audio recorded and discussed during clinical supervision with a supervisor who is an experienced clinical psychologist (20 years).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107122 0
Mr Mitchell Hubert
Address 107122 0
Faculty of Health, School of Psychology and Counselling, Queensland University of Technology, Room U240, U Block, Level 2, 44 Musk Avenue, Kelvin Grove QLD 4059.
Country 107122 0
Australia
Phone 107122 0
+61 7 3138 3161
Fax 107122 0
Email 107122 0
n10673202@qut.edu.au
Contact person for public queries
Name 107123 0
Dr Esben Strodl
Address 107123 0
Faculty of Health, School of Psychology and Counselling, Queensland University of Technology, Room O Block Wing B - Level 6 B634, 44 Musk Avenue, Kelvin Grove, QLD, 4059.
Country 107123 0
Australia
Phone 107123 0
+61 7 3138 8416
Fax 107123 0
+61 7 3138 0486
Email 107123 0
e.strodl@qut.edu.au
Contact person for scientific queries
Name 107124 0
Dr Esben Strodl
Address 107124 0
Faculty of Health, School of Psychology and Counselling, Queensland University of Technology, Room O Block Wing B - Level 6 B634, 44 Musk Avenue, Kelvin Grove, QLD, 4059.
Country 107124 0
Australia
Phone 107124 0
+61 7 3138 8416
Fax 107124 0
+61 7 3138 0486
Email 107124 0
e.strodl@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data may include personal information and there are nil current plans for this to be release to uphold confidentiality.


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.