Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001284752
Ethics application status
Approved
Date submitted
20/11/2013
Date registered
20/11/2013
Date last updated
11/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of individual imagery based cognitive-behavioural therapy for clinical perfectionism
Scientific title
In adults with clinical perfectionism, does a single individual imagery cognitive-behavioural therapy session reduce clinical perfectionism and related psychological symptoms when compared to individual cognitive therapy and relaxation?
Secondary ID [1] 283619 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinical perfectionism
 290544 0
Intrusive/distressing mental imagery 290566 0
Depression symptoms 290567 0
Anxiety symptoms 290568 0
Condition category
Condition code
Mental Health 290943 290943 0 0
Other mental health disorders
Mental Health 290944 290944 0 0
Anxiety
Mental Health 290945 290945 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two separate intervention groups
Intervention group 1:
Individual imagery rescripting based cognitive behavioural therapy for clinical perfectionism. In this intervention participants receive 1 x 2 hour sessions of individual therapy, where they explore and manipulate distressing mental imagery related to clinical perfectionism. The strategies are derived from the book Oxford guide to imagery in cognitive therapy (Hackmann, Bennett-Levy, & Holmes, 2011)

Intervention group 2:
Individual cognitive restructuring based cognitive behavioural therapy for clinical perfectionism. In this intervention participants receive 1 x 2 hour sessions of individual therapy, where they explore distressing mental imagery related to clinical perfectionism and use cognitive disputations to re-evaluate their appraisal of the images. The strategies are derived from the book Overcoming Perfectionism (Shafran, Egan, & Wade, 2010)
Intervention code [1] 288312 0
Treatment: Other
Intervention code [2] 288313 0
Behaviour
Comparator / control treatment
Individual relaxation session for clinical perfectionism. In this control group participants receive 1 x 2 hour sessions of relaxation, where they explore distressing mental imagery related to clinical perfectionism and learn relaxation techniques to reduce stress experienced.
Control group
Active

Outcomes
Primary outcome [1] 290924 0
Clinical Perfectionism score as assessed by the Clinical Perfectionism Questionnaire (Fairburn, Cooper, & Shafran, 2003)
Timepoint [1] 290924 0
At baseline, immediately after the intervention, and at 1 week, 1 month, and 3 months after the intervention
Primary outcome [2] 290925 0
Personal Standards, Concern over Mistakes, Doubts about Actions, Parental Expectations, Parental Criticism, and Organisation as assessed by Frost Multidimensional Perfectionism Scale (Frost, Marten, Lahart, & Rosenblate, 1990)
Timepoint [2] 290925 0
At baseline, immediately after the intervention, and at 1 week, 1 month, and 3 months after the intervention
Secondary outcome [1] 305603 0
Depression score as assessed by the Depression, Anxiety and Distress Scale-21 (DASS-21; Lovibond & Lovibond, 1995)
Timepoint [1] 305603 0
At baseline, immediately after the intervention, and at 1 week, 1 month, and 3 months after the intervention
Secondary outcome [2] 305604 0
Anxiety score as assessed by the Depression, Anxiety and Distress Scale-21 (DASS-21; Lovibond & Lovibond, 1995).
Timepoint [2] 305604 0
At baseline, immediately after the intervention, and at 1 week, 1 month, and 3 months after the intervention
Secondary outcome [3] 305605 0
Stress score as assessed by the Depression, Anxiety and Stress Scale-21 (DASS-21; Lovibond & Lovibond, 1995)
Timepoint [3] 305605 0
At baseline, immediately after the intervention, and at 1 week, 1 month, and 3 months after the intervention
Secondary outcome [4] 305606 0
Depression score as assessed by the Beck Depression Inventory (BDI; Beck, Steer, & Garbin, 1988).
Timepoint [4] 305606 0
At baseline, immediately after the intervention, and at 1 week, 1 month, and 3 months after the intervention
Secondary outcome [5] 305607 0
State Anxiety questions from State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, & Lushene, 1970).
Timepoint [5] 305607 0
At baseline, immediately after the intervention, and at 1 week, 1 month, and 3 months after the intervention
Secondary outcome [6] 305608 0
Repetitive negative thinking score as assessed by the repetitive negative thinking - short scale (RNT-10; McEvoy, Mahoney, & Moulds, 2010)
Timepoint [6] 305608 0
At baseline, immediately after the intervention, and at 1 week, 1 month, and 3 months after the intervention
Secondary outcome [7] 305609 0
Imagery Interview Questionnaire which has 7 questions assessing Image intensity, Image Distress, Difficulty Dismissing Imagery, Impact of Imagery, and Imagery Frequency (Lee, Roberts-Collins, Coughtrey, Phillips, & Shafran, 2011).
Timepoint [7] 305609 0
At baseline, immediately after the intervention, and at 1 week, 1 month, and 3 months after the intervention
Secondary outcome [8] 305610 0
Future oriented imagery scores as assessed by the Impact of Future Events (IFES; Deeprose & Holmes, 2010)
Timepoint [8] 305610 0
At baseline, immediately after the intervention, and at 1 week, 1 month, and 3 months after the intervention
Secondary outcome [9] 305611 0
Interpretation task which is developed for specifically examining interpretation bias in participants with perfectionism. Based on work by Yiend, Savulich, Coughtrey, & Shafran (2011). Consisting of 40 items designed to explore perfectionist interpretations of three line passages that depict a scenario where a protagonist falls just short of reaching perfection.
Timepoint [9] 305611 0
At baseline and 3 months after the intervention
Secondary outcome [10] 305612 0
Cognitive Dot-Probe Task designed to measure attention to failure, achievement or neutral stimuli. Based on work by Grafton, Watkins, & Macleod (2012); Posner, Snyder, & Davidson (1980).
Timepoint [10] 305612 0
At baseline and 3 months after the intervention
Secondary outcome [11] 305613 0
Imagery interview is a semi-structured interview that examines intrusive mental thoughts, images and associated sensations related to a specific memory (Lee, Roberts-Collins, Coughtrey, Phillips, & Shafran, 2011).
Timepoint [11] 305613 0
At baseline and 3 months after the intervention

Eligibility
Key inclusion criteria
Aged 18 years or older. Not have undergone specific treatment for perfectionism prior to starting the study. Have met or currently meet a diagnosis of an Axis I disorder. They must have been stable on any anti-depressant medication/s for a minimum of two months prior to commencement of the study, and be willing to remain on the same medication for the duration of the study (if applicable). Clinical levels of perfectionism as defined by a score of 24.7 or greater on the Concern Over Mistakes Scale (Frost et al., 1990)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Moderate to severe suicidality section of the MINI (Sheehan et al., 1998a). Meeting the DSM-IV-TR (American Psychiatric Association, 2000) criteria for psychosis. Meeting the DSM-IV-TR (American Psychiatric Association, 2000) criteria for alcohol/substance dependence. Adults who wish to receive treatment for perfectionism prior to commencement or duration of the study.

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 Joel Howell 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. This software allows the number of individuals per group and the number of groups to be accounted for in the system to enable equal group sizes (Steele & Wade, 2008).
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
Previous research on single session imagery rescripting in disorders (Nilsson et al., 2012; Wild & Clark, 2011) has yielded a large effect size (Cohen, 1992). The current study will plan to detect a Group x time interaction, therefore to detect a small-moderate effect size (f = .2), there needs to be 15 participants in each treatment group condition (N = 45) (power = .80, alpha = .05). This is because there is still limited research on imagery rescripting, and no research has examined imagery rescripting for perfectionism related imagery. By planning for a conservative effect size, any interactions and effects from the treatment that may not have been captured in previous literature can be observed.

The intervention data is best analysed using mixed effects linear regression model (Bryk & Raudenbush, 1987). This analysis will analyse the data within a hierarchical data structure, in which time is nested within the participant. This will be implemented through SPSS’s Generalised Linear Mixed Models (GLMM; SPSS version 19) procedure. GLMM does not rely on participants providing data at both pre- and post-test; GLMM uses all the data present at each assessment point thereby reducing the impact of subject attrition on statistical power. Moreover, GLMM is robust to unequal group sizes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 288299 0
University
Name [1] 288299 0
Curtin University
Country [1] 288299 0
Australia
Primary sponsor type
Individual
Name
Senior Lecturer Dr. Sarah Egan, Principal investigator of the study
Address
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country
Australia
Secondary sponsor category [1] 287019 0
Individual
Name [1] 287019 0
Dr Rebecca Anderson
Address [1] 287019 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country [1] 287019 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290196 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 290196 0
Ethics committee country [1] 290196 0
Australia
Date submitted for ethics approval [1] 290196 0
Approval date [1] 290196 0
05/07/2013
Ethics approval number [1] 290196 0
HR88/2012

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

Contacts
Principal investigator
Name 44430 0
Dr Sarah Egan
Address 44430 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 44430 0
Australia
Phone 44430 0
+61 8 9266 2367
Fax 44430 0
Email 44430 0
[email protected]
Contact person for public queries
Name 44431 0
Joel Howell
Address 44431 0
Curtin University Psychology and Speech Clinic, Kent Street, Bentley, Western Australia 6102.
Country 44431 0
Australia
Phone 44431 0
+61 8 92663436
Fax 44431 0
Email 44431 0
[email protected]
Contact person for scientific queries
Name 44432 0
Sarah Egan
Address 44432 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 44432 0
Australia
Phone 44432 0
+61 8 9266 2367
Fax 44432 0
Email 44432 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

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