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Does the use of a mindfulness app combined with peer support improve pregnant women's mental health?

Does the use of a mindfulness app combined with peer support improve pregnant women's mental health?

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001113640
Enrollment
20
Registered
2023-10-25
Start date
2024-02-06
Completion date
2025-01-13
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

School of Nursing and Midwifery, University of Newcastle
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Phase 1 criteria: - Pregnant women who are at risk of anxiety and minor depression (Edinburgh Postnatal Depression Scale (EPDS) = 10) - Pregnant women aged at least 18 years - Able to read and understand English Phase 2 criteria: - Pregnant women who are less than 30 weeks gestation at the time of recruitment. - Pregnant women aged at least 18 years - Able to read and understand English and own a smartphone

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 14, 2026