Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000199415
Ethics application status
Approved
Date submitted
21/09/2015
Date registered
15/02/2016
Date last updated
15/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised control trial of cognitive behavioural treatment for perfectionism in Athletes
Scientific title
Randomised control trial of Online guided self-help version of Cognitive Behavioural Treatment for Perfectionism in athletes: evaluating impact on perfectionism, eating disorder pathology, compulsive exercise and burnout.
Secondary ID [1] 287506 0
nil
Universal Trial Number (UTN)
U1111-1174-7139
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinical Perfectionism 296264 0
Eating Disorder Pathology 296265 0
Compulsive Exercise 296266 0
Condition category
Condition code
Mental Health 296534 296534 0 0
Other mental health disorders
Mental Health 296535 296535 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8 week Online guided self help Cognitive Behavioural Treatment Program for Clinical Perfectionism. Participants will be sent the text "Overcoming Perfectionism" by Shafran, Egan and Wade which is a self help guided CBT intervention targeting perfectionism, Through weekly emails participants will be directed to read certain areas of the text and complete the associated activities. Each session should approximately require 2 hours to complete. Participants are required to complete each section of text and activities by the end of one week. Activities include worksheets exploring the perfectionist beliefs and cognitive restructuring and problem solving as well as reflections. Participants may also have to plan and participate in behavioural experiments. The time taken to complete Behavioural experiments would depend on the complexity of the design from 5 minutes to 1 hour. Communication via email with an investigator will ensure participants complete each session.
Intervention code [1] 292895 0
Treatment: Other
Comparator / control treatment
Waitlist Control will be offered the intervention after 8 weeks on the waitlist.
Control group
Active

Outcomes
Primary outcome [1] 296160 0
Clinical Perfectionism: measured by mean global and sub scale scores Frost Multidimensional Perfectionism Scale (Frost, Marten, Lahart, & Rosenblate, 1990) and Clinical Perfectionism Questionnaire (Fairburn, Cooper & Shafran, 2003).
Timepoint [1] 296160 0
Pre treatment, post treatment(after 8 week treatment), 3 months after last treatment session and 6 months after last treatment session.
Secondary outcome [1] 317657 0
Athlete Burnout measured by mean scores on Athlete Burnout Questionnaire(Raedeke & Smith, 2001).
Timepoint [1] 317657 0
Pre treatment, post treatment(after 8 week treatment), 3 months after last treatment session and 6 months after last treatment session.
Secondary outcome [2] 317658 0
Compulsive exercise measured by means scores on the Compulsive exercise test(Taranis et al., 2011).
Timepoint [2] 317658 0
Pre treatment, post treatment(after 8 week treatment), 3 months after last treatment session and 6 months after last treatment session.
Secondary outcome [3] 317659 0
Eating Disorder Pathology as measured by global and sub scale scores on the Eating Disorder Examination- Questionnaire (Fairburn & Beglin, 2008)
Timepoint [3] 317659 0
Pre treatment, post treatment(after 8 week treatment), 3 months after last treatment session and 6 months after last treatment session.

Eligibility
Key inclusion criteria
1) Elevated perfectionism as indicated by a score of 24.7 or greater, on the Concern over Mistakes (CM) subscale of the Frost Multidimensional Perfectionism Scale (FMPS; Frost, Marten, Lahart, & Rosenblate, 1990).
2) Participants must be at least 18 years of age.
3) Refrain from entering psychological treatment or medication during treatment.
4) Stable use of psychological medication for at least 1 month prior to participation in research.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Participants who are found to have psychological disorders assessed by the Mini International Psychiatric Interview (MINI) (Sheehan et al., 1998)
2) Participants who are found to have medium to high risk on the suicide risk assessment on the MINI (Sheehan et al., 1998).
3) Participants who demonstrate diagnosis of Anorexia Nervosa as measured by BMI less than or equal to 17kg/m2.

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)
Once found to be eligible, Participants will be randomly assigned to the treatment group, an online guided self-help CBT treatment for clinical perfectionism, (CBT-CP) or the waitlist control group (CG). This allocation will be conducted by an individual not involved in the research project.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using Saghaei's (2004) software (simple 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
Mixed effects linear regression (Generalised Linear Mixed Models; GLMM) will be utilized through SPSS. The Categorical random effect is the participant, fixed categorical effect is the group (intervention and control) and ordinal fixed effect is time (pre-test, post-test, 3 month follow up and 6 month follow up). The treatment of perfectionism has been found to demonstrate large effects (Egan et al., 2011). Steele & Wade, (2008) found the treatment of perfectionism reduced eating disorder symptoms on the global scale of EDE (d=1.73) and depression (d=.86) according to Cohen’s 1988 criteria (Cohen, 1988). Using G*power it is estimated that 34 participants (17 per group) are required for a 80% chance of detecting a moderate intervention effect time (pre vs post) x Group (intervention vs control) interaction at alpha level .05. This estimate represents an analysis with a standard ANOVA, a GLMM analysis is more sensitive to detecting an intervention effect and as such the proposed power analysis is relatively conservative. However, 34 participants will be used a minimum requirement, recruitment will aim for 25 per cent more to account for attrition rates.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/12/2015
Date of last participant enrolment
Anticipated
20/02/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 292082 0
University
Name [1] 292082 0
Curtin University
Country [1] 292082 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Dr. Sarah Egan
School of Psychology and Speech Pathology, Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 290760 0
None
Name [1] 290760 0
Address [1] 290760 0
Country [1] 290760 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293564 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 293564 0
Ethics committee country [1] 293564 0
Australia
Date submitted for ethics approval [1] 293564 0
01/10/2015
Approval date [1] 293564 0
07/10/2015
Ethics approval number [1] 293564 0
HR88/2013

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

Contacts
Principal investigator
Name 60474 0
Dr Sarah Egan
Address 60474 0
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, Perth Western Australia 6102
Country 60474 0
Australia
Phone 60474 0
+618 9266 2367
Fax 60474 0
Email 60474 0
[email protected]
Contact person for public queries
Name 60475 0
Sarah Egan
Address 60475 0
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, Perth Western Australia 6102
Country 60475 0
Australia
Phone 60475 0
+618 9266 2367
Fax 60475 0
Email 60475 0
[email protected]
Contact person for scientific queries
Name 60476 0
Sarah Egan
Address 60476 0
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, Perth Western Australia 6102
Country 60476 0
Australia
Phone 60476 0
+618 9266 2367
Fax 60476 0
Email 60476 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.