Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000563965
Ethics application status
Approved
Date submitted
14/04/2020
Date registered
14/05/2020
Date last updated
14/05/2020
Date data sharing statement initially provided
14/05/2020
Date results provided
14/05/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of emotion-focused therapy for binge-eating disorder.
Scientific title
Emotion-focused therapy for binge-eating disorder: A pilot randomized control trial.
Secondary ID [1] 301009 0
Nil known.
Universal Trial Number (UTN)
U1111-1250-4173
Trial acronym
EFTBED
Linked study record
Not applicable.

Health condition
Health condition(s) or problem(s) studied:
Binge-eating disorder 317048 0
Condition category
Condition code
Mental Health 315213 315213 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involved 12 weekly one hour sessions of emotion-focused therapy delivered by an experienced Clinical Psychologist with approximately 25 years of practice experience. The Clinical Psychologist had undergone Level 1, 2 and 3 training in EFT at the York University Psychology Clinic with the primary developer of the EFT approach, Distinguished Professor Emeritus, Leslie Greenberg. The goal of EFT is to assist clients in processing unpleasant emotions by attending to and increasing awareness and expression of emotion; learning to tolerate and regulate experience; reflecting upon and make meaning of emotion by symbolizing emotional experience in words; and transforming maladaptive emotions by activating healthy, adaptive emotions together with their associated needs and action tendencies. The standardized treatment manual used in the current study was initially adapted from Wnuk et al. (2015) by Glisenti et al. (2018) in a series of case studies exploring the use of individual EFT to treat BED. Phase 1 of the treatment focused on promoting awareness of emotions, welcoming and accepting emotions, putting emotions into words, and identifying primary emotions. Phase 2 focused on evaluating whether the primary emotion was adaptive or maladaptive, identifying destructive emotions, accessing other adaptive emotions and needs, and transforming maladaptive emotion schemes. Six main marker guided interventions were used in individual treatment sessions in line with EFT protocol: 1. Empathic attunement and validation for vulnerability and establishing the therapeutic alliance 2. Evocative unfolding for problematic reactions 3. Experiential focusing for unclear feelings 4. Two-chair dialogues for self-critical splits 5. Two-chair enactment for self-interruptive splits and 6. Empty chair work for unfinished business. Adherence to therapy was monitored by use of a session attendance checklist. There was not an expectation that EFT techniques were to be practiced at home and there were no homework tasks associated with the treatment sessions.

Glisenti. K,, Strodl, E., King, R. (2018) Emotion-focused therapy for binge-eating disorder: A review of six cases. Clinical Psychology and Psychotherapy, 25, 842-855.

Wnuk, S.M., Greenberg L., & Dolhanty, J. (2015).Emotion-focused group therapy for women with symptoms of bulimia nervosa. Eating Disorders, 23, 253–261.
Intervention code [1] 317327 0
Treatment: Other
Intervention code [2] 317460 0
Behaviour
Comparator / control treatment
Participants were randomly allocated to either a treatment or 12 week waitlist control group.
Control group
Active

Outcomes
Primary outcome [1] 323471 0
Binge eating frequency was assessed using items from the Eating Disorder Examination Questionnaire – EDE-Q-6.0 which is a widely used measure of eating disorder attitudes and behaviors in both community and clinical populations. The EDE-Q-6.0 also provides frequency data on the number of episodes of the eating disorder behavior and the number of days on which the behavior occurred. The EDEQ-6.0 items used to measure binge eating frequency were: “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)?; and “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 [1] 323471 0
Binge-eating frequency was assessed at pretherapy (Week 0), weekly during treatment (Weeks 1-12), and at follow-up (Weeks 16, 20 and 24).
Primary outcome [2] 323647 0
Binge eating psychopathology was assessed using the Binge Eating Scale – BES. which is a commonly used self-report screening tool for binge eating in clinical practice and research. A total of 16 items are rated using 3-4 separate responses assigned a numerical value. An example of an item is “(a.) I feel capable to control my eating urges when I want to; (b.) I feel like I have failed to control my eating more than the average person; (c.) I feel utterly helpless when it comes to feeling in control of my eating urges; (d.) Because I feel so helpless about controlling my eating I have become very desperate about trying to get in control.” Total scores range from 0 to 46, with higher scores indicating more severe binge-eating symptoms.
Timepoint [2] 323647 0
Binge-eating psychopathology was assessed at pretherapy (Week 0), weekly during treatment (Weeks 1-12), and at follow-up (Weeks 16, 20 and 24).
Secondary outcome [1] 382016 0
Anxiety was assessed using the Beck Anxiety Inventory – which is one of the most used clinical self-rating scales for measuring the intensity of anxiety. Respondents are presented with a list of 21 common symptoms of anxiety and indicate how much they have been bothered by that symptom during the past month. Items are rated on a scale of 0 = not at all to 3 = severely. The total score is calculated by summing the ratings for the 21 items with a maximum possible score of 63.
Timepoint [1] 382016 0
Anxiety was measured at pretherapy (Week 0), and at follow-up (Weeks 16, 20 and 24).
Secondary outcome [2] 382478 0
Depression was assessed using the Beck Depression Inventory-II – BDI-II which is one of the most widely adopted measures of depressive symptoms. The BDI-II measures both cognitive-affective (negative mood or negative affect) and somatic (fatigue or loss of energy) dimensions of depressive symptoms. Respondents read 21 groups of statements and then choose the one statement in each group that best describes the way he/she felt in the previous two weeks. Items are rated on a scale of 0 to 3, with higher ratings indicating more severe depressive symptoms. The total score is calculated by summing the 21 items, and the maximum possible score is 63.
Timepoint [2] 382478 0
Depression was measured at pretherapy (Week 0), and at follow-up (Weeks 16, 20 and 24).

Eligibility
Key inclusion criteria
Inclusion criteria included the following: meeting the Diagnostic and Statistical Manual of Mental Disorders: DSM-V American Psychiatric Association – DSM-5 (2013) diagnostic criteria for binge-eating disorder, and possessing sufficient English language skills to provide informed consent and participate in the study without translation.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria included current psychosis, intellectual disability, high suicide risk, drug or alcohol abuse, concurrent treatment for obesity, pregnancy and the presence of anorexia nervosa or bulimia nervosa.

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)
Participants were randomly allocated to either an EFT intervention or 12-week wait-list using a permuted block randomization method by a statistician independent to the research team. Allocation was concealed by the use of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not applicable.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations were made using GPower 3.1.9.2 with alpha =.05, power = 0.95, 2 groups and 4-time points

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/07/2018
Date of last participant enrolment
Anticipated
Actual
20/04/2019
Date of last data collection
Anticipated
Actual
21/12/2019
Sample size
Target
20
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 305453 0
University
Name [1] 305453 0
Queensland University of Technology
Country [1] 305453 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Queensland University of Technology
149 Victoria Park Rd
Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 305852 0
None
Name [1] 305852 0
Address [1] 305852 0
Country [1] 305852 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305770 0
Queensland University of Technology (QUT) University Human Research Ethics Committee (UHREC).
Ethics committee address [1] 305770 0
Ethics committee country [1] 305770 0
Australia
Date submitted for ethics approval [1] 305770 0
27/10/2017
Approval date [1] 305770 0
02/05/2018
Ethics approval number [1] 305770 0
1700000986

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

Contacts
Principal investigator
Name 101538 0
Mr Kevin Glisenti
Address 101538 0
Moderation Clinic
Suite 1, Level 1
99 Marine Parade
Redcliffe QLD 4020
Country 101538 0
Australia
Phone 101538 0
+61 422663573
Fax 101538 0
Email 101538 0
[email protected]
Contact person for public queries
Name 101539 0
Kevin Glisenti
Address 101539 0
Moderation Clinic
Suite 1, Level 1
99 Marine Parade
Redcliffe QLD 4020
Country 101539 0
Australia
Phone 101539 0
+61 422663573
Fax 101539 0
Email 101539 0
[email protected]
Contact person for scientific queries
Name 101540 0
Kevin Glisenti
Address 101540 0
Moderation Clinic
Suite 1, Level 1
99 Marine Parade
Redcliffe QLD 4020
Country 101540 0
Australia
Phone 101540 0
+61 422663573
Fax 101540 0
Email 101540 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator who can be contacted via email on [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7620Study protocol  [email protected]
7621Statistical analysis plan  [email protected]
7622Informed consent form  [email protected]
7623Clinical study report  [email protected]
7624Ethical approval  [email protected]
7625Analytic code  [email protected]



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.