Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000295640
Ethics application status
Approved
Date submitted
11/03/2014
Date registered
20/03/2014
Date last updated
23/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Perfectionism treatment for obsessive compulsive disorder: A randomised controlled trial
Scientific title
The efficacy of cognitive behavioural therapy for perfectionism in the treatment of obsessive compulsive disorder symptoms for patients with obsessive compulsive disorder and elevated perfectionism
Secondary ID [1] 284211 0
Nil
Universal Trial Number (UTN)
U1111-1154-1322
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive Compulsive Disorder 291316 0
Obsessive Compulsive Personality Disorder 291317 0
Condition category
Condition code
Mental Health 291669 291669 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of the study is to determine whether directly targeting elevated perfectionism traits is an effective first-line therapeutic intervention in a clinical population of OCD participants, relative to a waitlist control group. The intervention is based on the transdiagnostic intervention developed by Egan, S. J., Wade, T. D., Shafran, R., & Antony, M. M., Cognitive Behavioral Treatment of Perfectionism (2014). The intervention involves psycho-education, self-monitoring, behavioral experiments, cognitive restructuring and motivation work.
Administration and duration: Group therapy sessions run by two therapists, once-weekly for 2 hours over an eight week period, plus homework exercises. Following an 8-week waitlist period, control participants receive the same intervention.
Intervention code [1] 288907 0
Treatment: Other
Intervention code [2] 288969 0
Behaviour
Comparator / control treatment
Participants randomly allocated to waitlist control receive the same 8-week group CBT for perfectionism intervention following their 8-week waitlist period.
Control group
Active

Outcomes
Primary outcome [1] 291617 0
To determine pre and post treatment obsessive compulsive disorder symptom severity as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) whereby scores will indicate the following: 32-40 extreme; 24-31 severe; 16-23 moderate; 8-15 mild; 0-7 sub-clinical.
Timepoint [1] 291617 0
CBT for perfectionism treatment condition - pre-treatment, post treatment, 3 month follow up
Waitlist control - baseline, post-waitlist/pre treatment, post treatment
Primary outcome [2] 291618 0
To determine pre and post-treatment obsessive compulsive personality disorder symptom severity as measured by the 49-item Pathological Obsessive Compulsive Personality Scale (POPS).
Timepoint [2] 291618 0
CBT for perfectionism treatment condition - pre-treatment, post treatment, 3 month follow up
Waitlist control - baseline, post-waitlist/pre treatment, post treatment
Primary outcome [3] 291619 0
To measure pre and post treatment perfectionism symptom severity as measured by the 12-item Clinical Perfectionism Questionnaire (CPQ) and 35-item Frost Multidimensional Perfectionism Scale (FMPS).
Timepoint [3] 291619 0
CBT for perfectionism treatment condition - pre-treatment, post treatment, 3 month follow up
Waitlist control - baseline, post-waitlist/pre treatment, post treatment
Secondary outcome [1] 307344 0
To To measure pre and post treatment quality of life as measured by Quality of Life and Enjoyment Satisfaction Questionnaire Short Form (14-item QLES-Q), where by higher scores are indicative of a higher subjective quality of life satisfaction.
Timepoint [1] 307344 0
CBT for perfectionism treatment condition - pre-treatment, post treatment, 3 month follow up
Waitlist control - baseline, post-waitlist/pre treatment, post treatment

Eligibility
Key inclusion criteria
A current primary diagnosis of OCD (as measured by Structured Clinical Interview for DSM-IV, Curtin Adult Psychology Clinic Version)
Presence of perfectionism pathology as determined by a score of 22 or higher on the concern over mistakes subscale of the FMPS
*18 years of age or above
*If on pharmacotherapy, participants will be asked to be on a stable dose for one month before the study and to stay on that dose during the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*If the individual's primary pathology is consistent with another principal diagnosis and determined to be more relevant at the time of assessment as indicated by the American Psychiatric Association (2013)
*If undergoing concurrent psychological intervention between baseline and follow-up
*Presence of an organic mental disorder or serious active suicidal ideation as determined by the SCID-IV.

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)
Eligibility and diagnostic assessments will be completed by clinical psychology trainees from Curtin University as part of their supervised clinical placements. Individuals who express interest in participating in the study will be screened via telephone to determine their eligibility to participate. If eligible, a face-to-face diagnostic assessment will take place using baseline measure and participants will be randomly allocated to groups. Whilst the trainees will have knowledge of the broad purpose of the study, they will be blind as to the exact hypotheses and expected outcomes from treatment in order to reduce experimental bias. A registered psychologist supervisor external to the study with experience in the delivery of CBT will randomly select and view group therapy sessions during supervision with therapists to confirm that treatment protocol is adhered to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization with a maximum of 8 participants per condition (CBT for perfectionism or waitlist control) is used to allocate participants. Participants randomised to waitlist will be allocated to the next available treatment group as practicable in the study. An independent clinician will conduct the randomisation process to minimise selection bias.
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
An initial G*Power (3.1) statistical calculation used to calculate the minimum power required to detect a small to moderate (f = .10 - .25) group x time interaction in this study (power = 0.8, two-tailed alpha = .05), suggested that a total of 102 participants would be required, equating to 34 participants, for each of the three conditions. However, given the difficulties experienced with recruitment and participant attrition, this has been modified. A total of 11 participants have completed the intervention (inclusive of CBT for perfectionism and wait-list). Given the smaller sample size, Reliable change (RC) and Clinically Significant Change analyses will be used to assess the treatment outcomes of this study,

The pre-post reliable change (RC) score will be interpreted as the degree to which participants change on the main outcome variables divided by the standard error of difference between the pre-test and post-test and pre-test and follow up scores. The standard error of difference between pre-intervention and post-intervention scores will be obtained derived from the reliability of the measures used or previously reported Cronbach's a for the existing measures, as appropriate. As per standard convention, an RC score of greater than or equal to 1.96 will be considered a reliable change. Clinically significant change will be operationally defined i.e. a reliable improvement from a pre-test score of above 14 points on the YBOCS, to a post-intervention score of less than or equal to 14 will be indicative of clinically significant improvement.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2014
Actual
2/06/2014
Date of last participant enrolment
Anticipated
6/07/2015
Actual
6/07/2015
Date of last data collection
Anticipated
Actual
30/09/2015
Sample size
Target
102
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 288853 0
University
Name [1] 288853 0
Curtin University Australia
Country [1] 288853 0
Australia
Primary sponsor type
Individual
Name
Dr. Sarah Egan
Address
Curtin University
School of Psychology & Speech Pathology
GPO Box U1987
Perth
Western Australia 6845
Country
Australia
Secondary sponsor category [1] 287547 0
Individual
Name [1] 287547 0
Shalane Sadri (PhD student)
Address [1] 287547 0
Curtin University
School of Psychology & Speech Pathology
GPO Box U1987
Perth
Western Australia 6845
Country [1] 287547 0
Australia
Secondary sponsor category [2] 287548 0
Individual
Name [2] 287548 0
Dr. Rebecca Anderson
Address [2] 287548 0
Curtin University
School of Psychology & Speech Pathology
GPO Box U1987
Perth
Western Australia 6845
Country [2] 287548 0
Australia
Secondary sponsor category [3] 287549 0
Individual
Name [3] 287549 0
Dr. Robert Kane
Address [3] 287549 0
Curtin University
School of Psychology & Speech Pathology
GPO Box U1987
Perth
Western Australia 6845
Country [3] 287549 0
Australia
Secondary sponsor category [4] 291996 0
Individual
Name [4] 291996 0
Associate Professor Peter McEvoy
Address [4] 291996 0
Curtin University School of Psychology & Speech Pathology GPO Box U1987 Perth Western Australia 6845
Country [4] 291996 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290688 0
Human Research Ethics Committee
Ethics committee address [1] 290688 0
Ethics committee country [1] 290688 0
Australia
Date submitted for ethics approval [1] 290688 0
16/12/2013
Approval date [1] 290688 0
17/02/2014
Ethics approval number [1] 290688 0
All ethics modifications approved (trial no. HR38/2014

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

Contacts
Principal investigator
Name 46734 0
Dr Sarah Egan
Address 46734 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth
Western Australia 6845
Country 46734 0
Australia
Phone 46734 0
+61 8 9266 2367
Fax 46734 0
+61 8 9266 2464
Email 46734 0
[email protected]
Contact person for public queries
Name 46735 0
Sarah Egan
Address 46735 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth
Western Australia 6845
Country 46735 0
Australia
Phone 46735 0
+61 8 9266 2367
Fax 46735 0
+61 8 9266 2464
Email 46735 0
[email protected]
Contact person for scientific queries
Name 46736 0
Shalane Sadri
Address 46736 0
Curtin University
Health Sciences Graduate Research Hub
Building 603, Technology Park
6 Sarich Way
Bentley 6102
Western Australia
Country 46736 0
Australia
Phone 46736 0
+61 431370733
Fax 46736 0
+61 8 9266 2464
Email 46736 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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