Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12622000305729
Ethics application status
Approved
Date submitted
18/10/2021
Date registered
17/02/2022
Date last updated
17/02/2022
Date data sharing statement initially provided
17/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Interprofessional Enhanced Cognitive Behaviour Therapy (CBT-IE): A pilot trial exploring the feasibility and efficacy of an interprofessional outpatient treatment in anorexia nervosa
Scientific title
Interprofessional Enhanced Cognitive Behaviour Therapy (CBT-IE): A pilot trial exploring the feasibility and efficacy of an interprofessional outpatient treatment in anorexia nervosa
Secondary ID [1] 305489 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CBT-IE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia Nervosa 323874 0
Atypical Anorexia Nervosa 323875 0
Condition category
Condition code
Mental Health 321388 321388 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interprofessional Enhanced Cognitive Behavioural Therapy (CBT-IE) is an interprofessional adaptation to Enhanced Cognitive Behavioural Therapy (CBT-E) which is a leading outpatient psychotherapeutic model for eating disorders. CBT-IE retains the structure and content of CBT-E, although it is distinct in its delegation of content regarding malnutrition, nutritional rehabilitation, and dietary restraint to the dietitian. Detailed information regarding session content can be found in Cristopher Fairburn’s (2008) book 'Cognitive behaviour therapy and eating disorders' (henceforth referred to as 'The CBT-E manual').

CBT-E is traditionally delivered in 'focused' (20 sessions) or 'broad' (40 sessions) form based on the participant's need for weight restoration to a minimum body mass index (BMI) of 20.
- Where a participant has a BMI of less than 20 at the start of treatment they will receive treatment up to 40 sessions to achieve a BMI of greater than or equal to 20. Where a participant achieves a BMI of 20 and has completed all session content detailed in the CBT-E manual prior to 40 sessions this will mark the end of treatment.
- Where a participant has a BMI of equal to or greater than 20 at the start of treatment sessions will continue until they have addressed undereating and have completed all session content detailed in the CBT-E manual to a maximum of 40 sessions.
- Sessions will be one hour in duration
- Session attendance checklists will be documented throughout the pilot trial
- The number of sessions required to achieve a minimum BMI of 20 and address undereating will determine the duration of the intervention; intervention duration may therefore vary among participants

Assessment (Sessions A1 and A2)
- The assessment stage of Interprofessional Enhanced Cognitive Behaviour Therapy (CBT-IE) involves one assessment session with the mental health professional and dietitian, respectively
- The mental health professional’s CBT-IE assessment session is conducted as per ‘The Initial Evaluation Interview’ as per the CBT-E manual
- The dietitian’s CBT-IE assessment session is conducted as per ‘The Initial Session’ of the CBT-E manual, including a standard dietetic assessment
- An interprofessional case consultation is held after A1 and A2 are completed
- Assessment sessions will be held at approximately weekly intervals

Stage One (Sessions 1 to 7)
- Stage one is focused on gaining a shared understanding of the person’s eating problem, providing education about the impact of the eating disorder, and helping the individual improve nutritional intake
- The dietitian delivers stage one of CBT-IE, adapted as per the ‘Underweight and Undereating’ chapter of the CBT-E manual
- Sessions with the mental health professional are conducted in stage one if acute and severe psychological concerns are identified
- Stage one sessions will be held at approximately weekly intervals

Stage Two (Session 8 to maximum 9)
- Stage two is a brief transitional stage involving one interprofessional case consultation followed by one or two joint sessions with the dietitian, mental health professional and the patient where progress is reviewed, and plans are made for stage three
- Although joint sessions are preferred, where this is not practical, the mental health professional should independently conduct stage two sessions without the dietitian
- Stage two sessions will be held at approximately weekly intervals

Stage Three (Sessions 9 or 10 to maximum 36)
- Stage three is focused on the processes that maintain the person’s eating problem
- Sessions are delivered by the dietitian and mental health professional in a modular or alternating format at varied frequency based on patient need
- The dietitian delivers modules ‘Underweight and Undereating’ (where still relevant after stages one and two) and ‘Dietary Restraint, ‘Dietary Rules and Controlling Eating’ as per the CBT-E manual
- The mental health professional delivers modules ‘Shape Concern, Shape Checking, Feeling Fat and Mindsets’ and ‘Events, Mood and Eating’ as per the CBT-E manual
- The dietitian delivers optional modules to address comorbid nutrition diagnoses, nutrition for physical activity, and nutrition for weight maintenance if relevant to the patient
- The mental health professional delivers optional modules to address ‘Clinical Perfectionism’, ‘Core Low Self-Esteem’, and ‘Interpersonal Relationships’ as per the CBT-E manual if relevant to the patient
- An interprofessional case consultation between the dietitian and mental health professional is held after sessions 20 and 30
- Stage three sessions are held at approximately weekly intervals if ongoing weight restoration is required, or at approximately fortnightly intervals where ongoing weight restoration is not required

Stage Four (The final 4 to 6 of maximum 40 sessions)
- Stage four is concerned with ending treatment well
- The mental health professional addresses concerns about ending treatment, discusses strategies to ensure psychological progress is maintained, and makes plans to minimise risk of lapse/relapse relating to these issues
- The dietitian discusses strategies to ensure progress is maintained with regards to dietary change, and makes plans to minimise risk of lapse/relapse relating to these issues
- The final session is a joint session between the dietitian, mental health professional and the patient
- An interprofessional case consultation between the dietitian and mental health professional is held after the final session
- Stage four sessions are held at approximately fortnightly intervals if ongoing weight restoration is required, or at approximately monthly intervals where ongoing weight restoration is not required

Interprofessional case consultations between the mental health professional and dietitian will be held after sessions 7, 20 and 30. These will be 30-60 minutes in duration. Interprofessional case consultations are included to facilitate delivery of Interprofessional Collaborative Practice which has been shown to improve health outcomes as well as the patient and clinician experience of treatment. Discussion points at interprofessional case consultations will include:
- Clinical impression
- Progress to date:
- Weight
- EDE-Q
- Barriers to change
- Formulation and proposed changes
- Any changes to the treatment plan
Intervention code [1] 321890 0
Treatment: Other
Intervention code [2] 322709 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329159 0
Body Mass Index (BMI) assessed as a composite of height measured using a stadiometer and weight measured using digital scales
Timepoint [1] 329159 0
BMI will be measured at:
- Baseline
- Session 7 (approximately 7 weeks post-intervention commencement)
- Session 20 (approximately 20 weeks post-intervention commencement)
- Session 30 (approximately 8 weeks post-intervention commencement)
- Session 40 (approximately 10 months post-intervention commencement)
- 12 months post treatment completion
Primary outcome [2] 330253 0
Eating disorder psychopathology measured with the Eating Disorder Examination Questionnaire (EDE-Q)
Timepoint [2] 330253 0
EDE-Q will be measured at:
- Baseline
- Session 7 (approximately 7 weeks post-intervention commencement)
- Session 20 (approximately 20 weeks post-intervention commencement)
- Session 30 (approximately 8 weeks post-intervention commencement)
- Session 40 (approximately 10 months post-intervention commencement)
- 12 months post treatment completion
Primary outcome [3] 330254 0
Diet quality measured using the Australian Eating Survey (AES)
Timepoint [3] 330254 0
AES will be measured at:
- Baseline
- Session 20 (approximately 20 weeks post-intervention commencement)
- Session 40 (approximately 10 months post-intervention commencement)
- 12 months post treatment completion
Secondary outcome [1] 401684 0
Team collaboration will be measured using the Assessment of Interprofessional Team Collaboration Scale-II (AITCS-II)
Timepoint [1] 401684 0
Session 40 (approximately 10 months post-intervention commencement)
Secondary outcome [2] 405475 0
Attrition will be measured by determining the number of completers as a percentage of the total intervention sample, This data will be collected via an audit of study enrolment logs.
Timepoint [2] 405475 0
Session 40 (approximately 10 months post-intervention commencement)
Secondary outcome [3] 405476 0
Psychosocial impairment will be measured using the Clinical Impairment Assessment Questionnaire
Timepoint [3] 405476 0
- Baseline
- Session 20 (approximately 20 weeks post-intervention commencement)
- Session 40 (approximately 10 months post-intervention commencement)
- 12 months post treatment completion
Secondary outcome [4] 405477 0
Dietary intake will be measured using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Timepoint [4] 405477 0
- Baseline
- Session 20 (approximately 20 weeks post-intervention commencement)
- Session 40 (approximately 10 months post-intervention commencement)
- 12 months post treatment completion
Secondary outcome [5] 406436 0
Relationship to food will be measured using the Intuitive Eating Scale
Timepoint [5] 406436 0
- Baseline
- Session 20 (approximately 20 weeks post-intervention commencement)
- Session 40 (approximately 10 months post-intervention commencement)
- 12 months post treatment completion

Eligibility
Key inclusion criteria
(1) Age 17-60
(2) Have a DSM-V diagnosis of Anorexia Nervosa or Atypical Anorexia Nervosa
Minimum age
17 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Severe physical or mental illness rendering outpatient treatment inappropriate
(2) Insufficient knowledge of English to understand the treatment, or intellectual disability
(3) Inability to complete full course of treatment
(4) Other active psychotherapy or dietetic treatment focusing on Anorexia Nervosa or Atypical Anorexia Nervosa
(5) Current substance use
(6) Pregnancy
(7) Individuals taking antidepressants/antipsychotics will not be excluded where they are on a stable dose at the commencement of treatment, that is, they have been on the same dose for a minimum of four weeks.

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
Continuous outcome data will be analysed using linear mixed-effects modelling, with restricted maximum likelihood estimation, adjusted for baseline values of the variable under investigation. Effect sizes will be calculated using Cohen's d. Recruitment, retention, and attrition rates will be calculated.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/01/2022
Date of last participant enrolment
Anticipated
30/06/2022
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment postcode(s) [1] 35471 0
6008 - Subiaco
Recruitment postcode(s) [2] 36477 0
4556 - Forest Glen

Funding & Sponsors
Funding source category [1] 309848 0
University
Name [1] 309848 0
University of Queensland
Country [1] 309848 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Human Movement and Nutrition Sciences
The University of Queensland
26b Blair Dr, St Lucia QLD 4067
Country
Australia
Secondary sponsor category [1] 310886 0
None
Name [1] 310886 0
Address [1] 310886 0
Country [1] 310886 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309586 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 309586 0
Ethics committee country [1] 309586 0
Australia
Date submitted for ethics approval [1] 309586 0
16/08/2021
Approval date [1] 309586 0
03/11/2021
Ethics approval number [1] 309586 0
2021/HE001779

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

Contacts
Principal investigator
Name 114682 0
Dr Olivia Wright
Address 114682 0
School of Human Movement and Nutrition Sciences, The University of Queensland, Human Movement Studies Building, 26b Blair Dr, St Lucia QLD 4067
Country 114682 0
Australia
Phone 114682 0
+61 7 336 56116
Fax 114682 0
Email 114682 0
[email protected]
Contact person for public queries
Name 114683 0
Megan Bray
Address 114683 0
School of Human Movement and Nutrition Sciences, The University of Queensland, Human Movement Studies Building, 26b Blair Dr, St Lucia QLD 4067
Country 114683 0
Australia
Phone 114683 0
+61458100585
Fax 114683 0
Email 114683 0
[email protected]
Contact person for scientific queries
Name 114684 0
Olivia Wright
Address 114684 0
School of Human Movement and Nutrition Sciences, The University of Queensland, Human Movement Studies Building, 26b Blair Dr, St Lucia QLD 4067
Country 114684 0
Australia
Phone 114684 0
+61 7 336 56116
Fax 114684 0
Email 114684 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.