jmir-2025-1-e56601
jmir-2025-1-e56601
jmir-2025-1-e56601
Original Paper
Sehwan Park1,2, MA; Hee Young Cho3, MD, PhD; Jin Young Park4,5,6, MD, PhD; Kyungmi Chung4,5,6, PhD; Kyungun
Jhung7, MD, PhD
1
Biomedical Research Institute, Catholic Kwandong University International St. Mary’s Hospital, Incheon, Republic of Korea
2
Medical Research Team, Digital Medic co., Ltd., Seoul, Republic of Korea
3
Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea
4
Department of Psychiatry, Yongin Severance Hospital, Yonsei University College of Medicine, Yonsei University Health System, Yongin, Republic
of Korea
5
Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Yonsei University Health System, Seoul, Republic of Korea
6
Center for Digital Health, Yongin Severance Hospital, Yonsei University College of Medicine, Yonsei University Health System, Yongin, Republic
of Korea
7
Department of Psychiatry, Catholic Kwandong University International St. Mary’s Hospital, Catholic Kwandong University College of Medicine,
Incheon, Republic of Korea
Corresponding Author:
Kyungun Jhung, MD, PhD
Department of Psychiatry
Catholic Kwandong University International St. Mary’s Hospital
Catholic Kwandong University College of Medicine
25, Simgok-ro 100 Beon-gil
Incheon, 22711
Republic of Korea
Phone: 82 1090563807
Email: kyungun12@gmail.com
Abstract
Background: Perinatal mental health problems, such as anxiety, stress, and depression, warrant particularly close monitoring
and intervention, but they are often unaddressed in both obstetric and psychiatric clinics, with limited accessibility and treatment
resources. Mobile health interventions may provide an effective and more accessible solution for addressing perinatal mental
health. Development and evaluation of a mobile mental health intervention specifically for pregnant women are warranted.
Objective: This study aimed to evaluate the effectiveness of a 4-week, self-administered mobile mindfulness intervention in
reducing anxiety, depression, and stress, and improving emotional well-being, maternal-fetal attachment, and mindfulness skills
in a general population of pregnant women.
Methods: Pregnant women were recruited and randomized to an intervention or a wait-list control group. The intervention
group participated in a self-administered 4-week smartphone-based mindfulness program. Anxiety, depression, and stress were
assessed as primary outcomes at baseline and postintervention. Secondary outcomes were mental health well-being, maternal-fetal
attachment, and skills of mindfulness. The usability of the mobile intervention was also evaluated.
Results: A total of 133 pregnant women were randomly assigned to the intervention (n=66) or the control group (n=67). The
overall dropout rate was 30% (39/133). Anxiety scores of the intervention group significantly decreased from baseline to
postintervention (P=.03, Wilcoxon Signed-Rank test), whereas no significant changes were observed in the control group.
Depression and stress scores showed no significant changes. Emotional well-being significantly improved in the intervention
group (P=.01). Improvements were observed in maternal-fetal attachment, particularly in attributing characteristics to the fetus
(P=.003) and in differentiating the self from the fetus (P=.006). Mindfulness awareness also showed significant improvement
(P=.008). Significant between-group effects were identified for mindfulness awareness (P=.006) and attributing characteristics
to the fetus (P=.002). After applying the false discovery rate corrections, within-group improvements in emotional well-being,
maternal-fetal attachment, and mindfulness awareness remained significant, while between-group differences for emotional
well-being and differentiation were not significant.
Conclusions: A mobile mindfulness program effectively reduced anxiety and improved emotional well-being, maternal-fetal
attachment, and mindfulness awareness in the general population of pregnant women. Mobile interventions may offer a cost-effective
and feasible method for promoting perinatal mental health.
Trial Registration: Clinical Research Information Service KCT0007166; https://tinyurl.com/458vfc4r
KEYWORDS
anxiety; perinatal mental health; depression; mobile health care; mindfulness; mobile phone
Mindfulness training techniques through mindfulness-based The randomization was performed by a designated member of
stress reduction or MBCT have been shown to be effective for the research team who was not involved in the data analysis.
pregnant women in reducing stress, anxiety, depressive The randomization sheet was only accessible to the person
symptoms, and emotional distress during pregnancy responsible for assigning participants to their respective groups.
[26,28,30,31]. A systematic review on the effectiveness of MBIs A designated member of the research team allocated the
on maternal perinatal mental health outcomes showed reductions participants to the intervention or control group using the
in perinatal anxiety and less consistent results for the effect on randomized list. Those randomly assigned to the wait-list control
depression, but the review was limited by the number of studies group received the intervention after 4 weeks. The reporting of
available and their methodological quality [25]. Even though this trial adheres to the CONSORT-EHEALTH (Consolidated
mindfulness interventions may be effective in perinatal mental Standards of Reporting Trials of Electronic and Mobile Health
health care, gold-standard mindfulness training often requires Applications and Online Telehealth) guidelines (Multimedia
rigorous hours of in-person instruction and training. Thus, Appendix 1).
traditional mindfulness programs pose similar accessibility
barriers to pregnant women.
Sample Size
The sample size was determined using G*Power (version
Mobile-based MBIs may offer a promising solution to 3.1.9.7), based on standard assumptions for detecting differences
overcoming these barriers in perinatal mental health care between 2 groups over time. The calculation assumed a
[32-35]. Sun et al [33] implemented an 8-week mindfulness small-to-medium effect size and a statistical power of 80%,
program, which was shown to be effective for pregnant women with the required sample size estimated at 90 participants (45
who screened positive for depressive symptoms. In the study, per group) [18,25]. To account for potential attrition, which has
only 8% (7/84) completed the entire 8-week training program. been reported to reach up to 33% in similar interventions
As smartphone-based mobile interactions are mostly [18,25], the recruitment target was set at 134 participants.
self-administered, the acceptability of the intervention by the
participant is an important part of treatment viability. We aimed Participants
to address this point by developing a shorter, more usable Participants were recruited both from internet-based
self-administered mobile MBI that is effective for perinatal advertisement and on-site at the Obstetrics and Gynecology
mental health. Furthermore, increased depression, anxiety, and Department of the CHA Bundang Medical Center in Seongnam,
stress during pregnancy are associated with negative prenatal South Korea, from March to November 2020. The hospital is
outcomes, even at a subclinical level. Subclinical anxiety and the largest and first specialized center for pregnancy and
stress were linked to increased risks of preterm birth, low birth women’s health in the country. Informational posters displayed
weight, and lower Apgar scores [36]. In addition, mild in the hospital and internet-based advertisements were used for
depressive symptoms are reported to be associated with recruitment. Potential participants were provided with detailed
heightened cortisol levels, impacting fetal neurodevelopment information about the study, and those interested were invited
and increasing the likelihood of neonatal complications [36]. to contact the research team for further screening and
This suggests that addressing even mild symptoms in pregnancy enrollment. The inclusion criteria were as follows: (1) at least
could improve maternal and neonatal health outcomes. Thus, 18 years of age, (2) between 1 and 32 weeks of gestation, (3)
in developing the intervention, we aimed to target the general having a smartphone, (4) being able to use the app on a
population of pregnant women to improve their mental health smartphone for the study, (5) being able to read and understand
and well-being, compared with previous studies that often focus Korean, (6) willing to be randomized, and (7) willing to provide
on the clinical population. informed consent. Exclusion criteria were as follows: (1) over
In this randomized controlled trial, we evaluated the 32 weeks of gestation and (2) expected to give birth within 4
effectiveness of our newly developed, 4-week mindfulness-based weeks (during the intervention period). The study did not
mobile app in reducing perinatal anxiety, depression, and stress exclude participants based on medical history (eg, obstetric
among a general population of pregnant women. We also complications or mental illness) unless these conditions reached
investigated mental health well-being, maternal-fetal attachment, a clinically significant level that would affect participation or
and mindfulness skills as secondary outcomes, and assessed the safety of the participant.
usability of the intervention to determine feasibility for broader Upon obtaining informed consent and ensuring random
application. allocation, all participants completed a baseline evaluation,
including sociodemographic, medical, pregnancy-related, and
Methods mental health information. If participants could not visit the
obstetric department or complete the questionnaire at the site,
Trial Design and Randomization they received a Google survey link of the questionnaire through
This study was a single-center, randomized wait-list controlled email or smartphone.
trial with assessments at baseline and post intervention (trial
Participants assigned to the intervention group were instructed
registration KCT0007166). Participants were randomized using
to download a mobile-based mindfulness intervention app named
a list created in the R (4.0.2 version; R Core Team) program,
AvecMom (Digital Medic Co) and were instructed to use it for
which was set to randomize in a 1:1 ratio. To ensure the integrity
4 weeks. They received printed guides on how to use the mobile
of the data analysis and eliminate potential bias, the data analysts
app and direct download links for both Android (Google) and
remained blinded to the group allocation of each participant.
iPhone (Apple Inc) devices. Participants were instructed to and they were recommended to seek professional help when
practice each practice session at least 3 times a week for the 4 necessary.
weeks of participating in the program.
The intervention program consisted of 4 sections—breathing
Participants assigned to the wait-list control group were mindfulness meditation, body scanning, emotional awareness,
instructed not to participate in any events of meditation, yoga, and self-kindness mindfulness (Multimedia Appendix 2). Each
or mindfulness-based activities during the 4 weeks. After the session was divided into 2 subsessions—instruction and practice
4-week period, all participants received a Google survey link sessions. In the instruction session, participants learned about
for a postintervention assessment through email, messenger, or mindfulness techniques according to the thematic curriculum
in person at the site. The control group received access to the and were guided through the mindfulness training. In the
mobile app with instructions after the 4 weeks and the practice session, participants entered the mindfulness practice
postintervention assessment. directly without the introduction content of the instruction
session. Participants needed to complete the instruction session
Ethical Considerations to enter the practice session. The sessions were designed to be
This study was approved by the institutional review board, CHA completed sequentially, with the subsequent session
Bundang Medical Center, CHA University College of Medicine automatically unlocking once the participant performs the
(HI18C0911). All participants provided written informed previous session at least twice. This sequence was clearly
consent before enrollment. Participants were fully informed outlined in the user manual provided to the participants.
about the study’s purpose, procedures, potential risk, and their
right to withdraw at any time without consequence. To ensure Each session had a duration of about 20 minutes. Participants
privacy and confidentiality, all data were deidentified before were instructed to practice each session at least twice, ensuring
analysis and securely stored on encrypted servers, accessible they engaged with the content multiple times to reinforce their
only to authorized research staff. For data with potential learning and practice. This structured approach aimed to enhance
reidentification risks, access was strictly limited to authorized usability and effectiveness, providing a comprehensive yet
research staff. Comprehensive data management protocols were manageable intervention for pregnant women. Sessions took
implemented to prevent unauthorized access and ensure into consideration the prenatal-specific psychological, physical,
participant confidentiality throughout the study. Participants and emotional changes specific to pregnancy. After each session,
received pregnancy-related gifts, valued at approximately US participants received a sequential worksheet to complement the
$41 (50,000 KRW), as an incentive for their participation in the session and aid in understanding and developing mindfulness
study. skills (Multimedia Appendix 3).
Mental Health Continuum-Short Form while categorical variables were analyzed using the chi-square
Mental health well-being was measured using the Mental Health test to ensure baseline comparability between the intervention
Continuum-Short Form (MHC-sf) [46,47]. This scale consists and control groups.
of 14 items measuring social (5 items), psychological (6 items), For demographic variables, missing data points related to
and emotional (3 items) well-being, which is scored using a smoking (1 participant) and alcohol use (2 participants) were
6-point Likert scale ranging from 0 to 5. Higher scores indicate imputed using the last observation carried forward method [54].
better mental health. The 3 MHC-sf subscales had high This method involved using the most recent patient records to
test-retest reliability, discriminant validity, and convergent impute the missing values, ensuring completeness of the
validity in Korean adults [47]. Adequate reliability was found demographic dataset for analysis.
in this study (Cronbach =0.096, at baseline).
The primary analysis was conducted using an intent-to-treat
Maternal-Fetal Attachment Scale approach, ensuring that all randomized participants were
Attachment between the mother and fetus was assessed using included in the analysis based on their originally assigned
the Maternal-Fetal Attachment Scale (MFAS) [48]. In this study, groups. Due to the nonnormal distribution of the primary and
23 items of the revised Korean version were used, which were secondary outcome data, nonparametric methods were applied
scored using a 4-point Likert scale. The 5 subscales of the using Python 3. The Mann-Whitney U test was used to compare
MFAS are designed to measure differentiation of self from the outcomes between the Intervention and Control groups, while
fetus (3 items), interaction with the fetus (4 items), attributing within-group changes from pre- to postintervention were
characteristics to the fetus (6 items), giving of self (4 items), assessed using the Wilcoxon Signed-Rank test.
and maternal role-taking (6 items). Construct and criterion Effect sizes for both the Mann-Whitney U and Wilcoxon tests
validity and reliability have been reported for pregnant Korean were calculated using the following formula:
women [49]. The study’s α coefficient for the baseline MFAS
score was 0.92.
Cognitive and Affective Mindfulness Scale-Revised
Version where Z is the test statistic and N is the number of observations.
Mindfulness was assessed with the Cognitive and Affective Effect sizes were interpreted based on the following guidelines:
Mindfulness Scale-revised (CAMS-r) [50,51]. The scale contains small (r=0.1), medium (r=0.3), and large (r=0.5).
a 10-item inventory. The response items were scored on a
To account for the nonparametric nature of the data, 95% CIs
4-point Likert scale ranging from 1 to 4. The CAMS-r consists
for the effect sizes were calculated using the bootstrapping
of 3 factors that assess mindfulness levels—awareness, attention,
method with 1000 resamples. These CIs provide a measure of
and acceptance. The awareness and attention factors comprise
precision, indicating the range within which the true effect size
4 items, and acceptance consists of 2 items. Higher scores
is likely to lie with 95% CI.
indicated higher levels of mindfulness. The CAMS-r has good
internal reliability (Cronbach α=0.73), internal validity For secondary outcomes, multiple comparisons were addressed
(Cronbach α=0.70), and test-retest reliability (r=0.77, P<.001) using the false discovery rate (FDR) correction method to
among Korean undergraduate students [51]. This study’s α control for Type I errors [55]. This method ensures that the
coefficient for the baseline CAMS-r score was 0.86. statistical significance of the results is maintained while
minimizing the risk of false positives due to multiple testing,
Usability particularly in the analysis of secondary outcomes.
To assess the usability of the mindfulness mobile app, the
Usefulness, Satisfaction, and Ease of Use questionnaire (USE All statistical results, including test statistics, P values, effect
questionnaire) [52] was used after 4 weeks of using the app. sizes, and 95% CIs, are reported to provide a comprehensive
This scale consists of 30 items measuring usefulness (8 items), understanding of the intervention’s effectiveness.
ease of use (4 items), ease of learning (11 items), and satisfaction
(7 items). The scale used was a 7-point Likert scale ranging Results
from strongly disagree (1) to strongly agree (7). The reliability
Participant Enrollment and Flow
of the questionnaire in this study was assessed using Cronbach
α, with results demonstrating high internal consistency across A total of 143 perinatal women were recruited as eligible for
all 4 dimensions (usefulness: 0.914, ease of use: 0.898, ease of the study. Of the 143 participants, 2% (3/143) did not meet the
learning: 0.883, satisfaction: 0.905). These findings are inclusion criteria, and 5% (7/143) did not complete the baseline
consistent with those reported by Gao et al [53], who found assessment. Thus, 133 participants were allocated randomly,
similarly high reliability (Cronbach α=0.98 overall). of which 66 were allocated to the intervention group and 67 to
the wait-list control group. During the follow-ups, 13% (17/133)
Data Analysis did not complete the follow-up assessment and 17% (22/133)
All statistical analyses were conducted using SPSS (version were not willing to continue participation. The overall
18.0; IBM Corp) and Python 3 (Python Software Foundation). completion rate was 71% (94/133; Figure 1; see Multimedia
Demographic characteristics were analyzed in SPSS 18.0. An Appendix 1 for the CONSORT-EHEALTH checklist).
independent samples t test was used for continuous variables,
weeks of the 2 groups were 20.61 (SD 6.42) months and 20.04
Demographics and Clinical Characteristics (SD 6.76) months, respectively. There were no significant
Demographic characteristics are presented in Table 1. All 133 differences between the 2 groups across all the baseline
participants were pregnant and married at baseline. The mean characteristics, including pregnancy period, occupation,
ages of the participants for the intervention (n=66) and control education level, income, pregnancy plan, medical diagnosis,
groups (n=67) included in the analysis were 32.6 (SD 4.3) years and other characteristics.
and 32.8 (SD 4.44) years, respectively, and the mean gestational
No 44 (67) 51 (76)
Yes 22 (33) 16 (24)
Smoking, n (%) 0b (1) .99
No 64 (97) 65 (97)
Yes 2 (3) 2 (3)
Alcohol use, n (%) 1.1b (1) .29
No 60 (91) 64 (96)
Yes 6 (9) 3 (4)
Depression history, n (%) .3b (1) .57
No 57 (86) 60 (90)
No 52 (79) 60 (90)
Yes 14 (21) 7 (10)
a
Independent t test.
b
Chi-square test.
c
All monetary values are presented in US $. The conversion rate used is US $1=1220.14 KRW, reflecting the exchange rate at the time of the study.
d
Not applicable.
(SD 5.5), and 9.7 (SD 8.2) for depression, anxiety, and stress,
Effectiveness of the Mobile-Based Mindfulness respectively. The mean scores of depression, anxiety, and stress
Intervention of the compared control group were 7.4 (SD 7.7), 6.9 (SD 7.3),
Primary Outcomes: Anxiety, Depression, and Stress and 11.7 (SD 8.6), respectively. Considering the recommended
cutoff scores from previous research, mean scores for
Table 2 shows the mean scores of pre- and postmeasures of the
depression, anxiety, and stress were in the normal range [42].
DASS-21, EPDS, CAMS-r, MHC-sf, and MFAS in the
The baseline mean scores of the EPDS in the intervention and
intervention and control groups. The DASS-21 mean scores of
control groups were 7.1 (SD 5.1) and 7.6 (SD 6.3), respectively.
the intervention group at preintervention were 6.7 (SD 7.2), 6.9
Table 2. Comparison of depression, anxiety, and stress scores at pre- and postintervention time points between the intervention and control groups
using nonparametric analysis.
Scale, variable, and group Pretest Posttest P valuea P valueb
Mean (SD) Median (IQR) Mean (SD) Median (IQR)
DASS-21c
Anxiety
EPDSg
IG 7.1 (5.1) 6 (4-9) 6.2 (4.6) 6 (2-9.75) .16 .11
CG 7.6 (6.3) 6 (2-10.5) 8.3 (6) 8 (3.75-11.25) .29 —
a
P value for Wilcoxon Signed-Rank test for within-group comparisons (pre- to posttest).
b
P value for Mann-Whitney U test for between-group comparisons (posttest).
c
DASS-21: Depression, Anxiety and Stress Scale, 21-question version.
d
IG: intervention group.
e
CG: control group.
f
Not applicable.
g
EPDS: Edinburgh Postnatal Depression Scale.
Anxiety scores, measured using the DASS-21, significantly significant changes were observed in the control group, where
decreased in the intervention group from pre- to anxiety scores increased from a median of 5 (IQR 2-8) to 8 (IQR
postintervention, with the median score dropping from 6 (IQR 2-10.5; W=244, P=.11, r=5.083, 95% CI –5 to 1). The
2-10) to 4 (IQR 2-7.5), as shown by the Wilcoxon Signed-Rank Mann-Whitney U test showed no significant difference between
test (W=295, P=.03, r=6.413, 95% CI –2 to 5). In contrast, no the groups at baseline (U=1191, P=.51, r=–0.068, 95% CI –2
to 4). Postintervention comparisons approached significance, medians of 10 (IQR 4-18) for preintervention and
favoring the intervention group (U=869, P=.08, r=–0.183, 95% postintervention (IQR 4-16) time points (W=387.5, P=.98,
CI –6 to 0). r=8.073, 95% CI –5 to 6). The Mann-Whitney U test revealed
no significant differences between the groups at baseline
Depression scores, measured using the DASS-21, did not
(U=951.5, P=.25, r=–0.119, 95% CI –8 to 2), nor
significantly change in the intervention group, with the median
postintervention time points (U=911.5, P=.15, r=–0.150, 95%
remaining at 4 (IQR 2-9.5) for preintervention and 4 (IQR 2-8)
CI –9 to 2).
for postintervention (W=352.5, P=.60, r=7.663, 95% CI –4 to
4). Although the control group showed an increase in depression The intervention group showed no significant changes in EPDS
scores from a median of 4 (IQR 2-10.5) to 7 (IQR 2-12), this scores, with a median score of 6 (IQR 4-9) for preintervention
change was not statistically significant (W=238, P=.09, r=4.958, and 6 (IQR 2-9.75) for postintervention (W=272.5, P=.16,
95% CI –6 to 0). No significant difference between the groups r=5.924, 95% CI –3.5 to 3.0). In the control group, EPDS scores
was observed at baseline (U=1068.5, P=.79, r=–0.028, 95% CI increased slightly from a median of 6 (IQR 2-10.5) to 8 (IQR
–3 to 3), and postintervention group comparisons did not reach 3.75-11.25), but this change was not significant (W=331.5,
statistical significance (U=903.5, P=.13, r=–0.156, 95% CI –6 P=.29, r=6.906, 95% CI –5.0 to 2.5). Baseline comparisons
to 1). showed no significant differences between the groups
(U=1094.5, P=.95, r=–0.007, 95% CI –5 to 3), and
Stress scores, measured using the DASS-21, remained stable
postintervention group differences were also nonsignificant
in the intervention group, with a median score of 8 (IQR 4-13.5)
(U=888, P=.11, r=–0.169, 95% CI –5.0 to 1.5).
for preintervention and 8 (IQR 2-13.5) for postintervention time
points (W=321.5, P=.48, r=6.989, 95% CI –4 to 5). The control The primary outcomes results are summarized in Table 2 and
group also showed no significant change in stress scores, with depicted in Figure 2.
Figure 2. Comparison of median anxiety scores with IQR at pre- and postintervention between intervention and control groups using nonparametric
analysis.
Table 3. Comparison of well-being, maternal-fetal attachment, and mindfulness scores at pre- and postintervention time points between the intervention
and control groups using nonparametric analysis.
Scale, variable, and group Pretest Posttest P valuea P valueb
Mean (SD) Median (IQR) Mean (SD) Median (IQR)
MHC-sfc score
Total
CGe 34.8 (16.1) 31.5 (20.8-47.5) 32.3 (16.3) 31.5 (20.8-46) .34 —f
Emotional
IG 9.5 (2.9) 9 (8-12) 10.5 (3.0) 11.5 (8-12) .02g .07
MFAS scoreh
Total
IG 72.1 (11.2) 72.5 (65-80) 74.5 (11.4) 75.5 (68-83.8) .15 .18
CG 71.1 (11.6) 71.5 (62.8-79.2) 70.9 (12.9) 73 (60.5-82) .93 —
Differentiation self from fetus
IG 9.0 (1.7) 9 (8-10) 9.8 (1.7) 10 (9-11) .006g .04
CAMS-ri score
Total
IG 25.3 (5.9) 25 (21.2-29.8) 26.7 (7.0) 26.5 (21.2-31.8) .25 .08
CG 24.7 (5.4) 26 (21.8-27) 24.2 (5.2) 24 (21-27.2) .59 —
Awareness
IG 9.9 (2.8) 10 (8-12) 11.2 (3.2) 11 (9-13.8) .008g .006g
a
P value for Wilcoxon Signed-Rank test for within-group comparisons (pre- to posttest).
b
P value for Mann-Whitney U test for between-group comparisons (posttest).
c
MHC-sf: Mental Health Continuum-Short Form.
d
IG: intervention group.
e
CG: control group.
f
Not applicable.
g
Significant changes after false discovery rate correction.
h
MFAS: Maternal-Fetal Attachment scale.
i
CAMS-r: Cognitive and Affective Mindfulness Scale-revised.
Differentiation self from fetus dimension of maternal-fetal intervention group and the between-group difference remained
attachment significantly improved in the intervention group, significant.
with median scores increasing from 9 (IQR 8-10) to 10 (IQR
Awareness from CAMS-r showed a significant increase in the
9-11), as reflected in the Wilcoxon Signed-Rank test (W=129.5,
intervention group from pre- to postintervention time points.
P=.006, effect size r=2.815, 95% CI –1.5 to 0.0). No significant
The median score rose from 10 (IQR 8-12) to 11 (IQR 9-13.75),
changes were found in the control group (W=206.5, P=.81,
as indicated by the Wilcoxon Signed-Rank test (W=200, P=.008,
effect size r=4.302, 95% CI –0.5 to 0.0). Postintervention
effect size r=4.348, 95% CI –3.0 to 0.5). In contrast, the control
comparisons revealed a significant difference between groups,
group did not exhibit significant changes in awareness over the
favoring the intervention group (U=1379, P=.04, effect size
same period (W=406.5, P=.97, effect size r=8.469, 95% CI –1
r=–0.215, 95% CI 0.0-1.5). After FDR correction, the
to 1). Postintervention comparisons between the groups revealed
within-group improvement in the intervention group remained
a significant difference favoring the intervention group
significant, while the between-group difference was not
(U=1467.5, P=.006, effect size r=–0.284, 95% CI 0-3). The
significant.
FDR correction confirmed that both the within-group
The attributing characteristics to fetus dimension of improvement and the between-group difference were significant.
maternal-fetal attachment significantly improved within the
Subscales within the secondary outcomes, such as (1) social
intervention group, with median scores rising from 21 (IQR
and psychological well-being (MHC-sf); (2) interaction with
18-22) to 22 (IQR 20.25-24), as indicated by the Wilcoxon
the fetus, giving of self, and maternal role-taking (MFAS); and
Signed-Rank test (W=107, P=.003, effect size r=2.326, 95% CI
(3) attention and acceptance in mindfulness (CAMS-r), did not
–3 to 0). No significant changes were observed in the control
show significant changes postintervention, as indicated by the
group (W=316, P=.79, effect size r=6.583, 95% CI –2.0 to 2.5).
FDR-adjusted analyses.
The Mann-Whitney U test revealed a significant postintervention
difference between the groups, favoring the intervention group The comprehensive effects of both primary and secondary
(U=1506.5, P=.002, effect size r=–0.314, 95% CI 0.5-4.0). After outcomes, including statistical significance and CIs, are detailed
FDR correction, both the within-group improvement in the in Table 4.
Table 4. Effect sizes and 95% CIs for significant primary and secondary outcomes, comparing intervention and control groups.
Variable and group Within comparison Between comparison
Effect Size r (95% CI) P value Effect size r (95% CI) P value
Anxiety
Emotional well-being
IG 3.348 (–4.0 to 0.5) .01 –0.19 (–0.5 to 4.0) .07
CG 5.99 (–1.5 to 2.5) .47 — —
Differentiation self from fetus
IG 2.815 (–1.5 to 0.0) .006 –0.215 (0.0 to 1.5) .04
CG 4.302 (–0.5 to 0.0) .81 — —
Attributing characteristics to fetus
IG 2.326 (–3.0 to 0.0) .003 –0.314 (0.5 to 4.0) .002
CG 6.583 (–2.0 to 2.5) .79 — —
Awareness
IG 4.348 (–3.0 to 0.5) .008 –0.284 (0.0 to 3.0) .006
CG 8.469 (–1.0 to 1.0) .96 — —
a
IG: intervention group.
b
CG: control group.
c
Not applicable.
be very challenging with demands on the time and cost of the benefits, such as a reduction in postpartum depression [57].
pregnant mothers, along with other barriers to treatment This study shows that a self-administered mindfulness program
including the scarcity of perinatal treatment resources and stigma may promote maternal-fetal attachment, even in a relatively
of going to psychiatric clinics. In previous research, the mean short duration of 4 weeks. Whether these effects may have a
number of completed training weeks of the 8-week intervention lasting, long-term benefit should be evaluated in the future.
was 3 [33]. Mobile-based or internet-based forms of treatment
Increased mindful awareness was shown in the intervention
delivery may help overcome these limitations and promote
group, and supporting the newly developed 4-week mobile
access to timely interventions. Our study demonstrates that an
mindfulness program may cultivate or increase skills of
MBCT-modified, short-term, self-administered mobile
mindfulness. Mindful awareness is nonjudgmental and
mindfulness intervention may benefit mental health during the
nonreactive attention to experiences occurring at the present
perinatal period.
moment, including cognition, emotion, and bodily sensations,
An analysis of the secondary outcomes from the mobile as well as surrounding environmental stimuli [58]. When one
mindfulness intervention program revealed significant is mindfully aware, adaptation to stressful situations increases
improvements in emotional well-being, a subscale of the by enhancing attention to the negative emotional states [59].
well-being questionnaire (MHC-sf), among pregnant women Promotion of actual skills may have more persisting benefits,
following the 4-week intervention. Previous research has shown as these skills can be used in everyday life. Our findings suggest
that poor maternal emotional well-being is associated with that these skills can be fostered through mobile-based,
childbirth complications, such as low birth weight and fetal self-administration, even within a relatively short period of 4
developmental issues, as well as long-term cognitive and weeks. Maintaining awareness, without judgment or reactivity,
behavioral problems in the child [56]. Enhanced emotional toward emotions about the dramatic changes that come with
well-being has also been linked to better physical and mental childbirth and related beliefs or automatic thoughts, may help
health outcomes for pregnant women, improved labor outcomes, in emotion regulation and behavioral adaptation. In a previous
better health outcomes for offspring, and stronger maternal study that investigated the effect of the in-person MBCT
attachment [27,56]. Our findings suggest that mobile program for 9 weeks increased natural childbirths for pregnant
mindfulness training has the potential to promote emotional women with high fears of childbirth, increased mindful
well-being during pregnancy and could serve as an accessible awareness was the most powerful mechanism of change to better
and effective tool for supporting mental health during this adapt to the challenges of childbirth [60]. The present mobile
challenging period. In addition, the significant improvements intervention may be an accessible tool to effectively cultivate
in emotional well-being observed in the intervention group mindful awareness to increase tolerance to negative emotional
reinforce the effectiveness of MBIs in enhancing mental states and cope with them better.
well-being, even in populations not at high risk for mental health
The mindfulness program scored high on usefulness, ease of
disorders [56].
use, ease of learning, ease to use, and overall satisfaction.
Another notable finding from our study was the positive effect Previously, it was noted that the traditional mindfulness
of the mobile program on maternal-fetal attachment. Attachment, intervention was challenging to access for women who already
or the relationship between the mother and her infant, begins had children because of time limitations and existing family
before birth (during pregnancy) as a result of dynamic responsibilities, which led to a high loss to follow-up [60]. While
psychological and physiological events. During pregnancy, mobile apps may be a preferable mode of delivery for mental
women have intellectual, physical, and kinesthetic awareness health interventions to mitigate these barriers, the benefits of
of the fetus. Gradually, they become aware of the fetus as a the intervention may be limited if it is difficult for users to
separate individual. Women notice and interpret different administer. Current findings suggest that the mobile program
movements of the fetus, elaborating personal relationships. is both feasible and acceptable. Furthermore, the responses from
Using the MFAS, domains of differentiation from the fetus and the usability study provided useful information for future
attribution of characteristics to the fetus were significantly program modifications. The mobile app used in our study
increased in the intervention group. Differentiation of the self automatically provides push notification services to serve the
from the fetus indicates that the woman recognizes the fetus as purpose of the mindfulness intervention program (eg, a reminder
an individual separate from her body [57]. The ability to attribute to use the app at least twice a week). This feature helped
characteristics, such as personality, emotions, and physical space improve adherence for some participants. Features like these
in the uterus, to the fetus is part of the dynamic relationship within a mobile app have the potential to enhance adherence
between mother and fetus [48,57]. Increased scores on these and effectiveness, while a user-friendly design can facilitate the
characteristics mean that mothers have a high level of attachment broad and efficient implementation of the app to provide
with their fetuses, by forming an identity as a mother and motivation for continued use [61].
recognizing their developing fetuses; in turn, they may be more
prepared and invested in their pregnancy [49]. Being in a
Limitations
mindful state means being aware of both the self and others, as Several limitations should be acknowledged. First, we only
well as one’s inner and outer self. Mobile-based mindfulness found results from the immediate effects of postintervention
training may lead to an increased awareness of the fetus as an because our study design did not include a long-term follow-up.
individual, leading to qualitative changes in the interaction with Future research should explore the long-term effects, potentially
the fetus. Improved maternal-fetal attachment has long-term including postpartum outcomes for both the mother and infant,
to better inform perinatal care. Given the relatively short study sample size. This also suggests that outcomes such as depression
period (4 weeks), it is important to determine whether the and stress may have shown no significant effect due to
observed benefits are long-term, or if additional or booster insufficient power. Future studies should aim to recruit a larger
sessions might be necessary to maintain or enhance these sample size to ensure adequate power to detect significant
benefits. Second, our sample consisted of a general pregnancy effects.
population, and thus, the results of the current study do not
represent effectiveness in a clinical sample such as that of a
Conclusions
depressive disorder group [25]. No significant effect was Mindfulness-based mobile interventions offer an effective tool
observed on depression scores in this study, which may be for alleviating prenatal anxiety and improving emotional
attributed to the low scores that represent no clinical depression well-being as well as maternal-fetal attachment. This
at baseline. It will be helpful to investigate whether the intervention may serve as a cost-effective and highly accessible
intervention can reduce clinical levels of anxiety or depression method of intervention to overcome the current limitations of
in the future. Finally, the effect sizes of depression, anxiety, perinatal mental health management. Further research is needed
and stress in this study were small, potentially due to the limited to investigate whether the program provides lasting benefits for
both mother and infant.
Acknowledgments
This research was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry
Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant RS-2022-KH131144).
Data Availability
The datasets generated and/or analyzed during this study are not publicly available because of restrictions containing information
that could compromise the privacy of study participants but are available from the corresponding author upon reasonable request.
Authors' Contributions
SP contributed to the study design, data acquisition, organization of the data, all statistical analyses, and interpretation of data,
and wrote all sections of the manuscript. HYC was involved in the study concept, funding acquisition, recruitment of participants,
and data acquisition. JYP was involved in the study concept, design, interpretation of data, and supervision. KC was involved in
the protocol development, technical supervision, and interpretation of data. KJ was involved in the study concept, design, data
acquisition, interpretation of data, preparation and review of the manuscript, and supervision. All authors have read and approved
the final manuscript.
Conflicts of Interest
None declared.
Multimedia Appendix 1
CONSORT-eHEALTH checklist (V 1.6.2).
[PDF File (Adobe PDF File), 158 KB-Multimedia Appendix 1]
Multimedia Appendix 2
Overview of the mindfulness-based intervention AvecMom mobile app content.
[DOCX File , 14 KB-Multimedia Appendix 2]
Multimedia Appendix 3
Screenshots of AvecMom mindfulness mobile app.
[DOCX File , 180 KB-Multimedia Appendix 3]
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Abbreviations
CAMS-r: Cognitive and Affective Mindfulness Scale-revised
CONSORT-EHEALTH: Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications
and Online Telehealth
DASS-21: 21-item Depression, Anxiety and Stress Scale
EPDS: Edinburgh Postnatal Depression Scale
FDR: false discovery rate
MBCT: mindfulness-based cognitive therapy
MBI: mindfulness-based intervention
MFAS: Maternal-Fetal Attachment scale
MHC-sf: Mental Health Continuum-Short Form
USE: Usefulness, Satisfaction, and Ease of Use
Edited by A Mavragani; submitted 03.05.24; peer-reviewed by K Lee, F Mao; comments to author 26.05.24; revised version received
29.09.24; accepted 28.11.24; published 17.01.25
Please cite as:
Park S, Cho HY, Park JY, Chung K, Jhung K
Development and Evaluation of a Mindfulness-Based Mobile Intervention for Perinatal Mental Health: Randomized Controlled Trial
J Med Internet Res 2025;27:e56601
URL: https://www.jmir.org/2025/1/e56601
doi: 10.2196/56601
PMID:
©Sehwan Park, Hee Young Cho, Jin Young Park, Kyungmi Chung, Kyungun Jhung. Originally published in the Journal of
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