PONE-D-23-05385MediYoga compared to physiotherapy treatment as usual for patients with stress-related symptoms in primary care rehabilitation: a randomized controlled trialPLOS ONE

Dear Dr. Bellfjord,

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 Oct 06 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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We look forward to receiving your revised manuscript.

Kind regards,

Enock Madalitso Chisati, PhD

Academic Editor

PLOS ONE

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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: No

Reviewer #3: Yes

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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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: No

Reviewer #2: Yes

Reviewer #3: Yes

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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: No

Reviewer #3: 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: A two-arm randomized clinical trial was conducted which aimed to compare the effect of MediYoga to conventional treatment for people with perceived stress-related symptoms. For the primary outcome, Perceived Stress Scale, the MediYoga group showed an advantage over physiotherapy, but the difference did not reach statistical significance. As for secondary outcomes, the group effect over time was statistically significant in HADS anxiety and EQ-VAS.

Minor revisions:

1- In the abstract, briefly identify the statistical testing methods used to estimate the p-values.

2- Table 1: For age, provide the mean, standard deviation, and range. For sex, in addition to the frequencies, provide the corresponding percentages.

3- Table 3: In addition to the frequencies, provide the corresponding percentages.

4- Page 9: Statistical Power Calculation: State the statistical testing method which attains 80% power. Perhaps it is a t-test.

5- Page 9: The t-test is denoted with lower case t.

6- Page 9: Perhaps “t-test 2 signed” is a typo for “two-sided t-test.”

7- Page 9: Indicate the underlying covariance structure used in the mixed-effects linear models.

8- Table 5: Clarify if CI represents 95% CI.

9- Table 5: Merge the cells for 8 week follow-up and 20 week follow-up, separately, in the first row. Use the same cell merging format that has been applied to the Baseline section.

10- Clearly describe the results of significant interaction effects.

11- To assist in the review process, add line numbering to the document.

Reviewer #2: Summary

The study was conducted to examine the effects of MediYoga (MY), in comparison to Physiotherapy management techniques, on stress, anxiety and depression measurement scores among adults presenting with the associated symptoms such as musculoskeletal discomfort, headache and sleeping disorders. No clinical diagnoses were made on such conditions in this study; participants self-reported the symptoms using the self-administered questionnaires. Measures of stress constituted the primary outcome, whereas the anxiety and depression measures were secondary outcomes. On a 1:1 ratio, 46 participants were randomized either to MY (n=23) or PT (n=23). The MY was received once a week for 12 weeks, using a group therapy approach, each session lasting an hour. The PT intervention was sub-categorized further into 6; body and mind (=4), exercise therapy (4), combination of body and mind and exercise therapy (n=8), combination of exercise therapy and pain management (n=2), and ‘no treatment’ (n=5 [n=3 just assessment?]). The PT was delivered to each participant, individually, one to three times a week for ‘several weeks?’, each session lasting 30-45 minutes. Participants were assessed at baseline, 8- and 20-weeks. All treatments were delivered by Physiotherapists. Participants on medications or psychological related treatment continued with their therapies alongside the interventions in this study. Whereas those who were receiving or had received MY and PT interventions within the past 3-months were excluded from participation.

Authors report that at 8-weeks, nearly half of the participants were lost to follow-up. Authors claim that MY is more effective in improving stress, anxiety and HR-QOL than PT interventions. Authors report poor adherence to the intervention as the study’s major limiting factor.

Major issues

1. On page 6, it is not clear what criteria was used to allocate participants to the various conventional PT interventions.

2. The rationale of having other participants not receiving any conventional PT intervention (within the PT as standard care

arm) is not clear

3. ‘Age was considered a confounder, but never met the inclusion criteria for confounders hence the decision to not adjust

the models for age’. Was this, in any way, due to the recruitment (by chance)?

a. Did you consider matching the participants, in both arms, for age, gender and weight? (Potential confounders

for stress, anxiety, and depression [severity/progressiveness/recovery])

i. Could the inability to match the participants limit the interpretation/generalizability of the results?

4. The comparison group (PT) was a heterogeneous. Different participants received different PT conventional interventions

(also with varying dosage?), which might affect the findings differently as well (as reported in your results). This makes the

conclusion that MY is more effective to 'PT' arguable due to lack of standardization of the comparison intervention.

Comparing MY to each sub-group of PT interventions (bearing in mind the sample size calculation approach) would have

been ideal. You may wish to incorporate this in the interpretation and discussion of the results.

Minor issues

1. Line 8 of page 2, consider removing the space between ‘b ut’ (for ‘but’)

2. Line 5 of page 5 , consider replacing ‘control’ with usual/standard care

3. Consider putting SI unit for age in table 1 on page 5

4. ‘Participation during 8-weeks in mean’ column in table 1, is this for number of sessions?

5. Line 5 of page 7 ‘of practical reasons’….. may benefit from a sentence reconstruction

6. Line 2 on page 8 ‘for use with people with…’ may benefit from a sentence reconstruction

7. Line 4 on page 8 ‘to access’, did you want to say ‘to assess’?

8. Lines 8-9 on page 10; the sentence is not clear, may benefit from a sentence reconstruction

9. Lines 8-10 on page 15 may benefit from a sentence reconstruction

10. Lines 18-19 on page 15 may benefit from a sentence reconstruction

a. Do you mean there was no statistical difference between the two groups? Or no statistical changes within groups?

b. The trend of improvement, was it for MY or PT or in both groups?

11. Lines 7-8 on page 16, sentence starting wit ‘consistent with previous research, as in randomized……16’, may benefit from a

sentence reconstruction

Reviewer #3: Summary of short comings

1. Page 1; Write something in the abstract on how data was analysed

2. Page 1: “There was a group trend over time advantaging MediYoga in HADS depression (P = 0.08)”. This sentence is a little confusing. The results were not statistically significant, yet you indicate that there was a trend using that P value.

3. Page 5, line 3: The font color is not consistent with the rest of the text.

4. Page 5, line 5: There is a hyphen as a sign of correction… need to remove it

5. Page 7: Explain how “no assessment and no treatment” is part of PT intervention group

6. Page 7 & 8: indicate the psychometric properties of the instruments used

7. Page 9, paragraph 2: stick to third person instead of first person speech.

8. Page 10-14: Table 4 is too long, crowded and confusing. If possible find a way to separate the results for each outcome instead of combining all outcomes in one table. Of course there will be too many tables but if there is a provision of submitting tables separately, would be good.

9. Is there a reason for presenting the intercept in Table 4? I don’t see the results of intercept being explained in this manuscript.

10. There is some inconsistence in the reference list. For instance for reference 25, there is a need to add other authors.

11. Table 4: it should be “95%CI” and not just “CI”

12. Table 4: Mean should be written together with standard deviation.

13. Page 15, line 4/5: The sentence doesn’t seem complete. HADS had significant difference in comparison to which variable?

14. Page 17, line 2: Majority of the interventions require participants to travel to the clinical site. However, was there something very specific to your study that contributed to the high dropouts?

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

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PONE-D-23-05385R1MediYoga compared to physiotherapy treatment as usual for patients with stress-related symptoms in primary care rehabilitation: a randomized controlled trialPLOS ONE

Dear Dr. Larsson,

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 Mar 04 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,

Enock Madalitso Chisati, 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.

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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: (No Response)

Reviewer #2: All comments have been addressed

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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: Yes

Reviewer #2: Yes

**********

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

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: 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

**********

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: Minor revisions:

1- Line 212: Variance component is not a covariance structure. The three most common underlying covariance structures used in mixed effects linear models are: unstructured, autoregressive, and compound symmetry.

2- Pertaining to the statistical power calculation, within the manuscript indicate that the t-test was the statistical method which attained 80% power. Prior Comment: "Statistical Power Calculation: State the statistical testing method which attains 80% power. Perhaps it is a t-test." And the response: "Yes, the statistical power calculation was done with a t-test."

Reviewer #2: The authors have responded (with scientifically sound justification) to the questions and comments given in the initial review to my satisfactory.

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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 #1: No

Reviewer #2: 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.

MediYoga compared to physiotherapy treatment as usual for patients with stress-related symptoms in primary care rehabilitation: a randomized controlled trial

PONE-D-23-05385R2

Dear Dr. Larsson,

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,

Enock Madalitso Chisati, PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

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: (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)

**********

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 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)

**********

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)

**********

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: (No Response)

**********

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

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