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Trial registered on ANZCTR


Registration number
ACTRN12617000307303
Ethics application status
Approved
Date submitted
20/02/2017
Date registered
27/02/2017
Date last updated
5/07/2021
Date data sharing statement initially provided
5/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot trial of group metacognitive therapy for perinatal onset obsessive compulsive disorder
Scientific title
A pilot trial on the effectiveness of group metacognitive therapy for perinatal onset obsessive compulsive disorder
Secondary ID [1] 291214 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive compulsive disorder 302132 0
Condition category
Condition code
Mental Health 301745 301745 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The program will follow the manualised metacognitive therapy procedure outlined in Rees, “OCD: A practical guide to treatment (2009)”. Eight group treatment sessions of two hours duration each will be held once per week over eight weeks. Sessions 1-2 will cover engagement (psychoeducation and normalisation, increasing motivation to change, goal setting, treatment rationale, and shifting to the metacognitive mode). Sessions 3-7 will focus on metacognitive therapy (awareness and modification of attentional strategies and maladaptive metacognitive beliefs, including behavioural experiments). Session 8 will detail relapse prevention planning.
The intervention will be delivered by psychologists undertaking postgraduate training in clinical psychology, under the supervision of a Registered Clinical Psychologist. Supervision will be provided on a weekly basis to ensure adherence to the treatment protocol. The intervention will be delivered at the Curtin University Psychology Clinic.
Intervention code [1] 297217 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301142 0
The Mini-International Neuropsychiatric Interview (M.I.N.I.), Version 7: The MINI-7 is a short, structured diagnostic interview for the major psychiatric disorders in DSM-5.
Timepoint [1] 301142 0
The MINI will be used to assess the inclusion/exclusion criteria for the project and provide a categorical outcome measure regarding diagnosis at an initial baseline assessment 3 weeks prior to the treatment, the day prior to the treatment, the day after treatment and at 3 month follow-up.
Secondary outcome [1] 331831 0
Yale-Brown Obsessive Scale (Y-BOCS; Goodman et al., 1989): The Y-BOCS is a semi-structured interview used to evaluate the severity and intensity of OCD symptoms. The scale is a composite measure that includes 10 items, and measures severity through the following five parameters of obsessions (items 1–5) and compulsions (items 6–10): (a) time occupied/frequency, (b) interference, (c) distress, (d) resistance, and (e) perceived control. Each item is rated on a 5-point scale ranging from 0 (none) to 4 (extreme), and the scale has a maximum score of 40. This score will supplement the primary categorical outcome measure by providing dimensional data on outcomes.
Timepoint [1] 331831 0
The Y-BOCS will be used across three baseline data points (three, two and one week prior to intervention, weekly (ie 8 times) during treatment, and at three month follow-up to track obsessive compulsive symptoms throughout the treatment.
Secondary outcome [2] 331832 0
Edinburgh Postnatal Depression Scale (EPDS; Cox, Holden, & Sagovsky, 1987): The EPDS is a 10 item, self-report measure designed as a screening tool for depressive symptoms for both men and women during the perinatal period.
Timepoint [2] 331832 0
The EPDS will be used across three baseline data points (three, two and one week prior to intervention, weekly (ie 8 times) during treatment, and at three month follow-up to track depression, which is often comorbid with perinatal OCD.
Secondary outcome [3] 331833 0
Thought Fusion Instrument (TFI; Wells, Gwilliam, & Cartwright-Hatton, 2001):
The TFI is a 14 item self-report composite measure that assesses metacognitive beliefs about the power and meaning of intrusive thoughts.
Timepoint [3] 331833 0
The TFI will be used across three baseline data points (three, two and one week prior to intervention, weekly (ie 8 times) during treatment, and at three month follow-up to track changes in metacognitive beliefs throughout the treatment program.
Secondary outcome [4] 331834 0
The Obsessive-Beliefs Questionnaire (OBQ-44; OCCWG, 2005): This questionnaire is a key composite measure of the metacognitive and cognitive belief domains that have been implicated in causal theories of OCD. This is a 44 item measure, and therefore not suitable for weekly use but will provide additional information for the trial regarding metacognitive and cognitive changes consistent with predominant theories.
Timepoint [4] 331834 0
This measure will be used at an initial baseline assessment 3 weeks prior to the treatment, the day prior to the treatment, the day after treatment and at 3 month follow-up.

Eligibility
Key inclusion criteria
Individuals with a primary OCD diagnoses with onset or worsening of symptoms, and a significant impact on functioning, within 6 months of having a baby will be included in the study. Every participant included in the intervention must have a referring clinician who is a registered health professional. Males and females. Over 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any individuals with psychotic symptoms, drug and alcohol dependency, severe intellectual disabilities, child protection issues, current high-risk for self-harm/suicidality, or engaging in concurrent psychological treatment will be excluded from the study. Participants will be asked to maintain their current medication dose unless otherwise indicated by their managing medical professional.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Three baseline data points will be collected prior to the intervention to provide a comparison point between no intervention (baseline) and the intervention time periods. This will allow us to examine symptom stability prior to the active treatment being introduced, providing better evidence for the role of the intervention in an uncontrolled trial than simple pre and post intervention data.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis of clinical effectiveness will be conducted as follows. The MINI-7 will provide a categorical outcome measure regarding OCD diagnosis at baseline, pre, post and follow-up. In addition to this any categorical changes to secondary diagnosis, such as depression, can be assessed with the MINI-7 at baseline, pre, post and follow-up. In addition to this, paired samples t-tests will be used to compare pre and post intervention scores on secondary measures (Y-BOCS, TFI, OBQ-44 & EPDS) to assess the effect size of individual symptom improvement as a result of the intervention. Jacobson and Truax (1991) criteria assessing clinically significant and reliable change indices will be used on the Y-BOCS and EPDS to determine if and at which point in time clients have improved, remained the same, or deteriorated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/03/2017
Actual
8/03/2017
Date of last participant enrolment
Anticipated
3/04/2017
Actual
3/04/2017
Date of last data collection
Anticipated
31/10/2017
Actual
24/09/2017
Sample size
Target
8
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 295661 0
University
Name [1] 295661 0
Curtin University
Country [1] 295661 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, WA 6102
Country
Australia
Secondary sponsor category [1] 294508 0
None
Name [1] 294508 0
NA
Address [1] 294508 0
NA
Country [1] 294508 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296978 0
Human Research Ethics Committee, Curtin University
Ethics committee address [1] 296978 0
Kent Street, Bentley WA 6102
Ethics committee country [1] 296978 0
Australia
Date submitted for ethics approval [1] 296978 0
Approval date [1] 296978 0
01/02/2017
Ethics approval number [1] 296978 0
HRE2017-0034

Summary
Brief summary
The perinatal period has been identified as a period of increased risk for obsessive compulsive disorder (OCD) onset and worsening, for both mothers and fathers. Preliminary research suggests that metacognitive therapy (MCT) may be an effective treatment for OCD. MCT focuses on correcting misinterpretations about the meaning and importance of intrusive thoughts, and the need to control these. MCT does not involve the use of traditional exposure and response prevention exercises for OCD, often experienced as aversive by participants. Small trials to date have noted low drop out rates for MCT, so it proposed to be well tolerated by participants.

Preliminary research also indicates that MCT may be an effective transdiagnostic treatment approach, meaning that it may be able to treat multiple psychological problems by targeting shared underlying maintaining factors. In clinically diverse populations, significant improvements were noted in depression, anxiety, worry, rumination and metacognition following a MCT intervention, with treatment gains sustained over 6 month follow-up. In populations with a primary OCD diagnosis MCT was found to be effective with a range of comorbid mental health conditions reflecting transdiagnostic efficacy of the treatment. To date, no studies have evaluated the use of MCT for OCD that has onset or worsened in the perinatal period. The aim of the present study is to investigate the efficacy of an 8-week group MCT program for perinatal OCD. It is hypothesised that:
1. Participants will show a categorical improvement in OCD symptoms following MCT, demonstrated by no longer meeting the diagnostic criteria for OCD at post-treatment, and maintained at 3-month follow-up.
2. Participants will show a reduction in symptom severity and intensity of OCD following MCT, demonstrated by meeting clinically significant and reliable change criteria, at post-treatment and maintained at follow-up.
3. Participants will show a reduction in co-morbid depressive symptoms following MCT, demonstrated by decreased scores on measures of depressive symptoms.
4. Participants will show decreases in scores of unhelpful metacognitive and cognitive beliefs following MCT
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72602 0
Dr Rebecca Anderson
Address 72602 0
Kent Street, Bentley WA 6102
Country 72602 0
Australia
Phone 72602 0
+61 8 9266 1717
Fax 72602 0
Email 72602 0
rebecca.anderson@curtin.edu.au
Contact person for public queries
Name 72603 0
Rebecca Anderson
Address 72603 0
Kent Street, Bentley, WA 6102
Country 72603 0
Australia
Phone 72603 0
+61 8 9266 1717
Fax 72603 0
Email 72603 0
rebecca.anderson@curtin.edu.au
Contact person for scientific queries
Name 72604 0
Rebecca Anderson
Address 72604 0
Kent Street, Bentley, WA 6102
Country 72604 0
Australia
Phone 72604 0
+61 8 9266 1717
Fax 72604 0
Email 72604 0
rebecca.anderson@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.