Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001259639
Ethics application status
Approved
Date submitted
18/10/2023
Date registered
5/12/2023
Date last updated
5/12/2023
Date data sharing statement initially provided
5/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Schema therapy for people with binge eating disorders
Scientific title
Effectiveness of schema therapy addressing early life experiences in reducing symptom severity in transdiagnostic binge eating: a case series analysis
Secondary ID [1] 310807 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bulimia Nervosa 331797 0
Binge Eating Disorder 331798 0
Other Specified Feeding and Eating Disorder 331799 0
Condition category
Condition code
Mental Health 328534 328534 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will provide 25-session course of schema therapy to adults with eating disorders featuring binge-eating. The treatment will be tailored to each participants' unique combination of symptoms early maladaptive schemas, perceived parenting style and temperament. The 25 treatment sessions will be divided into a number of phases: initial assessment session, psychoeducation and orientation to treatment, implementing eating interventions, reflecting on childhood experiences and temperament, in-depth exploration of coping modes, implementing behavioural experiments before preparing for discharge from therapy and planning to prevent relapse.
The 25 treatment sessions will occur over approximate 30 weeks and consist of 23 x 1-hour weekly sessions followed by 2 x 1-hour fortnightly sessions. The intervention will be administered through one-on-one face-to-face sessions conducted by experienced psychologists trained in using schema therapy for eating disorders. These sessions will be held in two NHS eating disorder services in the UK and three private practice centres in Australia.
Intervention code [1] 327217 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336349 0
Eating Disorder Symptoms
Timepoint [1] 336349 0
Baseline, mid-treatment (after session 12), post-treatment (after session 25), 3 months after conclusion of treatment, 6 months after conclusion of treatment
Secondary outcome [1] 427960 0
Early Maladaptive Schemas and Coping Modes
Timepoint [1] 427960 0
Baseline, mid-treatment (after session 12), post-treatment (after session 25) , 3 months after conclusion of treatment, 6 months after conclusion of treatment
Secondary outcome [2] 427961 0
Perceived Parenting Style
Timepoint [2] 427961 0
Baseline, mid-treatment (after session 12), post-treatment (after session 25) , 3 months after conclusion of treatment, 6 months after conclusion of treatment
Secondary outcome [3] 427962 0
Interoceptive Awareness
Timepoint [3] 427962 0
Baseline, mid-treatment (after session 12), post-treatment (after session 25) , 3 months after conclusion of treatment, 6 months after conclusion of treatment
Secondary outcome [4] 427963 0
Temperament
Timepoint [4] 427963 0
Baseline, mid-treatment (after session 12), post-treatment (after session 25) , 3 months after conclusion of treatment, 6 months after conclusion of treatment
Secondary outcome [5] 427964 0
Participant experience and perspective of the treatment
Timepoint [5] 427964 0
After completion of treatment (after session 25)

Eligibility
Key inclusion criteria
Aged 18 years or older,
Diagnosed with disorders featuring binge-eating (e.g., bulimia nervosa, binge eating disorder or other specified feeding or eating disorder with either bulimia nervosa of low frequency/duration or binge eating disorder of low frequency/duration), and
Can read and speak English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Experiencing active psychosis,
- Experiencing acute severe suicidality,
- Have intellectual disability or cognitive impairment,
- Abuse substances,
- Pregnant,
- Underweight and actively losing weight,
- Have already tried schema therapy.

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
Because the anticipated sample is small, non-parametric analyses will be used to validate findings in addition to repeated-measures ANOVAs. Friedman tests will be used to identify changes in ED symptoms at each time point with effect sizes calculated by Kendall’s W. To identify significant differences between timepoints, pairwise Wilcoxon signed-rank tests will be used. Spearman’s rho will be used as a non-parametric measurement of the relationship between change in EMS and ED symptoms, between change in schema modes and ED symptoms, and between interoceptive awareness and ED symptoms. While the validity of ANOVAs can be limited in smaller samples, all other analyses (Friedman tests, Kendall’s W, Wilcoxon signed-rank tests and Spearman’s rho) are non-parametric and thus appropriate to use in a sample size of 5-10. The validity of the ANOVA will be assessed by repeating that analysis (changes of ED symptoms over time) using a combination of Friedman tests, Kendall’s W and Wilcoxon signed-rank tests.

The minimum expected sample size is 5 participants, however if more are able to be recruited the sample size may increase to 10 participants. The combination of the qualitative measures and quantitative interview with clinicians and participants will provide detailed and comprehensive information about the effects of the treatment on numerous aspects of the participant’s life and symptoms. Furthermore, the qualitative interview will provide information about what worked well in the treatment and what was less effective, which will allow the treatment to be refined before being provided to a larger number of participants. The small sample size will allow the nuances of these findings to be discussed in detail upon dissemination, so that each participants’ experience through the study can be shared and inform future treatment of eating disorders.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/11/2023
Date of last participant enrolment
Anticipated
1/03/2024
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
5
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment outside Australia
Country [1] 25906 0
United Kingdom
State/province [1] 25906 0

Funding & Sponsors
Funding source category [1] 315048 0
Government body
Name [1] 315048 0
UK National Health Service
Country [1] 315048 0
United Kingdom
Primary sponsor type
University
Name
University of Canberra
Address
11 Kirinari St, Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 317071 0
None
Name [1] 317071 0
Address [1] 317071 0
Country [1] 317071 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314003 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 314003 0
11 Kirinari St, Bruce ACT 2617
Ethics committee country [1] 314003 0
Australia
Date submitted for ethics approval [1] 314003 0
06/06/2023
Approval date [1] 314003 0
22/09/2023
Ethics approval number [1] 314003 0
13243
Ethics committee name [2] 314004 0
South East Scotland Research Ethics Committee 01
Ethics committee address [2] 314004 0
2-4 Waterloo Place Edinburgh EH1 3EG
Ethics committee country [2] 314004 0
United Kingdom
Date submitted for ethics approval [2] 314004 0
13/06/2023
Approval date [2] 314004 0
28/09/2023
Ethics approval number [2] 314004 0
326901

Summary
Brief summary
This study will provide a course of schema therapy to adults with eating disorders featuring binge-eating. The treatment will be tailored to certain aspects of personality: early maladaptive schemas, perceived parenting style and temperament. The aim of the study is to determine whether this treatment reduces eating disorder symptoms and behaviours and whether there is a relationship between change in early maladaptive schemas and eating disorder symptoms. People aged 18 or older with eating disorders featuring binge eating (e.g., bulimia nervosa, binge eating disorder) will be eligible to participate in the study. The study will be conducted at multiple sites, including two eating disorder services in the UK and three private practice centres in Australia. The treatment includes 25 x 1-hour sessions over approximately 30 weeks. Participants will complete questionnaire measures before starting treatment, halfway through treatment, at the end of treatment and at 3- and 6-months after treatment is complete. To understand participants' perspective of the treatment, an optional qualitative interview will be conducted after treatment is complete.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130090 0
Ms Phoebe Joshua
Address 130090 0
University of Canberra, 11 Kirinari St, Bruce ACT 2617
Country 130090 0
Australia
Phone 130090 0
+61 2 6201 5111
Fax 130090 0
Email 130090 0
[email protected]
Contact person for public queries
Name 130091 0
Phoebe Joshua
Address 130091 0
University of Canberra, 11 Kirinari St, Bruce ACT 2617
Country 130091 0
Australia
Phone 130091 0
+61 2 6201 5111
Fax 130091 0
Email 130091 0
[email protected]
Contact person for scientific queries
Name 130092 0
Phoebe Joshua
Address 130092 0
University of Canberra, 11 Kirinari St, Bruce ACT 2617
Country 130092 0
Australia
Phone 130092 0
+61 2 6201 5111
Fax 130092 0
Email 130092 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.