Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000985684
Ethics application status
Approved
Date submitted
23/08/2023
Date registered
8/09/2023
Date last updated
15/09/2024
Date data sharing statement initially provided
8/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Ten Session Intervention in the Treatment of Disordered Eating: A Randomised Controlled Pilot and Feasibility Study (ED10)
Scientific title
Ten Session Intervention comparing CBT and Guided Self-Help in the Treatment of Disordered Eating: A Randomised Controlled Pilot and Feasibility Study (ED10)
Secondary ID [1] 309879 0
None
Universal Trial Number (UTN)
Trial acronym
ED10
Linked study record

Health condition
Health condition(s) or problem(s) studied:
disordered eating 330335 0
eating disorders 330336 0
depression 330342 0
anxiety 330343 0
stress 330344 0
quality of life 330345 0
Condition category
Condition code
Public Health 327184 327184 0 0
Other public health
Mental Health 328064 328064 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention treatment will be ten session Cognitive Behaviour Therapy (CBT-T) compared to ten session guided self-help (GSH-T).

Baseline:
Assessment interviews:
• Semi-structured clinical interview based on that recommended by C. G. Fairburn (2008)
• Eating Disorder Examination 17.0D (EDE 17.0D; C. G. Fairburn, 2008), a structured, investigator-based clinical interview that generates DSM-5 eating disorder diagnoses.
Questionnaires:
• Demographic items: This questionnaire was developed for the purpose of this study. It includes information about height and weight, family structure, education, employment, weight, eating and activity history.
• Depression Anxiety and Stress Scale Short Form (DASS-21; Lovibond & Lovibond, 1995): This 21-item scale measures the participant’s negative emotional states, specifically depression, anxiety and stress. Each item is rated on a scale from ‘did not apply to me at all’ to ‘applied to me very much, or most of the time’.
• Eating Disorder Examination Questionnaire (6.0) (EDE-Q 6.0; Fairburn & Beglin, 2008) is a 28-item scale that measures behavioural components of disordered eating. A global score and four subscales can be derived: (a) restraint (b) eating concerns (c) weight concerns, and (d) shape concerns.
• Clinical Impairment Assessment Questionnaire 3.0 (CIA: Bohn & Fairburn, 2008): A 16-item scale designed to assess severity of psychosocial impairment due to eating disorder features.
• Assessment of Quality of Life 8D (AQOL 8D; Richardson et al., 2014): A 35-item health-related multi-attribute utility quality of life instrument assessing attributes of independent living, happiness, mental health, coping, relationships, self-worth, pain, and senses.
• Client measure
o Client outcome measure, satisfaction with treatment: ~40 items asks clients about their experience, specific to treatment modality (I.e., there are two separate measures with items specific to GSH-T and CBT-T). This measure also includes qualitative, open-ended questions.
o Measure intervention/appropriateness: This 9-item measure created for this project includes a range of items asking about the weekly measures length/appropriateness, and the quality, content, and length of sessions (3-point Likert scale). Measure also includes qualitative, open-ended questions.

Mid-treatment assessment:
Participants will repeat the DASS-21, EDE-Q6, CIA, AQOL 8D

Weekly monitoring:
Participants will complete the Kessler 10 and brief EDE-Q
• Brief Eating Disorder Examination Questionnaire (Brief EDE-Q6; Fairburn & Beglin, 2008): A brief 8 item version of the EDE-Q6 assessing frequency of eating disorder behaviours.
• Kessler 10 (K10; Kessler et al., 2002): A 10-item scale assessing level of psychological distress. Items are rated on a 5-point scale of 1 (All the time) to 5 (None of the time).
• Client measure intervention/appropriateness

End of treatment:
• Participants will complete the EDE clinical interview and the DASS-21, EDE-Q6, CIA, AQOL 8D.
• Client experience / satisfaction: Clients will complete the Client Rating Scale and outcome measure, as well as the measure/intervention appropriateness

Follow up (6m, 12m, 18, 24m):
Participants will complete the DASS-21, EDEQ, CIA, AQOL 8D.

These measures will be delivered via REDCap and completed online by participants.

The intervention will be delivered by provisional psychologists on placement at La Trobe University as part of their Masters of Professional Psychology (MPP) program, under the supervision of two experienced clinical psychologists.

Treatment will be delivered via telehealth consults or on campus at La Trobe University's Wodonga campus.

Each treatment group will have 10 sessions, ideally in sequential weeks, but there is some flexibility and reasonable adjustments where the treatment window can be as long at 15 weeks, where if participants are sick or have genuine reasons for missing sessions, they will not be excluded from receiving treatment. However, three consecutive weeks of cancellations will result in treatment ceasing. The sessions will last 60 minutes for CBT-T, and 30 minutes for GSH-T.

Intervention will occur via telehealth or on campus at La Trobe University's Wodonga campus.

Strategies to monitor treatment adherence are indicated above in measures and will be monitored by the treating clinician. Treatment fidelity will be monitored in weekly supervision.
Intervention code [1] 326302 0
Behaviour
Comparator / control treatment
The Ten session Guided Self Help (GSH-T) will serve as the comparator group. GSH-T will be based on the self-help cognitive behavioural therapy manual Break Free From ED (https://www.cci.health.wa.gov.au/Resources/Looking-After-Yourself/Disordered-Eating). . Participants will be provided a copy of the manual and will be guided by a clinician through the 14 self-help steps across 10 weeks. Session will last 30 minutes. Participants will be asked to read the modules in order and at a pace that enables them to engage in the matched guided session at the appropriate time (i.e., to read module 1 to 3 across week one and not skip ahead by reading multiple steps within one treatment week). Participants will be encouraged to complete all self-help activities provided in each step and to bring this work to the guided sessions. Comparator treatment occurs in the same location(s) as the intervention (mostly via telehealth, but also face-to-face at the Wodonga campus of La Trobe University).
Control group
Active

Outcomes
Primary outcome [1] 335064 0
Symptoms of disordered eating (as measured by the Eating Disorder Examination Questionnaire (EDE-Q), a brief 28 item self-report measure of disordered eating
Timepoint [1] 335064 0
Baseline, 5-sessions in, and end of 10-session treatment. Also measured weekly throughout treatment. Also measured at 6, 12, 18, and 24 month follow ups
Primary outcome [2] 335498 0
Symptoms of disordered eating as measured by the Eating Disorder Examination, which is different from the EDE-Q. The EDE is a clinical examination that takes around 60 minutes to complete.
Timepoint [2] 335498 0
Baseline, post-treatment (end of 10 session treatment)
Secondary outcome [1] 422905 0
Quality of life (as measured by the Assessment of Quality of Life tool (AQoL-8D).
Timepoint [1] 422905 0
Basline, at session 5, and end of 10-session treatment, Also measured at 6, 12, 18, and 24 month follow up.
Secondary outcome [2] 424805 0
Changes in symptoms of depression (scores on the Depression Anxiety Stress Scale (DASS-21)).
Timepoint [2] 424805 0
Baseline, mid-treatment (at session 5), and end of 10 session treatment. Also measured at 6, 12, 18, and 24 month follow up.
Secondary outcome [3] 425621 0
Client satisfaction with treatment, study specific questionnaire
Timepoint [3] 425621 0
Weekly and end of 10-session treatment.
Secondary outcome [4] 426173 0
Intervention appropriateness, study specific questionnaire
Timepoint [4] 426173 0
End of 10 session treatment

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 - >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 equal to or more than three instances per day. Haematemesis
* Psychological risk - Acute comorbid mental health disorder. Depression, Anxiety or Stress in the 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 through REDCap.
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 La Trobe University - Albury-Wodonga (LTU-AW) and Eating Disorders Victoria (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 ten-session guided-self help (GSH-T) relative to ten session Cognitive Behaviour Therapy (CBT-T) to aid in decisions concerning a full RCT (e.g., treatment outcome equivalence - completion rates, missing data, estimates, variances and 95% confidence intervals)
• Produce preliminary evidence regarding client satisfaction and clinician acceptability
• Inferential statistics will be conducted looking at the group differences (CBT-T vs. GSH-T) 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-T, GSH-T) by 3 (time: baseline, mid-treatment, post-treatment) between-groups factorial ANOVA.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/09/2023
Actual
14/09/2023
Date of last participant enrolment
Anticipated
29/11/2024
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
44
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314063 0
University
Name [1] 314063 0
La Trobe University
Country [1] 314063 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
113 McKoy St, West Wodonga, VIC. 3690
Country
Australia
Secondary sponsor category [1] 315967 0
None
Name [1] 315967 0
Address [1] 315967 0
Country [1] 315967 0
Secondary sponsor category [2] 319696 0
Other Collaborative groups
Name [2] 319696 0
Philanthropic funding
Address [2] 319696 0
Country [2] 319696 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313199 0
La Trobe University HREC
Ethics committee address [1] 313199 0
Ethics committee country [1] 313199 0
Australia
Date submitted for ethics approval [1] 313199 0
02/06/2023
Approval date [1] 313199 0
21/08/2023
Ethics approval number [1] 313199 0
HEC23211

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

Contacts
Principal investigator
Name 127322 0
Prof Leah Brennan
Address 127322 0
La Trobe University133 McKoy St, West Wodonga VIC 3690
Country 127322 0
Australia
Phone 127322 0
+61 2 6024 9743
Fax 127322 0
Email 127322 0
[email protected]
Contact person for public queries
Name 127323 0
Leah Brennan
Address 127323 0
La Trobe University 133 McKoy St, West Wodonga VIC 3690
Country 127323 0
Australia
Phone 127323 0
+61 2 6024 9743
Fax 127323 0
Email 127323 0
[email protected]
Contact person for scientific queries
Name 127324 0
Leah Brennan
Address 127324 0
La Trobe University133 McKoy St, West Wodonga VIC 3690
Country 127324 0
Australia
Phone 127324 0
+61 2 6024 9743
Fax 127324 0
Email 127324 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 July 2024 on the OSF where it will remain indefinitely.
Available to whom?
The OSF information is available to anyone with an internet connection.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
On the Open Science Framework (OSF). Please contact the study coordinator or 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.