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    <front>
        <journal-meta>
            <journal-id journal-id-type="pmc">F1000Research</journal-id>
            <journal-title-group>
                <journal-title>F1000Research</journal-title>
            </journal-title-group>
            <issn pub-type="epub">2046-1402</issn>
            <publisher>
                <publisher-name>F1000 Research Limited</publisher-name>
                <publisher-loc>London, UK</publisher-loc>
            </publisher>
        </journal-meta>
        <article-meta>
            <article-id pub-id-type="doi">10.12688/f1000research.135375.1</article-id>
            <article-categories>
                <subj-group subj-group-type="heading">
                    <subject>Study Protocol</subject>
                </subj-group>
                <subj-group>
                    <subject>Articles</subject>
                </subj-group>
            </article-categories>
            <title-group>
                <article-title>The prevalence of cyclothymic disorder among first-year students at a health sciences university in Central India</article-title>
                <fn-group content-type="pub-status">
                    <fn>
                        <p>[version 1; peer review: awaiting peer review]</p>
                    </fn>
                </fn-group>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author" corresp="yes">
                    <name>
                        <surname>Quazi</surname>
                        <given-names>Anam</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Funding Acquisition</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <uri content-type="orcid">https://orcid.org/0009-0008-9315-1751</uri>
                    <xref ref-type="corresp" rid="c1">a</xref>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Berry</surname>
                        <given-names>Svanjita</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <xref ref-type="aff" rid="a2">2</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Logue</surname>
                        <given-names>Rachel</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0009-0008-4883-1379</uri>
                    <xref ref-type="aff" rid="a3">3</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Gaidhane</surname>
                        <given-names>Shilpa</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="aff" rid="a4">4</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Parve</surname>
                        <given-names>Swapnil</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-8069-4350</uri>
                    <xref ref-type="aff" rid="a5">5</xref>
                    <xref ref-type="aff" rid="a6">6</xref>
                    <xref ref-type="aff" rid="a7">7</xref>
                </contrib>
                <aff id="a1">
                    <label>1</label>Global Consortium for Public Health Research, Jawaharlal Nehru Medical College; Datta Meghe Institute of Higher Education and Research (DU), Wardha, Maharastra, 442001, India</aff>
                <aff id="a2">
                    <label>2</label>Trinity Health Livonia Hospital, Livonia, Michigan, USA</aff>
                <aff id="a3">
                    <label>3</label>Emory University, Atlanta, Georgia, USA</aff>
                <aff id="a4">
                    <label>4</label>Centre for Global Health Academy and Center for One Health, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharastra, India</aff>
                <aff id="a5">
                    <label>5</label>Nuvance Health Global Health Program, Danbury, CT, USA</aff>
                <aff id="a6">
                    <label>6</label>Datta Meghe Institute of Higher Education and Research, Wardha, India</aff>
                <aff id="a7">
                    <label>7</label>MD College of Medicine, University of Vermont Robert Larner, Burlington, Vermont, USA</aff>
            </contrib-group>
            <author-notes>
                <corresp id="c1">
                    <label>a</label>
                    <email xlink:href="mailto:anamquazi251@gmail.com">anamquazi251@gmail.com</email>
                </corresp>
                <fn fn-type="conflict">
                    <p>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>6</day>
                <month>10</month>
                <year>2023</year>
            </pub-date>
            <pub-date pub-type="collection">
                <year>2023</year>
            </pub-date>
            <volume>12</volume>
            <elocation-id>1277</elocation-id>
            <history>
                <date date-type="accepted">
                    <day>5</day>
                    <month>9</month>
                    <year>2023</year>
                </date>
            </history>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2023 Quazi A et al.</copyright-statement>
                <copyright-year>2023</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <self-uri content-type="pdf" xlink:href="https://f1000research.com/articles/12-1277/pdf"/>
            <abstract>
                <p>
                    <bold>Background:</bold> Cyclothymic disorder includes hypomanic and depressive symptoms that do not meet standards for hypomanic episodes and major depressive symptoms.</p>
                <p>
                    <bold>Objectives:</bold> To assess the prevalence of cyclothymic disorders in medical, physiotherapy, and dental 1st-year students aged 18&#x2013;22 years old in Datta Meghe Institute of Higher Education and Research (DMIHER), Wardha.</p>
                <p>
                    <bold>Methods:</bold> The study is designed as a cross-sectional study where a web-based survey will be used to evaluate the prevalence of the cyclothymic disorder in 154 first-year Health Professional Education (HPE) students at a university in Central India.</p>
                <p>
                    <bold>Conclusions:</bold> This study will assess the prevalence of cyclothymic disorders in HPE students and investigate relationships between different fields of study, age, gender, socio-economic status, place of temporary residence (home/hostel/paying guest), history of addiction (smoking/alcohol/substance abuse/other), past medical history (physical and/or mental), and family history (divorced parents/history of childhood abuse).</p>
            </abstract>
            <kwd-group kwd-group-type="author">
                <kwd>Cyclothymia</kwd>
                <kwd>Bipolar disorder</kwd>
                <kwd>BP</kwd>
                <kwd>Akiskal Questionnaire</kwd>
                <kwd>TEMPS-A</kwd>
            </kwd-group>
            <funding-group>
                <award-group id="fund-1">
                    <funding-source>Datta Meghe Institute of Higher Education and Research</funding-source>
                    <award-id>10073</award-id>
                </award-group>
                <funding-statement>Global Consortium for Public Health and Research, Datta Meghe Institute of Higher Education and Research is funding the study with grant number 10073 to Anam Quazi. </funding-statement>
                <funding-statement>
                    <italic>The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.</italic>
                </funding-statement>
            </funding-group>
        </article-meta>
    </front>
    <body>
        <sec id="sec1" sec-type="intro">
            <title>Introduction</title>
            <p>Cyclothymic disorder is defined by temperamental mood reactivity and instability, as well as hypomanic and depressed symptoms that do not satisfy standards for hypomanic episodes and significant depressive symptoms during a two-year period in adults and one year in children (
                <xref ref-type="bibr" rid="ref6">Jain and Mitra, 2023</xref>; 
                <xref ref-type="bibr" rid="ref9">Sekhon and Gupta, 2023</xref>). These individuals also have anxiety, poor impulse control, and personality disorders, which result in psychological, and interpersonal problems (
                <xref ref-type="bibr" rid="ref7">Perugi 
                    <italic toggle="yes">et al.</italic>, 2017</xref>). From a neurodevelopmental standpoint, it is more correctly described as an amplification of the cyclothymic temperament (
                <xref ref-type="bibr" rid="ref7">Perugi 
                    <italic toggle="yes">et al.</italic>, 2017</xref>).</p>
            <p>The cyclothymic disorder has a male-to-female ratio of 1:1 and a lifetime frequency of about 0.4% and 1% (
                <xref ref-type="bibr" rid="ref6">Jain and Mitra, 2023</xref>). A study conducted by Elleuch 
                <italic toggle="yes">et al.</italic> demonstrated that the cyclothymic and hyperthymic temperament scores were the highest among medical students (
                <xref ref-type="bibr" rid="ref5">Elleuch 
                    <italic toggle="yes">et al.</italic>, 2021</xref>). There is limited evidence on the prevalence of the cyclothymic disorder in Indian students despite evidence of its clinical relevance and long-term sequelae. There are still concerns about its diagnostic delimitation and its relationship with other factors, such as age, sex, socioeconomic status, social environment, etc.</p>
            <p>The current diagnostic criteria for cyclothymic disorder as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and International Classification of Diseases, Tenth Revision (ICD-10), emphasize on the episodic nature of the mood symptoms observed in this disorder, which can be challenging from both diagnostic and therapeutic standpoints (
                <xref ref-type="bibr" rid="ref7">Perugi 
                    <italic toggle="yes">et al.</italic>, 2017</xref>). Hagop Akiskal developed validated questionnaires &#x2013; Cyclothymic-Hypersensitivity and the TEMPS-A (Temperament Evaluation of the Memphis, Pisa, Paris, and San Diego Auto) questionnaire which is a self-evaluation measure that assesses five affective temperaments &#x2013; depressive, cyclothymic, hyperthymic, irritable, and anxious &#x2013; and has sufficient reliability and validity in a non-clinical sample, opening up new avenues for clinical research at the intersection of mental disorders, temperament, and personality (
                <xref ref-type="bibr" rid="ref1">Bielecki and Gupta, 2023</xref>; 
                <xref ref-type="bibr" rid="ref3">Bl&#x00f6;ink 
                    <italic toggle="yes">et al.</italic>, 2005</xref>; 
                <xref ref-type="bibr" rid="ref4">Borkowska 
                    <italic toggle="yes">et al.</italic>, 2010</xref>). The TEMPS-A was developed in a self-rated version to help with the assessment of clinically relevant aspects of temperament in the context of affective disorders because previous questionnaires for assessing personality aspects were derived from statistical analyses of &#x201c;normal&#x201d; personality having no specific relation to affectivity or affective disorders (
                <xref ref-type="bibr" rid="ref3">Bl&#x00f6;ink 
                    <italic toggle="yes">et al.</italic>, 2005</xref>). Recent research in the United States and Europe have demonstrated that shortened versions of the TEMPS-A can be just as effective as the full versions while potentially increasing respondent compliance (
                <xref ref-type="bibr" rid="ref10">Woodruff 
                    <italic toggle="yes">et al.</italic>, 2011</xref>).</p>
        </sec>
        <sec id="sec2">
            <title>Aims and objectives</title>
            <p>
                <bold>Primary objective:</bold> To assess the prevalence of cyclothymic disorder among first-year students of Health Profession Education (Medical, Physiotherapy, and Dental) at a health sciences university in Central India.</p>
            <p>
                <bold>Secondary objective:</bold> To investigate the relationship between the prevalence of cyclothymia with student specific factors such as their field of study, age, sex, gender, sexual orientation, socio-economic status, housing situation, past and present medical, social and developmental history, substance use, and prior experience in psychotherapy.</p>
        </sec>
        <sec id="sec3" sec-type="methods">
            <title>Methods</title>
            <sec id="sec4">
                <title>Study design</title>
                <p>The study is designed as a single-centric, cross-sectional study where a web-based survey will be used to evaluate the prevalence of cyclothymic disorder in a chosen population.</p>
            </sec>
            <sec id="sec5">
                <title>Participant and public involvement</title>
                <p>The participants included in this study have not been involved in drafting the study design or objectives. Additionally, information about the study protocols will be shared with the university authorities prior to data collection.</p>
            </sec>
            <sec id="sec6">
                <title>Ethical considerations and dissemination</title>
                <p>The study will be initiated upon receiving approval from the Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research. Participant data will be collected anonymously and confidentiality will be maintained. Participants enrolling for this study will be given the option of allowing their data to be used for analyses.</p>
                <p>The results from this study will be disseminated through the publication of peer-reviewed manuscripts in indexed journals, presentations at scientific meetings, and/or conferences with local stakeholders. The researchers may also communicate aggregated results to members of the public and clinical professionals through 
                    <italic toggle="yes">ad hoc</italic> meetings/events or mass media releases.</p>
                <p>
                    <italic toggle="yes">Inclusion criteria for participants</italic>
                </p>
                <p>The participant must be between the ages of 18&#x2013;22, willing to sign a voluntary informed written consent, be able to read and comprehend English, have access to a smartphone/tablet/laptop with an internet connection, and have an absence of any psychiatric illness.</p>
                <p>
                    <italic toggle="yes">Exclusion criteria for participants</italic>
                </p>
                <p>Participants who deal with psychiatric illness and/or take psychotropic medications and/or have a history of substance abuse will be excluded from the study.</p>
            </sec>
            <sec id="sec7">
                <title>Sample size</title>
                <p>A minimum sample size of 154 participants has been calculated, as seen below.</p>
                <p>The minimum sample size required:
                    <disp-formula id="e1">
                        <mml:math display="block">
                            <mml:mi>N</mml:mi>
                            <mml:mo>=</mml:mo>
                            <mml:mfrac>
                                <mml:msubsup>
                                    <mml:mi>Z</mml:mi>
                                    <mml:mrow>
                                        <mml:mn>1</mml:mn>
                                        <mml:mo>&#x2212;</mml:mo>
                                        <mml:mfrac>
                                            <mml:mi>&#x03b1;</mml:mi>
                                            <mml:mn>2</mml:mn>
                                        </mml:mfrac>
                                    </mml:mrow>
                                    <mml:mn>2</mml:mn>
                                </mml:msubsup>
                                <mml:msup>
                                    <mml:mi>D</mml:mi>
                                    <mml:mn>2</mml:mn>
                                </mml:msup>
                            </mml:mfrac>
                            <mml:mo>&#x2217;</mml:mo>
                            <mml:mi>p</mml:mi>
                            <mml:mo>&#x2217;</mml:mo>
                            <mml:mfenced close=")" open="(">
                                <mml:mrow>
                                    <mml:mn>1</mml:mn>
                                    <mml:mo>&#x2212;</mml:mo>
                                    <mml:mi>p</mml:mi>
                                </mml:mrow>
                            </mml:mfenced>
                        </mml:math>
                    </disp-formula>
                </p>
                <p>Z
                    <sub>1&#x2212;&#x03b1;/2</sub> = 1. 96 at 5% level of significance</p>
                <p>Considering lifetime prevalence of cyclothymic disorder is approximately = 0.4% = 0.004 as per ref. article (
                    <xref ref-type="bibr" rid="ref1">Bielecki and Gupta, 2023</xref>).
                    <disp-formula id="e2">
                        <mml:math display="block">
                            <mml:mtable columnalign="center" displaystyle="true">
                                <mml:mtr>
                                    <mml:mtd>
                                        <mml:mi mathvariant="normal">D</mml:mi>
                                        <mml:mo>=</mml:mo>
                                        <mml:mtext>estimated&#x2009;error</mml:mtext>
                                        <mml:mspace width="0.12em"/>
                                        <mml:mfenced close=")" open="(">
                                            <mml:mrow>
                                                <mml:mn>1</mml:mn>
                                                <mml:mo>%</mml:mo>
                                            </mml:mrow>
                                        </mml:mfenced>
                                        <mml:mo>=</mml:mo>
                                        <mml:mn>0.01</mml:mn>
                                    </mml:mtd>
                                </mml:mtr>
                                <mml:mtr>
                                    <mml:mtd>
                                        <mml:mi mathvariant="normal">N</mml:mi>
                                        <mml:mo>=</mml:mo>
                                        <mml:mfenced close=")" open="(">
                                            <mml:msup>
                                                <mml:mfenced close=")" open="(">
                                                    <mml:mn>1.96</mml:mn>
                                                </mml:mfenced>
                                                <mml:mrow>
                                                    <mml:mn>2</mml:mn>
                                                    <mml:mo>&#x2217;</mml:mo>
                                                </mml:mrow>
                                            </mml:msup>
                                            <mml:msup>
                                                <mml:mfenced close=")" open="(">
                                                    <mml:mn>0.004</mml:mn>
                                                </mml:mfenced>
                                                <mml:mo>&#x2217;</mml:mo>
                                            </mml:msup>
                                            <mml:mfenced close=")" open="(">
                                                <mml:mrow>
                                                    <mml:mn>1</mml:mn>
                                                    <mml:mo>&#x2212;</mml:mo>
                                                    <mml:mn>0.004</mml:mn>
                                                </mml:mrow>
                                            </mml:mfenced>
                                            <mml:mo>/</mml:mo>
                                            <mml:msup>
                                                <mml:mfenced close=")" open="(">
                                                    <mml:mn>0.01</mml:mn>
                                                </mml:mfenced>
                                                <mml:mn>2</mml:mn>
                                            </mml:msup>
                                        </mml:mfenced>
                                        <mml:mo>=</mml:mo>
                                        <mml:mn>154</mml:mn>
                                        <mml:mo>.</mml:mo>
                                    </mml:mtd>
                                </mml:mtr>
                            </mml:mtable>
                        </mml:math>
                    </disp-formula>
                </p>
            </sec>
            <sec id="sec8">
                <title>Duration</title>
                <p>Data will be collected over a period of 4 weeks.</p>
            </sec>
            <sec id="sec9">
                <title>Data collection</title>
                <p>Participants will be contacted through their respective official WhatsApp (online messaging portal) groups that are regulated by class representatives. Background and qualifying information regarding the study along with the link to access the web-based survey will be sent to the students via the WhatsApp groups.</p>
                <p>Participation in the study will be entirely voluntary and participants will have the choice to withdraw from the study at any point during the survey period without giving any reasons.</p>
                <p>The web-based survey will consist of three parts.
                    <list list-type="order">
                        <list-item>
                            <label>1.</label>
                            <p>
                                <bold>Part one:</bold> Electronic consent for participation in the study</p>
                        </list-item>
                        <list-item>
                            <label>2.</label>
                            <p>
                                <bold>Part two:</bold> Personal information</p>
                        </list-item>
                        <list-item>
                            <label>3.</label>
                            <p>
                                <bold>Part three:</bold> TEMPS-A questionnaire for the assessment of cyclothymic disorder</p>
                        </list-item>
                    </list>
                </p>
            </sec>
            <sec id="sec10">
                <title>Instruments to be used</title>
                <p>The three-part survey will be conducted using Google Forms as the survey administration software of choice. The TEMPS-A questionnaire will be administered as part three of the survey for the assessment of cyclothymic disorder in the sample population.</p>
            </sec>
            <sec id="sec11">
                <title>Consent and confidentiality</title>
                <p>We provide a clear description of the study&#x2019;s objectives and procedures, which will ensure that participants give written informed consent on a voluntary basis. We will collect non-identifying data from students who consent to participate in the survey, and exclude students who do not sign the consent form that is in part one of the survey.</p>
            </sec>
            <sec id="sec12">
                <title>Statistical analysis plan</title>
                <p>Demographic variables will be presented as descriptive summaries such as median&#x00b1;SD, or percentages for continuous variables and proportions for categorical variables. Specifically, group differences will be analysed using independent-sample t-tests and analysis of variance. P values of &lt;0.05&#x2009;will be considered statistically significant. Stata version 15 software will be used for statistical analysis.</p>
            </sec>
        </sec>
        <sec id="sec13" sec-type="discussion">
            <title>Discussion</title>
            <p>Despite the study&#x2019;s limitation of screening HPE university students at a single site, we seek to propose clinical trials throughout the region if results show a strong association between incidence of cyclothymic disorder and medical, socio-economic, environmental, social, or developmental factors. We will also inform students at DMIHER about beneficial community programmes and practicing psychotherapists. Early recognition of cyclothymic disorder avails physicians to specifically treat their patients and avoid unnecessary complications.</p>
            <sec id="sec14">
                <title>Study strengths and limitations</title>
                <p>The proposed study will be among the first few studies that will comprehensively investigate the prevalence of cyclothymic disorder among HPE students in Central India. Although the results are generalised to HPE students, this study may contribute to a better understanding of relationships between students based on certain criteria and cyclothymic symptoms, enable subsequent interventional studies to identify at-risk groups and test the feasibility of clinical interventions and community programmes that aim to improve mental health outcomes in students. It will provide helpful health information about young adults that is relevant to clinicians, researchers and policymakers in India. On the other hand, it lacks other in-depth analysis of mental health assessments owing to sample size and cost considerations.</p>
            </sec>
            <sec id="sec15">
                <title>Study status</title>
                <p>We are firming up the study&#x2019;s survey so we can start piloting the study.</p>
            </sec>
        </sec>
    </body>
    <back>
        <sec id="sec18" sec-type="data-availability">
            <title>Data availability</title>
            <p>No data are associated with this article.</p>
        </sec>
        <ref-list>
            <title>References</title>
            <ref id="ref1">
                <mixed-citation publication-type="book">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Bielecki</surname>
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                        </name>

                        <name name-style="western">
                            <surname>Gupta</surname>
                            <given-names>V</given-names>
                        </name>
</person-group>:
                    <chapter-title>Cyclothymic Disorder.</chapter-title>
                    <source>

                        <italic toggle="yes">StatPearls.</italic>
</source>
                    <publisher-loc>Treasure Island (FL)</publisher-loc>:
                    <publisher-name>StatPearls Publishing</publisher-name>;<year>2023</year>.</mixed-citation>
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                <mixed-citation publication-type="journal">
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                        <etal/>
</person-group>:
                    <article-title>Factorial structure and internal consistency of the German TEMPS-A scale: validation against the NEO-FFI questionnaire.</article-title>
                    <source>

                        <italic toggle="yes">J. Affect. Disord.</italic>
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                    <year>2005</year>;<volume>85</volume>:<fpage>77</fpage>&#x2013;<lpage>83</lpage>.
                    <pub-id pub-id-type="pmid">15780678</pub-id>
                    <pub-id pub-id-type="doi">10.1016/S0165-0327(03)00101-0</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref4">
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                        <name name-style="western">
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                        <name name-style="western">
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