Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001113640
Ethics application status
Approved
Date submitted
27/09/2023
Date registered
25/10/2023
Date last updated
21/06/2024
Date data sharing statement initially provided
25/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the use of a mindfulness app combined with peer support improve pregnant women's mental health?
Scientific title
Does the use of a mindfulness app combined with peer support improve pregnant women's mental health?
Secondary ID [1] 310653 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal anxiety 331541 0
Perinatal depression 331737 0
Condition category
Condition code
Mental Health 328277 328277 0 0
Anxiety
Mental Health 328278 328278 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An exploratory sequential mixed method design consisting of two phases will be used in the study. In the first phase, focus groups or one-to-one interviews will be conducted by midwife researchers to explore pregnant women's experiences related to support groups and mindfulness. The ideal sample size for the focus groups or interviews will be between five and eight pregnant women. The interview questions will be focused specifically on combined peer support and mindfulness-based approach: asking their suggestions about the strategies and activities, their particular likes/dislikes, and what the most important features of a peer support program are. Findings from phase one will inform the design and structure of the intervention in phase two. Phase two will involve a pilot study that utilizes a quasi-experimental design.

Intervention: phase two will be a peer support group combined with mindfulness app as an intervention for pregnant women with anxiety and depression. Peer support groups aim to bring women together for mutual support and use of the mindfulness-based app (Headspace) activity together. The facilitators (researchers) will hold a joint peer support group with a mindfulness-based approach for four weeks each session will last for about one-hour duration. A hybrid meeting option (in-person or online) will be provided. Peer support will be offered through the general discussion of listening, acknowledging, and sharing of strategies to maintain a positive outlook. The group sessions will be designed according to recommended activities derived from the findings of study phase one which explore women’s knowledge, experiences and perceptions about peer support combined with a mindfulness-based approach to support perinatal mental health. The intervention will consist of four group sessions: 1) Introduction to the program and focusing on one’s personal health and well-being; 2) Ideas related to physical and emotional common discomforts of pregnancy; 3) Increasing helpful thoughts that affect my baby and myself; 4) Transition to motherhood and community and mindfulness-based resources. (The topics vary weekly and could be adjusted based on results from phase one of the study). Following the topic discussion participants will engage in 10 minutes of mindfulness activities through the Headspace App. The mindfulness session content will include (a) practicing mindfulness meditation and coping strategies, (b) using mindfulness to connect with their babies, (c) understanding stress and how to prepare for unexpected moments during new parenthood. The approximate size of the mindfulness app and the peer support group session will be six pregnant women. There will be a total of four sessions, to be held weekly for four weeks and using session attendance checklists to monitor adherence to the intervention.

Intervention code [1] 327059 0
Lifestyle
Intervention code [2] 327252 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336138 0
Anxiety
Timepoint [1] 336138 0
Baseline: before the first peer support combined with mindfulness app session
Post-intervention: after the last peer support combined with mindfulness app session
Primary outcome [2] 336303 0
Depression
Timepoint [2] 336303 0
Baseline: before the first peer support combined with mindfulness app session
Post-intervention: after the last peer support combined with mindfulness app session
Secondary outcome [1] 427017 0
mindfulness practice
Timepoint [1] 427017 0
Baseline: before the first peer support combined with mindfulness app session
Post-intervention: after the last peer support combined with mindfulness app session
Secondary outcome [2] 427018 0
Perceived social support
Timepoint [2] 427018 0
Baseline: before the first peer support combined with mindfulness app session
Post-intervention: after the last peer support combined with mindfulness app session
Secondary outcome [3] 427020 0
Cortisol level
Timepoint [3] 427020 0
Baseline: before and after the first peer support combined with mindfulness app session
Intervention four weeks of peer support combined with mindfulness app
Post-intervention: before and after the last peer support combined with mindfulness app session
Secondary outcome [4] 427264 0
Participants’ experiences with peer support combined with the mindfulness app
Timepoint [4] 427264 0
Post-intervention: after the last peer support combined with mindfulness app session

Eligibility
Key inclusion criteria
- Pregnant women who are less than 30 weeks gestation at the time of recruitment.
- Pregnant women who have an Edinburgh Postnatal Depression Scale (EPDS) greater than or equal to 10 and/or women who self-report a history of anxiety and depression.
- Pregnant women aged at least 18 years
- Able to read and understand English and own a smartphone
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant women with multiple gestations, pregnancy complications requiring specialist care, or specific clinical mental health conditions.
- Pregnant women who are currently taking asthma or thyroid medication.

Study design
Purpose of the study
Educational / counselling / training
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/11/2023
Actual
6/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
29
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314902 0
University
Name [1] 314902 0
University of Newcastle
Country [1] 314902 0
Australia
Primary sponsor type
University
Name
School of Nursing and Midwifery, University of Newcastle
Address
School of Nursing and Midwifery The University of Newcastle University Drive, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 316909 0
None
Name [1] 316909 0
Address [1] 316909 0
Country [1] 316909 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313867 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 313867 0
Hunter Medical Research Institute, Lot 1 Kookaburra Circuit, New Lambton
Ethics committee country [1] 313867 0
Australia
Date submitted for ethics approval [1] 313867 0
24/05/2023
Approval date [1] 313867 0
26/07/2023
Ethics approval number [1] 313867 0

Summary
Brief summary
The study aims to investigate whether the use of mindfulness applications that incorporate peer support improves perinatal mental health outcomes. An exploratory sequential mixed method design consisting of two phases will be used in the study. The first phase involves qualitative study conducted through a focus group to explore women's knowledge and experiences of support groups and mindfulness. Phase one findings will inform the design and structure of the intervention in phase two. In the second phase, a pilot study using a quasi-experimental one-group pre-post test design will be used to assess peer support combined with a mindfulness app on anxiety, depression, mindfulness practices, perceived social support, and salivary cortisol levels. Peer support groups intervention aim to bring women together for mutual support and use of the mindfulness-based app (Headspace) activity together.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129610 0
A/Prof Allison Cummins
Address 129610 0
The University of Newcastle, Central Coast Clinical School 77a Holden St, Gosford Hospital, Gosford NSW 2250
Country 129610 0
Australia
Phone 129610 0
+61243484220
Fax 129610 0
Email 129610 0
allison.cummins@newcastle.edu.au
Contact person for public queries
Name 129611 0
Miss Sudjit Liblub
Address 129611 0
School of Nursing and Midwifery, College of Health Medicine and Wellbeing The University of Newcastle, University Drive, Callaghan NSW 2308.
Country 129611 0
Australia
Phone 129611 0
+61 423013344
Fax 129611 0
Email 129611 0
sudjit.liblub@uon.edu.au
Contact person for scientific queries
Name 129612 0
Miss Sudjit Liblub
Address 129612 0
School of Nursing and Midwifery, College of Health Medicine and Wellbeing The University of Newcastle, University Drive, Callaghan NSW 2308.
Country 129612 0
Australia
Phone 129612 0
+61 423013344
Fax 129612 0
Email 129612 0
sudjit.liblub@uon.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.