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/NCT06004232</url>
    </required_header>
    <id_info>
      <org_study_id>R34MH131573</org_study_id>
      <secondary_id>R34MH131573</secondary_id>
      <nct_id>NCT06004232</nct_id>
    </id_info>
    <brief_title>Prenatal Yoga to Prevent Postpartum Depression</brief_title>
    <acronym>PRY-D</acronym>
    <official_title>Prenatal Yoga to Prevent Postpartum Depression (PRY-D)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Henry Ford Health System</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Mental Health (NIMH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Colorado, Boulder</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Henry Ford Health System</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Although psychological interventions exist for the prevention of PPD, a yoga-based&#xD;
        intervention to prevent PPD among at-risk women utilizes a similar theoretical foundation&#xD;
        (i.e., mindfulness), may be more acceptable to women of minority status, and may confer&#xD;
        additional physical activity benefits. The purpose of this pilot study is to determine the&#xD;
        effectiveness of using a virtually delivered prenatal yoga intervention for the prevention of&#xD;
        PPD among at-risk women in a diverse health care system and explore preliminary factors which&#xD;
        influence implementation of the intervention. This study has 2 phases: Phase 1 will evaluate&#xD;
        facilitators and barriers to intervention implementation among patient, clinician, and health&#xD;
        system stakeholders, followed by an open trial, and Phase 2 will include conducting an&#xD;
        8-session pilot randomized controlled trial to assess the feasibility and acceptability of&#xD;
        the proposed prenatal yoga intervention among women with a history of depression, as well as&#xD;
        the onset and course of PPD and mediating factors. The specific aims are to: 1) Optimize&#xD;
        delivery of a yoga intervention within a healthcare system to prevent PPD through examining&#xD;
        facilitators and barriers of implementation, 2) Examine feasibility, acceptability and&#xD;
        satisfaction of the intervention within a health care system, and 3) Evaluate preliminary&#xD;
        effectiveness of the intervention on PPD and proposed mechanisms. For Phase 1, separate focus&#xD;
        groups with patient stakeholders and clinician and administrative stakeholders will inform&#xD;
        intervention implementation, and an open trial to refine and optimize the intervention. For&#xD;
        Phase 2, women with a history of depression who are 8-28 weeks pregnant will be randomized to&#xD;
        the intervention group (n=24) or treatment-as-usual (n=24) and will complete survey measures&#xD;
        at baseline, post-intervention, and 1 and 3 months postpartum. It is hypothesized that the&#xD;
        intervention will be feasible and acceptable, engage women of racial/ethnic minority status,&#xD;
        and contribute to lower rates of PPD onset. Embodiment and mindfulness are the proposed&#xD;
        mediators. Knowledge gained from this study can support prevention efforts for PPD and&#xD;
        improve the adverse public health impact of this disorder.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Postpartum depression (PPD) affects approximately 13% of women, contributing to poorer&#xD;
        overall maternal psychological health, as well as adverse infant health, behavior, and&#xD;
        emotional development. Women with a history of depression are 21 times more likely to&#xD;
        experience PPD, which most commonly occurs within 4 weeks of delivery. Intervening in&#xD;
        pregnancy to prevent the onset of perinatal mental health disorders can ameliorate these&#xD;
        adverse outcomes and contribute to significant cost savings at $32,300/affected woman.&#xD;
        Despite evidence-based prenatal preventive mental health services for depression, there are&#xD;
        barriers to access, and these services do not offer the adjunctive benefits provided by&#xD;
        yoga-based interventions, including shorter labor duration and increased likelihood of&#xD;
        vaginal birth. Yoga interventions during pregnancy have been shown to significantly improve&#xD;
        depressive symptoms in pregnancy. Yet, previous work examining prenatal yoga was not&#xD;
        prevention-focused; prior studies of prenatal yoga for depression have only examined&#xD;
        treatment for women with current depression or did not evaluate PPD. Because nearly half of&#xD;
        women with a history of depression who develop PPD did not exhibit depressive symptoms in&#xD;
        pregnancy, it is important to include this high-risk group in preventive interventions.&#xD;
  &#xD;
        Yoga is more beneficial than other physical activity interventions for depression symptoms,&#xD;
        including fatigue and stress, and PPD interventions yield greater benefits with targeted&#xD;
        populations. Specifically, yoga may prevent PPD through embodiment-facilitated improvements&#xD;
        in body image and increasing mindfulness. Yet, there are several gaps in examining&#xD;
        effectiveness of yoga for preventing PPD: 1) although racial/ethnic minority women have&#xD;
        higher rates of PPD than White women, they are significantly less likely to initiate&#xD;
        treatment for PPD; yoga interventions may be more engaging; 2) generalizability of previous&#xD;
        studies of prenatal yoga for depression have also been limited by excluding women with&#xD;
        particular psychiatric disorders and/or excluding women already practicing yoga. Expanding&#xD;
        this evidence-based practice to women vulnerable to developing PPD (i.e., those with a&#xD;
        history of depression) within a health care system may be effective for engaging high-risk&#xD;
        women in a preventive intervention to decrease the risk of PPD. The proposed study focuses on&#xD;
        preventing PPD and improving generalizability by delivering a virtual prenatal yoga&#xD;
        intervention for at-risk, racially diverse women in a health care system.&#xD;
  &#xD;
        The proposed study seeks to pilot test the effectiveness of an adapted evidence-based,&#xD;
        virtually-delivered 8-session group prenatal yoga pilot preventive intervention for women at&#xD;
        high risk of PPD (i.e., history of depression) to assess onset and evaluate factors which&#xD;
        influence implementation within a health care system. The intervention incorporates&#xD;
        evidence-based integrated yoga with mindfulness and embodiment techniques (i.e., proposed&#xD;
        mechanisms). The investigators will also promote the inclusion of individuals of&#xD;
        racial/ethnic minority status in yoga interventions by assessing strategies for inclusion of&#xD;
        these individuals from patient stakeholders. Pregnant participants with a history of&#xD;
        depression will be recruited from Henry Ford Health (HFH), a metropolitan health system that&#xD;
        delivers prenatal care for diverse women (29% non-Hispanic Black). The inclusion of patient,&#xD;
        provider, and administrative stakeholders will inform recruitment, engagement, and delivery&#xD;
        of the intervention, facilitating scalability and sustainability by assessing barriers and&#xD;
        facilitators to implementation.&#xD;
  &#xD;
        The specific aims are to:&#xD;
  &#xD;
        1. Optimize a yoga intervention to prevent PPD within a healthcare system.&#xD;
  &#xD;
        1.a. Examine facilitators and barriers of implementation. Conduct 3 focus groups with patient&#xD;
        (n=6-10 pregnant women in each group with a history of depression) and a separate focus group&#xD;
        of administrative (n=6-10 HFH women's health clinicians and administrators) stakeholders to&#xD;
        assess logistics, engagement of racially/ethnically diverse women with a history of&#xD;
        depression, and sustainability of the intervention. Phenomenological analyses will be used to&#xD;
        analyze qualitative findings to increase patient-centeredness.&#xD;
  &#xD;
          1. b. Optimize delivery. An open trial of pregnant women (n=12) will aid in refining&#xD;
             intervention delivery.&#xD;
  &#xD;
          2. Examine feasibility, acceptability, and satisfaction of the intervention within a health&#xD;
             care system. Pregnant women (n=48) with a history of depression will be randomized to&#xD;
             the intervention (n=24) or treatment as usual (TAU; n=24). Feasibility will be assessed&#xD;
             by measuring enrollment, retention across follow-up time points, and engagement (e.g.,&#xD;
             attendance at yoga sessions) rates. A post-intervention survey will measure&#xD;
             acceptability and satisfaction. The investigators hypothesize that the intervention will&#xD;
             be effective for engaging racial/ethnic minorities and that there will be representative&#xD;
             enrollment rates of these groups.&#xD;
  &#xD;
          3. Evaluate effectiveness of the intervention on PPD and proposed mechanisms. Participants&#xD;
             will complete measures of depression, embodiment, and mindfulness at baseline,&#xD;
             post-intervention, and 1 and 3 months post-delivery. The investigators anticipate that&#xD;
             the intervention group will have lower rates of PPD (primary outcome) at each follow-up&#xD;
             time point, higher levels of mindfulness and embodiment (i.e., proposed mediators; a&#xD;
             path), and that these mediators will be associated with reduced likelihood of PPD (b&#xD;
             path).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 2024</start_date>
    <completion_date type="Anticipated">March 2026</completion_date>
    <primary_completion_date type="Anticipated">March 2026</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>PRY-D intervention vs treatment as usual (TAU)</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Edinburgh Postnatal Depression Scale</measure>
      <time_frame>1-month and 3-months postpartum</time_frame>
      <description>The Edinburgh Postnatal Depression Scale (EPDS) will be used to measure presence of postpartum depression (yes/no). EPDS scores range from 0 to 30; a score of 10 or above indicates the presence of current depression symptoms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Edinburgh Postnatal Depression Scale</measure>
      <time_frame>1-month and 3-months postpartum</time_frame>
      <description>The Edinburgh Postnatal Depression Scale (EPDS) will be used to measure severity of postpartum depression (continuous). EPDS scores range from 0 to 30.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Postpartum Depression</condition>
    <arm_group>
      <arm_group_label>PRY-D intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in the intervention group will complete 8 prenatal yoga sessions (1x/week) in a virtual group format. The first session will be in person, in which they will meet the instructor, connect with one another through brief introductions, receive their yoga practice materials, practice basic yoga poses, and be given the schedule for the remaining sessions, including virtual access links (e.g., Webex).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants in the the TAU group will receive routine prenatal care, during which time all patients are given information on the importance of physical activity during pregnancy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Prenatal Yoga to Prevent Postpartum Depression (PRY-D) intervention</intervention_name>
      <description>The PRY-D curriculum is a mindfulness-based prenatal yoga intervention which utilizes techniques to build both embodiment and mindfulness, and has previously been shown to reduce depression in a small sample of pregnant women with clinical depression.</description>
      <arm_group_label>PRY-D intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Treatment as Usual (TAU)</intervention_name>
      <description>TAU involves routine prenatal care, during which time all patients are given information on the importance of physical activity during pregnancy.</description>
      <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥ 18 years of age,&#xD;
  &#xD;
            -  pregnant between 8-28 weeks gestation&#xD;
  &#xD;
            -  receiving prenatal care at Henry Ford Health&#xD;
  &#xD;
            -  have a history of depression&#xD;
  &#xD;
            -  have an internet-enabled device with video capability for the purpose of viewing&#xD;
               virtual yoga classes&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  not being fluent in English since this will be required to engage in yoga classes&#xD;
  &#xD;
            -  physician guidance NOT to participate in exercise&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Amy M Loree, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Henry Ford Health</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sara Santarossa, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Henry Ford Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Amy M Loree, PhD</last_name>
      <phone>313-874-5452</phone>
      <email>aloree1@hfhs.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sara Santarossa, PhD</last_name>
      <phone>313-874-7960</phone>
      <email>ssantar1@hfhs.org</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Postpartum</keyword>
    <keyword>Depression</keyword>
    <keyword>Prenatal</keyword>
    <keyword>Pregnant</keyword>
    <keyword>Yoga</keyword>
    <keyword>Mindfulness</keyword>
    <keyword>Embodiment</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression, Postpartum</mesh_term>
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Quantitative data from this study will be transferred to a de-identified dataset that will be available for noncommercial research use by outside investigators via a data-sharing agreement and under the auspices of the investigators. The study team will be available for support. Information related to errors in the data, future releases, and publication lists will also be shared with users.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data will become available within 1 year after the main trial paper is published, and will be available for a period of 5 years.</ipd_time_frame>
      <ipd_access_criteria>The data sharing agreement will include (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; (3) a commitment to destroying or returning the data after analyses are completed; and (4) a brief written plan for how the data will be used. Furthermore, users must agree to the conditions of use governing access to the data, including reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.</ipd_access_criteria>
    </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/NCT06004232
  org study id: R34MH131573
  secondary id: R34MH131573
  nct id: NCT06004232
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Although psychological interventions exist for the prevention of PPD, a yoga-based
        intervention to prevent PPD among at-risk women utilizes a similar theoretical foundation
        (i.e., mindfulness), may be more acceptable to women of minority status, and may confer
        additional physical activity benefits. The purpose of this pilot study is to determine the
        effectiveness of using a virtually delivered prenatal yoga intervention for the prevention of
        PPD among at-risk women in a diverse health care system and explore preliminary factors which
        influence implementation of the intervention. This study has 2 phases: Phase 1 will evaluate
        facilitators and barriers to intervention implementation among patient, clinician, and health
        system stakeholders, followed by an open trial, and Phase 2 will include conducting an
        8-session pilot randomized controlled trial to assess the feasibility and acceptability of
        the proposed prenatal yoga intervention among women with a history of depression, as well as
        the onset and course of PPD and mediating factors. The specific aims are to: 1) Optimize
        delivery of a yoga intervention within a healthcare system to prevent PPD through examining
        facilitators and barriers of implementation, 2) Examine feasibility, acceptability and
        satisfaction of the intervention within a health care system, and 3) Evaluate preliminary
        effectiveness of the intervention on PPD and proposed mechanisms. For Phase 1, separate focus
        groups with patient stakeholders and clinician and administrative stakeholders will inform
        intervention implementation, and an open trial to refine and optimize the intervention. For
        Phase 2, women with a history of depression who are 8-28 weeks pregnant will be randomized to
        the intervention group (n=24) or treatment-as-usual (n=24) and will complete survey measures
        at baseline, post-intervention, and 1 and 3 months postpartum. It is hypothesized that the
        intervention will be feasible and acceptable, engage women of racial/ethnic minority status,
        and contribute to lower rates of PPD onset. Embodiment and mindfulness are the proposed
        mediators. Knowledge gained from this study can support prevention efforts for PPD and
        improve the adverse public health impact of this disorder.
  Postpartum depression (PPD) affects approximately 13% of women, contributing to poorer
        overall maternal psychological health, as well as adverse infant health, behavior, and
        emotional development. Women with a history of depression are 21 times more likely to
        experience PPD, which most commonly occurs within 4 weeks of delivery. Intervening in
        pregnancy to prevent the onset of perinatal mental health disorders can ameliorate these
        adverse outcomes and contribute to significant cost savings at $32,300/affected woman.
        Despite evidence-based prenatal preventive mental health services for depression, there are
        barriers to access, and these services do not offer the adjunctive benefits provided by
        yoga-based interventions, including shorter labor duration and increased likelihood of
        vaginal birth. Yoga interventions during pregnancy have been shown to significantly improve
        depressive symptoms in pregnancy. Yet, previous work examining prenatal yoga was not
        prevention-focused; prior studies of prenatal yoga for depression have only examined
        treatment for women with current depression or did not evaluate PPD. Because nearly half of
        women with a history of depression who develop PPD did not exhibit depressive symptoms in
        pregnancy, it is important to include this high-risk group in preventive interventions.
  
        Yoga is more beneficial than other physical activity interventions for depression symptoms,
        including fatigue and stress, and PPD interventions yield greater benefits with targeted
        populations. Specifically, yoga may prevent PPD through embodiment-facilitated improvements
        in body image and increasing mindfulness. Yet, there are several gaps in examining
        effectiveness of yoga for preventing PPD: 1) although racial/ethnic minority women have
        higher rates of PPD than White women, they are significantly less likely to initiate
        treatment for PPD; yoga interventions may be more engaging; 2) generalizability of previous
        studies of prenatal yoga for depression have also been limited by excluding women with
        particular psychiatric disorders and/or excluding women already practicing yoga. Expanding
        this evidence-based practice to women vulnerable to developing PPD (i.e., those with a
        history of depression) within a health care system may be effective for engaging high-risk
        women in a preventive intervention to decrease the risk of PPD. The proposed study focuses on
        preventing PPD and improving generalizability by delivering a virtual prenatal yoga
        intervention for at-risk, racially diverse women in a health care system.
  
        The proposed study seeks to pilot test the effectiveness of an adapted evidence-based,
        virtually-delivered 8-session group prenatal yoga pilot preventive intervention for women at
        high risk of PPD (i.e., history of depression) to assess onset and evaluate factors which
        influence implementation within a health care system. The intervention incorporates
        evidence-based integrated yoga with mindfulness and embodiment techniques (i.e., proposed
        mechanisms). The investigators will also promote the inclusion of individuals of
        racial/ethnic minority status in yoga interventions by assessing strategies for inclusion of
        these individuals from patient stakeholders. Pregnant participants with a history of
        depression will be recruited from Henry Ford Health (HFH), a metropolitan health system that
        delivers prenatal care for diverse women (29% non-Hispanic Black). The inclusion of patient,
        provider, and administrative stakeholders will inform recruitment, engagement, and delivery
        of the intervention, facilitating scalability and sustainability by assessing barriers and
        facilitators to implementation.
  
        The specific aims are to:
  
        1. Optimize a yoga intervention to prevent PPD within a healthcare system.
  
        1.a. Examine facilitators and barriers of implementation. Conduct 3 focus groups with patient
        (n=6-10 pregnant women in each group with a history of depression) and a separate focus group
        of administrative (n=6-10 HFH women's health clinicians and administrators) stakeholders to
        assess logistics, engagement of racially/ethnically diverse women with a history of
        depression, and sustainability of the intervention. Phenomenological analyses will be used to
        analyze qualitative findings to increase patient-centeredness.
  
          1. b. Optimize delivery. An open trial of pregnant women (n=12) will aid in refining
             intervention delivery.
  
          2. Examine feasibility, acceptability, and satisfaction of the intervention within a health
             care system. Pregnant women (n=48) with a history of depression will be randomized to
             the intervention (n=24) or treatment as usual (TAU; n=24). Feasibility will be assessed
             by measuring enrollment, retention across follow-up time points, and engagement (e.g.,
             attendance at yoga sessions) rates. A post-intervention survey will measure
             acceptability and satisfaction. The investigators hypothesize that the intervention will
             be effective for engaging racial/ethnic minorities and that there will be representative
             enrollment rates of these groups.
  
          3. Evaluate effectiveness of the intervention on PPD and proposed mechanisms. Participants
             will complete measures of depression, embodiment, and mindfulness at baseline,
             post-intervention, and 1 and 3 months post-delivery. The investigators anticipate that
             the intervention group will have lower rates of PPD (primary outcome) at each follow-up
             time point, higher levels of mindfulness and embodiment (i.e., proposed mediators; a
             path), and that these mediators will be associated with reduced likelihood of PPD (b
             path).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: PRY-D intervention vs treatment as usual (TAU)
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Edinburgh Postnatal Depression Scale
  time frame: 1-month and 3-months postpartum
  description: The Edinburgh Postnatal Depression Scale (EPDS) will be used to measure presence of postpartum depression (yes/no). EPDS scores range from 0 to 30; a score of 10 or above indicates the presence of current depression symptoms.
  measure: Edinburgh Postnatal Depression Scale
  time frame: 1-month and 3-months postpartum
  description: The Edinburgh Postnatal Depression Scale (EPDS) will be used to measure severity of postpartum depression (continuous). EPDS scores range from 0 to 30.
  arm group label: PRY-D intervention
  arm group type: Experimental
  description: Participants in the intervention group will complete 8 prenatal yoga sessions (1x/week) in a virtual group format. The first session will be in person, in which they will meet the instructor, connect with one another through brief introductions, receive their yoga practice materials, practice basic yoga poses, and be given the schedule for the remaining sessions, including virtual access links (e.g., Webex).
  arm group label: Treatment as Usual (TAU)
  arm group type: Active Comparator
  description: Participants in the the TAU group will receive routine prenatal care, during which time all patients are given information on the importance of physical activity during pregnancy.
  intervention type: Behavioral
  intervention name: Prenatal Yoga to Prevent Postpartum Depression (PRY-D) intervention
  description: The PRY-D curriculum is a mindfulness-based prenatal yoga intervention which utilizes techniques to build both embodiment and mindfulness, and has previously been shown to reduce depression in a small sample of pregnant women with clinical depression.
  arm group label: PRY-D intervention
  intervention type: Behavioral
  intervention name: Treatment as Usual (TAU)
  description: TAU involves routine prenatal care, during which time all patients are given information on the importance of physical activity during pregnancy.
  arm group label: Treatment as Usual (TAU)
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Amy M Loree, PhD
  role: Principal Investigator
  affiliation: Henry Ford Health
  last name: Sara Santarossa, PhD
  role: Principal Investigator
  affiliation: Henry Ford Health
  last name: Amy M Loree, PhD
  phone: 313-874-5452
  email: aloree1@hfhs.org
  last name: Sara Santarossa, PhD
  phone: 313-874-7960
  email: ssantar1@hfhs.org
  responsible party type: Sponsor
  mesh term: Depression, Postpartum
  mesh term: Depression
  mesh term: Depressive Disorder
  sharing ipd: Yes
  ipd description: Quantitative data from this study will be transferred to a de-identified dataset that will be available for noncommercial research use by outside investigators via a data-sharing agreement and under the auspices of the investigators. The study team will be available for support. Information related to errors in the data, future releases, and publication lists will also be shared with users.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Analytic Code
  ipd time frame: Data will become available within 1 year after the main trial paper is published, and will be available for a period of 5 years.
  ipd access criteria: The data sharing agreement will include (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; (3) a commitment to destroying or returning the data after analyses are completed; and (4) a brief written plan for how the data will be used. Furthermore, users must agree to the conditions of use governing access to the data, including reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.