Evaluation of the feasibility and acceptability of an integrative group psychological intervention for people with Multiple Sclerosis: A study protocol

Evangelia Fragkiadaki; Nikki Cotterill; Claire Rice; Jonathan A. Smith; Isabella E. Nizza

doi:10.1371/journal.pone.0288295

Peer Review History

Original SubmissionDecember 20, 2022
23 May 2023 Decision Letter - Gunasekara Vidana Mestrige Chamath Fernando, Editor PONE-D-22-34801 Evaluation of the feasibility and acceptability of an integrative group psychological intervention for people with Multiple Sclerosis: a study protocol PLOS ONE Dear Dr. Eva Fragkiadaki & co-authors, 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. Your study protocol deserves much admiration for addressing an important area of need in psychology; managing patients with MS. The intervention and the research project seem to be well-planned. In addition to the two reviewers' comments, I wish you to clarify/address the following aspects. 1. Suggest briefing the relevant quantitative and qualitative methodologies adopted in the abstract. 2. Line 427: Status and timeline of the study. - I understand there was a significant delay in peer-reviewing your article. However, please update the current study stage, indicating the actual time as well. Please submit your revised manuscript by 5th of June 2023. 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: <ul><li> 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'.<li> 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'.<li> 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, GVM Chamath Fernando, MBBS PgD-FM DipPallMed MCGP MRCGP 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 in the Acknowledgments Section of your manuscript: “The current study was funded by the University of the West of England (UWE, Bristol) through the internal funding scheme Vice Chancellor’s Early Career Researcher Development Award acquired by EF. The funders had and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.” We note that you have provided funding information that is not currently declared in your Funding Statement. However, funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows: “The current study was funded by the University of the West of England (UWE, Bristol) through the internal funding scheme Vice Chancellor’s Early Career Researcher Development Award acquired by EF. The funders had and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.” Please include your amended statements within your cover letter; we will change the online submission form on your behalf. 3. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. 4. 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. 5. The in-house editorial staff feels that your study meets the World Health Organization definition of a clinical trial because it is a prospective study in which participants were assigned to receive the MyMS-Ally intervention to investigate the effects on quality of life, anxiety, depression, emotion regulation. Please can you provide the following when you resubmit your manuscript: - SPIRIT checklist, and - SPIRIT schedule of enrolment, interventions, and assessments as the manuscript’s Figure 1 - Protocol as submitted to the IRB for approval Please upload a copy of your trial study protocol as a supporting information file. By the study protocol, we mean the complete and detailed plan for the conduct and analysis of the trial that the ethics committee approved before the trial began. Please send this in the original language. Your study protocol will be made available to the editors and reviewers, and will be published as supporting information with your manuscript if accepted for publication. (If you do not agree to this, we will not be able to publish your manuscript). - Trial registration PLOS ONE requires that all clinical trials are registered in an appropriate registry (the WHO list of approved registries is at http://www.who.int/ictrp/network/primary/en/index.html and more information on trial registration is at http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/). Please state the name of the registry and the registration number (e.g. ISRCTN or ClinicalTrials.gov) in the submission data and on the title page of your manuscript 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 ******** 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 ****** 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 ****** 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 ****** 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 Reviewer #2: 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 indicate that standard CBT practices have been re-directed to address issues of MS. This is a useful endeavor. However, reading through the little information provided on the content of the intended psychotherapy intervention, I do not see anything that novel the authors have included in their MyMAS-Ally. Hence, new contribution to the literature is minimal, in my opinion. If the authors think otherwise, they could provide more details on HOW their intervention actually offers novel input to the psychological aspects of MS. Further, in the inclusion criteria, the last bullet point, could those diagnosed with MS do this?. And, the objectives stated in article seems to be for the overall study whilst the article per se only reports a section of this overall study – this is confusing to the reader. Reviewer #2: Very interesting topic and well discussed. The study clearly state, who will be the samples (inclusion and exclusion), how will the intervention be implemented, who will conduct the intervention, the duration of the intervention as well as the data collection for pre, post and follow-up and also the information related to the qualititative study. Just a minor one, would like to suggest adding the reliability information for Satisfaction with Life Scale, Hospital Anxiety and Depression Scale (HADS). ****** 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: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. <quillbot-extension-portal></quillbot-extension-portal> https://doi.org/10.1371/journal.pone.0288295.r001
Revision 1
7 Jun 2023 Author Response Thank you for your encouraging words for our research project. We strongly believe there if great benefit in the exploration of psychological interventions focused on the people with MS’ needs and preferences and engage into more idiographic methods of evaluating these interventions. Thank you for the constructive comments. We have amended the article following the feedback. Please find below each point of the feedback along with our response to it. Editors’ feedback: 1. Briefing the relevant quantitative and qualitative methodologies adopted in the abstract: more details on the methods have been added in the abstract (p. 4, line 85). 2. Update the timeline of the study: the timeline of the study has been updated with the progress of study so far (p. 22, line 434). Journal requirements: 1. Formatting the article as well as naming files: the format of the article and the file names have been adjusted to adhere to the journal guidelines. 2. Funding statement: I have deleted the funding statement from the manuscript, please include the statement in my Funding Statement online form: “The current study was funded by the University of the West of England (UWE, Bristol) through the internal funding scheme Vice Chancellor’s Early Career Researcher Development Award acquired by EF. The funders did not have and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.” Thank you. 3. Include captions for supporting information: I have updated the manuscript and included the captions for supporting information in the end of the manuscript (p. 24, line 505). 4. References: Reference 32 has changed (line 625) and no other changes in the references have been made. 5. Clinical trials registration: we appreciate how the editorial has a sense that our study could fall under clinical trial definition. However, this is a feasibility and acceptability study of a psychological intervention that follows a case – series mixed method design, not an experimental or randomised controlled trial design. The project has been thoroughly and robustly reviewed by National Health Service Ethics Health Research Authority (governmental authority) committee as well as University of the West of England (Bristol) Faculty Research Ethics committee and they did not identify this project as a clinical trial or requested registration as such. Following the National Institute for Health and Care Research definition of a clinical trial: “A clinical trial is a research project that compares two or more treatments in patients with a particular condition or at risk of a condition to help generate high quality evidence about which is the more effective treatment or preventative strategy. The treatment being investigated in a clinical trial can be a medicinal product, a procedure, a device or another type of therapeutic intervention.” (https://www.nihr.ac.uk/documents/clinical-trials-guide/20595). The current study does not meet these criteria. On the contrary, we advocate the need to move away from large scale clinical trials and focus on more idiographic methods of psychological intervention evaluations. There is already a public registry of the study which can be found here: https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/myms-ally-feasibility-and-acceptability-study-of-ms-intervention/ We hope our rationale is sufficient. Please let me know if we need to discuss this further. Thank you. Reviewers’ comments: 1. Thank you for noting the contribution of the study in the field of psychological interventions for people with MS. 2. The protocol describes a mixed-method research design with primarily qualitative methods of data collection and analysis. There is no control group and it is not an experimental design therefore the statistical measurements mentioned in this comment do not apply. 3. The study design is explicitly outlined and provides the context for future research that would follow similar idiographic methods of evaluation of psychological intervention. 4. As this is a protocol for the study, no data has been generated yet. However, data and findings will be available as the project progresses. 5. The article has been further edited. 6. Reviewer 1: • We appreciate that CBT has been the prominent psychological intervention for people with MS in the literature. The goal of the current research project is to move away from theory – based interventions and towards a patient – led perspective of intervention development and implementation. We followed the trend in recent literature on clinical therapy processes to move from nomothetic to idiographic approaches of research and intervention (Hofmann & Hayes, 2019). As we have been developing MyMS-Ally group psychological intervention, our aspiration has been to establish processes that correspond to procedures, needs and characteristics of people with MS (Hofmann & Hayes, 2019). Thus, the structure of this intervention has also been based on what people with MS have found significant, helpful and beneficial in their accounts of their experience of psychological interventions they have engaged into (Fragkiadaki et al., 2021). The themes represented the change processes from the people with MS’ perspective as they related them to intervention processes. These themes guided the development of the integrative psychological group intervention MyMS-Ally. However, we acknowledge that as an integrative model we do not suggest an innovative approach therefore we have rephrased it in the article: lines 155, 176, 194. References: Hofmann, S. G., & Hayes, S. C. (2019). The Future of Intervention Science: Process-Based Therapy. Clinical Psychological Science, 7(1), 37–50. https://doi.org/10.1177/2167702618772296 Fragkiadaki, E., Anagnostopoulos, F., & Triliva, S. (2022). The experience of psychological therapies for people with multiple sclerosis: A mixed-methods study towards a patient-centred approach to exploring processes of change. Counselling and Psychotherapy Research, https://doi.org/10.1002/capr.12615 • People with Multiple Sclerosis have access to the internet and are of course able to use devices and gain access to digital resources of support, including attending online interventions. • The article explicates the objectives of the study presented in this protocol. The detailed outline of the research design and expected outcomes hopefully provides a comprehensive account of what the authors intent to do, which is the scope of this study protocol article. Reviewer 2: Thank you for the encouraging feedback and support of our project. The reliability information for the scales have been added: • Satisfaction with Life Scale: p. 17, line 323. • Hospital Anxiety and Depression Scale: p. 17, line 330. Thank you for the constructive feedback. We hope the responses and amendments now make the article suitable for publication with Plos One. We are looking forward to hearing back from you. Kind regards, Eva Fragkiadaki & co-authors https://doi.org/10.1371/journal.pone.0288295.r002
26 Jun 2023 Decision Letter - Gunasekara Vidana Mestrige Chamath Fernando, Editor Evaluation of the feasibility and acceptability of an integrative group psychological intervention for people with Multiple Sclerosis: a study protocol PONE-D-22-34801R1 Dear Dr. Evangelia Fragkiadaki 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, GVM Chamath Fernando, MBBS PgD-FM DipPallMed MCGP MRCGP Academic Editor PLOS ONE <quillbot-extension-portal></quillbot-extension-portal> https://doi.org/10.1371/journal.pone.0288295.r003
Formally Accepted
14 Jul 2023 Acceptance Letter - Gunasekara Vidana Mestrige Chamath Fernando, Editor PONE-D-22-34801R1 Evaluation of the feasibility and acceptability of an integrative group psychological intervention for people with Multiple Sclerosis: a study protocol Dear Dr. Fragkiadaki: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr Gunasekara Vidana Mestrige Chamath Fernando Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0288295.r004

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