Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000787987
Ethics application status
Approved
Date submitted
26/07/2011
Date registered
27/07/2011
Date last updated
27/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of group cognitive behavioural therapy for clinical perfectionism
Scientific title
In adults with clinical perfectionism, does group cognitive-behavioural therapy reduce clinical perfectionism and related psychological symptoms when compared to a waitlist control group?
Secondary ID [1] 262708 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
clinical perfectionism 270413 0
depression symptoms 270414 0
anxiety symptoms 270415 0
eating disorder symptoms 270416 0
Condition category
Condition code
Mental Health 270557 270557 0 0
Other mental health disorders
Mental Health 270573 270573 0 0
Depression
Mental Health 270574 270574 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Group cognitive behavioural therapy for clinical perfectionism. In this intervention participants receive 8 x 2-hour sessions of group therapy over 8 weeks, where they learn strategies to reduce their clinical perfectionism. The strategies are derived from the book Overcoming Perfectionism: A Self-help Guide Using Cognitive Behavioural Techniques (Shafran, Egan & Wade, 2010).
Intervention code [1] 267052 0
Treatment: Other
Intervention code [2] 267053 0
Behaviour
Comparator / control treatment
Waitlist control group: Participants assigned to the waitlist condition will wait for 8 weeks, and then will receive the group cognitive behavioural therapy for clinical perfectionism intervention for eight weeks.
Control group
Active

Outcomes
Primary outcome [1] 269297 0
Concern Over Mistakes score as assessed by the Concern Over Mistakes subscale of the Frost Multi-dimensional Perfectionism Scale (Frost, Marten, Lahart, & Rosenblate, 1990)
Timepoint [1] 269297 0
At baseline, immediately after the intervention, and at 3 and 6 months after the intervention
Primary outcome [2] 269298 0
Personal Standards score as assessed by the Personal Standards subscale of the Frost Multi-dimensional Perfectionism Scale (Frost et al., 1990).
Timepoint [2] 269298 0
At baseline, immediately after the intervention, and at 3 and 6 months after the intervention.
Primary outcome [3] 269299 0
Clinical Perfectionism score as assessed by the Clinical Perfectionism Questionnaire (Fairburn, Cooper & Shafran, unpublished in Riley, Lee, Cooper, Fairburn & Shafran, 2007)
Timepoint [3] 269299 0
Timepoint: At baseline, immediately after the intervention, and at 3 and 6 months after the intervention.
Secondary outcome [1] 279324 0
Self-criticism score as assessed by the Dysfunctional Attitudes Scale: Self Criticism (Weissman & Beck, 1978).
Timepoint [1] 279324 0
At baseline, immediately after intervention, and three to six months after the intervention.
Secondary outcome [2] 279325 0
Distress and interference caused by perfectionism as assessed by the Distress and Interference rating scales adapted from the Anxiety Disorder Interview Schedule (ADIS; Brown, Dinardo & Barlow, 1994).
Timepoint [2] 279325 0
At baseline, immediately after intervention, and three to six months after the intervention.
Secondary outcome [3] 279326 0
Depression score as assessed by the Depression, Anxiety and Distress Scale-21 (DASS-21; Lovibond & Lovibond, 1995)
Timepoint [3] 279326 0
At baseline, immediately after intervention, and three to six months after the intervention.
Secondary outcome [4] 279327 0
Anxiety score as assessed by the Depression, Anxiety and Distress Scale-21 (DASS-21; Lovibond & Lovibond, 1995).
Timepoint [4] 279327 0
At baseline, immediately after intervention, and three to six months after the intervention.
Secondary outcome [5] 279328 0
Stress score as assessed by the Depression, Anxiety and Stress Scale-21 (DASS-21; Lovibond & Lovibond, 1995).
Timepoint [5] 279328 0
At baseline, immediately after intervention, and three to six months after the intervention.
Secondary outcome [6] 279329 0
Eating disorder symptomatology as assessed by the Eating Disorder Examination-Questionnaire (EDE-Q; Fairburn & Beglin, 1994)
Timepoint [6] 279329 0
At baseline, immediately after intervention, and three to six months after the intervention.
Secondary outcome [7] 279330 0
Self-esteem score as assessed by the Rosenberg Self-Esteem Scale (RSES; Rosenberg, 1965).
Timepoint [7] 279330 0
At baseline, immediately after intervention, and three to six months after the intervention.
Secondary outcome [8] 279331 0
Quality of life score as assessed by the Quality of Life-Enjoyment and Satisfaction Questionnaire (Ritsner, Kurs, Gibel, Ratner & Endicott, 2005).
Timepoint [8] 279331 0
At baseline, immediately after intervention, and three to six months after the intervention.
Secondary outcome [9] 279332 0
Diagnosis of a psychological disorder as assessed by the Mini International Neuropsychiatric Interview, (Sheehan et al., 1998).
Timepoint [9] 279332 0
At baseline, immediately after intervention, and three to six months after the intervention.

Eligibility
Key inclusion criteria
Aged 18 years or over; Clinical levels of perfectionism as defined by a score of 24.7 or greater on the Concern Over Mistakes Scale (Frost et al., 1990); Willing to not engage in other psychological treatment between baseline assessment and six month follow-up assessment; if on anti-depressant medication participants must have been stable on this medication for at least one month before their baseline assessment, and they must also be willing to remain on the same dosage of the same medication from the time of their baseline assessment until their six month follow-up assessment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adults who report high suicidal ideation on the Suicidality module of the Mini International Neuropsychiatric Interview (MINI; Sheehan et al., 1998); Adults who meet DSM-IV-TR (APA, 2000) criteria for alcohol or substance dependence; Adults who meet DSM-IV-TR (APA, 2000) criteria for psychosis and/or schizophrenia; Adults who wish to receive other forms of psychological treatment during the study; Adults who currently meet DSM-IV-TR (APA, 2000) criteria for anorexia nervosa, and/or those who have an extremely low body weight (i.e., Body Mass Index < 17.5).

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)
Individuals interested in the study who telephone the Curtin University Psychology and Speech Clinic will be emailed or posted the Concern over Mistakes subscale of the Frost Multi-dimensional Perfectionism Scale (Frost et al., 1990), an information sheet about the study and a consent form. Participants who score at 24.7 + on the Concern Over Mistakes subscale (i.e., have clinical levels of perfectionism) and consent to the study will be telephone- screened by Alicia Handley to assess their eligibility. Ineligible participants will be referred to external services. The telephone screening will involve administering the MINI-screen (Sheehan & Lecrubier, 2006), the MINI modules corresponding to the exclusion criteria (Sheehan et al., 1998) and asking questions corresponding to the inclusion criteria. Ineligible individuals will be referred to external services. At this point the researcher has no knowledge of the condition that a participant will be in. Eligible individuals will be advised on the telephone that they will have a baseline assessment in a few days and that only after they have had this baseline assessment, they will be randomly allocated to either be in the intervention condition or the waitlist control condition. Eligible individuals then have their baseline assessment, where they will be administered a battery of assessment measures. At this point the researcher still does not know which condition the participant will be allocated to. The researcher will then use Saghaei’s (2004) Random Allocation computer software version 1.0 to randomly allocate participants to conditions. It is only after this random allocation has occurred that the researcher becomes aware which condition the participant has been allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple random allocation procedure will be employed to randomly allocate participants to conditions. The researcher will use Saghaei’s (2004) Random Allocation software version 1.0, which generates randomised number lists. The number of individuals per group and the number of groups will be inputted into the system to ensure that group sizes are equal (Steele & Wade, 2008).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not applicable.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4280 0
6153
Recruitment postcode(s) [2] 4281 0
6992
Recruitment postcode(s) [3] 4282 0
6061
Recruitment postcode(s) [4] 4283 0
6063
Recruitment postcode(s) [5] 4284 0
6104
Recruitment postcode(s) [6] 4285 0
6982
Recruitment postcode(s) [7] 4286 0
6154
Recruitment postcode(s) [8] 4287 0
6149
Recruitment postcode(s) [9] 4288 0
6028
Recruitment postcode(s) [10] 4289 0
6107
Recruitment postcode(s) [11] 4290 0
6101
Recruitment postcode(s) [12] 4291 0
6020
Recruitment postcode(s) [13] 4292 0
6031
Recruitment postcode(s) [14] 4293 0
6018
Recruitment postcode(s) [15] 4294 0
6015
Recruitment postcode(s) [16] 4295 0
6010
Recruitment postcode(s) [17] 4296 0
6030
Recruitment postcode(s) [18] 4297 0
6152
Recruitment postcode(s) [19] 4298 0
6911
Recruitment postcode(s) [20] 4299 0
6981
Recruitment postcode(s) [21] 4300 0
6027
Recruitment postcode(s) [22] 4301 0
6014
Recruitment postcode(s) [23] 4302 0
6058
Recruitment postcode(s) [24] 4303 0
6959
Recruitment postcode(s) [25] 4304 0
6064
Recruitment postcode(s) [26] 4305 0
6016
Recruitment postcode(s) [27] 4306 0
6022
Recruitment postcode(s) [28] 4307 0
6926
Recruitment postcode(s) [29] 4308 0
6111
Recruitment postcode(s) [30] 4309 0
6026
Recruitment postcode(s) [31] 4310 0
6966
Recruitment postcode(s) [32] 4311 0
6007
Recruitment postcode(s) [33] 4312 0
6076
Recruitment postcode(s) [34] 4313 0
6065
Recruitment postcode(s) [35] 4314 0
6054
Recruitment postcode(s) [36] 4315 0
6956
Recruitment postcode(s) [37] 4316 0
6009
Recruitment postcode(s) [38] 4317 0
6062
Recruitment postcode(s) [39] 4318 0
6000
Recruitment postcode(s) [40] 4319 0
6151

Funding & Sponsors
Funding source category [1] 267527 0
University
Name [1] 267527 0
Curtin University of Technology
Country [1] 267527 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Clare Rees, Principal Investigator of the study
Address
School of Psychology and Speech Pathology, Curtin University of Technology, Kent Street, Bentley, W.A 6102
Country
Australia
Secondary sponsor category [1] 266568 0
None
Name [1] 266568 0
N/A
Address [1] 266568 0
N/A
Country [1] 266568 0
Other collaborator category [1] 252136 0
None
Name [1] 252136 0
N/A
Address [1] 252136 0
N/A
Country [1] 252136 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269489 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 269489 0
Ethics committee country [1] 269489 0
Australia
Date submitted for ethics approval [1] 269489 0
Approval date [1] 269489 0
22/07/2011
Ethics approval number [1] 269489 0
HR 75/2011

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

Contacts
Principal investigator
Name 32929 0
Address 32929 0
Country 32929 0
Phone 32929 0
Fax 32929 0
Email 32929 0
Contact person for public queries
Name 16176 0
Alicia Handley, PhD Student.
Address 16176 0
Curtin University Psychology and Speech Clinic, Kent Street, Bentley, Western Australia 6102.
Country 16176 0
Australia
Phone 16176 0
+61 8 92663436
Fax 16176 0
+61 8 92663178
Email 16176 0
[email protected]
Contact person for scientific queries
Name 7104 0
Associate Professor Clare Rees
Address 7104 0
School of Psychology, Curtin University of Technology, Kent Street, Bentley, Western Australia 6102.
Country 7104 0
Australia
Phone 7104 0
+61 8 92663442
Fax 7104 0
+61 8 92662464
Email 7104 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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