Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000331437
Ethics application status
Approved
Date submitted
6/02/2025
Date registered
17/04/2025
Date last updated
17/04/2025
Date data sharing statement initially provided
17/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Temperament Based Therapy with Support (TBT-S) for patients and supports in Victorian tertiary eating disorder services.
Scientific title
Temperament Based Therapy with Support (TBT-S): Assessing the feasibility, acceptability and efficacy for patients and supports in Victorian tertiary eating disorder services.
Secondary ID [1] 310334 0
Nil known
Universal Trial Number (UTN)
U1111-1296-3447
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia Nervosa 331060 0
eating disorders 331061 0
Condition category
Condition code
Mental Health 327852 327852 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TBT-S is a neurobiologically informed, support-based treatment that highlights the neurobiological underpinnings of ED psychopathology, the personality traits, and the family and interpersonal dynamics of eating disorders (EDs). .
The TBT-S program in this intervention is a 4-5 day intensive multi-family program. The TBT-S program runs each day: approximately from 9am-4pm (these hours may vary slightly at each site to allow for adequate staffing). Group numbers will range between 4-8 individuals plus their support person(s). Individuals may bring up to two support people each. Both the individual experiencing an eating disorder and their support person(s) attends the duration of the program.

The program structure consists of: psychoeducation delivered by powerpoint slides in workshop style, experiential activities designed to highlight key psychoeducation points through creative, playful games involving role play and group discussions with content focusing on the neurobiology, dietetic information and temperament of people with restrictive eating disorders.

Opportunities for the group to divide into support people and individuals experiencing an eating disorder will be provided. The program involves morning tea, lunch and afternoon tea breaks in which the individuals experiencing an eating disorder will be supported by both their support person and the TBT-S facilitators to complete meals. Meals are supplied by the support person and the patient. Both the support person and patient will meet with the TBT-S dietitian prior to the program to develop a meal plan and to ensure meals brought to the program align with treatment goals. They will also meet with a TBT-S facilitator to ensure they understand the expectations of the program and group guidelines.

To ensure adherence to the intervention, each program will be supervised by direct observation by an accredited TBT-S trainer and supervisor. The TBT-S facilitation team meet daily pre and post the program to ensure adequate time for supervision and feedback.
Intervention code [1] 326732 0
Behaviour
Intervention code [2] 330570 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335723 0
To assess feasibility and acceptability of TBT-S Assessment method: Patient and Supports Satisfaction Questionnaire (CSQ-8), End of day evaluation questionnaire. The End of Day Evaluation is a non-standardised questionnaire developed by the TBT-S developers. The evaluation is used as part of the program structure.
Timepoint [1] 335723 0
On completion of 5 day treatment program for . CSQ-8 At end of each day of treatment: End of Day Evaluation.
Primary outcome [2] 340773 0
To assess clinician-reported feasibility of the TBT-S program Assessment method: Feasibility Questionnaire. This questionnaire was developed by the TBT-S developers with questions specific to the implementation of the TBT-S program. It covers topics such as amount of time clinicians spend preparing for the program, content related feedback, likelihood of continuing with TBT-S programs.
Timepoint [2] 340773 0
On completion of 5 day treatment program
Secondary outcome [1] 425348 0
Changes in ED symptoms following TBT-S treatment Assessment method: Eating Disorder Questionnaire (EDQ)
Timepoint [1] 425348 0
EDQ will be completed pre and post intervention
Secondary outcome [2] 445052 0
Change in motivation for recovery following TBT-S treatment Assessment Method: Anorexia Nervosa Stages of Change Questionnaire (ANSOC-Q)
Timepoint [2] 445052 0
ANSOC-Q will be completed pre and post intervention
Secondary outcome [3] 445053 0
Change in psychological distress and accommodation/enabling behaviours among supports following TBT-S (composite) Assessment Methods: Depression, Anxiety and Stress Scale (DASS-21) and The Accommodation and Enabling Scale for Eating Disorders (AESED).
Timepoint [3] 445053 0
DASS-21 and AESED will be completed pre and post intervention
Secondary outcome [4] 446346 0
Changes in ED symptoms, depression, anxiety, and stress will be measured together as a composite outcome Assessment method: Depression, Anxiety and Stress Scale (DASS-21)
Timepoint [4] 446346 0
Depression, Anxiety and Stress Scale (DASS-21) completed pre and post intervention

Eligibility
Key inclusion criteria
Participation is sought from three population groups:
1. Consumers: People diagnosed with anorexia nervosa-restrictive subtype, atypical anorexia nervosa, anorexia binge-purge subtype who attend the TBT-S program at their relevant mental health service. Consumers will be aged 16 or older. The consumer will be required to meet medical stability criteria as determined by their treatment team (outlined in the eating disorder management guideline at each health service) and complete the TBT-S program.
2. Support person: The term support person is used in this project to define a person who provides support for the consumer. This could be a parent, partner, relative or friend. Support people will be 16 years or older. The term ‘support’ replaces the term ‘carer’ this is to ensure the project remains aligned with the correct terminology used by the TBT-S program
3. Clinicians: Clinicians involved in the facilitation of the TBT-S program at each health service.
All participants will have the option of opting into the research project alongside the TBT-S program. In the event one of the participants choose not to engage in the research project, their engagement and attendance in the TBT-S will not be impacted in any way.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the project for the following reasons:
1. Consumer:
- Participants aged 15 years or younger
- Diagnosed with an eating disorder other than of the anorexia subset of disorders
- People not attending the TBT-S program
- Diagnosed with an intellectual disability based on the criteria in DSM-V
- People experiencing an anorexia type disorder who are medically unstable as determined by their treatment team. Due to the complications both physical and mental associated with medical instability, the participants ability to comply with the study protocol will be limited. Medical stability is determined by the eating disorder management protocol in place at each health service.
2. Supports: support people who are not attending the TBT-S program
3. Clinicians: clinicians not involved in the delivery of the TBT-S program

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
Estimated participant numbers for the entire study:
18-28 Consumers
18-34 Carers
10-17 Clinicians

This is a pilot study.
Quantitative data: Descriptive statistics will be used in the form of percentages, standard deviation and frequency distributions. Paired samples t-tests will be used to provide preliminary efficacy data.
Qualitative data will be collected through the End of Day Evaluation form (TBT-S Institute, 2022). The data will be analysed using a content analysis approach. The purpose of content analysis is to organise and elicit meaning from the data collected and to draw realistic conclusions from it. (Bengtsson, 2016). The researchers have chosen a broad surface structure (a manifest analysis) describing what the participants actually say: using the participants words and statements to draw conclusions on the data collected. The data will be analysed by a team of CEED researchers and following the four steps outlined by Bengtsson: decontextualisation, recontextualisation, categorisation, and compilation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/06/2023
Date of last participant enrolment
Anticipated
22/12/2025
Actual
Date of last data collection
Anticipated
29/12/2025
Actual
Sample size
Target
46
Accrual to date
76
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25355 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 25356 0
Orygen Youth Health - Parkville - Parkville
Recruitment postcode(s) [1] 41085 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 314539 0
Hospital
Name [1] 314539 0
Victorian Centre of Excellence in Eating Disorders (CEED)
Country [1] 314539 0
Australia
Primary sponsor type
Hospital
Name
Victorian Centre of Excellence in Eating Disorders (CEED)
Address
34-54 Poplar Rd
Country
Australia
Secondary sponsor category [1] 316520 0
None
Name [1] 316520 0
Address [1] 316520 0
Country [1] 316520 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313581 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 313581 0
Ethics committee country [1] 313581 0
Australia
Date submitted for ethics approval [1] 313581 0
27/06/2023
Approval date [1] 313581 0
27/06/2023
Ethics approval number [1] 313581 0

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

Contacts
Principal investigator
Name 128630 0
Ms Jasmin Watson
Address 128630 0
Victorian Centre of Excellence in Eating Disorders (CEED). Jane Bell House. 10 Wreckyn St, North Melbourne. VICTORIA 3051
Country 128630 0
Australia
Phone 128630 0
+6138387 2673
Fax 128630 0
Email 128630 0
[email protected]
Contact person for public queries
Name 128631 0
Jasmin Watson
Address 128631 0
Victorian Centre of Excellence in Eating Disorders (CEED). Jane Bell House. 10 Wreckyn St, North Melbourne. VICTORIA 3051
Country 128631 0
Australia
Phone 128631 0
+6138387 2673
Fax 128631 0
Email 128631 0
[email protected]
Contact person for scientific queries
Name 128632 0
Jasmin Watson
Address 128632 0
Victorian Centre of Excellence in Eating Disorders (CEED). Jane Bell House. 10 Wreckyn St, North Melbourne. VICTORIA 3051
Country 128632 0
Australia
Phone 128632 0
+6138387 2673
Fax 128632 0
Email 128632 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.