Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001102561
Ethics application status
Approved
Date submitted
26/09/2015
Date registered
20/10/2015
Date last updated
1/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can intervention for perfectionism reduce the onset of postnatal depression?
Scientific title
Does a perfectionism self help guide for women during their third trimester of pregnancy change scores on measures of perfectionism, rumination, and symptoms of depression and anxiety.
Secondary ID [1] 287495 0
Nil
Universal Trial Number (UTN)
U1111-1174-6082
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postnatal Depression 296240 0
Condition category
Condition code
Mental Health 296511 296511 0 0
Depression
Reproductive Health and Childbirth 296753 296753 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the intervention group will be asked to work through a self-help booklet called Changing Perfectionism (Egan, Shafran, & Wade, 2012) over a four week period. This booklet was developed using a cognitive behavior therapy framework and is designed to help participants understand what perfectionism is, how it is maintained and to teach strategies to overcome or manage their perfectionism.
Participants will be asked to complete this booklet during their third trimester and will be provided to women after 28 weeks gestation. The booklet is estimated to take 4 hours to complete over the four week period. Women are expected to complete one hour per week and the researchers will telephone the participants weekly to monitor their progress.
Intervention code [1] 292878 0
Prevention
Comparator / control treatment
The control group will be a waitlist control group who will be given the opportunity to complete the intervention at the end of the 3 month follow-up period.
Control group
Active

Outcomes
Primary outcome [1] 296148 0
The primary outcome is mean Edinburgh Postnatal Depression Scale score.
Timepoint [1] 296148 0
The data will be collected baseline, immediately post the four week intervention and at 3 month follow up.
Primary outcome [2] 296149 0
Perfectionism as measured by the Frost Multidimensional Perfectionism Scale
Timepoint [2] 296149 0
The data will be collected baseline, immediately post the four week intervention and at 3 month follow up.
Primary outcome [3] 296150 0
Clinical perfectionism as measured by the Clinical Perfectionism Questionnaire
Timepoint [3] 296150 0
The data will be collected baseline, immediately post the four week intervention and at 3 month follow up.
Secondary outcome [1] 317633 0
Depression symptoms as measured by the Depression Anxiety Stress Scale - 21 item (DASS-21).
Timepoint [1] 317633 0
The data will be collected baseline, immediately post the four week intervention and at 3 month follow up.
Secondary outcome [2] 318258 0
Anxiety symptoms as measured by the Depression Anxiety Stress Scale - 21 item (DASS-21).
Timepoint [2] 318258 0
The data will be collected baseline, immediately post the four week intervention and at 3 month follow up.
Secondary outcome [3] 318259 0
Stress as measured by the Depression Anxiety Stress Scale - 21 item (DASS-21).
Timepoint [3] 318259 0
The data will be collected baseline, immediately post the four week intervention and at 3 month follow up.
Secondary outcome [4] 318260 0
Repetitive negative thinking traits as measured by the Repetitive Thinking Questionnaire - 10 items (RTQ-10)
Timepoint [4] 318260 0
The data will be collected baseline, immediately post the four week intervention and at 3 month follow up.

Eligibility
Key inclusion criteria
The inclusion criteria are (a) women, (b) who are at least 28 weeks pregnant, and (c) with high levels of perfectionism, as identified by a cutoff of 22 on the Concern over Mistakes subscale of the Frost Multidimensional Perfectionism Scale (FMPS; Frost, Marten, Lahart, & Rosenblate, 1990).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria are (a) any current suicidal ideation or intent; (b) substance abuse or dependence; or (c) currently receiving psychological treatment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited either through their private obstetrician practice or through their hospital antenatal class. In each case they will be given a brief explanation of the study and if they are interested in participating they will be given an information sheet and contact details of the researchers. Participants who contact the researchers expressing interest in taking part will be given a unique de-identified code and asked to complete a 20 minute online survey. The participants responses will be reviewed and those women whose responses indicate high levels of perfectionism will be invited to participate in the study. Allocation is not concealed from the researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing will be used to allocate participants two either the intervention or waitlist control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total sample of 80 participants, 40 per group, is needed to demonstrate ‘moderate’ to ‘large’ interaction effects with 80% power and an alpha of 5% and ‘large’ interaction effects with an Bonferroni adjusted alpha of 1% using Generalised Linear Mixed Models (GLMM) using an effect size of 0.8. Analysis will involve simple independent samples t-tests to compare demographics for each group and a mixed effects regression model using GLMM to compare the interaction effects between group and time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/11/2015
Actual
6/02/2016
Date of last participant enrolment
Anticipated
Actual
18/08/2016
Date of last data collection
Anticipated
Actual
12/01/2017
Sample size
Target
80
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6779 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 10609 0
6000 - Perth
Recruitment postcode(s) [2] 14431 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 292119 0
Self funded/Unfunded
Name [1] 292119 0
Country [1] 292119 0
Primary sponsor type
University
Name
Curtin University
Address
School of Psychology and Speech Pathology
GPO Box U1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 290795 0
None
Name [1] 290795 0
Address [1] 290795 0
Country [1] 290795 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293600 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 293600 0
Ethics committee country [1] 293600 0
Australia
Date submitted for ethics approval [1] 293600 0
Approval date [1] 293600 0
18/08/2015
Ethics approval number [1] 293600 0
HR106/2013
Ethics committee name [2] 296084 0
St John of God
Ethics committee address [2] 296084 0
Ethics committee country [2] 296084 0
Australia
Date submitted for ethics approval [2] 296084 0
21/10/2015
Approval date [2] 296084 0
19/01/2016
Ethics approval number [2] 296084 0
891
Ethics committee name [3] 296085 0
Women and Newborn Health Services - King Edward Memorial Hospital
Ethics committee address [3] 296085 0
Ethics committee country [3] 296085 0
Australia
Date submitted for ethics approval [3] 296085 0
18/05/2016
Approval date [3] 296085 0
28/06/2016
Ethics approval number [3] 296085 0
2015230EW

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

Contacts
Principal investigator
Name 60430 0
Dr Sarah Egan
Address 60430 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth WA 6845
Country 60430 0
Australia
Phone 60430 0
+61892662367
Fax 60430 0
Email 60430 0
[email protected]
Contact person for public queries
Name 60431 0
Sarah Egan
Address 60431 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth WA 6845
Country 60431 0
Australia
Phone 60431 0
+61892662367
Fax 60431 0
Email 60431 0
[email protected]
Contact person for scientific queries
Name 60432 0
Sarah Egan
Address 60432 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth WA 6845
Country 60432 0
Australia
Phone 60432 0
+61892662367
Fax 60432 0
Email 60432 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
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