xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05963581</url>
    </required_header>
    <id_info>
      <org_study_id>SOMA</org_study_id>
      <nct_id>NCT05963581</nct_id>
    </id_info>
    <brief_title>Oxford Social Movement Activation Study</brief_title>
    <acronym>SOMA</acronym>
    <official_title>Investigating the Effects of Social Movement on Mood and Social and Emotional Functioning in Young People Experiencing Low Mood</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Oxford</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Oxford</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        For adolescents and young people particularly, there is need for better and more readily&#xD;
        available treatments for depression and low mood. Comparatively less work has been done to&#xD;
        characterize and treat depression specifically in young people. Previous literature indicates&#xD;
        that often the unaddressed or under-addressed mental health difficulties in youth perseverate&#xD;
        into adulthood and contribute to a host of individual and communal difficulties throughout&#xD;
        the lifespan (Layard &amp; Clark, 2015). Specifically, if depression goes unaddressed in young&#xD;
        adulthood, the likelihood of a chronic course and multiple relapses or recurrences is much&#xD;
        higher (Saunders et al., 2021; Buckman et al., 2018).&#xD;
  &#xD;
        In the present research, we seek to investigate the potential efficacy of a novel&#xD;
        intervention for young people with low mood. Depression disrupts social functioning, and&#xD;
        social connectedness is especially important during adolescence for healthy development.&#xD;
        Within a growing body of literature, social dance has been linked to social and mental health&#xD;
        benefits along the dimensions of those disrupted in depression (Lakes et al., 2016; Shuper &amp;&#xD;
        Vulcan, 2021; Hyvönen et al., 2020). We hypothesize that social dance might preferentially&#xD;
        and efficiently target the goals of addressing loneliness, closeness, and enjoyment in young&#xD;
        people compared to other approaches to the treatment of low mood and depression in a way that&#xD;
        could lead to mood improvements.&#xD;
  &#xD;
        Specifically, we are interested in the impact of a social movement-based activity, salsa&#xD;
        dancing, on young peoples' mood and social and emotional processing. Social and emotional&#xD;
        processing (SEP) tasks, such as emotional facial recognition and memory for emotional words,&#xD;
        have been demonstrated to correspond with early changes that can be predictive of mood&#xD;
        changes and treatment efficacy downstream (e.g., Harmer et al., 2017). Including SEP tasks in&#xD;
        this research will help to elucidate the potential mechanisms underlying mood improvements,&#xD;
        should social dance correspond to improved mood in participants.&#xD;
  &#xD;
        The present research seeks to:&#xD;
  &#xD;
          1. Aim 1: Investigate the effect of a social dance intervention on low mood. This will be&#xD;
             assessed by administering psychological questionnaires to participants before, during,&#xD;
             and after the study course of social dance sessions. In particular, we hypothesize that&#xD;
             participants will experience reductions in low mood (assessed via the PHQ-9) following&#xD;
             the social movement intervention as compared to a waitlist control.&#xD;
  &#xD;
          2. Aim 2: Characterize any early social and emotional processing changes that correspond to&#xD;
             social dance versus a waitlist control. This will be assessed via social and emotional&#xD;
             processing task performance before, during, and following the social movement sessions.&#xD;
             We anticipate that improvements in social and emotional functioning as demonstrated via&#xD;
             one or several of these tasks will assist in elucidating the possible mechanisms&#xD;
             responsible for mood improvement from social movement.&#xD;
  &#xD;
          3. Aim 3: Characterize any social interaction difference from pre to post intervention that&#xD;
             correspond to the social dance versus waitlist condition. This will be assessed via a&#xD;
             version of the trust game before and following the social movement sessions and waitlist&#xD;
             control. We anticipate seeing more disrupted trust behavior prior to the intervention or&#xD;
             control conditions and less disrupted trust behavior following salsa dancing classes,&#xD;
             but not the waitlist control.&#xD;
  &#xD;
        In this randomized controlled trial, participants in the experimental group will complete six&#xD;
        to eight sessions of social movement (salsa dance) classes within an eight-week period, and&#xD;
        complete psychological questionnaires and tasks before, during, and after these eight weeks.&#xD;
        Their scores will be compared with those of a control group that will participate in an&#xD;
        active waitlist condition.&#xD;
  &#xD;
        If the present study suggests that social movement benefits young people with low mood, it&#xD;
        could form the basis for investigating a potential new cost-effective, non-invasive,&#xD;
        accessible intervention that could be made available to young people.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 17, 2023</start_date>
    <completion_date type="Anticipated">July 16, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 16, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Participants will be randomly assigned to either the salsa dancing intervention (46 participants) or the passive waiting-list control group (46 participants). Randomization will be stratified by gender.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in depressive symptoms from baseline at week four, eight, and twelve</measure>
      <time_frame>Will be assessed at week 0, 4, 8, and 12 of the intervention</time_frame>
      <description>Patient Health Questionnaire (PHQ-9) score. Higher scores indicate greater depressive symptoms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in anxiety symptoms from baseline at week four, eight, and twelve</measure>
      <time_frame>Will be assessed at week 0, 4, 8, and 12 of the intervention</time_frame>
      <description>Generalized Anxiety Disorder Scale (GAD-7) score. Higher scores indicate greater anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in social anxiety symptoms from baseline at week four, eight, and twelve</measure>
      <time_frame>Will be assessed at week 0, 4, 8, and 12 of the intervention</time_frame>
      <description>Social Anxiety Scale - Adolescent (SAS-A) score. Higher scores indicate greater social anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in loneliness from baseline at week four, eight, and twelve</measure>
      <time_frame>Will be assessed at week 0, 4, 8, and 12 of the intervention</time_frame>
      <description>UCLA Loneliness Scale (+ Loneliness Question) score. Higher scores indicate more loneliness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in daily mood questionnaire scores</measure>
      <time_frame>daily from baseline through week 12 of the intervention</time_frame>
      <description>Scoring one Likert scale mood questionnaire (&quot;How happy do you feel?&quot;), range 1-10. Higher values represent more happiness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in social anhedonia from baseline at week four, eight, and twelve</measure>
      <time_frame>Will be assessed at week 0, 4, 8, and 12 of the intervention</time_frame>
      <description>Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) score. Higher scores indicate lower social anhedonia.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in recognition of positive and negative facial expressions from baseline at week 8</measure>
      <time_frame>Will be assessed at week 0 and week 8 of the intervention</time_frame>
      <description>Hit rate for detecting positive versus negative faces in a facial expression recognition task (FERT)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in speed during recognition of positive and negative facial expressions</measure>
      <time_frame>Will be assessed at week 0 and week 8 of the intervention</time_frame>
      <description>Reaction times for correctly recognised positive versus negative faces in facial expression recognition task (FERT)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in emotional categorisation (ECAT)</measure>
      <time_frame>Will be assessed at week 0 and week 8 of the intervention</time_frame>
      <description>Reaction times for correctly classifying positive versus negative personality characteristic words</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in recall in the emotional recall task (EREC)</measure>
      <time_frame>Will be assessed at week 0 and week 8 of the intervention</time_frame>
      <description>Number of positive and negative words correctly (and incorrectly) recalled in the EREC task</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in memory in the emotional memory task (EMEM)</measure>
      <time_frame>Will be assessed at week 0 and week 8 of the intervention</time_frame>
      <description>Number of positive and negative words correctly (and incorrectly) recalled as familiar and novel</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in trust behavior in the trust game (Trust Game)</measure>
      <time_frame>Will be assessed at week 0 and week 8 of the intervention</time_frame>
      <description>Investment behavior and sensitivity to trustee's generosity when playing the role of the investor in a trust game</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">92</enrollment>
    <condition>Depression</condition>
    <condition>Low Mood</condition>
    <condition>Depressive Disorder</condition>
    <condition>Mood Disorders</condition>
    <condition>Depressive Symptoms</condition>
    <arm_group>
      <arm_group_label>Salsa Dancing</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will complete eight weeks of a salsa course in Oxford (of which they need to attend six classes to remain in the study), followed by a one-month follow-up time point.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants will wait twelve weeks, completing the questionnaires and tasks at the same study time points as participants in the experimental condition.They will then be offered the opportunity to complete the eight-week salsa course. Should they choose to participate in the salsa course, they will additionally be offered the opportunity to complete questionnaires at two additional time points.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Salsa Dancing</intervention_name>
      <description>Participants will complete salsa dancing classes in central Oxford with instructor(s) from the Oxford University Salsa Society</description>
      <arm_group_label>Salsa Dancing</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Individuals aged 18 to 24 at time of eligibility screening;&#xD;
  &#xD;
            -  Competency to give informed consent;&#xD;
  &#xD;
            -  Individuals will *not* be excluded for a formal diagnosis of depression from a GP or&#xD;
               other mental healthcare provider, nor for being presently or formerly on medication&#xD;
               for depression; nor for presently or formerly attending talk therapies;&#xD;
  &#xD;
            -  Individuals who do not meet the exclusion criteria specified below.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals with a PHQ-9 score of less than 5 (indicating no low mood) or greater than&#xD;
               19 (indicating a low mood that could be too severe for this research);&#xD;
  &#xD;
            -  individuals who self-report a current or recent diagnosis of any psychotic disorder&#xD;
               (e.g., bipolar, schizophrenia, schizoaffective disorder), substance use disorders,&#xD;
               eating disorders, or personality disorders&#xD;
  &#xD;
            -  individuals who self-report that they are unfit for light physical exertion;&#xD;
  &#xD;
            -  individuals who regularly, or have regularly, attended partner dance classes or&#xD;
               partner dance events within the last six months (as they would already be receiving&#xD;
               the potential benefits we are investigating in this study);&#xD;
  &#xD;
            -  and individuals for whom the Principal Investigator determines that the study is not&#xD;
               suitable.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>24 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Susannah Murphy, DPhil</last_name>
      <phone>+44 (0)1865 618313</phone>
      <email>susannah.murphy@psych.ox.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Catherine Harmer, DPhil</last_name>
      <email>catherine.harmer@psych.ox.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Oxford</name>
        <address>
          <city>Oxford</city>
          <zip>OX3 7JX</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Susannah Murphy, DPhil</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>low mood, depression, social movement, dance, salsa dance</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Mood Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05963581
  org study id: SOMA
  nct id: NCT05963581
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  For adolescents and young people particularly, there is need for better and more readily
        available treatments for depression and low mood. Comparatively less work has been done to
        characterize and treat depression specifically in young people. Previous literature indicates
        that often the unaddressed or under-addressed mental health difficulties in youth perseverate
        into adulthood and contribute to a host of individual and communal difficulties throughout
        the lifespan (Layard & Clark, 2015). Specifically, if depression goes unaddressed in young
        adulthood, the likelihood of a chronic course and multiple relapses or recurrences is much
        higher (Saunders et al., 2021; Buckman et al., 2018).
  
        In the present research, we seek to investigate the potential efficacy of a novel
        intervention for young people with low mood. Depression disrupts social functioning, and
        social connectedness is especially important during adolescence for healthy development.
        Within a growing body of literature, social dance has been linked to social and mental health
        benefits along the dimensions of those disrupted in depression (Lakes et al., 2016; Shuper &
        Vulcan, 2021; Hyvönen et al., 2020). We hypothesize that social dance might preferentially
        and efficiently target the goals of addressing loneliness, closeness, and enjoyment in young
        people compared to other approaches to the treatment of low mood and depression in a way that
        could lead to mood improvements.
  
        Specifically, we are interested in the impact of a social movement-based activity, salsa
        dancing, on young peoples' mood and social and emotional processing. Social and emotional
        processing (SEP) tasks, such as emotional facial recognition and memory for emotional words,
        have been demonstrated to correspond with early changes that can be predictive of mood
        changes and treatment efficacy downstream (e.g., Harmer et al., 2017). Including SEP tasks in
        this research will help to elucidate the potential mechanisms underlying mood improvements,
        should social dance correspond to improved mood in participants.
  
        The present research seeks to:
  
          1. Aim 1: Investigate the effect of a social dance intervention on low mood. This will be
             assessed by administering psychological questionnaires to participants before, during,
             and after the study course of social dance sessions. In particular, we hypothesize that
             participants will experience reductions in low mood (assessed via the PHQ-9) following
             the social movement intervention as compared to a waitlist control.
  
          2. Aim 2: Characterize any early social and emotional processing changes that correspond to
             social dance versus a waitlist control. This will be assessed via social and emotional
             processing task performance before, during, and following the social movement sessions.
             We anticipate that improvements in social and emotional functioning as demonstrated via
             one or several of these tasks will assist in elucidating the possible mechanisms
             responsible for mood improvement from social movement.
  
          3. Aim 3: Characterize any social interaction difference from pre to post intervention that
             correspond to the social dance versus waitlist condition. This will be assessed via a
             version of the trust game before and following the social movement sessions and waitlist
             control. We anticipate seeing more disrupted trust behavior prior to the intervention or
             control conditions and less disrupted trust behavior following salsa dancing classes,
             but not the waitlist control.
  
        In this randomized controlled trial, participants in the experimental group will complete six
        to eight sessions of social movement (salsa dance) classes within an eight-week period, and
        complete psychological questionnaires and tasks before, during, and after these eight weeks.
        Their scores will be compared with those of a control group that will participate in an
        active waitlist condition.
  
        If the present study suggests that social movement benefits young people with low mood, it
        could form the basis for investigating a potential new cost-effective, non-invasive,
        accessible intervention that could be made available to young people.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be randomly assigned to either the salsa dancing intervention (46 participants) or the passive waiting-list control group (46 participants). Randomization will be stratified by gender.
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Change in depressive symptoms from baseline at week four, eight, and twelve
  time frame: Will be assessed at week 0, 4, 8, and 12 of the intervention
  description: Patient Health Questionnaire (PHQ-9) score. Higher scores indicate greater depressive symptoms.
  measure: Change in anxiety symptoms from baseline at week four, eight, and twelve
  time frame: Will be assessed at week 0, 4, 8, and 12 of the intervention
  description: Generalized Anxiety Disorder Scale (GAD-7) score. Higher scores indicate greater anxiety.
  measure: Change in social anxiety symptoms from baseline at week four, eight, and twelve
  time frame: Will be assessed at week 0, 4, 8, and 12 of the intervention
  description: Social Anxiety Scale - Adolescent (SAS-A) score. Higher scores indicate greater social anxiety.
  measure: Change in loneliness from baseline at week four, eight, and twelve
  time frame: Will be assessed at week 0, 4, 8, and 12 of the intervention
  description: UCLA Loneliness Scale (+ Loneliness Question) score. Higher scores indicate more loneliness.
  measure: Change in daily mood questionnaire scores
  time frame: daily from baseline through week 12 of the intervention
  description: Scoring one Likert scale mood questionnaire ("How happy do you feel?"), range 1-10. Higher values represent more happiness.
  measure: Change in social anhedonia from baseline at week four, eight, and twelve
  time frame: Will be assessed at week 0, 4, 8, and 12 of the intervention
  description: Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) score. Higher scores indicate lower social anhedonia.
  measure: Change in recognition of positive and negative facial expressions from baseline at week 8
  time frame: Will be assessed at week 0 and week 8 of the intervention
  description: Hit rate for detecting positive versus negative faces in a facial expression recognition task (FERT)
  measure: Change in speed during recognition of positive and negative facial expressions
  time frame: Will be assessed at week 0 and week 8 of the intervention
  description: Reaction times for correctly recognised positive versus negative faces in facial expression recognition task (FERT)
  measure: Change in emotional categorisation (ECAT)
  time frame: Will be assessed at week 0 and week 8 of the intervention
  description: Reaction times for correctly classifying positive versus negative personality characteristic words
  measure: Change in recall in the emotional recall task (EREC)
  time frame: Will be assessed at week 0 and week 8 of the intervention
  description: Number of positive and negative words correctly (and incorrectly) recalled in the EREC task
  measure: Change in memory in the emotional memory task (EMEM)
  time frame: Will be assessed at week 0 and week 8 of the intervention
  description: Number of positive and negative words correctly (and incorrectly) recalled as familiar and novel
  measure: Change in trust behavior in the trust game (Trust Game)
  time frame: Will be assessed at week 0 and week 8 of the intervention
  description: Investment behavior and sensitivity to trustee's generosity when playing the role of the investor in a trust game
  arm group label: Salsa Dancing
  arm group type: Experimental
  description: Participants will complete eight weeks of a salsa course in Oxford (of which they need to attend six classes to remain in the study), followed by a one-month follow-up time point.
  arm group label: Waitlist Control
  arm group type: No Intervention
  description: Participants will wait twelve weeks, completing the questionnaires and tasks at the same study time points as participants in the experimental condition.They will then be offered the opportunity to complete the eight-week salsa course. Should they choose to participate in the salsa course, they will additionally be offered the opportunity to complete questionnaires at two additional time points.
  intervention type: Behavioral
  intervention name: Salsa Dancing
  description: Participants will complete salsa dancing classes in central Oxford with instructor(s) from the Oxford University Salsa Society
  arm group label: Salsa Dancing
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 24 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Susannah Murphy, DPhil
  phone: +44 (0)1865 618313
  email: susannah.murphy@psych.ox.ac.uk
  last name: Catherine Harmer, DPhil
  email: catherine.harmer@psych.ox.ac.uk
  facility: 
  contact: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Mood Disorders
  sharing ipd: Undecided