Prevalence and correlates of symptoms of depression, anxiety, and psychological distress among women of reproductive age with delayed conception in urban and peri-urban low to mid-socioeconomic neighborhoods of Delhi, India: A cross-sectional study

Barsha Gadapani Pathak; Gitau Mburu; Ndema Habib; Rita Kabra; Aiysha Malik; James Kiarie; Ranadip Chowdhury; Neeta Dhabhai; Sarmila Mazumder

doi:10.1371/journal.pone.0315347

Peer Review History

Original SubmissionApril 18, 2024
29 Jul 2024 Decision Letter - Yuan-Pang Wang, Editor PONE-D-24-11366Prevalence and correlates of symptoms of depression, anxiety,and psychological distress among women of reproductive age with delayed conception in urban and peri-urban low to mid-socioeconomic neighborhoods of Delhi, India: A cross-sectional study.PLOS ONE Dear Dr. Mazumder, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Sep 12 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. 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The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: I Don't Know ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: The manuscript titled “Prevalence and correlates of symptoms of depression, anxiety, and psychological distress among women of reproductive age with delayed conception in urban and periurban low to mid-socioeconomic neighborhoods of Delhi, India: A cross-sectional study” by B. G. Pathak and co-workers have investigated the occurrence of mental health problems (including depression, anxiety, psychological distress) among infertile women. The manuscript is informative and the findings are of significant importance since there are rising number of infertility cases in India. The findings supported that mental health problems in women delayed pregnancy. However, the authors should also take into account the prevalence of psychological distress among the fertile women carried out by previous studies and compare their findings with the present study. The authors should also consider association of women’s mental health with determinants such as educational level, age, employment status, alcohol addiction problem of husband or other family members living with the subjects. In the methodology section, please mention how sample size was calculated and what sampling method was used. The strategies required to identify women at increased risk of mental disorders due to inability to conceive and approaches to provide support systems needs to be elaborated in the discussion part. Reviewer #2: Manuscript Number: PONE-D-24-11366 Title: Prevalence and correlates of symptoms of depression, anxiety, and psychological distress among women of reproductive age with delayed conception in urban and periurban low to mid-socioeconomic neighborhoods of Delhi, India: A cross-sectional study. Thank you for giving me the opportunity to review the above-titled manuscript. I have the following comments about the manuscript: Abstract 1.Please define psychological distress and how it differs from anxiety or depression. 2.What was the response rate? 3.Are there any factors that could interfere with implementing the recommendations? Does this state in India have enough resources to provide such recommended services? If not, the implementation should be subject to the availability of resources. Introduction 4.Are there any particular ethnic groups in India that report a higher incidence of psychological distress such as depression or anxiety as the results of delayed conception? 5.What are the differences between depression and anxiety on one side and psychological distress on the other, given that anxiety and depression are the main causes of psychological distress? This needs more explanation and definitions within the context of the literature. Methods 6.What was the sample size calculation? 7.What were the exclusion criteria? Were women who were diagnosed with anxiety and depression, either with or without treatment, excluded? How were they identified? 8.How was the face-to-face response during data collection eliminated or at least minimized to prevent personal bias? Did the authors address these issues? 9.Please provide details on how the women were recruited, even though this study is part of a larger referenced study. 10.What were the reliability measures (Cronbach's alpha) for each instrument used to collect data? 11.Emotional abuse by husbands can cause psychological distress (either anxiety or depression) and social isolation can be a result of psychological distress. How were these causative or resultant factors controlled during the analysis? 12.Were any regression analyses conducted according to ethnic/religious backgrounds? What were the results? Study's Limitation 13.In addition to the limited generalizability of the study, as it has been conducted in a single city in North India, it was also conducted during the COVID-19 pandemic, which might have influenced the rates of anxiety or depression during this time. How was this accounted for? This might be a limitation of the study as people might have had a higher chance of developing psychological symptoms such as anxiety and depression during COVID-19 pandemic. Conclusion: 14.Although there were many recommendations that emerged from this study, their implementation is subject to the availability of resources, including financial aspects. This needs to be highlighted. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0315347.r001
Revision 1
6 Sep 2024 Author Response AUTHOR RESPONSE LETTER Dear Editor-in-chief PLOS ONE journal. We thank you for your response and invitation to resubmit the paper to the PLOS ONE journal. We have taken note of the comments and suggestions made by the reviewers and editor and have revised the manuscript accordingly. We have included the author’s responses below the original reviewer’s and editor’s comments. Where revision to the manuscript text has been made, the text is copied into this letter with blue highlights in italics (as they appear in the new/clean version) and references are inserted too. Both this clean version of the revised manuscript, as well as a version with the changes tracked (highlighted), are also submitted. Best regards, Sarmila Mazumder Reviewer’s comments and Author’s responses Reviewer 1: Comment 1: The manuscript titled “Prevalence and correlates of symptoms of depression, anxiety, and psychological distress among women of reproductive age with delayed conception in urban and periurban low to mid-socioeconomic neighborhoods of Delhi, India: A cross-sectional study” by B. G. Pathak and co-workers have investigated the occurrence of mental health problems (including depression, anxiety, psychological distress) among infertile women. The manuscript is informative and the findings are of significant importance since there are rising number of infertility cases in India. The findings supported that mental health problems in women delayed pregnancy. Response 1: Thank you for your positive feedback. We appreciate your recognition of our study findings, especially considering the rising infertility cases in India. Comment 2: However, the authors should also take into account the prevalence of psychological distress among the fertile women carried out by previous studies and compare their findings with the present study. Response 2: Thank you for the excellent suggestion and feedback. We have incorporated a write-up in the discussion section incorporating your suggestion “The National Mental Health Survey of India 2016, which collected data from multiple sites through a nationwide household survey using a uniform methodology, reported a prevalence of common mental disorders, including depression and anxiety, of 5.8% among women of reproductive age (WRA).(Annajigowda et al. 2023)But several studies, globally and in India, comparing mental health outcomes between fertile and infertile women have consistently demonstrated a significantly higher burden of psychological distress among infertile women. One study reported that infertile women had a significantly higher mean depression score on the Beck Depression Inventory (11.84) compared to fertile women (4.06), with 15.7% of infertile women experiencing moderate depression, compared to none in the fertile group.(Verma and Baniya 2016) Another study found that infertile women had twice the prevalence of depression compared to controls, with those experiencing infertility for 2-3 years showing significantly higher depression scores than those with shorter or longer durations of infertility.(Domar et al. 1992)” Comment 3: The authors should also consider association of women’s mental health with determinants such as educational level, age, employment status, alcohol addiction problem of husband or other family members living with the subjects. Response 3: Thank you for the suggestion. We conducted univariable analyses considering educational level, age, employment status, and the husband's alcohol addiction problems. While the husband's age and education showed significant associations in the univariable regression analysis, no significant associations were found for the husband's alcohol consumption or occupation. However, in the multivariable model, the husband's age and education were no longer significant. We have added the significant findings from the univariable regression analysis to Table 4. Comment 4: In the methodology section, please mention how sample size was calculated and what sampling method was used. Response 4: Thank you for the feedback. We have included the sentence in the methodology regarding the sample size “The minimum sample size needed to estimate infertility with 2% precision and 95% CI from this sample would be 1223, assuming a prevalence of 17% as reported in the literature, and a finite population of 12,500.(Rutstein 2016; Adamson et al. 2011) An allowance of 25% for rejection/ incomplete non-responses was made and the final sample size was 1530.” Additionally, the recruitment process and strategy for selection of participants in this study was carefully designed to ensure a systematic and unbiased selection of participants. Although this study is part of a larger referenced study (WINGS), the recruitment for the current study was conducted separately and followed a distinct protocol. Participants were recruited from women who had completed 18 months of follow-up in the WINGS trial without achieving pregnancy. Consent to participate in this new study on failure to conceive was sought at the time of their exit from WINGS. These research assistants contacted the women at least 14 days after their exit from WINGS (primary trial) to introduce the new study. Women were recruited consecutively based on their exit dates from WINGS, ensuring that those who met the study criteria (failure to conceive after 18 months) were invited to participate. The sample size for this study was calculated to ensure adequate precision, with a target of 1,530 participants. Recruitment continued until this sample size was achieved, based on preliminary data suggesting that approximately 50% of the WINGS participants had not conceived by the end of the 18 months. This methodical approach ensured a robust and representative sample for assessing the mental health outcomes of interest. We have added this strategy to the manuscript’s methods section “The recruitment for this study was conducted separately from the WINGS trial, targeting women who had completed 18 months of follow-up without achieving pregnancy. Consent was obtained at the time of their exit from WINGS, and research assistants contacted these women at least 14 days later to introduce the new study. Participants were consecutively recruited based on their exit dates, ensuring those who met the criteria were included. The study aimed for a sample size of 1,530, with recruitment continuing until this target was reached, ensuring a representative sample for assessing mental health outcomes.” Comment 5: The strategies required to identify women at increased risk of mental disorders due to inability to conceive and approaches to provide support systems needs to be elaborated in the discussion part. Response 5: Thank you for the valuable suggestion. We agree that elaborating on the strategies to identify women at increased risk of mental disorders due to infertility, as well as approaches to providing appropriate support systems, is crucial. We have modified the conclusion section of the manuscript and incorporated certain strategies “To effectively mitigate these mental health problems, a multi-pronged approach is needed, integrating psychosocial support in infertility prevention, diagnosis, and treatment. Evidence-based strategies, such as early screening for psychological distress using tools like the PHQ-4 and routine mental health assessments for women undergoing infertility treatment, can effectively identify those in need of support. Additionally, addressing social isolation, fostering supportive networks, combating violence, and incorporating fertility counseling, peer support groups, and mental health education into community and healthcare settings are crucial steps to alleviate the mental health burden among women facing difficulties in conceiving." Reviewer 2: Section: Abstract Comment 1: Please define psychological distress and how it differs from anxiety or depression. Response 1: Thank you for the feedback. We have added this sentence in the abstract “Psychological distress is a broad term encompassing emotional suffering and mental health discomfort that can include symptoms of anxiety and depression but is not limited to these conditions.” Comment 2: What was the response rate? Response 2: Thank you for the query. We acquired responses from all 1530 women for the scales. We have updated the information in abstract and result-section “We obtained responses from all 1,530 women using these scales” Comment 3: Are there any factors that could interfere with implementing the recommendations? Does this state in India have enough resources to provide such recommended services? If not, the implementation should be subject to the availability of resources. Response 3: Thank you for the suggestions and feedback. We understand that there are financial, human resources and infrastructure related issues, which may hinder recommendation implementation. We have modified and added a write-up in abstract “However, the successful implementation of these recommendations may be challenged by the availability of the state's healthcare resources, necessitating tailored strategies with contextual adaptations.” Section: Introduction Comment 4: Are there any particular ethnic groups in India that report a higher incidence of psychological distress such as depression or anxiety as the results of delayed conception? Response 4: Thank you for the query. Yes, there are certain articles highlighting the higher incidence of mental health issues among marginalized communities. We have added few sentences in the introduction “ “Additionally, certain ethnic groups in LMICs, such as those from marginalized communities or lower socio-economic backgrounds, may report higher incidences of psychological distress due to compounded social pressures and limited access to healthcare.(Selvaraj et al. 2014; Ghia and Rambhad 2023) Studies have shown that women from Scheduled Castes and Scheduled Tribes often face greater challenges in accessing reproductive health services, which can exacerbate mental health issues in cases of delayed conception” Comment 5: What are the differences between depression and anxiety on one side and psychological distress on the other, given that anxiety and depression are the main causes of psychological distress? This needs more explanation and definitions within the context of the literature. Response 5: Thank you for the comment and suggestion. There is difference between psychological distress, anxiety, and depression. Hence, for better clarity ( as per your suggestion), we have added a few sentences in the introduction section “While anxiety and depression are specific mental health disorders characterized by distinct diagnostic criteria, psychological distress is a more general term that encompasses a range of emotional disturbances. (Aline Drapeau 2012)Anxiety and depression are often primary contributors to psychological distress, but the latter can also include stress, worry, and other forms of mental discomfort that may not necessarily fit into a specific psychiatric category.(Mirowsky and Ross 2002; Horwitz 2007)” Section: Methods Comment 6:.What was the sample size calculation? Response 6: Thank you for the feedback on sample size calculation. We have included the sentence in the methodology “The minimum sample size needed to estimate infertility with 2% precision and 95% CI from this sample would be 1223, assuming a prevalence of 17% as reported in the literature, and a finite population of 12,500.(Rutstein 2016; Adamson et al. 2011) An allowance of 25% for rejection/ incomplete non-responses was made and the final sample size was 1530.” Comment 7: What were the exclusion criteria? Were women who were diagnosed with anxiety and depression, either with or without treatment, excluded? How were they identified? Response 7: Thank you for the comment. In this study, the population consisted of women who had completed 18 months of follow-up in the WINGS trial without achieving pregnancy. We excluded women who were over 49 years of age or were currently pregnant and we added a sentence in the manuscript “Any women who were > 49 years and currently pregnant were not considered eligible for this study.” In the primary WINGS trial, all enrolled women underwent mental health screening using the Patient Health Questionnaire (PHQ-9). Women with PHQ-9 scores above 10 were referred to study psychologists, while those with scores above 14 were referred to a psychiatrist at the collaborating study hospital. In the current study, a cross-sectional survey aimed at assessing the community-level burden of mental health issues, we did not perform any clinical tests prior to recruitment. Our focus was on capturing the mental health status of these women with delayed pregnancy within their community context. Comment 8:: How was the face-to-face response during data collection eliminated or at least minimized to prevent personal bias? Did the authors address these issues? Response 8: Thank you for the query. Yes, we tried to minimize the personal bias. For clarity we have added a few sentences in the methodology “To minimize personal bias during face-to-face data collection, interviewers were trained to use neutral language and standardized protocols. Additionally, privacy was ensured during interviews, and participants were reassured about the confidentiality of their responses to reduce social desirability bias” Comment 9:: Please provide details on how the women were recruited, even though this study is part of a larger referenced study. Response 9: Thank you for the suggestion. The recruitment process for this study was carefully designed to ensure a systematic and unbiased selection of participants. Although this study is part of a larger referenced study (WINGS), the recruitment for the current study was conducted separately and followed a distinct protocol. Participants were recruited from women who had completed 18 months of follow-up in the WINGS trial without achieving pregnancy. Consent to participate in this new study on failure to conceive was sought at the time of their exit from WINGS. These research assistants contacted the women at least 14 days after their exit from WINGS (primary trial) to introduce the new study. Women were recruited consecutively based on their exit dates from WINGS, ensuring that those who met the study criteria (failure to conceive after 18 months) were invited to participate. The sample size for this study was calculated to ensure adequate precision, with a target of 1,530 participants. Recruitment continued until this sample size was achieved, based on preliminary data suggesting that approximately 50% of the WINGS participants had not conceived by the end of the 18 months. This methodical approach ensured a robust and representative sample for assessing the mental health outcomes of interest. We have added this strategy to the manuscript’s methods section “The recruitment for this study was conducted separately from the WINGS trial, targeting women who had completed 18 months of follow-up without achieving pregnancy. Consent was obtained at the time of their exit from WINGS, and research assistants contacted these women at least 14 days later to introduce the new study. Participants were consecutively recruited based on their exit dates, ensuring those who met the criteria were included. The study aimed for a sample size of 1,530, with recruitment continuing until this target was reached, ensuring a representative sample for assessing mental health outcomes.” Comment 10: What were the reliability measures (Cronbach's alpha) for each instrument used to collect data? Response 10: Thank you for the query. Studies from various parts of the world have assessed the reliability of this study instrument i.e., PHQ-4, PHQ-2, and GAD-2 scales, consistently finding good internal consistency. For clarity, we have added this information, along with references, in the methodology section under 'Survey Instrument.“Numerous studies across various settings have demonstrated the PHQ-4 scale’s as well as PHQ-2 scales’ good internal consistency, reporting a Cronbach’s alpha of 0.80..(Kroenke et al. 2009; Manea, Gilbody, and McMillan 2012) Similarly, the GAD-4 ( Attachments Attachment Submitted filename: Response to reviewer_4thSep2024.docx https://doi.org/10.1371/journal.pone.0315347.r002
25 Nov 2024 Decision Letter - Yuan-Pang Wang, Editor Prevalence and correlates of symptoms of depression, anxiety,and psychological distress among women of reproductive age with delayed conception in urban and peri-urban low to mid-socioeconomic neighborhoods of Delhi, India: A cross-sectional study. PONE-D-24-11366R1 Dear Dr. Mazumder, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. 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Authors have addressed all reviewers' concerns and changes were made in the manuscript to reflect their responses. This article is well written and adds new insights for reproductive-age women in India. Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #3: All comments have been addressed ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #3: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #3: Yes ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #3: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #3: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #3: I am willing to accept your paper, “Prevalence and correlates of symptoms of depression, anxiety, and psychological distress among women of reproductive age with delayed conception in urban and peri urban low to mid-socioeconomic neighborhoods of Delhi, India: A cross-sectional- study” The author has very clearly explained all the queries raised by the reviewers. The author also added the latest references highlighted by the reviewers. Hence, I am ready to accept this paper ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #3: Yes: Dr.T.Beena ******** https://doi.org/10.1371/journal.pone.0315347.r003
Formally Accepted
15 Dec 2024 Acceptance Letter - Yuan-Pang Wang, Editor PONE-D-24-11366R1 PLOS ONE Dear Dr. Mazumder, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, if your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. If we can help with anything else, please email us at customercare@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Yuan-Pang Wang Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0315347.r004

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