Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000096550
Ethics application status
Approved
Date submitted
15/09/2023
Date registered
2/02/2024
Date last updated
2/02/2024
Date data sharing statement initially provided
2/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Stepped Care in the Treatment of Disordered Eating: A Randomised Controlled Pilot and Feasibility Study
Scientific title
Stepped Care in the Treatment of Disordered Eating: A Randomised Controlled Pilot and Feasibility Study Comparing CBT-E to Guided-Self Help.
Secondary ID [1] 310224 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eating disorder 330911 0
Condition category
Condition code
Mental Health 327694 327694 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Extended/Enhanced Cognitive Behavioural Therapy (CBT-E)
CBT-E is an evidence-based, transdiagnostic treatment for eating disorders that can be applied to all diagnostic categories of eating disorders including anorexia nervosa, bulimia nervosa, and binge eating disorder and other disordered eating presentations (C. G. Fairburn, 2008). The general protocol is described in ‘Cognitive Behavior Therapy and Eating Disorders’ (C. G. Fairburn, 2008) and will be followed in this study. CBT-E consists of a 20-session course of treatment offered over 20 weeks covering four distinct therapeutic stages - starting well (building rapport, regular eating), taking stock (identifying barriers to treatment), addressing maintaining factors (checking behaviours), and ending well (ways of maintaining progress). Each session runs for 50-60 minutes. At the end of treatment, the CBT-E group will have received 20 sessions over 20 weeks (i.e., weekly sessions).
Provisional psychologists will be delivering treatment under the supervision of multiple experienced clinical psychologists. Treatment will be delivered primarily face-to-face, but participants will have the option of telehealth. Treatment adherence will be monitored and documented closely by the treating clinician (a provisional psychologist), including session attendance, and will be a check=in topic for supervision sessions with the clinician's supervisor.

Provisional psychologists will receive training over the course of the month before beginning to see clients. This involves attending training with their clinical supervisor (i.e., Kim Haebich and/or Annemarie Hindle) and experts in the field (e.g., Tracey Wade) on delivering CBT-E and GSH, as well as watching recordings of additional psychotherapy training from these same individuals. Training modes will mostly be online, however, some clinical supervision with their primary supervision (KH) will be face to face.
Intervention code [1] 326613 0
Behaviour
Comparator / control treatment
Guided Self-Help Stepped Care (GSH-SC)
GSH will be based on the self-help cognitive behavioural therapy manual Overcoming Binge Eating (Fairburn, 2013). This manual is recommended for treating eating disorders under the transdiagnostic model of eating disorders (i.e., it applies across diagnoses) and has shown to be non-inferior to standard cognitive behavioural therapy for eating disorders (Carter & Fairburn, 1998; Peterson et al., 2020). Participants will be provided a copy of the manual and will be guided by a clinician through the 9 self-help steps across 16 weeks. Participants will be asked to read the chapters in order and at a pace that enables them to engage in the matched guided session at the appropriate time (i.e., to read step one across week one and not skip ahead by reading multiple steps within one treatment week). Chapter readings vary, but will take most clients around 15 to 20 minutes to complete. Participants will be encouraged to complete all self-help activities provided in each step and to bring this work to the guided sessions. Each GSH session will be of 30 minutes duration with the following general structure: 15 minutes review of self-help tasks completed, 15 minutes facilitating discussion / problem solving and planning for the following self-help step. The content of the manual includes, from the Centre for Clinical Interventions (CCI):

Module 1: What are Eating Disorders?
This module introduces you to eating disorders, their impact on physical, psychological and social functioning, and some of the factors that can lead to the development of an eating disorder.

Module 2: What Keeps Eating Disorders Going?
This module takes you through the key factors that keep eating disorders going and introduces you to the ways in which this workbook will address each of these factors.

Module 3: Understanding the Number on the Scale
This module discusses the many factors that influence the number on the scale, explores how much control people really have over their weight, and introduces Weekly Weighing.

Module 4: Self-monitoring
This module introduces self-monitoring, a key strategy that assists you to record your eating behaviours, thoughts, and feelings in real time, focusing on patterns occurring throughout each week.

Module 5: Food and Energy
This module discusses the relationship between what you eat and your energy levels, highlighting the impacts of low and high energy and guiding you through understanding how your own eating impacts your energy levels.

Module 6: Eating for Recovery - Part 1
This module introduces you to ‘Eating for Recovery’, focusing on establishing regular and adequate nutritional intake, and providing guidelines for change in these areas.

Module 7: Eating for Recovery - Part 2
This module focuses on another aspect of ‘Eating for Recovery’, the variety of your nutritional intake, highlighting the importance of tackling rigid food rules and experimenting with feared foods.

Module 8: Binge Eating
This module provides information about binge eating and introduces strategies for reducing and ceasing this behaviour.;

Module 9: Purging
This module provides information about purging and introduces strategies for reducing and ceasing this behaviour.

Module 10: Driven Exercise
This module provides information about driven exercise and introduces strategies for developing a more healthy and balanced relationship with moving your body.

Module 11: Body Image 1 - Body Checking
This module discusses body checking and uses experiments to examine whether body checking is as helpful as you think and how we can reduce it.

Module 12: Body Image 2 - Body Avoidance
This module discusses body avoidance and introduces exposure experiments to reduce body avoidance.

Module 13: Core Beliefs
This module introduces core beliefs, discussing the role these play in maintaining eating disorder behaviours and introducing strategies to challenge them.

Module 14: Maintaining Your Gains and Dealing with Setbacks
This final module summarises the key strategies from the workbook and guides you through developing a plan for maintaining your gains and dealing with setbacks.



In accordance with the National Institute for Health and Care Excellence (NICE) Guidelines for stepped care approaches to the treatment of eating disorders, participants in the GSH-SC group will be assessed at the end of the fifth guided session to determine treatment response. Assessment will involve repeating the battery of online tests conducted at baseline. Where treatment response is good (i.e., reduction in EDE-Q global score to less than 2.3 and / or reduction in binge / purge frequency of at least 70% (Linardon et al., 2016)) these participants will continue in GSH and complete the remaining 4 GSH steps for a total of 9 GSH sessions across 16 weeks.

For participants in the GSH-SC group whose treatment response is poor after the fifth GSH session (i.e., either less than 70% reduction in binge/purge frequency and / or EDE-Q global score greater than 2.3 (Linardon et al., 2016)), these participants will be “stepped up” to a full course of CBT-E beginning at CBT-E session 1. At the end of treatment, the “stepped up” group will have received 24 weeks of treatment consisting of 4 weeks (5 sessions) of GSH and 20 weeks (20 sessions) of CBT-E.

Treatment adherence will be monitored and documented closely by the treating clinician (i.e., a provisional psychologist), including session attendance, and will be a check=in topic for supervision sessions with the clinician's supervisor
Control group
Active

Outcomes
Primary outcome [1] 335499 0
Symptoms of disordered eating (as measured by the Eating Disorder Examination Questionnaire; EDE-Q)
Timepoint [1] 335499 0
Baseline, weekly during treatment, mid-treatment, end of treatment, and post-treatment follow ups (6-months, 12-months, 18-months, and 24-months post-baseline)
Primary outcome [2] 335500 0
Symptoms of disordered eating as measured by the Eating Disorder Examination (EDE). The EDE is a clinical examination that takes around 60 minutes to complete, and is different from the EDE-Q, which is a brief 28 item self-report questionnaire.
Timepoint [2] 335500 0
Baseline and post-treatment (immediately following completion of last session)
Secondary outcome [1] 424806 0
Quality of life as measured by the Assessment of Quality of Life tool (AQoL-8D).
Timepoint [1] 424806 0
Baseline, weekly during treatment, mid-treatment, end of treatment, and post-treatment follow ups (6-months, 12-months, 18-months, and 24-months post-baseline)
Secondary outcome [2] 424807 0
Depression as measured by the Depression Anxiety Stress Scale (DASS-21).
Timepoint [2] 424807 0
Baseline, weekly during treatment, mid-treatment, end of treatment, and post-treatment follow ups (6-months, 12-months, 18-months, and 24-months post-baseline)
Secondary outcome [3] 430421 0
Anxiety via the DASS-21
Timepoint [3] 430421 0
Baseline, weekly during treatment, mid-treatment, end of treatment, and post-treatment follow ups (6-months, 12-months, 18-months, and 24-months post-baseline)
Secondary outcome [4] 430422 0
Stress via the DASS-21
Timepoint [4] 430422 0
Baseline, weekly during treatment, mid-treatment, end of treatment, and post-treatment follow ups (6-months, 12-months, 18-months, and 24-months post-baseline)
Secondary outcome [5] 430423 0
Intervention descriptive statistics, including retention rates audited from study data tracking sheet.
Timepoint [5] 430423 0
baseline, mid-treatment, end of treatment. No follow ups will be conducted for this outcome.
Secondary outcome [6] 431106 0
recruitment rate audited from study data tracking sheet.
Timepoint [6] 431106 0
Assessed at the conclusion of the recruitment period,
Secondary outcome [7] 431107 0
compliance (treatment and attendance based) review from study data tracking sheet.
Timepoint [7] 431107 0
baseline, mid-treatment, end of treatment. No follow ups will be conducted for this outcome.

Eligibility
Key inclusion criteria
* Age - 18 years or older
• Disordered eating - Diagnosis of bulimia nervosa (BN), binge-eating disorder (BED), other-specified feeding or eating disorder (OSFED), unspecified feeding or eating disorder (UFED), based on EDE 17.0D assessment
• Medical monitoring- Participant has a GP who is aware of participant’s disordered eating. Both participant and GP are willing to conduct medical monitoring during the trial. At a minimum, medical monitoring will include a medical assessment prior to study commencement, and at any point at which (i) the treating clinician deems it appropriate (e.g., where there are indicators of medical risk or instability) or (ii) the GP deems it necessary.Consent is provided by the participant for treating clinicians to share clinical information with their nominated GP and any other members of their treating team (e.g., dietician, psychiatrist) and for the GP to share clinical information with the treating clinician.
• Suicide risk - No thoughts of suicide or self-harm, OR Irregular or fleeting thoughts of suicide or self-harm without intent or plan. Self-harm does not include binge eating, purging, laxative use or excessive exercise occurring as a symptom of disordered eating.
• Medically Stable Blood pressure, heart rate, Biochemistry including electrolytes indicate medical stability as assessed by the GP. No current rapid weight loss
• Purging behaviour Low frequency. Fewer than 3 instances per day
• Psychological risk No comorbid severe mental health disorder (e.g., depression, anxiety symptoms in the severe to extremely severe range) OR Symptoms likely to interfere with engagement in treatment (e.g., active psychosis)
• Recent hospital admission No eating disorder or other psychiatric (including self-harm) related hospital admission in previous 12 months.
• Drug and alcohol No drug and alcohol issues
• BMI BMI >17.5kg/m2
• Weight loss No significant rapid weight loss in previous 3 to 6 months
• Structure/supervision required for eating/weight gain Must demonstrate some level of independent eating
• Social and clinical supports Present (e.g., stable and safe housing, supportive family/friends/or living arrangements)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Age - under 18 years
* Disordered eating - Diagnosis of Anorexia nervosa (AN). No diagnosis of an eating disorder
* Medical monitoring - Participant does not want GP involved or unable to establish regular GP monitoring.
* Suicide risk - Regular thoughts or intent of suicide or self-harm, OR Current plan OR Previous attempts OR Serious and intentional self-harm
* Medically stable - Medically unstable i.e. Blood pressure, heart rate, electrolytes, cardiac function indicate medical instability or risk as assessed by the GP, OR Rapid weight loss (current), severe emaciation, OR Severe unstable medical comorbidity (e.g., unstable diabetes)
* Purging behaviour - Purging after every food/fluid intake or = than three instances per day. Haematemesis
* Psychological risk - Acute comorbid mental health disorder. Depression, Anxiety or Stress in Severe category (DASS21). Symptoms of psychosis
* Recent hospital admission - Long eating disorder or psychiatric (including self-harm) related admission history with minimal recovery OR Eating disorder or psychiatric (including self-harm) related hospital admission in previous 12 months.
* Drug and alcohol - Current active or untreated drug and alcohol use
* BMI - BMI less than 17.5kg/m2
* Weight loss - Experienced rapid weight loss across the past 3 to 6 months (e.g., a weight loss of more than 10-15% of total body mass in 3 – 6 months)
* Structure/supervision required for eating/weight gain - Supervision required at all meals
* Social and clinical supports - Not present

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)
Allocation will be completed by a researcher who is not involved with determining participant inclusion in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised random sequence generator will be used via REDCap administered by the study coordinator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive / basic inferential statistics such as means, SD, frequencies, t-tests, correlations, descriptive qualitative data for feasibility outcomes such as:
• Rate of recruitment, study retention rates (to end of treatment and follow up assessment) and compliance with allocated intervention (e.g., appointment attendance)
• Piloting the most appropriate outcome measures (i.e., assessing the balance between comprehensiveness and client-acceptability)
• Training and supervision capacity, degree of training required for competency, case load capacity of provisional psychologists working within an RCT
• Logistical load for EDV in terms of therapy / waiting room capacity and onsite supervision
• Estimate cost effectiveness based on (i) the Australian Medicare funding model and (ii) based on continuing a training-research and treatment partnership with EDV
• Estimate parameters related to treatment outcome (such as group variance) used to estimate sample size for a full-scale trial.
• Produce preliminary treatment outcome data of the performance of GSH-SC relative to CBT-E to aid in decisions concerning a full RCT (e.g., treatment outcome equivalence - completion rates, missing data, estimates, variances and 95% confidence intervals)
• Inferential statistics will be conducted looking at the group differences (CBT-E vs. GSH) on client psychosocial outcomes pre, during, and at the end of treatment, as well as at 6, 12, 18, and 24 month follow ups. These will be assessed through a series of analysis of variance (ANOVA) tests. For example, we will conduct a 2 (treatment group: CBT-E, GSH) by 3 (time: baseline, mid-treatment, post-treatment) between-groups factorial ANOVA.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/02/2023
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
100
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314386 0
University
Name [1] 314386 0
La Trobe University
Country [1] 314386 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
133 McKoy Street West Wodonga, VIC, 3690
Country
Australia
Secondary sponsor category [1] 316815 0
None
Name [1] 316815 0
Address [1] 316815 0
Country [1] 316815 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313480 0
La Trobe Human Ethics Committee
Ethics committee address [1] 313480 0
Ethics committee country [1] 313480 0
Australia
Date submitted for ethics approval [1] 313480 0
04/05/2022
Approval date [1] 313480 0
02/06/2022
Ethics approval number [1] 313480 0
HEC21425

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

Contacts
Principal investigator
Name 128314 0
Prof Leah Brennan
Address 128314 0
La Trobe University, Wodonga, 133 McKoy Street West Wodonga, VIC, 3690
Country 128314 0
Australia
Phone 128314 0
+61 2 6024 9743
Fax 128314 0
Email 128314 0
[email protected]
Contact person for public queries
Name 128315 0
Leah Brennan
Address 128315 0
La Trobe University, Wodonga, 133 McKoy Street West Wodonga, VIC, 3690
Country 128315 0
Australia
Phone 128315 0
+61 2 6024 9743
Fax 128315 0
Email 128315 0
[email protected]
Contact person for scientific queries
Name 128316 0
Leah Brennan
Address 128316 0
La Trobe University, Wodonga, 133 McKoy Street West Wodonga, VIC, 3690
Country 128316 0
Australia
Phone 128316 0
+61 2 6024 9743
Fax 128316 0
Email 128316 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?
To support open science, after the study has been submitted for publication, a complete dataset that has been cleaned, screened, and de-identified will be uploaded to the Open Science Framework (OSF), including all non-identifiable participant data collected during the trial.
When will data be available (start and end dates)?
Estimated that we will be ready to upload the most of the data (excluding all follow up data as this will not be complete) by December 2024 on the OSF where it will remain indefinitely.
Available to whom?
OSF is available to anyone with an internet connection.
Available for what types of analyses?
Any purpose, no restrictions
How or where can data be obtained?
On the Open Science Framework (OSF). Please contact the study coordinator for interim data requests: [email protected]


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.