PONE-D-24-33010Protocol for a Randomized Controlled Trial to Enhance Executive Function via Brief Mindfulness Training in Individuals with Internet Gaming DisorderPLOS 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 see the reviewers' comments.

Please submit your revised manuscript by Dec 22 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,

Marc N. Potenza

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

2. 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), Yunnan Fundamental Research Projects (202401AT070332), Joint Funds for Medical Specialization of KUST (KUST-KH2023002Y), Yunnan Ten Thousand Talents Plan Young and Elite Talents Project (YNWR-QNBJ-2018-027, YNWR-QNBJ-2018-056) and The innovation team of stress and disorder in nervous system in Yunnan Province (202305AS350011).]. 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." If this statement is not correct you must amend it as needed. Please include this amended Role 

Additional Editor Comments (if provided):

[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 #1: Yes

Reviewer #2: Yes

Reviewer #3: 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 #1: Partly

Reviewer #2: Yes

Reviewer #3: 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 #1: Yes

Reviewer #2: Yes

Reviewer #3: No

**********

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: Yes

Reviewer #2: Yes

Reviewer #3: No

**********

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: 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 #1: Line 226: the randomization is unclear. State clearly how these 82 individuals with internet gaming addiction and 40 recreational gamers are allocated into the intervention and control group.

Line 281: Several primary outcomes will be studied. Is the sample size calculated based on executive function sufficient to adequately support the analysis of the other primary outcomes?

Line 292 for the progressive muscle relaxation training: To mention it will be held 7 days similarly with the intervention group.

Line 294: The sentence ‘following the intervention’ is to be omitted.

Line 302: A separate subtitle to indicate intervention and control group respectively.

Information on the person who provide the training and do the data collection is to be provided.

Page 22 Table 3: Information on whether all these inventories/questionnaires are in Chinese version and has been validated is to be provided.

Data management on missing data if any is to be mentioned.

Line 476: Usually repeated measures ANOVA post hoc tests able to handle both within-group and between-group comparisons. Any reason why independent t test and paired t test are used?

Line 478: The name of the effect size is to be provided.

Line 478: Complete citation for SPSS 20.0 and R software including publisher name and version is to be provided.

Line 478-479: Effect size with 95%CI to be stated.

The accepted statistically significant level is to be provided.

Line 496-499: To state clearly whether both intent-to-treat analysis and per protocol analysis will be conducted. If there are differs ‘n’ at various time points (due to attrition rates or missing data), using repeated measure ANOVA becomes problematic.

When performing repeated measures ANOVA with multiple time points, there is a risk of inflating the type I error rate (false positives) due to multiple comparisons. Thus, it is important to impose Bonferroni correction during post hoc testing to adjust the significance level for each comparison.

Figure 2: the analysis section requires revision.

References did not conform to the journal format.

Reviewer #2: The manuscript presents a well-conceived study protocol that is likely to contribute valuable insights into the impact of mindfulness on executive function in individuals with IGD. By exploring the effects of mindfulness training on executive function in individuals with IGD, the authors aim to bridge a gap in current intervention methods and provide new therapeutic insights. The manuscript clearly defines both primary (e.g., EEG data, executive function) and secondary (e.g., anxiety, stress) outcomes, ensuring that both cognitive and psychological dimensions are covered. This comprehensive evaluation can provide a holistic understanding of the intervention's impact on IGD.

I only have some minor concerns for this well-documented manuscript.

1. Longitudinal Follow-up Justification: While the study’s longitudinal design is commendable, the rationale for the choice of follow-up intervals (e.g., one week, one month, etc.) could be strengthened. Are these intervals based on previous findings regarding the duration of mindfulness effects? Providing a clearer justification for these time points could clarify the expected temporal effects of mindfulness training.

2. Control Condition (Progressive Muscle Relaxation): The choice of progressive muscle relaxation (PMR) as a control condition is appropriate for differentiating between general relaxation and mindfulness-specific effects. However, the manuscript could benefit from a brief discussion on whether PMR is expected to influence executive function or gaming cravings to any degree, as this could affect the interpretation of results.

3. Terminology and Consistency: Ensure consistency in the terminology, such as using “Internet Gaming Disorder” (IGD) consistently instead of alternating with "gaming addiction" to prevent ambiguity.

4. Future Implications: The manuscript could be further strengthened by a more explicit discussion of how the findings may be translated into clinical practice, particularly for interventions beyond university-based or app-based contexts.

Reviewer #3: This manuscript presented an interesting RCT protocol that will examine the effectiveness of a brief mindfulness intervention on executive function in individuals that game (i.e., individuals with IGD and individuals without). I have provided comments on specific areas for improvement below.

Major issues:

1. Page 4, Rows 69-70: In the abstract, it may be beneficial to specify what you will be looking at in the EEG and what the behavioral metrics will specifically be measuring. Please also consider applying these changes to the main text of the manuscript (e.g., Page 21, Rows 370-371).

2. Page 6, Row 113: I would recommend being slightly cautious of the phrasing here, as there is no consensus in the literature on the primary diagnostic characteristic of IGD. However, I agree that “excessive gaming behavior despite awareness of negative consequences” is one of the key characteristics of IGD.

3. Page 7, Row 119: Given the focus on shifting and updating abilities throughout the manuscript, a brief description of each might be helpful to readers.

4. Page 7, Rows 123: Before introducing the mindfulness sections, please provide more context on current IGD treatment by briefly discussing the most common intervention types for IGD, those that have shown promise, and any associated limitations reported in the literature. This may also provide more context for the section on Page 10, Row 193, that states issues around relapse in studies testing IGD interventions.

5. Page 9, Rows 179-182: The discussion here appears to shift to smartphone addiction, which may overlap with but does not always encompass addictive gaming behaviors. Please consider making a clear link between smartphone addiction and IGD in this section.

6. Page 16, Row 314: Clarifying how, where, and when participants were encouraged to practice independently could strengthen this section.

7. Page 16, Row 333-337, and Page 17, Row 338-347: In the previous section 2.6, it states that the control group will be led by a psychology instructor. Could you please clarify the specific role of the psychology instructor, given the audio-guided nature of the progressive muscle relaxation training? If the instructor will not be providing the progressive muscle relaxation training, please clarify this in section 2.6 and perhaps state what exactly they will be responsible for (e.g., participant management).

8. Page 21, Rows 385-386: Please clarify what the data collection is referring to here, along with the total number of reminder messages that will be sent per timepoint if a participant does not complete evaluations/follow-up.

9. Page 23, Row 397: This section mentions a pilot study of the current project. You could consider including some results and insights from the pilot study in the introduction section of the manuscript.

10. Page 27, Row 497: The manuscript raises an important point on dropout throughout the manuscript. If any strategies to reduce dropout have been planned, please discuss them in the manuscript. The following systematic review stated that the average follow-up retention rate was only 24% for internet-delivered interventions for internet-enabled addictive behaviors (inclusive of IGD) and discussed ways in which some studies addressed the risk of attrition: Park, J. J., King, D. L., Wilkinson-Meyers, L., & Rodda, S. N. (2022). Content and effectiveness of web-based treatments for online behavioral addictions: systematic review. JMIR mental health, 9(9), e36662.

11. Table 2: You could consider providing a brief description of the following for readers unfamiliar with these practices or stories: (i) story of the old well and pebbles, (ii) raisin exercise, (iii) “life is now” reading, (iv) mountain meditation practice, (v) bean counting exercise.

12. Table 3: I am interested in knowing how “average daily gaming time” (under “primary outcome”) and “average weekly gaming time” (under “others”) differ in terms of how they will be measured and interpreted. The table states that participants will self-record their average daily gaming time – will this also be the case for average weekly gaming time?

Minor issues:

1. Page 4, Row 57, and Page 6, Row 106: I recommend using “especially” instead of the shortened version.

2. Page 4, Rows 58-59: Please indicate if this statement is specific to IGD or other disorders.

3. Page 4, Row 60: Stating the three subcomponents in the abstract may improve clarity.

4. Page 4, Row 63: Since the acronym was introduced above, “Internet Gaming Disorder” could be omitted here.

5. Page 5, Row 80: Please add a space after the period. Similar issues have been noted in other areas (e.g., the period at the start of the paragraph on Page 12, Row 257, the repeated period on Page 14, Row 265, and a missing period in Table 2).

6. Page 6, Rows 95: Perhaps you could remove “which” here for better flow.

7. Page 6, Row 115: I believe this should be written as “functional magnetic resonance imaging (fMRI).”

8. Page 7, Row 120: Please clarify which part is controversial.

13. Page 9, Row 177: I would recommend changing “internet gaming addiction” to “internet gaming disorder” or “IGD” for consistency – please apply these changes to other sections of the manuscript that have used “internet gaming addiction.” Also, the reference (38) appears to not align with the statement it is supporting. I encourage you to double-check all in-text citations and the reference list.

14. Page 11, Rows 216-218: This sentence may be unnecessary in this section. If retained, it would be helpful if the sentence clearly reflects the primary and secondary aims stated in the abstract.

15. Page 11, Row 220: As this is the “study design and participants” section, please briefly state the design of the trial. Please feel free to transfer a modified version of the sentence from Page 14, Row 284-285 here.

16. Page 11, Rows 223-225: This sentence appears to be similar to the previous sentence. The two could be potentially combined to improve readability.

17. Page 11, Row 230: To maintain a formal tone, I would recommend removing “by the way.”

18. Page 12, Row 239: Please put a space before the in-text citation.

19. Page 15, Row 297: Please specify which behavior the brief mindfulness interventions have had moderate effects on executive function.

20. Page 15, Row 300: For consistency, I would recommend capitalizing the T in Figure 1.

21. Page 15, Row 304: It may be useful to specify if “school” refers to the university the study is recruiting from or multiple schools in a region.

22. Page 16, Row 313: Please specify if the post-session check-ins occur once a day or multiple times a day.

23. Page 17, Rows 353-354: I would recommend providing some examples of adverse events that may occur or directing the readers to section 2.12.

24. Page 17, Rows 360-361: Please consider stating some examples of monitoring mechanisms.

25. Page 24, Row 421, and Page 29, Row 538: I would recommend unbolding “This task will evaluate the updating component of executive” (Page 24, Row 421) and the letter “i” (Page 29, Row 538).

26. Page 26, Row 474: Please clarify if those involved in data analysis will be blind to the intervention allocation.

9. Page 37, Row 812: Please clarify if this is a thesis or peer-reviewed journal article.

27. Table 1: In the main body of the manuscript, please state the reason for the chosen cut-off point for the Internet Addiction Test and cite supporting studies. You could also perhaps remove the fifth inclusion criterion, as it is the opposite of the sixth exclusion criterion. Lastly, please provide the full names of the acronyms provided in the table (e.g., GAD-7).

10. Table 2: In the “post-class exercise (Ruixin app)” row, could you please clarify whether participants were instructed to listen to relaxation music? If applicable, please also indicate who provided this guidance and how it was communicated. Also, please remove the space after “meditation” in the Day 6 row.

11. Table 3: Please consider changing “others” to “Others” for consistency.

12. Figure 1: It may be helpful to provide an explanation of why primary and secondary outcomes were measured at both enrolment (-T2) and allocation (-T1).

13. Figure 2: The caption for this figure could remove the acronyms for BMT, PMR, and CON, as they are not included in the figure.

14. Figure 3: Please provide the unabbreviated term for HRV.

**********

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: No

Reviewer #2: Yes: Kunru Song

Reviewer #3: Yes: Jennifer J. Park

**********

[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.

<p>Protocol for a Randomized Controlled Trial to Enhance Executive Function via Brief Mindfulness Training in Individuals with Internet Gaming Disorder

PONE-D-24-33010R1

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 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. If you have any questions relating to publication charges, 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,

Metin Çınaroğlu

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 #1: Yes

Reviewer #2: Yes

Reviewer #3: 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 #1: Partly

Reviewer #2: Yes

Reviewer #3: 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 #1: Yes

Reviewer #2: Yes

Reviewer #3: 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 #1: Yes

Reviewer #2: Yes

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 #1: Yes

Reviewer #2: Yes

Reviewer #3: 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 #1: The authors have addressed the comments. No further comments. The manuscript is suitable for publication.

Reviewer #2: The authors made significant improvements on their manuscript. All my concerns have been adequately addressed.

Reviewer #3: Thank you very much for addressing my comments and providing thoughtful revisions. I have no further concerns and am pleased to recommend the manuscript for acceptance.

**********

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: No

Reviewer #2: Yes: Kunru Song

Reviewer #3: Yes: Jennifer J. Park

**********