Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001588189
Ethics application status
Approved
Date submitted
16/08/2019
Date registered
19/11/2019
Date last updated
19/11/2019
Date data sharing statement initially provided
19/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does educating pregnant women who are expecting their first child about unwanted, intrusive thoughts influence obsessions and compulsions in the postnatal period?
Scientific title
A prospective randomised-controlled trial of the efficacy of brief antenatal psychoeducation in preventing postnatal obsessive-compulsive symptoms in first time mothers.
Secondary ID [1] 299011 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive-compulsive disorder 314020 0
Condition category
Condition code
Mental Health 312410 312410 0 0
Anxiety
Reproductive Health and Childbirth 313450 313450 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of brief psychoeducation intended to correct maladaptive metacognitive (i.e. psychological) beliefs about unwanted, intrusive thoughts that have been found to be linked to the onset of obsessive-compulsive symptoms in the postnatal period. Psychoeducation was provided via a single, short (7-minute) online informational video, developed by the research team (including two Clinical Psychologists, a Consultant Perinatal Psychiatrist, and a Provisionally-Registered Psychologist and Doctoral Candidate). Participants received the intervention during pregnancy (at >20 weeks' gestation). Adherence was monitored using a short validation survey that participants were required to complete after viewing the video and before childbirth that assessed their comprehension of the information presented in the video. Additionally, adherence to the intervention (i.e. participants' viewing of the video) was also verified by a researcher as part of the final telephone follow-up interview conducted at 5-6 months post participants' expected due date.

The video contained information on the nature and prevalence of postnatal intrusions, examples of common postnatal intrusions, and more helpful metacognitive appraisals of, and strategies for responding to, intrusive thoughts in the postnatal period.
Intervention code [1] 315281 0
Prevention
Intervention code [2] 315282 0
Early detection / Screening
Intervention code [3] 315283 0
Behaviour
Comparator / control treatment
The comparison group will receive treatment-as-usual (TAU) provided by their usual perinatal care provider (e.g., Obstetrician, Midwife, Maternal and Child Health Nurse, and/or General Practitioner). Participants in the waitlist-comparison group will receive the intervention video after they have completed the final follow-up interview and survey at 5-6 months post their expected due date.
Control group
Active

Outcomes
Primary outcome [1] 321062 0
OCD diagnosis, assessed using the MINI Neuropsychiatric Interview (MINI; Sheehan 1998).
Timepoint [1] 321062 0
2-3 months, and 5-6 months post the participant's expected delivery date.
Secondary outcome [1] 373834 0
Parental Thoughts and Behaviours Checklist (Abramowitz et al 2006); specifically, the Obsessions Subscale Severity Score (range 0-20).
Timepoint [1] 373834 0
2-3 months and 5-6 months post the participant's expected delivery date.
Secondary outcome [2] 373835 0
Obsessive-Compulsive Inventory Revised (OCI-R; Foa et al 2012) - Total and symptom-dimension subscale scores.
Timepoint [2] 373835 0
2-3 months and 5-6 months post the participant's expected delivery date.
Secondary outcome [3] 373836 0
Obsessive Beliefs Questionnaire - Short Form (OBQ-20; Moulding et al 2011) - Total and subscale scores.
Timepoint [3] 373836 0
2-3 months and 5-6 months post the participant's expected delivery date.
Secondary outcome [4] 373837 0
Generalised Anxiety Disorder 7-Item Scale (GAD-7; Spitzer et al 2006) - total summed scale scores.
Timepoint [4] 373837 0
2-3 months and 5-6 months post the participant's expected delivery date.
Secondary outcome [5] 373838 0
Edinburgh Postnatal Depression Scale (EPDS; Cox et al 1987) - total summed scale scores.
Timepoint [5] 373838 0
2-3 months and 5-6 months post the participant's expected delivery date.
Secondary outcome [6] 377020 0
Parental Thoughts and Behaviours Checklist (Abramowitz et al 2006); specifically, the Compulsions Subscale Severity Score (range 0-20).
Timepoint [6] 377020 0
2-3 months and 5-6 months post participants' expected delivery date.

Eligibility
Key inclusion criteria
Participants are females; at least 18 years of age; English-speaking; expecting first child and in the prenatal period - defined, for the purpose of this research, as the period from 20 to 32 weeks gestation (‘prenatal’) through to the 6-months post-childbirth (‘postnatal’) - at the time of diagnostic screening. To be included, participants also consented to be contacted by a researcher by telephone to complete a pretrial screening interview, and two follow-up assessments.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals were be excluded from the study if, based on a diagnostic screening
telephone interview (using the MINI), they met criteria for any of the following conditions; current OCD, substance disorder, borderline personality disorder, or antisocial personality disorder; current/past psychotic disorder or bipolar disorder; or are currently on psychotropic medication.

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)
Central randomisation by computer application program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a simulated, electronic coin toss (http://random.org)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
General linear modelling will be utilised with condition (metacognitive education, TAU) and time (prenatal, 3-months postnatal, 6-months postnatal) as IVs; metacognitive beliefs (TAF scores, importance and control beliefs as measured on the OBQ-20 subscales), self-reported dimensional postnatal OCS (OCI-R scores), as DVs; and prenatal metacognitive or cognitive beliefs (i.e. responsibility or perfectionism measured via select OBQ-20 subscales), prenatal OCS (i.e. OCI-R scores), or depression (EPDS scores) or generalised anxiety (GAD-7 scores), as the covariates. Mediational analyses will be used to determine whether changes in participants’ metacognitive beliefs (i.e. TAF scores, importance and control belief scores) mediate the effect of condition on postnatal OCS at 3- and 6-months follow-up. The above analyses will be augmented by performing the log rank test, a non-parametric survival analytic technique (Singh & Mukhopadhyay, 2011), to evaluate the effect of condition on OCD diagnosis rates at each follow-up time point (3-months and 6-months postnatal). G*Power was used to determine sample size requirements, and yielded a minimum required sample of 75 participants.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
9/07/2018
Date of last participant enrolment
Anticipated
Actual
18/02/2019
Date of last data collection
Anticipated
30/11/2019
Actual
Sample size
Target
150
Accrual to date
Final
138
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 21765 0
New Zealand
State/province [1] 21765 0

Funding & Sponsors
Funding source category [1] 303546 0
University
Name [1] 303546 0
Curtin University
Country [1] 303546 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street
Bentley, Perth, WA
6102
Country
Australia
Secondary sponsor category [1] 303621 0
None
Name [1] 303621 0
Address [1] 303621 0
Country [1] 303621 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304076 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 304076 0
Ethics committee country [1] 304076 0
Australia
Date submitted for ethics approval [1] 304076 0
16/12/2016
Approval date [1] 304076 0
07/03/2017
Ethics approval number [1] 304076 0
HRE2017-0087

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

Contacts
Principal investigator
Name 95734 0
Dr Rebecca Anderson
Address 95734 0
Curtin Health and Wellness Centre
Building 404
Kent Street
Bentley WA 6102
Country 95734 0
Australia
Phone 95734 0
+610892661717
Fax 95734 0
Email 95734 0
[email protected]
Contact person for public queries
Name 95735 0
Melissa Mulcahy
Address 95735 0
Curtin Health and Wellness Centre
Building 404
Kent Street
Bentley WA 6102
Country 95735 0
Australia
Phone 95735 0
+61089266 1717
Fax 95735 0
Email 95735 0
[email protected]
Contact person for scientific queries
Name 95736 0
Melissa Mulcahy
Address 95736 0
Curtin Health and Wellness Centre
Building 404
Kent Street
Bentley WA 6102
Country 95736 0
Australia
Phone 95736 0
+61089266 1717
Fax 95736 0
Email 95736 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be available, consistent with ethical approval for this trial.


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.