Smartphone-supported Positive Adjustment Coping Intervention (PACI) for couples undergoing fertility treatment: A randomised controlled trial

Franziska Kremer; Maren Schick; Sabine Roesner; Ariane Germeyer; Markus Moessner; Stephanie Bauer; Beate Ditzen; Tewes Wischmann

doi:10.1371/journal.pone.0335776

Peer Review History

Original SubmissionDecember 6, 2024
7 Mar 2025 Decision Letter - César González-Blanch, Editor Dear Dr. Kremer, 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. Based on the reviewers' feedback, major revisions are required. Particularly, add details on randomization, allocation concealment, and questionnaire language. Provide further details on statistical methods and adjust for multiple comparisons where applicable. Please remove unsupported claims from the conclusions. Finally, refine formatting and correct typographical errors. Please submit your revised manuscript by Apr 18 2025 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 . When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols . Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols . We look forward to receiving your revised manuscript. Kind regards, César González-Blanch, PhD Academic Editor PLOS ONE Journal Requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? Reviewer #1: Partly Reviewer #2: No ******** 2. Has the statistical analysis been performed appropriately and rigorously? -->?> Reviewer #1: No 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 Reviewer #1: Yes Reviewer #2: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English??> Reviewer #1: Yes Reviewer #2: Yes ****** Reviewer #1: The manuscript needs English proofreading, and significant revisions are required for the results presentation. Abstract Results: The N could be omitted. The p values for the significant results are to be included. Line 92: The waiting period is to be clearly defined e.g what is the duration? It would be good to provide a chart or incorporate it with Figure 1 showing the days, assessment points, type of assessment etc. Line 92-94: Days is to be used to indicate the pre intervention, post intervention and evaluation. Line 132: For the sample size calculation using GPower, other information to be provided such as one or two-tailed, type of study design, number of groups involved. Line 135: The person who prepared the list of names and the information on allocation concealment is to be stated. Line 136: The name of computerised randomization system is to be provided. Line 162: ‘also in the medical records’ is to be revised to ‘also from the medical records’ Line 164-165: Whether the language in English or German version is to be stated. Line 168: Typo Sociographics. Line 193: Open questions to be written as open ended questions. Line 196-198: The sentence unclear and requires revision. Line 198: The imputation method is to be stated. Line 201 and Table 1: Based on the CONSORT statement, all statistical tests for group comparison at baseline are to be avoided. The randomization is supposed to distribute both known and unknown confounders evenly between the groups and the groups should be similar at baseline concerning both the measured and unmeasured variables. However, if significant differences are noted between the groups at baseline, it suggests that the randomization process may not have been successful in achieving balance between the groups. Line 216-217: The application of ANOVA and Wilcoxon test is unclear. ANOVA is commonly used to compare means across three or more groups, but it can also be applied to two groups, although a t-test is usually preferred in such cases. For parametric data involving two related time points (e.g., pre and post), a paired t-test is the standard choice. Likewise with Line 250-252. The sentence requires revision.The specific type of Wilcoxon test is to be stated. Line 224: Typo chi-test. Line 226: The significance level, and multiple testing corrections where applicable are to be stated. Line 236-237: The sentence ‘The reason for the difference ….. was determined by applying the Bonferroni correction in the married subgroup.’ requires revision. Likewise with Line 240. Line 236: Unclear what other subgroup refers to. Line 234-242: The findings to be indicated with table number(s)/ denoted in the table and table footnote. Line 249: Depressivity is to be replaced with Depression. Table 1, 2, 3, 4: Two decimal points for SD are sufficient. Likewise with confidence interval. Table 1-8: The symbol +,‡:, §: can be omitted. The abbreviations CD, M, SD are sufficient. Line 267-268: The statistical test is to be mentioned. The detail to be attached as supplementary table. Line 310, 323: The p value for Bonferroni correction is to be presented. Likewise with other sections were applicable. The presentation format and data for Table 7 and 8 requires improvements. All the statistical tests used in the results section are to be stated in statistical analysis section. Table 6: The statistical test used to produce this output is to be mentioned. Line 306: chi-test to be replaced with chi-square test. All GLM analysis results preferably to be presented in table form and attached as supplementary. The detail description and application of GLM is to be described in the statistical analysis section. Some p value values were italicised and some were not. This needs to be standardized. Reviewer #2: Thanks for inviting me to review this paper. The purpose of this is to reduce the depression and anxiety among couples undergoing fertility treatment. Major revisions are needed to make it clearer. Details showed in the followings: 1. The primary objective of this study is to reduce anxiety and depression. To support this aim, it is essential to provide information on the prevalence and severity of anxiety and depression within this population. 2. It is recommended to provide a justification for including male participants, specifically addressing the relationship between anxiety and depression among couples and its relevance to the research objectives. Additionally, the results section presents data for male and female participants separately, which creates confusion regarding the purpose. 3. Additional details regarding the randomization process are needed to enhance the reproducibility of the study. 4. While the results indicate that the average scores for anxiety and depression fall below the clinical cutoff, it would be beneficial to report the percentage of participants exhibiting clinical anxiety and depression. Furthermore, discuss on the anxiety and depression scores observed in this study is suggested to inform future studies. 5. The conclusion should be firmly grounded in the statistical results obtained from the study to ensure scientific rigor and accuracy. The suggestions on using ‘face to face methods’ and ‘low mood by themselves do not impair fertility’ lack evidence support in this study. 6. Statistics methods are suggested to reviewed by a statistician. ****** 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.0335776.r001
Revision 1
7 May 2025 Author Response Review Comments to the Author: Reviewer #1: The manuscript needs English proofreading, and significant revisions are required for the results presentation. Response: Thanks for the suggestions. The text has been checked again. Abstract Results: The N could be omitted. The p values for the significant results are to be included. Line 92: The waiting period is to be clearly defined e.g what is the duration? It would be good to provide a chart or incorporate it with Figure 1 showing the days, assessment points, type of assessment etc. Response: Thank you for the suggestion. We have added a new Table 1 with more detailed information and expanded Figure 1. Line 92-94: Days is to be used to indicate the pre intervention, post intervention and evaluation. Response: The day was noted in Figure 1. Line 132: For the sample size calculation using GPower, other information to be provided such as one or two-tailed, type of study design, number of groups involved. Response: Thank you for this comment. We have added the missing information (page 7, line 132-133). Line 135: The person who prepared the list of names and the information on allocation concealment is to be stated. Response: Thanks for pointing that out. The relevant statistician is now mentioned in line 138 of the main text. Line 136: The name of computerised randomization system is to be provided. Response: Thanks, it has now been mentioned in line 139. Line 162: ‘also in the medical records’ is to be revised to ‘also from the medical records’ Response: Thanks for the hint. Line 164-165: Whether the language in English or German version is to be stated. Response: Thanks for the hint. Line 168: Typo Sociographics. Response: We have used the term sociographic variables. Line 193: Open questions to be written as open ended questions. Response: Thanks for the hint. Line 196-198: The sentence unclear and requires revision. Line 198: The imputation method is to be stated. Response: Thank you very much, we have added the information on page 10, lines 199-203. Line 201 and Table 1: Based on the CONSORT statement, all statistical tests for group comparison at baseline are to be avoided. The randomization is supposed to distribute both known and unknown confounders evenly between the groups and the groups should be similar at baseline concerning both the measured and unmeasured variables. However, if significant differences are noted between the groups at baseline, it suggests that the randomization process may not have been successful in achieving balance between the groups. Response: We believe that the randomization process reflects the law of large numbers and that the group size should be slightly larger due to the only very small real intervention effects. Line 216-217: The application of ANOVA and Wilcoxon test is unclear. ANOVA is commonly used to compare means across three or more groups, but it can also be applied to two groups, although a t-test is usually preferred in such cases. For parametric data involving two related time points (e.g., pre and post), a paired t-test is the standard choice. Likewise with Line 250-252. The sentence requires revision. The specific type of Wilcoxon test is to be stated. Response: Both T-test and ANOVA are possible. We have decided to use ANOVA. The Wilcoxon test is the Wilcoxon test for paired samples. Line 224: Typo chi-test. Response: Thank you very much. We have decided on the following writing style: χ²-test. Line 226: The significance level, and multiple testing corrections where applicable are to be stated. Response: Thank you for pointing that out. We have set the significance level at 5%. Line 236-237: The sentence ‘The reason for the difference ….. was determined by applying the Bonferroni correction in the married subgroup.’ requires revision. Likewise with Line 240. Line 236: Unclear what other subgroup refers to. Response: We have made every effort to simplify the statements and make them reader-friendly (page 12, line239-245). Line 234-242: The findings to be indicated with table number(s)/ denoted in the table and table footnote. Response: We have made every effort to adjust the tables accordingly. Line 249: Depressivity is to be replaced with Depression. Response: We have taken note of your comment and changed “Depressivity” to “Depression.” Table 1, 2, 3, 4: Two decimal points for SD are sufficient. Likewise with confidence interval. Response: Thank you very much. We have amended the information. Table 1-8: The symbol +,‡:, §: can be omitted. The abbreviations CD, M, SD are sufficient. Response: Thank you very much. We have amended the information. Line 267-268: The statistical test is to be mentioned. The detail to be attached as supplementary table. Response: We believe that this information is important for the body text and that it eliminates the need for an additional table. Line 310, 323: The p value for Bonferroni correction is to be presented. Likewise with other sections were applicable. The presentation format and data for Table 7 and 8 requires improvements. All the statistical tests used in the results section are to be stated in statistical analysis section. Response: In our opinion, all relevant information and statistical tests are included. Table 6: The statistical test used to produce this output is to be mentioned. Response: The odds ratio was calculated using SPSS and represents a standard procedure. Line 306: chi-test to be replaced with chi-square test. Response: As mentioned above, we use the following notation: χ²-test. All GLM analysis results preferably to be presented in table form and attached as supplementary. The detail description and application of GLM is to be described in the statistical analysis section. Some p value values were italicised and some were not. This needs to be standardized. Response: Thank you very much! We have made the necessary changes. Reviewer #2: Thanks for inviting me to review this paper. The purpose of this is to reduce the depression and anxiety among couples undergoing fertility treatment. Major revisions are needed to make it clearer. Details showed in the followings: 1. The primary objective of this study is to reduce anxiety and depression. To support this aim, it is essential to provide information on the prevalence and severity of anxiety and depression within this population. Response: Thank you very much, we have now included the ESHRE guideline to show the prevalence in the population. 2. It is recommended to provide a justification for including male participants, specifically addressing the relationship between anxiety and depression among couples and its relevance to the research objectives. Additionally, the results section presents data for male and female participants separately, which creates confusion regarding the purpose. Response: Please see above. Men are affected similarly to women. 3. Additional details regarding the randomization process are needed to enhance the reproducibility of the study. Response: Thank you very much. We have now added further information (page 8). 4. While the results indicate that the average scores for anxiety and depression fall below the clinical cutoff, it would be beneficial to report the percentage of participants exhibiting clinical anxiety and depression. Furthermore, discuss on the anxiety and depression scores observed in this study is suggested to inform future studies. Response: Thank you very much for this important note. We have now added the missing information on pages 14 and 15 and taken it into account in the discussion. 5. The conclusion should be firmly grounded in the statistical results obtained from the study to ensure scientific rigor and accuracy. The suggestions on using ‘face to face methods’ and ‘low mood by themselves do not impair fertility’ lack evidence support in this study. Response: Thank you very much for this improvement. We have revised lines 455 to 460 on page 23. We have improved the statement as follows: “This data is in line with research suggesting that individual daily stress levels or low mood by themselves usually do not impair fertility (Wischmann et al. 2021) and that a low-level “mini-intervention” alone therefore might not increase pregnancy rates. At the same time these results can contribute to more tailor-made face-to-face interventions that address both partners at the same time and, thereby, help couples to successfully navigate in this challenging time during ART.” 6. Statistics methods are suggested to reviewed by a statistician. Response: Please see above. https://doi.org/10.1371/journal.pone.0335776.r002
22 May 2025 Decision Letter - César González-Blanch, Editor Dear Dr. Kremer, 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 Jul 06 2025 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 . When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols . Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols . We look forward to receiving your revised manuscript. Kind regards, César González-Blanch, PhD Academic Editor PLOS ONE Journal Requirements: Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author Reviewer #1: (No Response) ******** 2. Is the manuscript technically sound, and do the data support the conclusions??> Reviewer #1: Partly ****** 3. Has the statistical analysis been performed appropriately and rigorously? -->?> Reviewer #1: No ****** 4. Have the authors made all data underlying the findings in their manuscript fully available??> The PLOS Data policy Reviewer #1: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English??> Reviewer #1: Yes ******** Reviewer #1: Table 2: Based on CONSORT statement/requirement, the column of t/X^2 and p value and the P ≤ .05 in the footnote are to be removed. For paired samples, Wilcoxon signed-rank test is to be mentioned. ******* 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 ******** [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 https://doi.org/10.1371/journal.pone.0335776.r003
Revision 2
3 Oct 2025 Author Response Reviewer #1: Table 2: Based on CONSORT statement/requirement, the column of t/X^2 and p value and the P ≤ .05 in the footnote are to be removed. For paired samples, Wilcoxon signed-rank test is to be mentioned. Response: Thanks for pointing that out. We removed the column of t/X^2 and p value and the P ≤ .05 in the footnote. We have added the missing information (page 14, line 260). Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0335776.r004
16 Oct 2025 Decision Letter - César González-Blanch, Editor Smartphone-Supported Positive Adjustment Coping Intervention (PACI) for Couples Undergoing Fertility Treatment: A Randomised Controlled Trial PONE-D-24-53960R2 Dear Dr. Kremer, 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. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. For questions related to billing, please contact billing support . If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. 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. Kind regards, César González-Blanch, PhD Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author Reviewer #1: (No Response) ******** 2. Is the manuscript technically sound, and do the data support the conclusions??> Reviewer #1: (No Response) ****** 3. Has the statistical analysis been performed appropriately and rigorously? -->?> Reviewer #1: (No Response) ****** 4. Have the authors made all data underlying the findings in their manuscript fully available??> The PLOS Data policy Reviewer #1: (No Response) ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English??> Reviewer #1: (No Response) ****** Reviewer #1: (No Response) ****** 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 ******** https://doi.org/10.1371/journal.pone.0335776.r005
Formally Accepted
Acceptance Letter - César González-Blanch, Editor PONE-D-24-53960R2 PLOS ONE Dear Dr. Wischmann, 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 You will receive further instructions from the production team, including instructions on how to review your proof when it is ready. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few days 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. You will receive an invoice from PLOS for your publication fee after your manuscript has reached the completed accept phase. If you receive an email requesting payment before acceptance or for any other service, this may be a phishing scheme. Learn how to identify phishing emails and protect your accounts at https://explore.plos.org/phishing. 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. César González-Blanch Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0335776.r006

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