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Maternal psychological distress during pregnancy is associated with unfavorable outcomes in infants. Mindfulness-based interventions (MBIs) can effectively alleviate psychological distress, but there are often barriers to the access of face-to-face interventions.
This study aimed to investigate the effectiveness of a digital guided self-help (GSH) MBI (GSH-MBI) in reducing maternal psychological distress and improving infant neuropsychological performance.
This was a randomized controlled trial. We recruited 160 women who were 12 to 20 weeks pregnant and exhibited psychological distress. We randomized them into a digital GSH-MBI group and a control group (usual perinatal care). The digital GSH-MBI consisted of a 6-week intervention through a WeChat mini program, with a daily reminder sent to the participants by a research assistant via WeChat. The primary outcomes consisted of maternal psychological distress, including depression, anxiety, and pregnancy-related anxiety symptoms, which were assessed at 6 time points from baseline to 6 months post partum (only pregnancy-related anxiety symptoms were assessed 3 times during pregnancy). The secondary outcomes were infant neuropsychological outcomes, including temperament and developmental behaviors, which were assessed at 6 weeks and 6 months post partum.
Compared with the control group, the digital GSH-MBI group showed a significant reduction in depression, anxiety, and pregnancy-related anxiety symptoms. In addition, the scores of the digital GSH-MBI group were lower than those of the control group for the 3 types of infant temperament at 6 weeks post partum, including quality of mood, distractibility, and adaptability.
Digital GSH-MBIs are effective in alleviating psychological distress among pregnant women and protecting infant outcomes.
Chinese Clinical Trial Register ChiCTR2000040717; https://www.chictr.org.cn/showproj.aspx?proj=65376
Psychological distress during pregnancy is a common condition worldwide. The overall prevalence of depression and anxiety symptoms during pregnancy is 22.4% and 22.9%, respectively [
Mindfulness-based interventions (MBIs) teach participants to recognize habitual patterns of response, to be more mindful in their daily lives, and to make changes in how they relate to their thoughts, feelings, bodily sensations, and external environments [
The digital guided self-help (GSH) approach is an innovative approach that circumvents many barriers to disseminating face-to-face interventions. It allows patients to take home a standardized psychological intervention protocol (downloaded from the internet) that functions more or less independently [
In recent years, we have developed 3 generations of a digital GSH-MBI that target psychological distress during pregnancy. The first generation [
This study includes the third-generation digital GSH-MBI. On the basis of our prior research, we made further improvements. First, the intervention program was presented in video and audio formats, as past studies have shown that psychological education produces better intervention effects in a video format than in a text format [
Although the impact of psychological distress during pregnancy on infant neurodevelopmental outcomes was discovered years ago, little progress has been made in addressing this problem [
The study protocol was reviewed and approved by the Ethics Committee of Shandong University School of Nursing (2020-R-025). Informed consent was obtained from all participants to participate in the study. The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and the Helsinki Declaration of 1975, as revised in 2008.
This study was a 2-arm RCT. The participants were pregnant women who underwent routine obstetric examinations at the outpatient centers of 2 comprehensive tertiary hospitals in Shandong Province from December 2020 to April 2021. The inclusion criteria were as follows: the participant must be aged ≥18 years, have single pregnancy, be at 12 to 20 weeks of gestation, have Edinburgh Postnatal Depression Scale (EPDS) score of ≥9 or Generalized Anxiety Disorder 7-item (GAD-7) scale score of ≥5, be fluent in reading and writing Chinese, not participated in any other psychological intervention, and be able to access the WeChat mini program. We excluded participants if they had suicidal ideation (score of item 10 of EPDS ≥1), serious mental disorders (eg, schizophrenia and bipolar disorder), physical illnesses (eg, cancer and cardiovascular or cerebrovascular diseases), drug abuse or dependence, or prior experience in mindfulness exercises. This study was registered in the Chinese Clinical Trial Register (identifier: ChiCTR2000040717).
We used the G* Power [
We invited pregnant women at 12 to 20 weeks of gestation (baseline, T1) to participate in screening for symptoms of anxiety and depression during routine obstetric visits. Then, we invited eligible women to complete a demographic questionnaire and pregnancy-related anxiety scale. Random sequences were generated using a computerized random number generator. Random numbers were placed in opaque envelopes and assigned to participants according to the sequence of participant enrollment. Eligible participants who agreed to participate were randomized 1:1 to one of 2 groups: the digital GSH-MBI group (ie, usual perinatal care and mindfulness intervention) or the control group (ie, usual perinatal care) according to the random numbers in the envelopes. Data collectors were blinded to the treatment allocation. Women in the digital GSH-MBI group were told about the requirements and notices of the intervention and then started receiving the mindfulness intervention.
The intervention program included 6 modules, each of which lasted for 1 week and was delivered on a WeChat mini program. Each module consisted of thematic lessons and homework. On the first day of each week, participants viewed animated videos that provided thematic lessons of each module. Each video was 10- to 20-minute long and included a variety of cartoon images and mindfulness practice demonstrations recorded by our research team. We hoped that this would increase the participants’ interest in the course content and improve their compliance. For the remaining 6 days of each week, participants were asked to do homework, including formal and informal practices. The formal practice involved daily audio-based practices, such as mindful breathing and body scan. Participants were also encouraged to engage in informal practice daily, such as mindfulness in everyday life or 3-minute breathing space exercises. Participants in the intervention group were sent standardized practice reminders every day by the research assistant via WeChat. The content of the reminder was, “Ding ~ remember to attend class! Today is week X, day X.”
Screenshot of WeChat mini program.
The primary outcome was maternal psychological distress, including symptoms of depression, anxiety, and pregnancy-related anxiety. We assessed depression and anxiety using the EPDS [
The EPDS comprises 10 items, with responses ranging from 0 to 3. Higher total scores indicate more depressive symptoms. An EPDS score of 9 is recommended for screening for depression in postpartum Chinese women [
The secondary outcomes were infant neuropsychological development, including temperament and developmental behaviors. We assessed infant temperament at 6 weeks post partum using the Early Infancy Temperament Questionnaire [
We collected baseline data on the participants’ demographic characteristics and pregnancy-related conditions using questions developed specifically for this study. These questions asked about age, nationality (Han or National minority), education (below undergraduate or undergraduate or above), marital status (married or single), average monthly household income (<6000 yuan or ≥6000 yuan, CNY 6000 yuan [US $884]), residence (urban or rural), height, gestational age, prepregnancy weight, pregnancy weight, parity (primipara or multipara), and complications during pregnancy (yes or no). We acquired information on neonatal outcomes, including birth weight and gestational age at delivery, from the hospital registry databases.
We defined adherence as the number of weeks of completed modules, and we defined module completion as at least 4 days of formal practice per week. We defined intervention completion as completion of all 6 modules. The backend system of the WeChat mini program could record the participants’ formal practice time each day. We calculated the intervention completion rate as the proportion of participants who completed the intervention divided by the number of participants who received the intervention.
We used the Little test to assess whether the missing mechanism is completely random. Because the
We used the generalized estimated equation with an unstructured working correlation matrix to explore the effect of the digital GSH-MBI on maternal psychological distress, including symptoms of depression, anxiety, and pregnancy-related anxiety. The generalized estimated equation does not require imputing missing values, which is especially advantageous in longitudinal studies with missing data, as all available data are used and no cases are deleted. We followed the intention-to-treat analysis and performed a sensitivity analysis using a mixed-effects modeling approach (
We used linear regression to scrutinize the effects of the intervention on infant neuropsychological development. Infant sex, maternal age, maternal education, and average monthly household income were included as covariates in the regression analysis according to previous RCT studies that focused on maternal psychological intervention and child neurodevelopment [
We performed further analyses using Amos (version 26.0; IBM Corp) to examine the effects of the intervention on infant neuropsychological development by mitigating maternal psychological distress. The model of mediation was established with an independent variable (X, treatment allocation), a mediating variable (M, maternal psychological distress at T2 or T3), and a dependent variable (Y, infant outcomes). We performed a partial correlation analysis to investigate the relationship between maternal psychological distress at T2 or T3 and infant neuropsychological development after adjusting for psychological distress at T1. We included only maternal psychological distress variables that were significantly correlated with infant neuropsychological development in the mediation analysis.
We conducted statistical analyses using SPSS (version 26.0; IBM Corp). We calculated Cohen
We approached and screened 608 pregnant women at 12 to 20 weeks of gestation for eligibility, and we obtained a final sample of 160 (
Participant flow diagram. GSH: guided self-help; MBI: mindfulness-based intervention. T1: baseline (12-20 weeks of gestation); T2: immediately after the intervention (approximately 20-28 weeks of gestation); T3: before birth (36-37 weeks of gestation); T4: 6 weeks post partum; T5: 3 months post partum; T6: 6 months post partum.
Demographic characteristics and pregnancy-related conditions of pregnant women.
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Total sample (N=160) | Digital GSH-MBIa group (n=80) | Control group (n=80) | ||||||
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Age (years), mean (SD) | 30.29 (4.29) | 30.36 (4.65) | 30.21 (3.93) | |||||
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Han | 158 (98.8) | 79 (98.8) | 79 (98.8) | ||||
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National minority | 2 (1.2) | 1 (1.2) | 1 (1.2) | ||||
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Below undergraduate | 62 (38.8) | 28 (35.0) | 34 (42.5) | ||||
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Undergraduate or above | 98 (61.2) | 52 (65.0) | 46 (57.5) | ||||
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Married | 156 (97.5) | 77 (96.2) | 79 (98.8) | ||||
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Single | 4 (2.5) | 3 (3.8) | 1 (1.2) | ||||
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<6000 | 43 (26.9) | 22 (27.5) | 21 (26.2) | ||||
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≥6000 | 117 (73.1) | 58 (72.5) | 59 (73.8) | ||||
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Urban | 141 (88.1) | 71 (88.8) | 70 (87.5) | ||||
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Rural | 19 (11.9) | 9 (11.2) | 10 (12.5) | ||||
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Gestational age (weeks) | 16.69 (1.60) | 16.71 (1.67) | 16.66 (1.53) | |||||
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Prepregnancy BMI (kg/m2) | 21.64 (3.27) | 21.14 (3.11) | 22.14 (3.36) | |||||
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Pregnancy BMI (kg/m2) | 22.64 (3.49) | 22.21 (3.30) | 23.08 (3.66) | |||||
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Primipara | 94 (58.8) | 45 (56.2) | 49 (61.2) | ||||
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Multipara | 66 (41.2) | 35 (43.8) | 31 (38.8) | ||||
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Yes | 43 (27.5) | 19 (23.8) | 24 (30.4) | ||||
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No | 116 (72.5) | 61 (76.2) | 55 (69.6) |
aGSH-MBI: guided self-help mindfulness-based intervention.
As shown in
Changes in maternal psychological distress over time in the digital guided self-help (GSH)–mindfulness-based intervention (MBI) group and the control group. T1: baseline (12-20 weeks of gestation); T2: immediately after the intervention (approximately 20-28 weeks of gestation); T3: before birth (36-37 weeks of gestation); T4: 6 weeks post partum; T5: 3 months post partum; T6: 6 months post partum.
Overall global test results and between-group differences in maternal psychological distress in the generalized estimating equations analysis.
Outcomes and time | Digital GSH-MBIa group, mean (SD) | Control group, mean (SD) | Estimated mean difference, mean (95% CI) | Cohen |
Group × time | ||||||||||||
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Wald |
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20.6 (5) | .001 | |||||||||||||||
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T1b | 8.91 (3.54) | 9.43 (3.26) | −0.53 (−1.57 to 0.52) | .33 | N/Ac |
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T2d | 5.21 (4.46) | 7.86 (5.07) | −2.64 (−4.12 to −1.16) | <.001 | 0.56 (0.24 to 0.87) |
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T3e | 4.48 (4.22) | 8.60 (5.58) | −4.22 (−5.79 to −2.66) | <.001 | 0.84 (0.50 to 1.17) |
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T4f | 5.81 (5.27) | 9.25 (6.34) | −3.23 (−5.10 to −1.37) | .001 | 0.59 (0.26 to 0.92) |
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T5g | 5.25 (4.47) | 8.27 (6.31) | −3.18 (−4.94 to −1.43) | <.001 | 0.56 (0.23 to 0.90) |
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T6h | 5.54 (5.44) | 8.45 (6.53) | −2.51 (−4.57 to −0.45) | .02 | 0.49 (0.15 to 0.83) |
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24.7 (5) | <.001 | |||||||||||||||
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T1 | 5.56 (2.61) | 5.80 (3.14) | −0.24 (−1.13 to 0.65) | .60 | N/A |
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T2 | 3.14 (2.74) | 5.61 (3.04) | −2.46 (−3.36 to −1.56) | <.001 | 0.85 (0.52 to 1.18) |
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T3 | 3.32 (3.19) | 6.18 (3.83) | −2.62 (−3.76 to −1.48) | <.001 | 0.82 (0.48 to 1.15) |
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T4 | 4.49 (3.63) | 7.31 (4.49) | −2.74 (−4.04 to −1.44) | <.001 | 0.69 (0.36 to 1.02) |
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T5 | 4.34 (3.31) | 5.90 (4.71) | −1.60 (−2.91 to −0.29) | .02 | 0.39 (0.05 to 0.72) |
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T6 | 3.75 (3.28) | 5.90 (4.76) | −1.52 (−2.92 to −0.13) | .03 | 0.53 (0.19 to 0.87) |
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46.5 (2) | <.001 | |||||||||||||||
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T1 | 22.61 (4.53) | 21.88 (4.64) | 0.74 (−0.67 to 2.15) | .31 | N/A |
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T2 | 19.47 (4.03) | 23.15 (5.55) | −3.70 (−5.20 to −2.19) | <.001 | 0.76 (0.43 to 1.08) |
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T3 | 19.41 (4.98) | 24.22 (5.77) | −4.92 (−6.60 to −3.23) | <.001 | 0.89 (0.55 to 1.23) |
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aGSH-MBI: guided self-help mindfulness-based intervention.
bT1: baseline (12-20 weeks of gestation).
cN/A: not applicable.
dT2: immediately after the intervention (about 20-28 weeks of gestation).
eT3: before birth (36-37 weeks of gestation).
fT4: 6 weeks post partum.
gT5: 3 months post partum.
hT6: 6 months post partum.
In terms of infant developmental behaviors at 6 weeks and 6 months at post partum, only problem-solving at 6 months was different between the digital GSH-MBI and control groups (β=−0.21, 95% CI −0.38 to −0.04;
Differences in infant neuropsychological development between the intervention and control groups.a
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Digital GSH-MBIb group, mean (SD) | Control group, mean (SD) | β (95% CI) | Cohen |
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Activity level | 3.51 (0.63) | 3.60 (0.65) | .07 (−0.10 to 0.23) | 0.15 (−0.18 to 0.47) | .43 | |||||
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Rhythmicity | 3.23 (0.61) | 3.37 (0.62) | .11 (−0.06 to 0.27) | 0.23 (−0.10 to 0.55) | .20 | |||||
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Approach | 2.50 (0.82) | 2.56 (0.92) | .03 (−0.13 to 0.20) | 0.07 (−0.26 to 0.39) | .70 | |||||
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Adaptabilityc | 2.57 (0.75) | 2.94 (0.78) | .22 (0.06 to 0.38) | 0.48 (0.15 to 0.81) | .006 | |||||
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Intensity of reaction | 3.34 (0.79) | 3.55 (0.88) | .12 (−0.04 to 0.29) | 0.25 (−0.08 to 0.57) | .13 | |||||
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Quality of moodc | 3.09 (0.52) | 3.41 (0.68) | .25 (0.09 to 0.41) | 0.53 (0.20 to 0.86) | .002 | |||||
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Attention span | 3.34 (0.81) | 3.61 (0.73) | .17 (0.01 to 0.33) | 0.35 (0.03 to 0.67) | .04 | |||||
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Distractibilityc | 2.42 (0.71) | 2.88 (0.71) | .30 (0.15 to 0.45) | 0.66 (0.33 to 0.99) | <.001 | |||||
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Threshold of reaction | 4.10 (0.72) | 3.94 (0.72) | −0.10 (−0.25 to 0.07) | 0.21 (−0.11 to 0.54) | .25 | |||||
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Surgency | 5.03 (0.96) | 4.74 (1.01) | −0.16 (−0.32 to 0.01) | 0.29 (−0.05 to 0.63) | .07 | |||||
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Negative affect | 3.82 (1.20) | 4.00 (1.29) | .06 (−0.11 to 0.23) | 0.15 (−0.19 to 0.48) | .51 | |||||
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Effortful control | 5.10 (0.85) | 4.80 (1.02) | −0.16 (−0.33 to 0.003) | 0.32 (−0.12 to 0.66) | .05 | |||||
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Communication | 43.33 (12.33) | 39.62 (15.34) | −0.13 (−0.30 to 0.05) | 0.27 (−0.07 to 0.61) | .14 | |||||
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Gross motor | 51.88 (11.08) | 51.46 (10.85) | −0.02 (−0.20 to 0.15) | 0.04 (−0.30 to 0.38) | .81 | |||||
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Fine motor | 47.03 (10.34) | 44.62 (11.33) | −0.13 (−0.30 to 0.04) | 0.22 (−0.12 to 0.56) | .12 | |||||
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Problem-solving | 48.99 (11.03) | 46.54 (13.58) | −0.11 (−0.28 to 0.07) | 0.20 (−0.14 to 0.54) | .21 | |||||
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Personal-social | 45.43 (11.59) | 44.08 (11.62) | −0.06 (−0.23 to 0.12) | 0.12 (−0.22 to 0.46) | .51 | |||||
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Communication | 51.45 (8.79) | 49.35 (11.18) | −0.10 (−0.27 to 0.07) | 0.21 (−0.13 to 0.55) | .26 | |||||
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Gross motor | 44.78 (12.59) | 42.02 (15.03) | −0.10 (−0.27 to 0.07) | 0.20 (−0.14 to 0.54) | .26 | |||||
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Fine motor | 48.99 (12.38) | 46.13 (13.56) | −0.11 (−0.29 to 0.06) | 0.22 (−0.12 to 0.56) | .20 | |||||
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Problem-solving | 52.25 (9.95) | 47.34 (13.42) | −0.21 (−0.38 to −0.04) | 0.41 (0.06 to 0.76) | .02 | |||||
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Personal-social | 45.94 (12.65) | 47.77 (16.55) | −0.14 (−0.32 to 0.03) | 0.28 (−0.07 to 0.62) | .11 |
aInfant sex, maternal age, education, and average monthly household income were adjusted for.
b GSH-MBI: guided self-help mindfulness-based intervention.
cAfter the adjustment of false discovery rate, their relationship was still significant.
The scores for the 3 types of temperament at 6 weeks (quality of mood, distractibility, and adaptability) in the digital GSH-MBI group were significantly lower than those in the control group. Thus, we used partial correlation analysis to explore the relationship between quality of mood, distractibility, and adaptability and maternal psychological distress at T2 or T3, adjusting for maternal psychological distress at T1. As shown in
On the basis of the partial correlation analysis, we tested a total of 9 mediation models, including: the indirect effect of treatment allocation, through maternal depression symptoms at T2 or T3, to infant quality of mood; the indirect effect of treatment allocation, through maternal anxiety symptoms at T2 or T3, to infant quality of mood; the indirect effect of treatment allocation, through maternal pregnancy-related anxiety symptoms at T2 or T3, to infant quality of mood; the indirect effect of treatment allocation, through maternal depression or anxiety symptoms at T3, to infant distractibility; and the indirect effect of treatment allocation, through maternal anxiety symptoms at T3, to infant adaptability. The results showed that only one indirect effect (treatment allocation, through maternal pregnancy-related anxiety symptoms at T2, on infant quality of mood) was statistically significant. The standardized indirect effect of maternal pregnancy-related anxiety symptoms at T2 was 0.071 (95% CI 0.001-0.167;
Mediation model of maternal pregnancy-related anxiety symptoms at T2 between treatment allocation and infant quality of mood. Standardized estimates are shown for relationships among treatment allocation, maternal pregnancy-related anxiety symptoms at T2, and infant quality of mood. T2: immediately after the intervention; a
The digital GSH-MBI group completed an average of 5 (SD 2.16) weeks of modules. Of the 80 participants, 65 participants completed the intervention (intervention completion rate=81.3%).
To our knowledge, this is the first RCT to examine the effectiveness of a digital GSH-MBI based on a WeChat mini program for alleviating maternal psychological distress and promoting infant neuropsychological development. Overall, the results imply that pregnant women who received digital GSH-MBI displayed less psychological distress (depression, anxiety, and pregnancy-related anxiety symptoms) compared with women in the control group at all postintervention time points. In addition, the digital GSH-MBI had a ripple effect on infant neuropsychological development, and the ripple effect on infants’ quality of mood at 6 weeks was mediated by mitigating pregnancy-related anxiety symptoms.
We explored new possibilities for delivering psychological interventions to improve maternal and child health. We used the WeChat mini program as the delivery medium and included video- and audio-based dissemination of educational information and exercises. The digital GSH-MBI, based on a WeChat mini program, has several strengths for mental health care. First, the high flexibility of the digital GSH-MBI allows women to attend classes and practice mindfulness at any time and place. Second, access to the intervention is increased. The shortage of mental health services is a major challenge in mental health care in low- and middle-income countries [
In this study, we noted the strongest treatment effects in 3 types of infant temperament at 6 weeks of age: quality of mood, distractibility, and adaptability. Higher scores of quality of mood represent a more negative mood, which is strongly associated with a neurotic personality in adults, both conceptually and empirically [
Notably, the digital GSH-MBI played a role in infants’ quality of mood through mitigating pregnancy-related anxiety symptoms rather than anxiety and depression symptoms. This finding is consistent with existing studies, which showed that pregnancy-related anxiety is a stronger predictor of offspring’s developmental outcomes than general negative emotions experienced by the mother [
Distractibility is characteristic of attentional regulation [
We did not find significant between-group differences in infant temperament at 6 months of age. On the one hand, in line with other intervention studies, the effectiveness of interventions might naturally decline over time [
This study has some limitations. First, there might be a reporting bias because the infants’ neuropsychological development outcomes were reported by their mothers. Women in the intervention group may have become more emotionally literate and thus more likely to notice specific reactions in their infants. Measurement of neuropsychological development outcomes by trained study team members is necessary to obtain robust results. Thus, our results on infant outcomes are exploratory and should be interpreted with caution. Second, most participants reported a high socioeconomic status, limiting the generalizability of the findings to disadvantaged pregnant populations. Third, some confounding factors were not measured in our study, which may have affected the results of the mediation analysis. According to a concept map [
Despite these limitations, we used a relatively convenient and novel technology that allowed participants to easily access the intervention from WeChat on their smartphones or PCs. The digital GSH-MBI, which is accessible, convenient, inexpensive, and requires fewer professionals to operate, brings new prevention and intervention opportunities for mental health problems experienced by pregnant women, especially during the COVID-19 pandemic. We conducted the study in China, as WeChat is the most popular app among the Chinese population; however, our intervention package can be used in other apps. It is important to note that using existing widely used apps to deliver brief psychological interventions is more promising than developing new apps as intervention delivery platforms. In addition, the low dropout rates and high adherence to the intervention in this study support our viewpoint that easy access to information might increase participation and compliance with psychological interventions.
The nonsignificant ripple effect of the digital GSH-MBI on infant outcomes at 6 months of age indicates that interventions need to be delivered in the postpartum period. However, our findings of the intervention’s ripple effect on infant temperament at 6 weeks of age are also encouraging. First, women tend to be more motivated to make healthy changes during pregnancy than at any other time in their lives [
Mindfulness program outline.
Parameter estimation results of mixed-effects model.
Correlation between maternal psychological distress during pregnancy and infant temperament.
CONSORT-eHEALTH checklist (V 1.6.1).
Consolidated Standards of Reporting Trials
Edinburgh Postnatal Depression Scale
Generalized Anxiety Disorder 7-item
guided self-help
mindfulness-based intervention
randomized controlled trial
The authors thank all the participants for their time and effort. This study was funded by the Surface Project of National Natural Science Foundation of China (grant 32071084) and the Fundamental Research Funds for the Central Universities (grant 2022JC016).
None declared.