Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001081000
Ethics application status
Approved
Date submitted
1/12/2010
Date registered
8/12/2010
Date last updated
9/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial of guided self help cognitive behavioural therapy for clinical perfectionism versus a guided self help cognitive behavioural therapy for anxiety and depression.
Scientific title
Cognitive behavioural therapy for clinical perfectionism versus Cognitive behavioural therapy for anxiety and depression: Is a treatment that targets clinical perfectionism as effective in reducing symptoms of anxiety and depression, as a treatment that targets anxiety and depression?
Secondary ID [1] 253218 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinical Perfectionism 258781 0
Depression 258782 0
Anxiety Disorders 258783 0
Condition category
Condition code
Mental Health 258898 258898 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) Guided Self Help Cognitive Behavioural Therapy for Clinical Perfectionism. The book titled “Overcoming Perfectionism: A self help guide using Cognitive Behavioural Techniques" by Shafran, Egan and Wade (2010) will be given to the participants in this group. They will be required to read a designated chapter each week and complete various homework tasks, such as behavioural experiments and thought diaries. The chapters and homework tasks will be completed when it is convenient for the participant in their own home. This will occur for 8 weeks. Each week the Clinical Psychologist Trainee will call each participant to see how they are going with the readings and the assigned homework tasks. Each phone call will be a maximum of 15 minutes.

2) Guided Self Help Cognitive Behavioural Therapy for Anxiety and Depression. The conditions for this group will be identical to the first experimental group, however a different text will be used. The book titled “Mind Over Mood: Change how you feel by changing the way you think” by Greenberg and Padesky (1995) will be given to the participants in this group. They will be required to read a designated chapter each week and complete various homework tasks, such as behavioural experiments and thought diaries. The chapters and homework tasks will be completed when it is convenient for the participant in their own home. This will occur for 8 weeks. Each week the Clinical Psychologist Trainee will call each participant to see how they are going with the readings and the assigned homework tasks. Each phone call will be a maximum of 15 minutes.
Intervention code [1] 257691 0
Treatment: Other
Comparator / control treatment
Waitlist/control - After the control group waits for 8 weeks they are randomly allocated to one of the two experimental conditions.
Control group
Active

Outcomes
Primary outcome [1] 259755 0
The participants change in their score on the Clinical Perfectionism Questionnaire (CPQ)
Timepoint [1] 259755 0
At baseline (pre-treatment), post treatment and 6 month follow-up.
Primary outcome [2] 259756 0
The participants change in their score on the Depression Anxiety Stress Scales (DASS)
Timepoint [2] 259756 0
At baseline (pre-treatment), post treatment and 6 month follow-up.
Primary outcome [3] 259757 0
The participants change in their score on the Frost Multidimensional Perfectionism Scale (FMPS)
Timepoint [3] 259757 0
At baseline (pre-treatment), post treatment and 6 month follow-up.
Secondary outcome [1] 268518 0
The mean score of the Dichotomous Thinking in Eating Disorders Scale (DTEDS)
Timepoint [1] 268518 0
At baseline (pre-treatment), post treatment and 6 month follow-up.
Secondary outcome [2] 268519 0
The mean score of the Dysfunctional Attitudes Scale (DAS)
Timepoint [2] 268519 0
At baseline (pre-treatment), post treatment and 6 month follow-up.

Eligibility
Key inclusion criteria
1) Age 18 years of age or older.
2) Must have an elevated score (>22.2) on the CM subscale of the FMPS.
3) A primary diagnosis of either a depressive disorder and/or an anxiety disorder
4) If on antidepressant medication, must have been stabilised on this medication for at least three months prior to the baseline assessment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) A primary diagnosis of OCD or PTSD.
2) DSM-IV diagnosis of schizophrenia/psychosis.
3) Serious suicide ideation.
4) Alcohol/Substance dependence.
5) Anyone currently in psychological therapy.
6) Anyone meeting the DSM-IV criteria for Anorexia Nervosa and/or a seriously low body weight (BMI < 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258164 0
University
Name [1] 258164 0
Curtin University
Country [1] 258164 0
Australia
Primary sponsor type
Individual
Name
Sarah Egan
Address
Kent Street, Bentley, Perth
Western Australia. 6102.
Country
Australia
Secondary sponsor category [1] 257338 0
Individual
Name [1] 257338 0
Kimberley Hoiles
Address [1] 257338 0
Kent Street, Bentley, Perth
Western Australia. 6102.
Country [1] 257338 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260150 0
Human Research Ethics Committee - Curtin University
Ethics committee address [1] 260150 0
Kent Street, Bentley, Perth
Western Australia. 6102.
Ethics committee country [1] 260150 0
Australia
Date submitted for ethics approval [1] 260150 0
Approval date [1] 260150 0
05/11/2010
Ethics approval number [1] 260150 0
HR120/2010

Summary
Brief summary
Based on previous studies reported in the literature (Riley et al., 2007; Steele & Wade, 2008) we propose that a treatment that targets clinical perfectionism will be as effective as a treatment that targets anxiety and depression. Due to only a small number of trials to date, with relatively small sample sizes, our study is required to effectively test this hypothesis in a Randomised Control Trial with an adequate sample size.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31976 0
Address 31976 0
Country 31976 0
Phone 31976 0
Fax 31976 0
Email 31976 0
Contact person for public queries
Name 15223 0
Kimberley Hoiles
Address 15223 0
Kent Street, Bentley, Perth
Western Australia. 6102.
Country 15223 0
Australia
Phone 15223 0
+61 4 21 976 235
Fax 15223 0
Email 15223 0
[email protected]
Contact person for scientific queries
Name 6151 0
Sarah Egan
Address 6151 0
Kent Street, Bentley, Perth
Western Australia. 6102.
Country 6151 0
Australia
Phone 6151 0
+61 8 9266 2367
Fax 6151 0
Email 6151 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.