Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000101684
Ethics application status
Approved
Date submitted
16/01/2023
Date registered
27/01/2023
Date last updated
27/01/2023
Date data sharing statement initially provided
27/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of different approaches to helping people get more out of therapy for non-underweight eating disorders
Scientific title
An adaptive trial design evaluating use of varying wait lists on the severity of disordered eating in people with non-underweight eating disorders
Secondary ID [1] 308766 0
Nil
Universal Trial Number (UTN)
U1111-1287-1029
Trial acronym
Preparing Ourselves With Early changes to Restriction (POWER)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eating disorders 328712 0
Condition category
Condition code
Mental Health 325722 325722 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The initial 90-minute semi-structured interview assessment will be conducted at the Flinders University Services for Eating Disorders clinic by a trainee psychologist. The assessment follows a semi-structured outline, and includes 4 motivational aspects: (1) examining the pros and cons of the eating disorder, (2) examining readiness and confidence to change and barriers to having higher ratings, (3) development of a personalised vicious cycle, and (4) examination of the advantages of change, fears about change, and responses to these fears. The interventions are described and the patient is asked whether they wish to commit to the treatment.

People who are suitable and interested to progress will be randomised to one of three 2-week wait-list conditions, single session interventions (SSI) informed by work from Jessica Schleider’s laboratory: growth mindset, behavioural activation and non-suicidal self-injury. All of the SSIs are contained in word documents that the person can do online or in hard copy, and include information and interactive exercises. Participants will be asked to spend 1 hour at the beginning of the 2-week waitlist completing the SSI. Compliance will be assessed using one question about how much was read at the second assessment, and also by the therapist asking them to discuss the last exercise in the SSI with them. The growth mindset SSI contains information about how we can shape our thoughts and feelings by changing our behaviours and the connections in our brains and the importance of nutrition in allowing the brain to adapt. The behavioural activation SSI discusses 4 actions that can improve mood: (1) Connecting with people who make you feel good; (2) Achieving goals that matter to you; (3) Enjoying activities on your own; (4) Feeding your brain. The non suicidal self-injury SSI discusses techniques for ceasing cease self-harming behaviours.

Those participants who decrease restriction (assessed using the dietary restriction subscale of the Eating Disorder Examination Questionnaire) by 30% at the end of the 2-week waitlist will be allocated to an online guided 10-session CBT-ED delivered weekly with therapist contact for 30-50 minutes each week. Those who show less response will be allocated face-to-face 10-session CBT-T, offered weekly for 50 minutes each session. The main difference between these two forms of CBT are that CBT-T includes a large component of body image work, while the online CBT focuses more on time on motivation. This approach is informed by a very consistent and large body of research showing that early response is the strongest and most consistent predictor of good outcome, and that people with non-underweight eating disorders who experience this early change do well with guided self-help CBT-ED.

For each form of CBT the therapist is a postgraduate Clinical Psychology trainee, provisionally registered. Adherence to sessions will be monitored by attendance at sessions, whether online or face-to-face.
Intervention code [1] 325217 0
Treatment: Other
Intervention code [2] 325288 0
Behaviour
Comparator / control treatment
The waitlist has three conditions: growth mindset, behavioural activation and tackling non-suicidal self-injury. The first two conditions are intervention conditions as they overtly discuss dietary restriction while the non-suicidal self-injury condition does not and thus is the active control condition.
Subsequent allocation to one of two conditions depends on response to these conditions. Those participants who decrease restriction by 30% at the end of the 2-week waitlist will be allocated to an online guided 8-session CBT-ED. Those who show less response will be allocated face-to-face 10-session CBT-T.
Control group
Active

Outcomes
Primary outcome [1] 333569 0
Eating Disorder Examination Questionnaire - Global score
Timepoint [1] 333569 0
24-weeks post-initial assessment
Secondary outcome [1] 417558 0
Eating Disorder 15 assessing severity of body image disturbance and frequency of binge eating, restriction, laxative or diuretic use, driven exercising.
Timepoint [1] 417558 0
2, 6, 12, 16, 24 weeks post-initial assessment
Secondary outcome [2] 417559 0
Severity of psychosocial impairment due to eating disorder assessed using the Clinical Impairment Assessment
Timepoint [2] 417559 0
2, 6, 12, 16, 24 weeks post-initial assessment
Secondary outcome [3] 417560 0
Recovering Quality of Life (ReQoL) Questionnaire, the 20-item version
Timepoint [3] 417560 0
2, 6, 12, 16, 24 weeks post-initial assessment
Secondary outcome [4] 417561 0
Mental health assessed using the Depression, anxiety and stress scales (DASS 21)
Timepoint [4] 417561 0
2, 6, 12, 16, 24 weeks post-initial assessment
Secondary outcome [5] 417562 0
Body Image-Acceptance and Action Questionnaire
Timepoint [5] 417562 0
2, 6, 12, 16, 24 weeks post-initial assessment
Secondary outcome [6] 417563 0
Self-Critical Rumination Scale
Timepoint [6] 417563 0
2, 6, 12, 16, 24 weeks post-initial assessment

Eligibility
Key inclusion criteria
(1) age 15 years and above; (2) body mass index greater than or equal to 18.5; (3) a DSM-5 eating disorder diagnosis excluding binge eating disorder; and (4) involvement of the general practitioner.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
substance dependence, active psychosis, high suicidality, or difficulty understanding or speaking English

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)
Central randomisation by computer program - generated by using the Web site Randomization.com http://www.randomization.com
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Adaptive trial - allocation to the form of CBT (face to face or online guided) depends on response to the waitlist conditions
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed models adjusting for baseline observations

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/01/2023
Date of last participant enrolment
Anticipated
20/12/2024
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
86
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 39296 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 312989 0
University
Name [1] 312989 0
In kind support - Flinders University
Country [1] 312989 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100, Adelaide, South Australia, 5001
Country
Australia
Secondary sponsor category [1] 314672 0
Individual
Name [1] 314672 0
Tracey Wade
Address [1] 314672 0
Flinders University, GPO Box 2100, Adelaide, South Australia, 5001
Country [1] 314672 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312252 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 312252 0
Flinders University
Sturt Road, Bedford Park, South Australia, 5042
GPO Box 2100, Adelaide, South Australia, 5001
Ethics committee country [1] 312252 0
Australia
Date submitted for ethics approval [1] 312252 0
10/10/2022
Approval date [1] 312252 0
21/12/2022
Ethics approval number [1] 312252 0
5857

Summary
Brief summary
The primary purpose of the study is to investigate if we can individualise treatment for non-underweight eating disorders in response to initial changes in dietary restriction.
We hypothesise that:
(1) Single session interventions tackling growth mindset or behavioural activation (both which will reinforce a message of decreasing restriction delivered in assessment) will significantly reduce dietary restriction over a waitlist period before participants receive cognitive behaviour therapy for eating disorders (CBT-ED) compared to a non-suicidal self-injury single session intervention.
(2) Those people whose dietary restriction decreases by 50% over the waitlist period and receive the less intensive version of CBT-ED (online guided self-help) will benefit commensurately to those whose dietary restriction does not decrease and who receive a more intensive form of CBT-ED (CBT-T).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123998 0
Prof Tracey Wade
Address 123998 0
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 123998 0
Australia
Phone 123998 0
+61 882013736
Fax 123998 0
+61882013877
Email 123998 0
tracey.wade@flinders.edu.au
Contact person for public queries
Name 123999 0
Prof Tracey Wade
Address 123999 0
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 123999 0
Australia
Phone 123999 0
+61 882013736
Fax 123999 0
+61882013877
Email 123999 0
tracey.wade@flinders.edu.au
Contact person for scientific queries
Name 124000 0
Prof Tracey Wade
Address 124000 0
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 124000 0
Australia
Phone 124000 0
+61 882013736
Fax 124000 0
+61882013877
Email 124000 0
tracey.wade@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified data at each time point: all of the individual participant data collected during the trial
When will data be available (start and end dates)?
By the end of 2025 then permanently available
Available to whom?
Researchers
Available for what types of analyses?
Replication studies and meta-analyses
How or where can data be obtained?
The data will be placed on Tracey Wade's Open Science Framework repository site: https://osf.io/rtzv3/


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
SourceTitleYear of PublicationDOI
EmbaseDeveloping the "single-session mindset" in eating disorder research: Commentary on Schleider et al., 2023 "Realizing the untapped promise of single-session interventions for eating disorders".2023https://dx.doi.org/10.1002/eat.23930
N.B. These documents automatically identified may not have been verified by the study sponsor.