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Trial registered on ANZCTR


Registration number
ACTRN12621001005842p
Ethics application status
Submitted, not yet approved
Date submitted
24/05/2021
Date registered
30/07/2021
Date last updated
30/07/2021
Date data sharing statement initially provided
30/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Peer Support as an Adjunct Treatment for Eating Disorder Patients Waitlisted for Clinical Treatment
Scientific title
Investigating the effect of Peer Support on disordered eating of People with Eating Disorders Waitlisted for Treatment
Secondary ID [1] 304290 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating Disorders 322023 0
Condition category
Condition code
Mental Health 319746 319746 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The waitlist at Statewide Eating Disorder Service (SEDS) for patients with an ED for subsequent clinical treatment (inpatient, day program, outpatient treatment) is thirty to forty individuals at any given time. They will be randomized to one of three conditions: peer support, trainee health worker support, or wait-list alone. Those in the peer support group and trainee health worker group will be provided with the same book evaluated by Ranzenhofer and colleagues (2020), “Eight Keys to Recovery from an Eating Disorder” developed by a person recovered from an ED (Costin & Grabb, 2011). Individuals in both groups will have a weekly 20-minute audio call via Skype with their peer support worker to discuss the weekly chapter/materials.
Mentees will also be able to email their peer support worker for questions on the weekly content. The program will run for 8-weeks with a chapter per week from the book. People on the waitlist as normal will not receive this input. Once appointed, peer workers will participate in 2 x half days of training, using the National Eating Disorder Collaboration training material, which also involves helping people curate a version of their recovery story for sharing in public. The training will be done online via video (Zoom/Skype/Microsoft Teams) and will be led by Professor Tracey Wade (trained psychologist) and Isobel Batt-Doyle (PhD Student).
During the RCT, no last names will be used of the peer support workers and they will be assigned a first name. There will be a generic email for mentees to contact through the study which will be overseen by the PhD student. The peer support worker’s introduction bio that includes their lived experience, recovery and what they are doing now will be provided to the mentees. The trainee health worker is the PhD student, Isobel Batt-Doyle. She will not have a bio as the peer support workers do, however the same topics will be off limit and the intervention will remain the same with the exception that participants will know that they have a peer support worker not a trainee health worker.
Email will be used for the first introduction then for follow up questions during the intervention. Contact will be a 20-minute skype audio call with the mentee and peer support worker (or trainee health worker) to discuss the week’s materials. Weekly materials will include reading a chapter ("Key") and completing the activities of that Key, e.g. KEY 1: Motivation, Patience, and Hope includes the writing assignments: Your Worst Eating Disorder Day; Exploring Your Phase of Recovery; Identifying, Exploring, and Enhancing Your Motivation, and; A Day In My Life When I Am Recovered. The book “Eight Keys to Recovery from an Eating Disorder” has been developed by a trained psychologist for people who are struggling with an eating disorder to work through. It is not specifically designed to be used in conjunction with a peer support worker, however, in a study using peer mentorship, Ranzenhofer and colleagues (2020) used this book/program to base their intervention content.
Peer support workers will have a semi-manualised script to work through and will be instructed on what topics they should and should not discuss with their mentee. Certain topics will be out of bounds and if mentees ask questions the peer support worker will point them towards resources, bring back to the content, or tell them they need to talk to their care team. The audio call has been chosen versus in person or a video call to protect the peer support worker’s confidentially, eliminate body comparisons and reduce risk of relapse. Peer support workers will tell their mentees they will check in once a week, they will email at the end of the week if they have not heard from them. Mentees can email up to twice a week for any follow up questions on the content. Adherence to the intervention will be monitored by participants completing a 20minute session with their peer support worker/trainee health worker and doing the homework (weekly materials reading and activities in the book). The PhD student will supervise the peer support workers and will be supervised by Tracey Wade. Flinders University will supply the books.
All mentees will be assessed at baseline, 4- and 8-weeks post-randomisation (the latter representing the end of the intervention), and one-month after treatment commences with SEDS using questionnaires assessing dimensions of recovery. All mentors will be asked to complete questionnaires to allow for assessment of any deterioration in well-being or eating at training, and then every 3 months until the end of the project.
Intervention code [1] 320631 0
Treatment: Other
Comparator / control treatment
People in the waitlist as normal group will not receive input from a peer support worker or trainee health worker or be provided the materials as outlined above. They will experience treatment as usual as they wait for clinical treatment through SEDS.
Control group
Active

Outcomes
Primary outcome [1] 327608 0
Change in eating disorder symptoms assessed by the Global Eating Disorder Examination (EDE-Q).
Timepoint [1] 327608 0
Outcomes will be measured at baseline, during the intervention (week 4 of 8), and after the intervention (after 8 weeks).
Secondary outcome [1] 395939 0
Change in eating disorder symptoms assessed by empowerment, as measured by the Making Decisions Empowerment Scale (Rogers et al., 1997).
Timepoint [1] 395939 0
Outcomes will be measured at baseline, during the intervention (week 4 of 8), and after the intervention (after 8 weeks).
Secondary outcome [2] 399048 0
Change in eating disorder symptoms assessed by hope, as measured by the the Domain Specific Hope Scale (Sympson, 1999).
Timepoint [2] 399048 0
Outcomes will be measured at baseline, during the intervention (week 4 of 8), and after the intervention (after 8 weeks).

Eligibility
Key inclusion criteria
On waitlist for SEDS Clinical services.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria.

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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use randomization function in Qualtrics
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Linear mixed models will be used to derive between group effect sizes, an extension of simple linear models to allow both fixed and random effects and are particularly used when there is non-independence in the data, such as repeated measures. Analyses are robust in handling missing data and unbalanced designs in repeated-measures research, offering the benefits of estimation maximization (EM), which provides joint linear modelling for each individual for observed and missing data based on maximizing likelihood for population parameters as a function of observed data. Thus, all participants (regardless of missing data at one or more assessment time points) are included in the data analyses and linear estimates are obtained.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 19520 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 34118 0
5042 - Bedford Park
Recruitment postcode(s) [2] 34119 0
5048 - Brighton

Funding & Sponsors
Funding source category [1] 308665 0
University
Name [1] 308665 0
Flinders University
Address [1] 308665 0
Sturt Rd, Bedford Park SA 5042, Bedford Park
Country [1] 308665 0
Australia
Funding source category [2] 308670 0
Government body
Name [2] 308670 0
SA Health
Address [2] 308670 0
Citi Centre Building, 11 Hindmarsh Square, Adelaide, South Australia 5000
Country [2] 308670 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Rd, Bedford Park, South Australia 5042, Australia
Country
Australia
Secondary sponsor category [1] 309544 0
Government body
Name [1] 309544 0
SA Health
Address [1] 309544 0
Citi Centre Building, 11 Hindmarsh Square, Adelaide, South Australia 5000
Country [1] 309544 0
Australia
Other collaborator category [1] 281796 0
Individual
Name [1] 281796 0
Professor Tracey Wade
Address [1] 281796 0
College of Education, Psychology and Social Work, Flinders University, Sturt Rd. Bedford Park, South Australia 5042
Country [1] 281796 0
Australia
Other collaborator category [2] 281797 0
Individual
Name [2] 281797 0
Isobel Batt-Doyle
Address [2] 281797 0
College of Education, Psychology and Social Work, Flinders University, Sturt Rd. Bedford Park, South Australia 5042
Country [2] 281797 0
Australia
Other collaborator category [3] 281798 0
Individual
Name [3] 281798 0
Andrew McGregor
Address [3] 281798 0
SALHN MH Division SEDS, Citi Centre Building, 11 Hindmarsh Square, Adelaide, South Australia 5000
Country [3] 281798 0
Australia
Other collaborator category [4] 281799 0
Individual
Name [4] 281799 0
Randall Long
Address [4] 281799 0
Department of Psychiatry, Flinders Medical Centre, Flinders Drive, Bedford Park South Australia 5042
Country [4] 281799 0
Australia
Other collaborator category [5] 281800 0
Individual
Name [5] 281800 0
Isabella Ferraro
Address [5] 281800 0
SALHN MH Division SEDS, Citi Centre Building, 11 Hindmarsh Square, Adelaide, South Australia 5000
Country [5] 281800 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308592 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 308592 0
Southern Adelaide Clinical Human Research Ethics Committee, Citi Centre Building, 11 Hindmarsh Square Adelaide, South Australia 5000
Ethics committee country [1] 308592 0
Australia
Date submitted for ethics approval [1] 308592 0
21/05/2021
Approval date [1] 308592 0
Ethics approval number [1] 308592 0

Summary
Brief summary
This study seeks to examine the feasibility and effectiveness of using peer support workers with lived experience of an eating disorder (ED) in the provision of treatment for EDs. While peer support and mentorship programs have been used in general mental health, there is little research to support their use in the field of EDs. However, there is some evidence to suggest that peer-led interventions might help overcome implementation barriers to clinician-led interventions and may increase feelings of hope and empowerment and decrease ED risk factors. For individuals waitlisted for treatment with the Statewide Eating Disorder Service, we hypothesize that peer support workers with lived experience of an ED offering 8 sessions of online guided self-help using the book “Eight Keys to Recovery from an Eating Disorder” will produce larger effect size decreases in eating disorder symptoms than guided self-help using a trainee health worker or wait-list alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111254 0
Prof Tracey Wade
Address 111254 0
College of Education, Psychology and Social Work, Flinders University, Sturt Rd. Bedford Park SA 5042
Country 111254 0
Australia
Phone 111254 0
+61 8 82013736
Fax 111254 0
Email 111254 0
tracey.wade@flinders.edu.au
Contact person for public queries
Name 111255 0
Prof Tracey Wade
Address 111255 0
College of Education, Psychology and Social Work, Flinders University, Sturt Rd. Bedford Park SA 5042
Country 111255 0
Australia
Phone 111255 0
+61 8 82013736
Fax 111255 0
Email 111255 0
tracey.wade@flinders.edu.au
Contact person for scientific queries
Name 111256 0
Prof Tracey Wade
Address 111256 0
College of Education, Psychology and Social Work, Flinders University, Sturt Rd. Bedford Park SA 5042
Country 111256 0
Australia
Phone 111256 0
+61 8 82013736
Fax 111256 0
Email 111256 0
tracey.wade@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will make summaries of group data available on request to research teams who wish to examine whether this type of intervention is effective across multiple studies.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 11742 0
Ethical approval
Citation [1] 11742 0
Link [1] 11742 0
Email [1] 11742 0
batt0187@flinders.edu.au
Other [1] 11742 0
Attachment [1] 11742 0
Summary results
No Results