PONE-D-23-27631Effects of brief mindfulness training on smoking cue-reactivity in tobacco use disorder: study protocol for a randomized controlled trialPLOS ONE

Dear Dr. Chen,

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 30 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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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.

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We look forward to receiving your revised manuscript.

Kind regards,

Lakshit Jain, MD

Academic Editor

PLOS ONE

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When you resubmit, please ensure that you provide the correct grant numbers for the awards you received for your study in the ‘Funding Information’ section.

3. Thank you for stating the following financial disclosure: 

 [This study was supported by the National Natural Science Foundation of China (NSFC) (Nos. 32060196, 82360271 and 82201597) and Yunnan Ten Thousand Talents Plan Young and Elite Talents Project (YNWR-QNBJ-2018-027, YNWR-QNBJ-2018-056), and Innovation team of Stress and disorder in nervous system in Yunnan.].  

Please state what role the funders took in the study.  If the funders had no role, please state: ""The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript."" 

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: No

Reviewer #4: Yes

Reviewer #5: No

Reviewer #6: Yes

Reviewer #7: Partly

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: No

Reviewer #4: Yes

Reviewer #5: Yes

Reviewer #6: Yes

Reviewer #7: Partly

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: No

Reviewer #4: Yes

Reviewer #5: Yes

Reviewer #6: Yes

Reviewer #7: No

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4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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

Reviewer #2: Yes

Reviewer #3: No

Reviewer #4: Yes

Reviewer #5: Yes

Reviewer #6: No

Reviewer #7: Yes

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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: Yes

Reviewer #2: Yes

Reviewer #3: No

Reviewer #4: Yes

Reviewer #5: Yes

Reviewer #6: Yes

Reviewer #7: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The design and study aim are good but I would wait to submit until have atleast phase 1 data to prove something. Also there should be some reason provided for inclusion and exclusion criteria like why only rt handed etc.

Reviewer #2: Thank you for the opportunity to review the manuscript.

The study outlined a research plan aiming to investigate the effects of Brief Mindfulness Training (BMT) on smoking cue reactivity in college students with Tobacco Use Disorder (TUD). A two-arm parallel Randomized Controlled Trial (RCT) design, incorporating multiple data collection time points, various analytical software tools, and rigorous data analysis techniques. Ethical considerations and transparency are emphasized.

Strengths:

Robust Study Design: The choice of a two-arm parallel RCT is well-justified for evaluating the intervention's impact, and the inclusion of multiple data collection time points enhances the study's ability to capture temporal changes.

Comprehensive Data Analysis: The utilization of diverse software tools and detailed analysis plans demonstrates a methodologically rigorous approach. The inclusion of effect size measurements and the commitment to addressing missing data enhance the study's robustness.

Ethical Considerations: The commitment to reporting protocol deviations underscores the study's ethical transparency.

Future Research Directions: The inclusion of prospective avenues for future research provides valuable guidance for further exploration in the field.

Recommendations:

Literature Review: The study would benefit from a more comprehensive literature review to provide context for the research question and to highlight existing knowledge in the area of mindfulness interventions for smoking cessation and cue reactivity. This would help justify the research question and demonstrate how the study contributes to existing knowledge.

Discussion Section: While the discussion section outlines the study's strengths and limitations, it could be improved by providing a more in-depth interpretation of potential implications of the findings. Discussing how the study's results might advance the understanding of smoking cue reactivity and the role of mindfulness in college students with TUD would enhance the discussion's academic value and functionality.

Limitations: While the study acknowledges certain limitations, such as the lack of double-blind methodology and the male-only sample, it would be beneficial to discuss these limitations in more detail and explore their potential impact on the study's outcomes. Additionally, discussing strategies to mitigate these limitations could be valuable.

Reviewer #3: Given the regional focus, the introduction would benefit from more emphasis on the Healthy China Action, its purpose, aims, and the interventions it aims to accomplish, rather than on global tobacco concerns.

The technical descriptions of addiction and cue-induced responses require rewording and clarification. Many sentences appear to exhibit a form of circular logic. For instance, consider the following example: "It is assumed that addiction partially develops due to classical conditioning, where drug-related contextual cues become triggers that automatically prompt drug use." In this context, there is an organism affected by the continued use of a reinforcing stimulus that elicits a strengthened response, commonly referred to as habit strength. Furthermore, the chemical properties of nicotine function on brain pathways in a manner that reinforces negative behavior with continued use. It's worth noting that a cue can be regarded as a stimulus according to basic principles of behaviorism, and "trigger" is essentially another term for cue. Therefore, what is meant by an "automatic prompt" needs clarification. Classic principles can be employed to provide a more scientifically precise description of these concepts.

A thorough explanation of extinction learning is required, including how this process can occur in smokers. Furthermore, it remains unclear how cue-reactivity can be applied beyond the realm of classic stimulus-response terminology.

Mindfulness Training (MT) is not widely recognized as a commonly used treatment for Tobacco Use Disorder (TUD) – a citation is needed to support this statement, and any other statements where a claim is made on a fact.

Clear content organization is needed to address the organism that encounters a stimulus/cue and how the organism is positively

PONE-D-23-27631R1Effects of brief mindfulness training on smoking cue-reactivity in tobacco use disorder: study protocol for a randomized controlled trialPLOS ONE

Dear Dr. Chen,

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 Feb 23 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. 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,

Lakshit Jain, MD

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:

Please address concerns raised by reviewer 8, and the article should be ready to accept once these additions are made.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #5: Yes

Reviewer #8: Yes

Reviewer #9: Yes

Reviewer #10: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #5: Yes

Reviewer #8: Yes

Reviewer #9: Yes

Reviewer #10: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #5: Yes

Reviewer #8: No

Reviewer #9: Yes

Reviewer #10: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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 #5: Yes

Reviewer #8: No

Reviewer #9: Yes

Reviewer #10: 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 #5: Yes

Reviewer #8: No

Reviewer #9: Yes

Reviewer #10: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #5: Thank you to the authors for addressing all of the comments. The manuscript is much stronger as a result.

Reviewer #8: This is an interesting study. However there are some fundamental information missing from the manuscript.

Some comments

Is the control group, usual care? As it seems to be another intervention? In which case should this be superiority/non-inferiority design?

For the sample size information, its unclear whether this sample size relates to one group, the experimental group or for both, in that is 45 the total?

Define your population of analyses,

In the data analysis section, can the authors state that results will be reported in accordance to CONSORT 2010 guidelines.

Inclusion of withdrawal of individuals in the study, be more explicit, unless the individuals withdraws consent of use of data, participant data an used at up to the point of withdrawal.

If there was no data monitoring committee appointed and the trial team reviewed the progress of the trial etc, how was blinding maintained?

Randomisation section, says matched for certain demographics, was this stratified randomisation?

Reviewer #9: Dr. Lakshit Jain, MD

PLOS ONE

Dear Dr. Lakshit Jain,

I have had the honor of reviewing the article titled "Effects of brief mindfulness training on smoking cue-reactivity in tobacco use disorder: study protocol for a randomized controlled trial” submitted to PLOS ONE for peer review.

The manuscript addresses a very important topic, psychological interventions to address tobacco use disorder, which is causing a significant burden on healthcare and one of the leading causes of global mortality rates. The authors stated that the current study proposed aims to explore the effect of brief mindfulness training (BMT) intervention on the smoking cue-reactivity in tobacco use disorder (TUD) among Chinese college students. The authors specifically targeted the smoking cue which is identified as an important trigger for relapse.

The authors of the manuscript hypothesized that brief mindfulness intervention can reduce smoking cue-reactivity in the population of TUD and can be reflected in subjective craving reports and changes in EEG functional indicators which they listed as their primary outcomes from this study adding secondary outcomes as daily smoking behaviors, affect and impulsivity, indicators reflecting correlation between mindfulness and smoking cue-reactivity. The authors further claimed that the study intends to explore the intervention effect of seven-day brief mindfulness practice on smoking cue-reactivity by a randomized controlled trial design, adding to the study the explanation of brain function mechanisms can also provide more targeted intervention strategies for smoking cessation.

To study the above association the authors employed a RCT design, assigned participants to a BMT group and a CON (control) group after gathering baseline data which included status related scales, EEG data for preintervention with the requirement for the participants not to smoke for at least three hours before collecting EEG data. At baseline the participants were required to report their last cigarette smoked and has to exhale CO concentration and only with those CO value below 10 to 7 PPM were asked to proceed to the EEG. Then the authors randomly assigned the participants to BMT and CON group, then they organized a seven-day mindfulness training guided by professional teachers specifically using “STOP” mindfulness exercises well the CON group carried out relaxation exercises. Postintervention data was collected when the training is completed and follow-up data in other four time points, specifically at one month, three-month, six-month and one-year along with the EEG data and skill data in the same time settings. The effects of mindfulness training were assessed using a series of linear mixed effects models. The authors used the image library proposed by Andre Manoliu where participants were asked to respond to both standard and deviant stimulate as part of the cue reactivity task.

The authors also disclosed the current status and timeline of the study protocol they proposed which stated that the participants of this study have been recruited and have completed some data collection, but subsequent experiments will be completed in April 2024 and all experimental data analysis will be completed by the end of May 2024 and results will be announced by end of June 2024 and article completion by the end of June 2024.

Some of the highlights of the study include the authors adopting a RCT design which removes the possibility of observer bias and to study the effectiveness of BMT in conjunction with obtaining EEG data which opens an avenue for further exploration of brain functioning mechanisms in TUD.

The authors appropriately identified multiple limitations including not using a double-blind RCT in the study along with identifying some demographic constraints including subjects being all male, not using urinary cotinine in conjunction with exhaled CO detection and no specialized behavioral measurement of intrinsic receptivity for mindfulness. Additional limitations include the participant population being confined to certain age group and a certain gender which may pose a challenge in application of the results to general population. Possible additional barrier to the results includes the application of the results based on the severity of TUD as the subjects were not screened if the current TUD is mild, moderate or severe. Though this is unique providing some references to existing data with similar studies and applications using EEG in substance use disorder would be helpful. Though may not be a limitation but needs attention is that the current study is under process and not complete.

Minor corrections include:

148: “Our previous trail” looks like the authors are referring to Trial and no trail.

Though the study does open the window in a specific direction and provide hypothetical novel approach of assessing brain functioning pre and post BMT and its effects on TUD, did not provide any conclusive data. Further research and data are needed upon conclusion of the study to build up on the findings and address the limitations comprehensively

Reviewer #10: All the comments seem to be addressed appropriately. Appears to be an interesting study and will be interesting to review results, when finished.

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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 #5: No

Reviewer #8: No

Reviewer #9: Yes: Surya Karlapati MD

Reviewer #10: No

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Effects of brief mindfulness training on smoking cue-reactivity in tobacco use disorder: study protocol for a randomized controlled trial

PONE-D-23-27631R2

Dear Dr. Chen,

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 for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.

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,

Lakshit Jain, MD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #8: Yes

Reviewer #9: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #8: No

Reviewer #9: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #8: Yes

Reviewer #9: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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 #8: Yes

Reviewer #9: 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 #8: Yes

Reviewer #9: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #8: All comments have been addressed.

Reviewer #9: Thank you for addressing the comments for the manuscript titled " Effects of brief mindfulness training on smoking cue-reactivity in tobacco use disorder: study protocol for a randomized controlled trial" submitted to PLOS ONE for peer review.

All the comments were appropriately addressed, and corresponding changes reflect the reviewers’ suggestions.

**********

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 #8: No

Reviewer #9: No

**********