Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001448831
Ethics application status
Approved
Date submitted
31/08/2021
Date registered
25/10/2021
Date last updated
2/09/2022
Date data sharing statement initially provided
25/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Focused Minds Program: Evaluating the effect of an online intervention on perfectionism and disordered eating
Scientific title
Evaluation of an online perfectionism intervention targeted towards young adults considered at-risk of developing an eating disorder.
Secondary ID [1] 305173 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disordered Eating
 323442 0
Perfectionism 323822 0
Condition category
Condition code
Mental Health 320995 320995 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised in one of three groups for the trial: an active control group, a waitlist group, or an intervention group.

Intervention group: Participants will be given access to an online intervention. The intervention program will be self-guided with a researcher’s email address provided for optional support. The intervention will consist of 8 online modules, each requiring approximately 20 minutes. Content for these modules has been adapted from the self-help guide "Overcoming Perfectionism" by Roz Shafran, Sarah Egan, and Tracey Wade. The modules consist of cognitive behavioural therapy activities designed to challenge the participants' perfectionistic thoughts and behaviours. The sessions used short videos, reflection exercises, thought diaries, and behaviour monitoring worksheets. Participants are encourage to complete activities both online and using downloadable Word documents. Participants are recommended to complete 2 sessions per week. Participants will complete weekly measures for four weeks to assess for symptoms of perfectionism and disordered eating. Weekly measures will be emailed to participants at the end of each week using survey invitation links from Qualtrics (survey hosting platform). Links to these surveys will expire 6 days after being distributed. Participants will be asked to complete the measures irrespective of whether they have engaged with the online program. Each survey is expected to take approximately 5 minutes to complete; the baseline and end of treatment surveys are expected to take approximately 10 minutes to complete. The intervention website can be accessed from the following link: https://www.focusedmindsprogram.com/
Adherence to the intervention will be monitored through self-report items in the weekly surveys as well as through the 'Visitor Analytics' section of the website dashboard. The Visitor Analytics is able to provide information relating to average number of minutes spent accessing the website, number of pages accessed, and number of times the website was accessed. Visitor Analytics is not able to provide information about individual website users.
Intervention Outline:
Session 1: Provides psychoeducation about what is perfectionism and why perfectionism is different to having high standards. Session activity addresses the consequences of reducing perfectionism or staying the same.
Session 2: Provides psychoeducation about what factors maintain a person’s perfectionism. Session activity requires the participant to create their own cycle of perfectionism.
Session 3: Provides psychoeducation about the cognitive-behavioural model of psychology and introduces thinking styles that can feed into a person’s perfectionism.
Session 4: Provides psychoeducation around self-criticism and self-compassion. Session activity involves practicing self-compassion and challenging the inner self-critic.
Session 5: Addresses procrastination and why procrastination can be a by-product of perfectionism. Session activities explore ways of tackling procrastination.
Session 6: Addresses some of the common misconceptions that exist around the benefits of being a perfectionist and overworking. Session activity includes using a schedule to plan pleasurable activities and breaks.
Session 7: Involves a self-reflection of what contributes to the participant’s self-worth. The session activity involves creating a self-worth pie chart.
Session 8: Summarises the previous sessions’ content. Session activity involves creating a relapse management plan.

Active control group: Participants will be given access to the Clinical Centre for Interventions’ Perfectionism modules. These modules will be made available after logging in to the relevant page of the Focused Minds website (https://www.focusedmindsprogram.com/). Each session will include a downloadble pdf handout. Each handout requires participants to complete cognitive-behavioural activities on the pdf. Sessions are expected to take approximately 20 minutes to complete, although some exercises may require behaviour monitoring over 3-4 days. Full content for these modules can be accessed from: https://www.cci.health.wa.gov.au/Resources/Looking-After-Yourself/Perfectionism.
Intervention outline:
Session 1: Provides psychoeducation around perfectionism, addresses helpful and unhelpful aspects of being a perfectionist.
Session 2: Addresses the possible reasons underlying a person’s perfectionism.
Session 3: Addresses the maintenance factors which keep perfectionism going.
Session 4: Uses a cost-benefit analysis to identify reasons to change or reasons to continue being a perfectionist.
Session 5: Identifies ways to challenge and change thoughts that keep perfectionism going. Introduces strategies to help identify perfectionistic thinking.
Session 6: Identifies the rules and assumptions which a person with perfectionism may use to help them achieve their high standards.
Session 7: Addresses the importance placed on achievement and looks at ways to re-evaluate achievement.
Session 8: Provides a summary of all previous sessions and creates a plan for the continuation of using the techniques learnt in these modules.
Participants are recommended to complete two perfectionism modules per week, over the course of four weeks. Participants will have access to all modules at all time during the course of their enrolment, although they are encouraged to complete the modules in the order provided. Participants will complete weekly measures to assess for symptoms of perfectionism and disordered eating. Weekly measures will be emailed to participants at the end of each week using survey invitation links from Qualtrics (survey hosting platform). Links to these surveys will expire 6 days after being distributed. Participants will be asked to complete the measures irrespective of whether they have engaged with the pdf handouts. Each survey is expected to take approximately 5 minutes to complete; the baseline and end of treatment surveys are expected to take approximately 10 minutes to complete. Participants will be sent one reminder email 3 days after the survey is distributed prompting them to complete the survey if they have not already done so. Adherence to the program will be monitored through self-report items in the weekly surveys.
Intervention code [1] 321575 0
Prevention
Intervention code [2] 321840 0
Treatment: Other
Comparator / control treatment
Waitlist control group: Participants will be given access to the online intervention (Focused Minds program) after eight weeks. Participants will complete weekly measures for four weeks during the waitlist period in order to assess symptoms of perfectionism and disordered eating. Weekly measures will be emailed to participants at the end of each week using survey invitation links from Qualtrics (survey hosting platform). Links to these surveys will expire 6 days after being distributed. Each survey is expected to take approximately 5 minutes to complete; the baseline and end of treatment surveys are expected to take approximately 10 minutes to complete.
Control group
Active

Outcomes
Primary outcome [1] 328777 0
Frost Multidimensional Perfectionism Scale: Concern over mistakes subscale
Timepoint [1] 328777 0
One weeks post-enrolment in online intervention program. Two weeks post-enrolment in online intervention program. Three weeks post-enrolment in online intervention program. Four weeks post-enrolment in online intervention program (primary time-point)
Primary outcome [2] 328780 0
Weight Concern Scale score
Timepoint [2] 328780 0
One weeks post-enrolment in online intervention program. Four weeks post-enrolment in online intervention program (primary time-point).
Secondary outcome [1] 400298 0
Eating Disorder - 15 scale
Timepoint [1] 400298 0
One week post-enrolment in online intervention program. Two weeks post-enrolment in online intervention program. Three weeks post-enrolment in online intervention program. Four weeks post-enrolment in online intervention program.
Secondary outcome [2] 400300 0
Depression Anxiety Stress Scale
Timepoint [2] 400300 0
One weeks post-enrolment in online intervention program. Four weeks post-enrolment in online intervention program.
Secondary outcome [3] 400301 0
The forms of self-criticising/attacking and self-reassuring scale
Timepoint [3] 400301 0
One weeks post-enrolment in online intervention program. Four weeks post-enrolment in online intervention program.
Secondary outcome [4] 401520 0
Credibility Expectancy Questionnaire
Timepoint [4] 401520 0
Two weeks post-enrolment in online intervention program. Four weeks post-enrolment in online intervention program.
Secondary outcome [5] 401523 0
Warwick Edinburgh Mental Wellbeing Scale
Timepoint [5] 401523 0
One weeks post-enrolment in online intervention program. Four weeks post-enrolment in online intervention program.

Eligibility
Key inclusion criteria
Weight or body image concerns (measured by the Weight Concern Scale score of >46).
Self-identified difficulties with perfectionism.
English proficiency.
Minimum age
17 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age outside of the selected bracket (17-25 years old)
Currently receiving treatment for an eating disorder
Active psychosis

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of participants performed via Qualtrics survey (online randomisation).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Performed by Qualtrics survey (online randomisation).
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
Main statistical analysis: To compare the reduction in disordered eating symptoms across three groups (active control, waitlist, and intervention) at post-intervention.

Secondary statistical analysis: To compare the reduction in all observed symptoms across three groups (active control, waitlist, and intervention) at post-intervention.

Estimated effect size: 0.6
Power level: 0.8
Alpha level: 0.05
Approximate number of participants need = 165 (55 participants per group)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/09/2022
Actual
Date of last participant enrolment
Anticipated
8/09/2022
Actual
Date of last data collection
Anticipated
31/07/2023
Actual
Sample size
Target
165
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24080 0
United Kingdom
State/province [1] 24080 0
Country [2] 24081 0
United States of America
State/province [2] 24081 0
Country [3] 24082 0
New Zealand
State/province [3] 24082 0

Funding & Sponsors
Funding source category [1] 309559 0
University
Name [1] 309559 0
Flinders University
Country [1] 309559 0
Australia
Primary sponsor type
Individual
Name
Kasia Robinson
Address
Flinders University, Sturt Road, Bedford Park, South Australia, 5042
Country
Australia
Secondary sponsor category [1] 310559 0
None
Name [1] 310559 0
Address [1] 310559 0
Country [1] 310559 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309339 0
Flinders’ Human Research Ethics Committee
Ethics committee address [1] 309339 0
Ethics committee country [1] 309339 0
Australia
Date submitted for ethics approval [1] 309339 0
15/12/2021
Approval date [1] 309339 0
22/07/2022
Ethics approval number [1] 309339 0

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

Contacts
Principal investigator
Name 113822 0
Ms Kasia Robinson
Address 113822 0
College of Education, Psychology, and Social Work, Flinders University, Sturt Road, Bedford Park, South Australia, 5042
Country 113822 0
Australia
Phone 113822 0
+61 08 8201 3998
Fax 113822 0
Email 113822 0
[email protected]
Contact person for public queries
Name 113823 0
Kasia Robinson
Address 113823 0
College of Education, Psychology, and Social Work, Flinders University, Sturt Road, Bedford Park, South Australia 5042
Country 113823 0
Australia
Phone 113823 0
+61 08 8201 3998
Fax 113823 0
Email 113823 0
[email protected]
Contact person for scientific queries
Name 113824 0
Kasia Robinson
Address 113824 0
College of Education, Psychology, and Social Work, Flinders University, Sturt Road, Bedford Park, South Australia, 5042
Country 113824 0
Australia
Phone 113824 0
+61 08 8201 3998
Fax 113824 0
Email 113824 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?
Raw data from the participants' self-report questionnaires. All data will first be de-identified.
When will data be available (start and end dates)?
Available following publication, no specified end date.
Available to whom?
Open access
Available for what types of analyses?
Verification studies, meta-analyses or reviews.
How or where can data be obtained?
Data files will be available from the open science framework database: https://osf.io/


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.