Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000354684p
Ethics application status
Submitted, not yet approved
Date submitted
2/02/2023
Date registered
5/04/2023
Date last updated
5/04/2023
Date data sharing statement initially provided
5/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Brains, Babies & Bodies: A group psychological intervention for pregnant women living with bipolar disorder – a pilot feasibility and acceptability study
Scientific title
A group psychological intervention for pregnant women living with bipolar disorder – a pilot feasibility and acceptability study
Secondary ID [1] 308893 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder 328886 0
Condition category
Condition code
Mental Health 325881 325881 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot study aims to assess the feasibility and acceptability of an online 8-week group psychological intervention for pregnant women with bipolar disorder. It will use a mixed methods design utilising both quantitative and qualitative data collection.

This study will deliver an 8-week group therapy program designed to meet the unique needs of women with bipolar disorder during the perinatal period. The program will include 8 weekly group sessions, and a 6 month individual follow up interview. The program will incorporate elements of therapies that have been demonstrated to be effective in the management of bipolar disorder in the context of the perinatal period, including: psychoeducation regarding sleep, circadian rhythms, breastfeeding and medication compliance, mindfulness skills and behavioural relaxation techniques, activity scheduling and well-being planning, connecting with social supports and exploring stigma, as well as child development and parenting information. Further to the development of the intervention, this study will assess the feasibility and acceptability of the telehealth platform online via zoom.

Two group facilitators will deliver the intervention; both group facilitators are registered psychologists who will monitor the well-being of the participants throughout the group.

The NIH (2020) guidelines suggest that research questions for pilot studies such as this should include: Is this innovation safe, acceptable and feasible? Can I recruit the target population? Are the treatment conditions acceptable to the population? Were there anticipated effects? Were there unanticipated effects? Did people participate as expected? As such, it is hypothesised that women with bipolar disorder will find the perinatal 8-week group therapy program both acceptable and feasible. In addition, the online delivery of the intervention, via zoom, will also be feasible and acceptable for pregnant women.

The duration of 8 weekly group sessions will approximately 1.5hrs. The group composition will include 6 participants with 2 group facilitators. This intervention will be delivered via the online platform, Zoom. The content will be delivered in the form of a structured powerpoint presentation, followed by a structured group discussion and the completion of the corresponding section of the well-being plan.

The duration of the follow-up interview will be approximately 1 hour. Session attendance, homework completion, and drop-out rates will monitored to assess the participant adherence to the intervention.
Intervention code [1] 325339 0
Treatment: Other
Comparator / control treatment
Nil - pilot acceptability and feasibility study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333718 0
Drop out/retention rate
This is assessed at the completion of the program through an audit of attendance.
Timepoint [1] 333718 0
Post-completion of the intervention (8 weeks post-baseline)
Secondary outcome [1] 418046 0
Mean number of sessions attended
Calculated at the conclusion of the study based through an audit of attendance.
Timepoint [1] 418046 0
Post-completion of the intervention (8 weeks post-baseline)
Secondary outcome [2] 418047 0
Qualitative feedback overall regarding content of the program. This will be assessed using a semi-structured interview. This includes questions relating to the content of the program and delivery
Timepoint [2] 418047 0
Post-completion of the intervention (8 weeks post-baseline)
Secondary outcome [3] 418048 0
Completion of wellbeing plan. The extent of the well-being plan that is completed is assessed by an audit of the study records.
Timepoint [3] 418048 0
Post-completion of the intervention (8 weeks post-baseline).

Eligibility
Key inclusion criteria
Inclusion Criteria: Diagnosis of bipolar disorder, female, over the age of 18 years, currently pregnant, currently under the care of a psychiatrist or GP with written approval from primary clinician to participate, not actively suicidal or experiencing severe mood symptoms (score of greater than 38 on the YMRS and 35 on the MADRS (Young, Biggs, Ziegler, & Meyer, 1978; Müller, Szegedi, Wetzel & Benkert, 2000).
Minimum age
18 Years
Maximum age
51 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: nil diagnosis of bipolar disorder, male or female and not pregnant under the age of 18 years, not currently under care of GP or psychiatrist, or primary clinician deems participant not eligible. Participants will also be excluded if they are actively suicidal or experiencing severe mood symptoms (score of greater than 38 on the YMRS and 35 on the MADRS (Young, Biggs, Ziegler, & Meyer, 1978; Müller, Szegedi, Wetzel & Benkert, 2000).

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)
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data on feasibility and acceptability (number of sessions attended, completion of well-being plan, dropout rates) are collected throughout this trial phase. Qualitative data are analysed using a content analysis framework employing a directed approach

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/04/2023
Actual
Date of last participant enrolment
Anticipated
28/02/2024
Actual
Date of last data collection
Anticipated
28/04/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313105 0
University
Name [1] 313105 0
Western Sydney University
Country [1] 313105 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797. Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 314804 0
University
Name [1] 314804 0
Western Sydney University
Address [1] 314804 0
Locked Bag 1797. Penrith NSW 2751.
Country [1] 314804 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312354 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 312354 0
Ethics committee country [1] 312354 0
Australia
Date submitted for ethics approval [1] 312354 0
02/02/2023
Approval date [1] 312354 0
Ethics approval number [1] 312354 0
H15250

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

Contacts
Principal investigator
Name 124354 0
Miss Isabel Fraser
Address 124354 0
Western Sydney University, Second Ave, Kingswood NSW 2747
Country 124354 0
Australia
Phone 124354 0
+61450838323
Fax 124354 0
Email 124354 0
[email protected]
Contact person for public queries
Name 124355 0
Isabel Fraser
Address 124355 0
Western Sydney University, Second Ave, Kingswood NSW 2747
Country 124355 0
Australia
Phone 124355 0
+61450838323
Fax 124355 0
Email 124355 0
[email protected]
Contact person for scientific queries
Name 124356 0
Isabel Fraser
Address 124356 0
Western Sydney University, Second Ave, Kingswood NSW 2747
Country 124356 0
Australia
Phone 124356 0
+61450838323
Fax 124356 0
Email 124356 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
From publication up to 15 years after completion of study
Available to whom?
Case-by-case basis
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Contacting the Principal Investigator [email protected]


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.