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Abstract
Introduction Perinatal anxiety (PNA) is a major public health concern.
Methods A hybrid effectiveness-implementation trial was conducted in two antenatal clinics in Hefei, China, to assess the effectiveness and cost-effectiveness of application-based tiered care (Mom’s Good Mood, MGM) in treating PNA and to understand how well it fits into routine practices. Pregnant women who scored at least 5 points on the 7-Item Generalised Anxiety Disorder Scale (GAD-7) scale were successively assigned to the control group or the intervention group, which were given the usual care and MGM on usual care, respectively. At 6 months post partum, anxiety, depression and life satisfaction were assessed. Intention-to-treat analysis and the Reach, Effectiveness, Adoption, Implementation and Maintenance framework were adopted.
Results A total of 214 women were assigned to the control group and 341 to the intervention group. The mean changes in GAD-7 scores (Least-squares means, LSM, −1.42, 95% CI −2.18 to −0.66) and the risk of anxiety (adjusted odds ratio, aOR 0.30, 95% CI 0.18 to 0.51) were decreased, and the anxiety remission rate (aOR 2.72, 95% CI 1.69 to 4.40) were improved in the intervention group. Similar findings were observed regarding the change in Edinburgh Postnatal Depression Scale scores (LS −1.92, 95% CI −2.85 to −0.99), depression remission rate (aOR 2.24, 95% CI 1.39 to 3.63) and the risk of depression (aOR 0.57, 95% CI 0.33 to 0.98). MGM only costs ¥1.88 (US$0.27) per pregnant woman to boost the postpartum anxiety remission rate by 1% and was revealed to have a high reach rate of 78.3%, an adoption rate of 51.3%–80.8%.
Conclusion MGM is a cost-effective and accessible tool in coping with PNA.
Trial registration number ChiCTR2100053419.
- Intervention study
- Public Health
- Mental Health & Psychiatry
- Treatment
Data availability statement
Data are available on reasonable request.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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WHAT IS ALREADY KNOWN ON THIS TOPIC
Perinatal anxiety is largely left undetected and untreated in low-income and middle-income countries (LMICs). Interventions tailored for complex prenatal health care settings, for example, primary maternal health care system, are urgently needed.
WHAT THIS STUDY ADDS
This study demonstrated that application-based tiered care (Mom’s Good Mood) achieved a balance between resources and efficiency in limited mental health care resource and tailored for real-world prenatal health care practices within primary health care system.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
Mom’s Good Mood can act as an efficacious, cost-effective, accessible tool with strong generalisability to bridge the treatment gap in coping with perinatal anxiety in LMICs.
Introduction
Perinatal anxiety (PNA) is common in women, with an estimated high prevalence of 22.9% during pregnancy and 15.0% during the first year post partum.1 PNA has been associated with both short-term and long-term adverse effects on women and children2 3 and is a strong predictor of perinatal depression4; if left untreated, it can be a heavy socioeconomic burden imposed on the health care system.5 Despite these deleterious consequences, PNA has received considerably little attention in both clinical practice and scientific research.6
In the real world, perinatal depression and anxiety are left undetected and untreated in the majority of women, especially in low-income and middle-income countries (LMICs), where the coverage of intervention for common mental disorders ranges from 7% to 28%. In China, the treatment gap is even worse, being estimated to be more than 90%.7 8 For example, a survey showed that only 2 of 16 maternal and child health institutions offered psychological counselling and treatment in Hunan Province.9 A variety of factors could contribute to the low adoption of interventions for PNA: (a) among health care organisations, the factors include limited mental health care resources, such as lack of therapists and available psychological service and (b) among pregnant women, factors include perceived stigma, time constraints, transportation problems and costs of therapy.7 10 In recent years, internet-based psychological interventions have been increasingly developed and evaluated.11 12 Such interventions characterised by anonymity, convenience to access and flexibility offer the potential to circumvent stigma and ease time restrictions.11 13 Thus, internet-based interventions can act as lower-cost means, providing an alternative to traditional face-to-face services.10 11 Among the internet-based interventions, internet-based cognitive behavioural therapy (iCBT) has received a lot of attention and has been shown as effective as face-to-face CBT in treating anxiety in the general population.14 However, few studies targeted the effectiveness of iCBT in treating PNA symptoms.15 More importantly, most interventions have been tested under highly controlled conditions, which often do not reflect real-world settings.16 Thus, interventions tailored for complex prenatal health care settings, for example, primary maternal health care system, are urgently needed.
Most prior studies followed a single-intervention approach, which is disadvantaged in achieving a balance between resources and efficiency, thus multitiered interventions are necessary, especially in limited mental health care resources settings. Evidence has shown that self-help CBT can effectively alleviate mild anxiety.17 Furthermore, media-delivered interventions of this kind have also been found to manage mild anxiety in adults,18 inspiring us to employ tiered care—treating varying severity of PNA with diverse interventions to maximise the efficiency of resource allocation in therapies.
Smartphones are widely used in China,19 which confers great opportunities for their application in health promotion of PNA. One randomised controlled trial has demonstrated the effectiveness of iCBT delivered via smartphone in reducing anxiety symptoms in the general population.20 Thus, by taking advantage of mobile devices and in recognition of the barriers to and large gap in the treatment of PNA in China, as well as considering Chinese culture and local circumstances, our team has developed an application-based intervention, ‘Mom’s Good Mood (MGM)’. MGM is a tiered intervention, which matches the intensity of the intervention to the severity of anxiety or depression symptoms. Women with moderate to severe anxiety symptoms would receive a high-intensity intervention (psychological counselling delivered by trained non-specialist health care providers (HCPs) combined with a brief self-administered iCBT lesson), while those with mild symptoms were guided to learn a brief self-administered iCBT lesson. The feasibility of MGM implemented within the primary health care system was primarily approved in our pilot study21; however, the effectiveness and cost-effectiveness of MGM in treating PNA under real-world circumstances need further evaluation, and more importantly, how well MGM fits into routine practices is still unknown.
Thus, by conducting a hybrid effectiveness-implementation trial under real-world circumstances, our current study aims to (1) evaluate the effectiveness of MGM in treating PNA within the primary health care system; (2) evaluate the cost-effectiveness of the MGM intervention and (3) describe the reach, adoption, implementation and maintenance of the MGM intervention to provide a more detailed understanding of its implementation.
Methods
Study design
A hybrid effectiveness-implementation trial was conducted at two primary maternal and child health care centres in the outskirt county in Hefei, Anhui Province, eastern China. Our current study was nested within the second stage of an effectiveness-implementation study of the Perinatal Depression Screening and Management programme, which aimed to establish an online platform adopting internet-based CBT for integration into offline maternal health check-up clinics and to provide a solution for the screening and management of perinatal depression within primary health care system settings in China.22 The perinatal period is broadly defined as during pregnancy and the first 12 months post partum.23 24 During the COVID-19 pandemic, much more work burden for epidemic prevention has been imposed on the HCPs in the antenatal health check-ups clinics, thus considering practicality, a non-randomised controlled trial was adopted. Pregnant women who consented to be enrolled were first recruited for the control group. After the target sample size was reached, women were then assigned to the intervention group.
Sample size
Comparing MGM with usual care, the between-group effect size (Hedges’ g) of anxiety symptom postpartum proportion was assumed to be at least 0.40, which was demonstrated in the previous study.15 With an α of 5% and a statistical power (1−β) of 80%, the sample size was computed to be 322 participants using PASS V.21.0.3 (NCSS). Based on a drop-out rate of 20% and an allocation rate of 1:1 (intervention group vs control group), a final sample size of 202 women in the control group and 202 women in the intervention group was proposed.
Participants
From 28 April 2020 to 20 July 2021, eligible women from two maternal health care clinics were recruited if they were (1) diagnosed as being pregnant; (2) at least 18 years old; (3) screened positive for anxiety (defined as a 7-Item Generalised Anxiety Disorder Scale (GAD-7) score of at least 5) and (4) capable of using smartphones. We only excluded pregnant women with abnormalities in expression or comprehension, no other exclusion criteria were applied. From 28 April 2020 to 30 June 2020, eligible pregnant women were included in the control group while those who were screened from 1 July 2020 to 20 July 2021, were included in the intervention group. The 6-month postpartum follow-up assessment was conducted from 22 May 2020 to 10 February 2022.
Procedures
WeChat is one of the most popular social media platforms, with over 1.2 billion active users in China,25 so the online screening platform was built on WeChat. All eligible pregnant women visiting the clinics for prenatal health care were introduced to our programme by their HCPs. After participants provided written consent, a QR code was offered for them to scan via WeChat to access the assessment of anxiety and depression using self-reported scales. At the same time, other information was also collected such as life satisfaction, and sociodemographic characteristics (including age, education, marital status, residence, etc). After the participants completed the assessments, the HCPs reviewed and approved the assessment through a backstage management system. Then, feedback and suggestions were provided to women both orally and through WeChat. The participants in the control group were provided with usual care, while those in the intervention group were instructed to download the MGM application (which was developed by our research team) by the HCPs and received tiered care in addition to usual care according to anxiety severity. Technical support was provided in a timely manner during the whole process to help women better use our tools. All data gathered during the process were automatically entered into a backstage management system that was designed to collect data, deliver results and recommendations of tiered care to the HCPs and participants, and to record videos watched and counselling sessions attended through the application.
Within 6 months post partum, anxiety status was reassessed either in person at women’s homes or at postnatal health care check-up clinics or remotely by telephone. In China, the first routine postpartum care is conducted through visiting mothers in person by trained community HCPs at 1-week post partum, and the second one is conducted at postnatal health check-up clinics at 6 weeks post partum. However, due to the high proportion of migrants at the recruitment sites and during the COVID-19 pandemic, a minority of the participants were followed up via telephone within 6 months post partum. The cost of screening and counselling was supported by research grants, and the participants in our study were required no expenditures. Regarding ethical considerations, at the 6-month postpartum follow-up, after the evaluation of the outcomes, we provided tiered care to the women who screened positive both in the intervention and control groups, since the care we gave to them after the evaluation, the sequential logic guarantee it will not affect our results at all. Moreover, for women identified to have extreme anxiety and for those at risk of suicide, a referral pathway was established, offering offline counselling services at local mental health centre.
Psychological intervention
All participants were provided with usual care, which was conducted by the HCPs responsible for anxiety assessment. Usual care included women were informed that they were screened positively for anxiety and were provided with information on how to take care of themselves and with brief advice on how to ease their emotions and seek family support. Along with usual care, additional tiered care was provided in the intervention group according to the severity of anxiety via the MGM application (a mobile app available on iPhone and Android operating systems) as follows.
Regardless of the severity of anxiety (GAD-7 score ≥5), self-administered animated videos consisting of 11 sessions were available for all women in the intervention group. The 11 video clips were adapted from the WHO Thinking Healthy Programme (THP) manual.26 THP is a low-intensity psychological intervention delivered by trained non-specialists (eg, community health workers), which was recommended by the WHO for treating perinatal depression in LMICs.26 27 Based on the core principles of CBT, the THP aims to help ease women’s feelings of depression by identifying and modifying their maladaptive thinking and behaviour and by encouraging them to seek family support.27 28 Considering the Chinese cultural context, our team translated the core content of the THP manual into Chinese and presented it in the form of vivid cartoons for easier understanding and higher acceptance. The series of videos covered the period from the first trimester of pregnancy to post partum. It mainly contained four modules: (1) an introduction to perinatal mental health problems and how to replace unhealthy thinking with positive thinking; (2) instruction on how to apply thinking healthy skills to mothers’ personal health, mother–baby interactions and relationships with others during pregnancy; (3) instruction on how to apply thinking healthy skills to mothers’ personal health, mother–baby interactions and relationships with others post partum and (4) instruction on how to fill out daily health records (eg, feelings, thoughts, sleep, diet, exercise) in the homework section. A clip was defined as ‘watched’ when more than 20 s of the video had been watched.
For women with moderate (10≤GAD‐7 score≤14) to severe (GAD‐7 score≥15) anxiety, additional one-to-one video counselling delivered by well-trained HCPs (the counselling HCPs were not the same persons as the assessing HCPs) was available for a maximum of 12 sessions. The participants could make an appointment with whichever therapist they preferred in the MGM application at the time of their convenience. At the scheduled time, the therapist made a video call through the MGM application to deliver online counselling, which typically lasted for 45 mins. Audio recordings of the counselling obtained with the women’s consent were used to assess the fidelity of therapists to the intervention.
Acceptance of the intervention was defined as having at least ‘watched’ one video clip or having at least one counselling session before the 6 months postpartum follow-up assessment. The interactive interface of the app is shown in figure 1.
The interacitve interface of the app.
HCPs training
All HCPs involved in the assessment received a 2-hour training session on the implementation of the research, including the study design, recruitment and informed consent, and data collection, and another 1-hour MGM intervention guidance training session before the trial.
The HCPs delivering counselling to the women with anxiety were experienced and qualified volunteers recruited from multiple maternal and child health care centres in Anhui Province. They attended six 2-day offline training sessions and two 1-day online training sessions on CBT (for anxiety and depression) given by professional psychologists specialised in CBT. Before providing treatment, these HCPs were assessed for their competence in delivering CBT by psychologists using the Cognitive Therapy Competence Scale29 and consistently received supervision during the trial. To ensure that the counselling was delivered as intended and according to the manuals, audiorecordings of the counselling and fidelity checklist completed by therapists were double-checked by one researcher and one psychologist.
Adverse event monitoring
Adverse events in both groups were monitored and recorded through both self-reporting and passive surveillance throughout the whole perinatal period. When adverse events, such as suicide ideation, attempts or acts, were reported, team members immediately called the participant’s emergency contact to check the participant’s condition. If suicide attempts or actions were confirmed, the pregnant women were referred to clinical psychiatrists.
Outcome measures
The primary outcomes were the changes in GAD-7 scores from baseline to 6 months post partum and the proportion of women with postnatal anxiety.
The secondary outcomes included the proportion of women with anxiety remission (remission is referred to as a reliable and clinically significant improvement status and anxiety remission is defined as the reduction of GAD-7 score to at least 4, a cut-off point, ie, a clinically meaningful measure of remission30 31), the changes in Edinburgh Postnatal Depression Scale (EPDS) scores and life satisfaction scores from baseline to 6 months post partum, the proportion of women with depression, and the proportion of women with depression remission (the reduction in the EPDS score to at least 4, a cut-off point, ie, a clinically meaningful measure of remission30) at 6 months post partum.
The GAD-7 score was measured using a self-reported GAD-7 scale that contains seven items. Each item is assigned four responses with a score from 0 to 3, and the total score ranges from 0 to 21, where a higher score indicates greater anxiety. The GAD-7 score can identify mild (5–9), moderate (10–14) or severe (15–21) anxiety symptoms.32 The GAD-7 scale has been verified in both pregnancy and post partum.33 Additionally, it has shown good internal consistency reliability and validity among Chinese women during pregnancy (Cronbach’s alpha is 0.84).34
The EPDS score was measured using the EPDS, a widely used 10-item measure of perinatal depression.35 Each item has four responses ranging from 0 to 3, with a maximum total score of 30. A standard cut-off score ≥9 was used to indicate depression symptoms.36 The EPDS has shown good internal validity, with a Cronbach’s alpha of 0.82.37
Life satisfaction was assessed by a life satisfaction questionnaire designed by VanderWeele et al.38 This questionnaire is composed of 12 items covering 6 domains: (1) happiness and life satisfaction, (2) self-rated physical and mental health, (3) meaning and purpose, (4) character and virtue, (5) close social relationships and (6) financial security. On this basis, we added the ‘overall survival quality evaluation’ item to the questionnaire. The sum score of the 13 items ranges from 0 to 130, with higher scores reflecting higher life satisfaction.
Process evaluation
Embedded in this trial, a process evaluation was conducted to gain insight into optimising the implementation of MGM. The Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework was chosen as the evaluation model.39 Reach was defined as the proportion of participants who were suggested to download the application who actually downloaded it and the adherence to the MGM intervention of participants. The adoption refers to the proportion of health service providers participating in this project out of those responsible for maternal health care in these two clinics. Implementation was determined by the fidelity of intervention delivered by the HCPs, which was assessed by a fidelity checklist.29 Effectiveness was how much the intervention can alleviate the anxiety symptom, which was reported as the most important component in our current paper.
To assess maintenance, the extent to which the programme became part of the routine organisational practices was explored based on postimplementation stakeholder (women involved, their families, HCPs and health policy-makers) interviews. The qualitative interviews included three focus group discussions (women involved, their families and HCPs) and two in-depth individual interviews (health policy-makers) using a semistructured interview guide; topics examined included acceptance, utility and willingness for the MGM programme. The interview audio was transcribed verbatim and was analysed using thematic analysis. Two researchers independently analysed and coded the qualitative data into each domain of the consolidated framework for implementation research40 using NVivo V.12.0 (QSR International, Melbourne, Australia) and reached a consensus on coding through regular discussion.
Statistical analysis
All analyses were performed after multiple imputation41 of missing data on demographic variables including marital status (n=2), income (n=64), education (n=3), employment status (n=17), intention of pregnancy (n=55) and type of conception (n=55). Categorical variables are expressed as frequencies (percentages) and were compared using the χ2 test, and continuous variables are presented as the mean±SD or median (25th–75th percentile) and were compared using Student’s t-test or the Mann-Whitney U test according to their distribution.
In the primary analysis, intention-to-treat analysis42 was conducted, in which outcomes were compared between the control and intervention groups regardless of their actual adherence to the intervention. To estimate the differences between the two groups, a linear mixed model (LMM) with restricted maximum likelihood estimation was used for continuous outcomes, and a generalised LMM (GLMM) was used for discrete outcomes, with results reported as ORs and corresponding 95% CIs. In all models, the individual level was assumed to be a random effect by the intercept, and the group level was treated as a fixed effect. Additional covariates were added to these models, including variables for which the distributions were imbalanced between the intervention and control groups and between pregnant women with and without anxiety (online supplemental appendix). Considering the potential differences of participants in the two recruitment sites, the analyses also controlled for sites. Of note, baseline GAD-7 scores or EPDS scores were incorporated as covariates in the GLMM model. All statistical significances were defined as a two-sided p<0.05.
Supplemental material
The number needed to treat (NNT) and 95% CI were calculated using GraphPad Software, which indicates the number of women who need to be treated to achieve one additional clinically significant improvement.
Sensitivity analyses were conducted in three aspects to test the robustness of our results. First, the missing data on outcome (n=108) were imputed using baseline features as predictors with five imputed data sets for the primary and secondary outcomes, and the primary analyses were performed again. Second, per-protocol analyses were done on participants who completed were performed restricted to participants in the intervention group who actually received the intervention. Third, effectiveness analyses were conducted among participants who were followed by the HCPs in person rather than remotely via telephone within 6 months post partum. Subgroup analyses were carried out according to the severity of baseline anxiety symptoms (eg, mild anxiety and moderate to severe anxiety). Differential treatment effects in subgroups were tested with the statistical significance of intervention×subgroup interaction terms, with results presented as p value for interaction.
The basic cost-effectiveness analysis43 was conducted to evaluate the cost-effectiveness of the MGM intervention versus usual care. From the patient’s perspective, costs should cover all direct medical costs, such as screening, consulting, drugs, hospitalisation, nursing care and additional costs. However, in our follow-up evaluation, no pregnant women were found to seek other treatments outside our programme. Thus, the overall treatment costs for all beneficiaries were based on the recorded costs at each step of care in our programme, including screening, access to the animated videos and counselling. Considering the postintervention anxiety remission status, the cost-effectiveness ratio was calculated, which can be compared across different interventions.
Statistical analysis was performed by using SPSS V.22 (IBM).
Role of the funding source
The funder of the study had no role in study design, data collection, data analysis, data interpretation or writing of the report.
Results
Participant characteristics
Since the proportion of women with moderate to severe PNA was much lower than we expected, we further expanded our sample size. Finally, a total of 2869 pregnant women were invited to participate in our study and received anxiety screening, and 555 (19.3%) were screened positive for anxiety, of which 214 women were assigned to the control group and 341 women were assigned to the intervention group. At 6 months post partum, 153 (71.5%) participants in the control group and 294 (86.2%) participants in the intervention group were successfully followed up and assessed for anxiety (shown in figure 2). The average postnatal days were 38.49 in the intervention group and 50.26 in the control group at follow-up. No differences in other baseline characteristics between women with 6-month outcome data and those without were observed, except for residence (online supplemental table 1). Those lost to follow-up were more likely to live in urban (82.4% vs 70.9%; p=0.016).
Flow diagram of the subjects included and excluded in this trial.
Overall, the participants had an average age of 28.36 (SD 4.32) (table 1). Most of them lived in urban areas (73.2%) and were married (97.1%); 40.9% of them had an education level of junior college or above and 56.9% of them were unemployed when participating in our study. Differences in prepregnancy body mass index (BMI), education level and intention of pregnancy were observed between the control and intervention groups (p<0.05); other than those, no baseline characteristics were different between the two comparison groups. No differences in the mean GAD-7 scores, EPDS scores or severity of anxiety were observed between the two groups at baseline when recruited.
Baseline characteristics of intervention and control group participants
Primary outcomes
GAD-7 scores decreased from baseline to 6 months post partum in both groups, and the mean changes in the control group and the intervention group were −2.91 (SD 3.74) and −4.12 (SD 3.48), respectively, with a significant group difference of mean change in GAD-7 scores of −1.21 (95% confidence interval, CI −1.92 to −0.50; p=0.001) (table 2). After adjustment for recruitment site, age, prepregnancy BMI, residence, income, education, intention of pregnancy and parity, the difference obtained from the LMM remained −1.42 (95% CI −2.18 to −0.66; p<0.001).
Differences in changes in GAD-7 scores, EPDS scores and life satisfaction scores from baseline to 6 months between the intervention and control groups
The proportions of women with anxiety within 6 months post partum in the control group and the intervention group were 41.8% and 22.3%, respectively, with a significantly lower risk of anxiety in the intervention group (OR 0.40, 95% CI 0.26 to 0.62; p<0.001) (table 3). After adjustment for the same covariates mentioned above and GAD-7 scores at baseline, the results of the GLMM indicated that the intervention led to a 70% reduction in the risk of anxiety (adjusted odds ratio, aOR 0.30, 95% confidence interval, CI 0.18 to 0.51; p<0.001). Sensitivity analysis suggested the robustness of our results (online supplemental tables 2−7).
Intervention effect for anxiety symptom/remission and depression symptom/remission at 6 months post partum
Secondary outcomes
The proportion of women with anxiety remission in the two groups indicated that the anxiety remission rate in the intervention group was significantly increased by 1.72-fold compared with that in the control group (aOR 2.72, 95% CI 1.69 to 4.40; p<0.001) (table 3). A significant group difference in the mean change in EPDS scores between the control group and the intervention group of −1.92 (95% CI −2.85 to −0.99; p<0.001) was observed in the adjusted model. The risk of depression within 6 months post partum in the intervention group was lower than that in the control group (aOR 0.57, 95% CI 0.33 to 0.98; p=0.044) (table 3). Similar findings were observed for depression remission, with the rate significantly improved in the intervention group compared with that in the control group (aOR 2.24, 95% CI 1.39 to 3.63; p=0.001) (table 3). However, no significant difference in the changes in life satisfaction scores from baseline to 6 months post partum was observed between the two groups. The sensitivity analyses indicated the reliability of our results (online supplemental tables 2−7).
The NNT for anxiety was 6.0 (95% CI 3.5 to 11.1), which means we needed to treat 6.0 women to achieve one additional clinically significant improvement in anxiety, and the number for depression was 7.0 (95% CI 4.0 to 17.9).
Subgroup analysis
Effects of the interactions of the intervention with severity of anxiety and comorbidity status on the change in GAD-7 scores were both statistically significant (Pinteraction≤0.001). In the mild anxiety subgroup, a significant difference in the mean changes in GAD-7 scores from baseline to 6 months post partum between the intervention group and the control group was observed (Least-squares means, LSM =−1.41, 95% CI −2.14 to −0.67; p<0.001), and a similar significance was observed in the subgroup with anxiety and depression comorbidity (LSM =−1.87, 95% CI −3.10 to −0.64; p=0.003) (online supplemental table 8).
Effects of the interactions of the intervention with severity of anxiety and comorbidity status on the proportion of women with anxiety symptoms and the proportion of women with anxiety remission at 6 months post partum were all statistically significant (Pinteraction≤0.05), except for the effect of the interaction of the intervention with the severity of anxiety on the proportion of women with anxiety remission (Pinteraction=0.068). Significantly lower risks of anxiety within 6 months post partum were observed in the intervention group in the subgroup with mild anxiety (aOR 0.32, 95% CI 0.18 to 0.54; p<0.001) and the subgroup with anxiety and depression comorbidity (aOR 0.15, 95% CI 0.06 to 0.35; p<0.001). A significantly higher probability of anxiety remission within 6 months post partum was observed in the intervention group in the subgroup with mild anxiety (aOR 2.78, 95% CI 1.71 to 4.54; p<0.001) and the subgroup with anxiety and depression comorbidity (aOR 3.17, 95% CI 1.44 to 6.98; p=0.004) (online supplemental table 9).
Economic evaluation
Since all women in our programme were not required to have any extra expenditures, the cost was calculated based on the fee paid by the grant. The cost for access to the videos was ¥20/per person (US$2.91) (table 4). The cost for one completed counselling session was ¥200 (US$29.08). If counselling failed (eg, due to women’s absence or an internet connection problem), the therapist still received ¥40/per appointment (US$5.82) for their efforts. Each time the HCPs instructed one pregnant woman to download the MGM application, they receive an additional ¥5 (US$0.73) incentive fee aside from the usual care (¥5 (US$0.73) per person). Therefore, according to the adherence to intervention in the intervention group (table 5), the total cost of providing MGM plus usual care was calculated to be ¥14 910 (US$2167.91) and the mean cost was ¥43.72 (US$6.36) per person. The total cost of control group was 1835 (US$266.81), and the mean cost was ¥8.57 (US$1.25) per person. The incremental cost of the intervention group was calculated to be ¥35.15 (US$5.11) per person. The identified change in health outcomes was defined as remission status at post partum. Thus, using the remission rates of the intervention group (remission rates: 68.0%) and the control group (remission rates: 49.3%), the incremental cost-effective ratio was estimated to be ¥1.88 (US$0.27), which means that MGM could boost the postpartum anxiety remission rate by 1% by spending ¥1.88 (US$0.27) per pregnant woman.
Per capita cost of MGM plus usual care and usual care only at 6 months post partum
Adherence of participants to MGM tiered care
Process evaluation
The process evaluation is presented with the RE-AIM framework (table 5). Regarding the reach, the percentage of women who downloaded the application was 78.3%. However, the overall adherence to the MGM intervention was 54.0% (184/341), including either ‘watched’ animated video (51.3%, 175/341) or finishing at least one counselling session (80.8, 21/46). Participants opened a mean of 3.49 (SD 2.52) videos, and the mean time of the longest watched video per person was 5.07 mins (the mean watched time of each video was displayed in online supplemental table 10). The average count of counselling sessions was 1.6, with a maximum 9 sessions. At the individual level, the adoption rate for the programme was estimated to be 80% (8 out of 10). Ten HCPs were responsible for maternal health care at the two clinics, and eight of them participated in the programme. Regarding implementation, according to the results of the fidelity checklist, the HCPs have delivered counselling with high fidelity to the core of CBT, with a mean score of 72.6.
Regarding maintenance, the interview data (n=13; 5 women involved, 2 their families, 4 HCPs and 2 health policy-makers) showed that the HCPs and health policy-makers had positive attitudes towards the programme being continued in their organisations. For example, a health policy-maker said ‘I’d like to see the program to be conducted in more cities, not just in our center’, and an HCP said ‘ I am positive and optimistic if this programme continues to be implemented. Because early intervention can reduce this pregnancy and postpartum anxiety well’. The pregnant women would be willing to pay for access to the programme in the future: ‘Depending on my own psychological condition, I would be willing to pay for the treatment if I think I can’t handle it myself’, and their families indicated that the program looked promising: ‘I think if the program can be implemented (in the future) quite good, because now the country can focus on this aspect (perinatal anxiety) is very necessary’.
Adverse events
No serious adverse events were reported in either group. There were five pregnant women in the intervention group and three in the control group who reported suicide ideation; however, none of them reported continuing to have suicide ideation when we contacted them later. We also got in touch with the women’s emergency contacts to make sure of their safety and guided their family members on how to handle such situation.
Discussion
This trial proved that MGM, an application-based tiered care with CBT as the core, could significantly improve PNA for an acceptable cost within the primary health care system in China.
Previous literature suggested that the CBT-based intervention could effectively improve remission from perinatal depression over 6 months postnatally.27 Our study demonstrated for the first time that the iCBT-based tiered intervention MGM could also be used to ease PNA. Although the effect of MGM on PNA was intermediate, it was still greater than other internet-based psychosocial interventions or psychotherapy (peer support, problem-solving treatment, mindfulness-based therapy)44–46 and was comparable to other iCBT interventions.6 47 MGM could be readily delivered for a low cost of only ¥1.88 (US$0.27)/person to boost the postpartum anxiety remission by 1%, indicating that MGM could serve as an ideal tool in addressing PNA and could have a substantial impact on public health. Furthermore, when targeting PNA, we found additional benefits of MGM in reducing postpartum depression, suggesting the importance of interventions for PNA, which could pave the way to prevent postpartum depression, as antenatal anxiety is a strong risk factor for postnatal depression.2
Prior successful CBT-based intervention studies were specifically aimed at women with moderate to severe perinatal mental health problems27; however, mild anxiety accounts for the largest part of PNA, and untreated anxiety has negative consequences for both women themselves and their offspring.3 48 Considering this, we adopted a tiered care model, which gave women-specific treatment according to the severity of PNA. The subgroup analysis showed that the self-watched videos could effectively alleviate mild PNA, indicating that MGM could provide access to effective treatment for mild PNA in a convenient way that did not require personnel to implement. However, we did not find significant protective effects of the intervention (self-watched video plus counselling) in the moderate to severe PNA subgroup. The proportion of women with moderate to severe PNA was much lower than we expected, and due to the COVID-19 pandemic and the sharply dropping birth rate in Anhui Province,49 our current study could not recruit enough women with moderate to severe PNA. Coupled with the fact that some pregnant women with anxiety had spontaneous remission after delivery,27 our current sample size might not be enough to detect significant effectiveness. Although the difference between the intervention group and control group did not reach statistical significance, a more obvious decrease in the GAD-7 score and a lower rate of postpartum anxiety was observed in the intervention group; therefore, a larger sample size of women with moderate to severe PNA in the future will be needed to further verify the effectiveness of MGM in this subgroup. Another reason we did not find significant protective effects of the intervention (self-watched video plus counselling) in the moderate to severe PNA subgroup might be the unsatisfactory retention for online counselling; although we provided a maximum of 12 rounds of free counselling, the average count of counselling in the intervention group was only 1.6, much lower than we expected. The difficulty of maintaining interventions has also been indicated by other studies; for example, a literature review suggested that the attrition rates for internet-based interventions can be as high as 63.8%.49 To address this issue, prior studies emphasised the importance of providing reminders to users, to increase retention and ultimately enhance outcomes.50 In our study, we also set up reminder sessions but were not by the same supervisor throughout the process. The first counselling appointments were all guided by the HCPs in the clinics in person, and 76.9% of the pregnant women with moderate to severe PNA completed one-time counselling. The subsequent appointments were suggested by therapists at the end of online counselling; however, only 14.3% of the women chose to make another appointment. In the interviews with the pregnant women, the phrase ‘I just did whatever the doctor told me’ was frequently used, indicating the high compliance of pregnant women with their HCPs, which might be attributed to the firm bond the women built with their HCPs when they performed routine health check-ups. Thus, when scaled up, selecting HCPs as exclusive supervisors for pregnant women would help boost retention for intervention.
Judging from the evaluation based on the RE-AIM framework, the MGM was well implemented in routine practice. The interviews after the implementation showed that the stakeholders reported a high level of intervention acceptability. Most health policy-makers and pregnant women were willing to maintain the intervention in their centres or cities. However, the adherence to the MGM intervention was 54.0%, which reflects the low awareness of mental health and indicates that the intention to seek help needs to be further raised in the future.
Limitations
Several limitations of this study should be noted. First, since a non-randomised controlled trial design was adopted, the internal validity of our results was probably weakened. However, most characteristics between the two groups were comparable except for three variables that were adjusted when performing the regression. Interestingly, the three unbalanced variables seemed more favourable for the control group regarding anxiety risk, which indicated the effect size of the intervention might be underestimated. Second, our sample size for moderate to severe anxiety symptoms individuals might be underpowered. Third, the follow-up rate was modest, and the interval follow-up time was longer in the control group. Fourth, the long-term effects of our intervention on women’s health have not been assessed and need further investigation. Last, since our study was conducted during the COVID-19 pandemic, the potential influence of the pandemic could not be totally excluded.
Strengths
First, our study was the first trial implemented within a real-world setting to test the effectiveness of online CBT-based tiered care in treating PNA in China. Second, we took full advantage of the maternal and child health care system in China to make the services accessible to nearly every woman; thus, health care equity was fully guaranteed in our study. Third, the utility of mobile phones could help conquer geographical barriers to integrate psychosocial resources, especially for those live in the remote resource-limited regions, and the tiered intervention model could improve cost and economic efficiency. Last, we innovatively used trained HCPs with rich knowledge and experience in maternal health care as counsellors, which could unlock new sources of service personnel to ease the tension created by limited mental health care for perinatal women in China.
Conclusion
Overall, this study demonstrated that application-based tiered care MGM is a cost-effective, accessible tool with strong generalisability in coping with PNA. We established a practical tool and management system integrating screening, treatment, counselling and data monitoring that can be quickly applied in the primary health care system, reducing the time it takes to be applied to practice. Our study potentially provides solutions to bridge the treatment gap for perinatal mental health care in LMICs where mental health care resources are largely limited.
Data availability statement
Data are available on reasonable request.
Ethics statements
Patient consent for publication
Ethics approval
This study involves human participants and was approved by the ethics committee of Anhui Medical University (83220006). Participants gave informed consent to participate in the study before taking part.
Acknowledgments
We acknowledge the assistance of Changfeng Maternal and Child Health Care Center in recruiting participants and collecting data. We extend our sincere appreciation to the individuals who agreed to participate in our study.
References
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
BZ, YH and XY are joint first authors.
Handling editor Soumitra S Bhuyan
Contributors FBT designed and supervised the project. BZ, YH and XY conducted the data analyses and drafted the manuscript. FBT and BZ revised the manuscript. ML and MJ were responsible project administration. MS, HZ, YG and HL were responsible for fieldwork and data collection. All authors contributed to and approved the final manuscript. FBT is acting as guarantor.
Funding This work was supported by the National Natural Science Foundation of China (No. 81761128034).
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.