Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001361493
Ethics application status
Approved
Date submitted
27/09/2016
Date registered
30/09/2016
Date last updated
30/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Instilling hope for a brighter future: A mentor-mentee support program for people with an eating disorder
Scientific title
Instilling hope for a brighter future: A mentor-mentee support program for people with an eating disorder
Secondary ID [1] 290221 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eating disorders 300402 0
Condition category
Condition code
Mental Health 300264 300264 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The below details have been retrieved from a published article – see below:

Nicholls D, Fogarty S, Hay P, Ramjan L, 2016, Participatory action research for women with anorexia nervosa, Nurse Researcher, vol 23, no 5, pp 26-30
For pilot 1: Anorexia Nervosa (AN) only. Pre-planning consultations took place with research team members, who consisted of a clinical psychiatrist, two specialist nurses and an allied health clinician before the commencement of the project. Pre-planning allowed for the identification of stakeholders for the study, discussion of potential risk management issues and development of a framework for a workbook to be used at the first workshop. The team considered it essential that a workbook be developed to provide some material structure for the programme. 5 mentors (recovered from Anorexia Nervosa) and 6 mentees (individuals with Anorexia Nervosa) took part in the first pilot.

Workshop: The workbook formed the basis for a workshop in which participants would learn about the support programme, and mentors and mentees would form partnerships. To develop the workshop and a workbook for the project, questions were formulated by the research team to generate discussion at the workshop. These questions were only used as a guide, but were needed to gain the views of participants before the workshop’s programme was finalised. This is consistent with Participatory Action Research (PAR), where stakeholder views are canvassed and respected. The questions concerned the following themes: matching of partners, the nature of support, roles and responsibilities, programme interaction, timelines and troubleshooting. The responses to these questions were collated and became part of the workshop.

The workshop took place on a Saturday, in a setting simulating a home environment conducive to establishing a warm atmosphere and allaying anxiety. The workshop began with introductions and an ice-breaking activity that focused on individuals’ interests. The group was then divided into sub-groups containing mentors and mentees, to lessen the chance of mentees feeling discomfort or intimidation. Later in the day, the groups were mixed as participants’ confidence grew, with some participants moving places on sofas or sitting on the floor to join different groups during the day. The sub-groups were encouraged to discuss the answers to the questions in the workbook. Butcher paper was used to record the responses. Participants also had the opportunity to express their views about the content and design of a final workbook. A selection of pictures and photographs provided by the research team and participants was shown, with the intention they be included in the final workbook. Participants were given voting slips to rank their preferences for the front cover and inside pages. The images were then incorporated into the design of the final workbook, based on these votes. Along with the images, all the participants’ responses before and during the workshop were collated and emailed to the participants for their final review.

Partnerships: As confidence levels increased during the day and they made connections, participants were keen to rank anonymously their preferences for who would be their mentor or mentee. Using a similar ranking system to that used for the images, mentors and mentees separately listed on a form their preferences for partners, from most to least preferred. The research team collected the forms and reviewed them in a separate location, returning to the group with a list of the determined pairings. Each pairing then had the opportunity to spend some time together, discussing their plans for the partnership. In one instance, there was the same mentor for two distinct pairings.
Programme Pilot over 3 months: The pairings piloted the programme over a three-month period. The programme was flexible enough that pairings could decide how often/when and how they communicated during the three months. The team stipulated a minimum of 3 face-to-face meetings, average time spent with mentor/mentee each week being approximately 1 hour of communication. The research team stipulated non-negotiables such as mentor is not a counsellor, provision of crisis care contacts and risk management plans. Two of the investigators Dr Ramjan and Dr Fogarty also monitored the partnerships at regular intervals through use of global outcome questionnaires, logbooks received from mentors/mentees, email, and phone conversations.
A final celebratory workshop was run at the completion of the program and allowed for evaluation of the effectiveness of the program through focus groups run by an independent facilitator.
For pilot 2: any Eating Disorder (ED). The same process took place as above except the number of participants increased to 10 mentors and 10 mentees and they could have any type of eating disorder. Based on feedback from the first pilot, the main difference was the inclusion of greater resources for mentors and mentees to access online during the 3 months and monthly video-conferenced catch-up sessions for mentors only to discuss progress and monthly video-conferenced sessions for all participants to join that focused on topics delivered by qualified experts such as dieticians, nurses, allied health on topics such as ‘body awareness’, ‘nutrition’ etc.
Intervention code [1] 295991 0
Treatment: Other
Intervention code [2] 295992 0
Rehabilitation
Intervention code [3] 295993 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299738 0
Qualitative evaluation of the efficacy of the program, assessed by log book entries, focus groups and individual interviews with mentors and mentees.
Timepoint [1] 299738 0
A log book recording the duration, method and issues discussed in each session/meeting will be completed by both the support mentors and mentees every two weeks. A focus group or individual interview will take place post-implementation of the program with mentors and mentees.
Primary outcome [2] 299739 0
Hope measured using the validated Domain Specific Hope Scale. A 50 item, self-report instrument for measuring an individual’s level of dispositional hope in relation to 6 life areas – social, academic, family, romance / relationships, work / occupation, and leisure activities. The higher the score the greater the level of hope. It has robust psychometrics
Timepoint [2] 299739 0
Before commencement of the program and at completion of the program
Secondary outcome [1] 327975 0
Quality of Life (measured using SF-12 (Ware, Kosinski, & Keller, 1996) & the Eating Disorder Quality of Life Scale (EDQoL) (Engel et al., 2005).

SF-12 is a 12-item self-report questionnaire that measures functional health and well-being using two subscales; the Physical component summary and the Mental component summary.

The EDQoL scale is a 25-item self-report measure assessing the degree to which an individual feels their eating disorder affects their quality of life. There are four subscales: Psychological, Physical/Cognitive, Work/School and Financial.

Timepoint [1] 327975 0
SF-12 assessed baseline (before program), midpoint - 7 weeks and completion of program.
EDQoL assessed baseline (before program), midpoint - 7 weeks and completion of program.
Secondary outcome [2] 327976 0
Distress (measured using the Kessler Psychological Distress Scale - K10 questionnaire)(Kessler et al., 2002).

The K10 is a 10-item self-report questionnaire that yields a global measure of distress based on questions about anxiety and depressive symptoms. It has robust psychometrics.
Timepoint [2] 327976 0
K10 assessed baseline (before program), midpoint-7 weeks and completion of program.
Secondary outcome [3] 328086 0
Quality of Mentoring Relationship (measured using Match Characteristic Questionnaire (MCQ) (Karcher, Nakkula, & Harris, 2005) and Global mentoring relationship questionnaire scale (GMeRQS) (Ferro, DeWit, Wells, & Lipman, 2013)).

The perception of the mentoring relationship was assessed using the validated Match Characteristic Questionnaire (MCQ). The MCQ is a 29 item, self-report instrument for measuring positive and negative perceptions of the mentoring relationship, the valuation of different purposes in the match, and the effects of external influences on the match.

The GMeRQS is a 5 item, self-report instrument assessing the mentoring relationship.
Timepoint [3] 328086 0
MCQ - completion of program.

GMeRQS - completed at Weeks 3 and 9 of the program.
Secondary outcome [4] 328087 0
Eating concerns measured using the short version eating disorder examination (EDE-Q).
Timepoint [4] 328087 0
EDE-Q (short version) completed baseline (before program), midpoint - 7weeks and post program.

Eligibility
Key inclusion criteria
Pilot 1: AN only
5 mentors (recovered from AN) and six mentees (AN sufferers)
The inclusion criteria for mentors were: 1) greater than or equal to 18 years of age; 2) self-reported recovery from AN for at least five years; 3) assessed as eligible via interview with a psychiatrist experienced with AN; and 4) female.
The inclusion criteria for mentees were: 1) greater than or equal to 18 years of age; 2) not currently receiving in-patient care for AN; and 3) female.

Pilot 2: any ED
10 mentors (recovered from ED) and 10 mentees (ED sufferers)
The inclusion criteria for mentors were: 1) greater than or equal to 18 years of age; 2) self-reported recovery from ED; 3) assessed as eligible via interview with a psychiatrist experienced with EDs.
The inclusion criteria for mentees were: 1) greater than or equal to 18 years of age; 2) not currently receiving in-patient care for ED.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children and/or young people (i.e. <18 yrs)
Currently receiving in-patient care.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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
Safety/efficacy
Statistical methods / analysis
Pilot studies - sample sizes for both trials were small and based on funding available to support trials. Pilot 1- AN sufferers only and max: 5 mentors and 5 mentees determined feasible. Pilot 2 - any ED sufferer and max: 10 mentors and 10 mentees determined feasible. The data in this project will be analysed to provide information about what AN and ED patients want and the support mentors want in a supportive mentoring program. The effectiveness of the program will also be assessed. Demographic characteristics will be analysed to describe the diversity of people participating in the study. The focus group data or interviews will be analysed qualitatively using content analysis or thematic analysis.
The questionnaires will be scored and described descriptively. The overall project will be under the umbrella of a mixed methods PAR project.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/02/2015
Date of last participant enrolment
Anticipated
Actual
9/10/2015
Date of last data collection
Anticipated
Actual
30/06/2016
Sample size
Target
30
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6745 0
Westmead Hospital - Westmead
Recruitment hospital [2] 6746 0
Northside West Clinic - Wentworthville
Recruitment postcode(s) [1] 14390 0
2145 - Westmead
Recruitment postcode(s) [2] 14391 0
2145 - Wentworthville

Funding & Sponsors
Funding source category [1] 294585 0
Charities/Societies/Foundations
Name [1] 294585 0
The Ian Potter Foundation
Country [1] 294585 0
Australia
Funding source category [2] 294586 0
University
Name [2] 294586 0
Western Sydney University
Country [2] 294586 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797
Penrith
NSW 2751
Country
Australia
Secondary sponsor category [1] 293454 0
None
Name [1] 293454 0
Address [1] 293454 0
Country [1] 293454 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296027 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 296027 0
Ethics committee country [1] 296027 0
Australia
Date submitted for ethics approval [1] 296027 0
29/09/2014
Approval date [1] 296027 0
04/11/2014
Ethics approval number [1] 296027 0
H10851

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

Contacts
Principal investigator
Name 69282 0
Dr Lucie Ramjan
Address 69282 0
c/o Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country 69282 0
Australia
Phone 69282 0
+61 2 9685 9032
Fax 69282 0
Email 69282 0
[email protected]
Contact person for public queries
Name 69283 0
Lucie Ramjan
Address 69283 0
c/o Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country 69283 0
Australia
Phone 69283 0
+61 2 9685 9032
Fax 69283 0
Email 69283 0
[email protected]
Contact person for scientific queries
Name 69284 0
Lucie Ramjan
Address 69284 0
c/o Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country 69284 0
Australia
Phone 69284 0
+61 2 9685 9032
Fax 69284 0
Email 69284 0
[email protected]

No information has been provided regarding IPD availability


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.