PONE-D-23-18446Effects of a mindfulness-based intervention and a health self-management programme on psychological well-being in older adults with subjective cognitive decline: Secondary analyses from the SCD-Well randomised clinical trialPLOS ONE

Dear Dr. Lutz,

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.

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ACADEMIC EDITOR:Dear Authors,

Please, respond to reviewers recommendations in order to submit the new version of the paper (incl. the responses to reviewers).

Best regards

Editor

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Please submit your revised manuscript by Oct 08 2023 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.

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Marcelo Marcos Piva Demarzo, MD, PhD

Academic Editor

PLOS ONE

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“GC has received research support from the EU’s Horizon 2020 research and innovation programme (grant agreement number 667696), Inserm, Fondation d’entreprise MMA des Entrepreneurs du Futur, Fondation Alzheimer, Programme Hospitalier de Recherche Clinique, Région Normandie, Association France Alzheimer et maladies apparentées and Fondation Vaincre Alzheimer (all to Inserm), and personal fees from Fondation d’entreprise MMA des Entrepreneurs du Futur. All other authors have declared that no competing interests exist.”

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Additional Editor Comments:

Dear Authors,

Please, respond to reviewers recommendations in order to submit the new version of the paper (incl. the responses to reviewers).

Best regards

Editor

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. 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 #1: Yes

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: I Don't Know

Reviewer #2: I Don't Know

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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: No

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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

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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: Important note: This review pertains only to ‘statistical aspects’ of the study and so ‘clinical aspects’ [like medical importance, relevance of the study, ‘clinical significance and implication(s)’ of the whole study, etc.] are to be evaluated [should be assessed] separately/independently. Further please note that any ‘statistical review’ is generally done under the assumption that (such) study specific methodological [as well as execution] issues are perfectly taken care of by the investigator(s). This review is not an exception to that and so does not cover clinical aspects {however, seldom comments are made only if those issues are intimately / scientifically related & intermingle with ‘statistical aspects’ of the study}. Agreed that ‘statistical methods’ are used as just tools here, however, they are vital part of methodology [and so should be given due importance]. I look at the manuscript in/with statistical view point, other reviewer(s) look(s) at it with different angle so that in totality the review is very comprehensive. However, there should be efforts from authors side to improve (may be by taking clues from reviewer’s comments). Therefore, please do not limit the revision only (with respect) to comments made here.

COMMENTS: Although this manuscript is well drafted and the study seems to have enough potential (is on very important/useful topic), I have few doubts/observations/concerns (different opinion) which are little serious and are given below:

In ‘Methods’ section it is stated that ‘Detailed information about the recruitment procedures, eligibility criteria, design of the interventions, and assessments can be found in the trial protocol’ and quoted reference (18). But reference 18 seems to be a report of the trial and not the ‘PROTOCOL’. It is stated there that ‘The treatment is based on a published manual [24], with every session of the program covering different subjects, including self-management’ which indicates that some sort of / some amount of ‘self-management’ component was there. Then is it not necessary to clarify regarding the overlap? It is well-known (NET/WWW search) that “Secondary analysis refers to the use of existing research data to find answer to a question that was different from the original work” then is this study can be called as ‘Secondary analyses’ [as mentioned in title]? I am sure that the authors are aware of limitations/disadvantages of Secondary Data Analysis, however, I request authors to kindly read the following pasted from one famous standard textbook on ‘Medical Research Methodology’:

Since the researcher did not collect the data, he or she has no control over what is contained in the data set. Often times this can limit the analysis or alter the original questions the researcher sought out to answer.

You may consider to change the ‘title’ (only if convinienced). The present study (manuscript) seems to be a report of component/part [hitherto unpublished in this form] of the same (the SCD-Well randomised controlled trial of the European) trial. Further, please note that though application of ‘Mixed effects models’ here is perfectly alright, they are [any regression techniques for that matter] are not basically/originally developed for any sort of [between or within group(s)] comparison(s). In ‘Methods’ section you stated that “Mixed effects models were used to assess between- and within-group differences in change”. Head-to-head comparison is expected, as this is [through ‘Mixed effects models’] an indirect/secondary/by-product testing, in my opinion. Application of ‘Mixed effects models’ could definitely be (useful) addition (I am sure). Even if ultimate results are same, one should follow a correct way (I think).

Note that, though the measures/tools used are appropriate {example: 42-item Psychological Well-being Scale (PWBS), Quality of Life Assessment (by WHOQOL-BREF), four self-report measures (displayed in Table 2) - The Multidimensional Assessment of Interoceptive Awareness (MAIA) questionnaire and the 39-item Five Facet Mindfulness Questionnaire (FFMQ-39), etc.}, most of them are likely to yield data that are in [at the most] ‘ordinal’ level of measurement [and not in ratio level of measurement for sure {as the score two times higher does not indicate presence of that parameter/phenomenon as double (for example, a Visual Analogue Scales VAS score or say ‘depression’ score)}]. Then application of suitable non-parametric (or distribution free) test(s) is/are indicated/advisable [even if distribution may be ‘Gaussian’ (also called ‘normal’)]. Agreed that there is/are no non-parametric test(s)/technique(s) available to be used as alternative in all situation(s), but should be used whenever/wherever they are available. Therefore, in short use suitable non-parametric test(s)/technique(s) while dealing with data that are in ‘ordinal’ level of measurement even if [despite that] the distribution may be ‘Gaussian’. Testing ‘normality’ in sample [by using any normality test(s)} is not required/desired while dealing with data that are in ‘ordinal’ level of measurement [as most of the normality tests are not valid for ‘ordinal’ data].

It may also (as often said) please be noted, [as you stated: Each dimension is measured by a 7-item subscale using a 7-point Likert scale ranging from 1 (strongly agree) to 7 (strongly disagree). After reverse scoring 21 items, subscale scores were derived by averaging their respective item scores; a total score was derived by averaging all items] that whenever response options ranged from 1 (=strongly agree) to 7 (=strongly disagree) {or from 1=very bad to 3=neither good nor bad to 5=very good), while using a ‘Likert’ scale responses, recoding [like strongly disagree=-2, disagree=-1, neutral=0, agree=1, strongly agree=2] may yield correct and meaningful ‘arithmetic mean’ which is useful not only for comparison but has absolute meaning, in my opinion. Application of any statistical test(s) assume that meaning of entity used (mean, SD, etc) has a particular meaning. Though ‘α’ [alpha] or most other measures of reliability/correlation will remain same, however, use of non-parametric methods should/may be preferred while dealing with data yielded by any questionnaire/score.

At the end of ‘Introduction’ section it is said that “We hypothesised that both interventions would improve well-being but that CMBAS would be superior to HSMP”, then what about the principle of ‘equipoise’ [equipoise means that there is genuine uncertainty in the expert medical community over whether a treatment will be beneficial. An ethical dilemma arises in a clinical trial when the investigator(s) begin to believe that the treatment or intervention administered in one arm of the trial is significantly outperforming the other arms.]? Again, as often said, some sort of ‘bias’ is (are) likely be introduced/present when the principle of ‘equipoise’ is not observed/followed.

In ‘Statistical analyses -Sample size’ section is it adequate to say “Sample size calculations in SCD-Well were based on the expected effect size ….’? Do not it necessary to mention ‘what that expected effect size’ you are referring to?

Except these minor points, the article is acceptable [drafting is excellent]. Nevertheless, mind you that as pointed out in ‘important note’ above “This review pertains only to ‘statistical aspects’ of the study and so ‘clinical aspects’ should be assessed separately/independently. ‘Minor Revision’ is recommended.

Reviewer #2: This is a well-written manuscript reporting the findings of an RCT comparing the effects of a mindfulness-based intervention vs. a health education program on wellbeing-related outcomes in participants with subjective cognitive decline. I will defer to the statistical reviewer regarding the appropriateness and rigor of the statistical analysis. While the data is not being made fully available without restriction, it appears that the authors have addressed the issue satisfactorily. The following are items I believe still need to be addressed.

1. It appears that some items recommended by CONSORT were not reported. I suggest consulting the CONSORT NPT extension and addressing any items that are currently lacking. I believe PLOS ONE also requires a completed CONSORT checklist and flow diagram as part of the submission for manuscripts reporting results of clinical trials.

2. The citation style is inconsistent and should be corrected.

3. In describing the HSMP intervention a published manual is mentioned. A citation to the manual should be provided.

4. In the comparative analyses section a pre-registered statistical analysis plan is mentioned. If this plan is available, information on where to access it should be provided.

5. Session attendance is included as a potential moderator variable, yet home practice did not seem to be included. Given that the majority of the time spent doing the intervention appears to be during home practice, I believe it warrants attention. On a related note, information on adherence (e.g., number of sessions attended, number/hours of home practice completed) would also be useful.

6. Looking at table 2, in general it appears there was a drop off in the number of participants from V1 to V2 for both groups, then V3 rebounded a bit for the HSMP group but not the CMBAS group. Was there some reason that might explain this difference?

7. When discussing generalizability of the findings, it is mentioned that the participants were largely white. The data supporting this should be provided in Table 1.

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Reviewer #1: No

Reviewer #2: No

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PONE-D-23-18446R1Effects of a mindfulness-based intervention and a health self-management programme on psychological well-being in older adults with subjective cognitive decline: Secondary analyses from the SCD-Well randomised clinical trialPLOS ONE

Dear Dr. Lutz,

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 Nov 24 2023 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.

Please include the following items when submitting your revised manuscript:

• 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,

Marcelo Marcos Piva Demarzo, MD, 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.

Additional Editor Comments:

Dear Authors,

Thank you for sending the revised manuscript, which partially met the quality criteria for final acceptance.

For final acceptance of the manuscript to occur, please pay attention to the following minor points (raised by our reviewers):

- In the introduction, the authors indicated “Although the condition could be an indication of prodromal Alzheimer’s disease (AD), which is the most common form of dementia (3), SCD has also been related to other factors (e.g., physical and mental illness, sleep disturbances, personality traits, effects of drugs).” It could be that the lack of effect is due to these other factors, especially when there is no consensus of what constitutes an SCD. Please, address this point in the discussion;

- Note that was suggested by one reviewer that (refer to previous item 4) “Head-to-head comparison” could be ideally used instead of ‘Mixed effects models’. Please, answer this comment in more details, and, if necessary, point this as a limitation in the discussion section.

Best regards

Editor

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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 #1: All comments have been addressed

Reviewer #3: (No Response)

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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 #1: (No Response)

Reviewer #3: (No Response)

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: (No Response)

Reviewer #3: (No Response)

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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 #1: (No Response)

Reviewer #3: (No Response)

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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 #1: (No Response)

Reviewer #3: (No Response)

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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 #1: COMMENTS: All the comments are answered and so I recommend the acceptance because the manuscript has now achieved the acceptable level.

[However, please note that I suggested (refer to item 4) “Head-to-head comparison” {and said comparative inference drawn through ‘Mixed effects models’ done here is an indirect/secondary/by-product testing, in my opinion. Application of ‘Mixed effects models’ could definitely be (useful) addition (I am sure). Even if ultimate results are same, one should follow a correct way (I think)]. In response it is said that “We agree with the reviewer that the mixed effects models we have employed are an appropriate and effective method to answer our research questions” and there is NO mention of “Head-to-head comparison”.]

Reviewer #3: In the introduction, the authors indicated “Although the condition could

be an indication of prodromal Alzheimer’s disease (AD), which is the most common form of

dementia (3), SCD has also been related to other factors (e.g., physical and mental illness,

sleep disturbances, personality traits, effects of drugs).” It could be that the lack of effect is due to these other factors, especially when there is no consensus of what constitutes an SCD. It will be prudent to address this issue in the discussion.

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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 #1: Yes: Dr. Sanjeev Sarmukaddam

Reviewer #3: No

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[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.

Effects of a mindfulness-based intervention and a health self-management programme on psychological well-being in older adults with subjective cognitive decline: Secondary analyses from the SCD-Well randomised clinical trial

PONE-D-23-18446R2

Dear Dr. Marchant,

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.

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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,

Marcelo Marcos Piva Demarzo, MD, PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments: