<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/NCT03276208</url>
  </required_header>
  <id_info>
    <org_study_id>2000021692</org_study_id>
    <nct_id>NCT03276208</nct_id>
  </id_info>
  <brief_title>Pregnancy, Mindfulness, and Massage</brief_title>
  <official_title>Pregnancy Massage and Mindfulness Study for Tobacco Smoking Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Massage Therapy Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</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>
      This trial will examine the contribution of massage therapy and mindfulness to&#xD;
      tobacco-smoking women in the third trimester of pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Massage therapy may be a viable approach to decrease stress during pregnancy that may in turn&#xD;
      reduce tobacco consumption. Massage therapy may not be sufficient as a stand-alone approach,&#xD;
      and may be better suited partnered with a cessation approach that targets another mechanism&#xD;
      of addiction, craving. Therefore, participants (N=60) will be enrolled in the Craving to&#xD;
      Quit® tobacco cessation program, designed by researchers at Yale, which employs a&#xD;
      mindfulness-based approach to train participants to recognize and bring cravings into their&#xD;
      conscious awareness. Each mother will be randomly assigned to a bi-weekly massage&#xD;
      intervention (n=30) or control (n=30) group. Participants in the intervention group will&#xD;
      receive two prenatal massages a week for a three-week period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Terminated due to lack of enrollment.&#xD;
  </why_stopped>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Actual">January 24, 2020</completion_date>
  <primary_completion_date type="Actual">January 24, 2020</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>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>During initial telephone screening participants will be randomized to either intervention or control group</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Tobacco Use Change from Baseline to Post-Intervention</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Number of cigarettes smoked in past 24 hours</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Withdrawal Symptoms Change from Baseline to Post-Intervention</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Mood and Physical Symptoms Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nicotine Dependence Change from Baseline to Post-Intervention</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>FTND (Fagerstrom Test for Nicotine Dependence) measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression Change from Baseline to Post-Intervention</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>EPDS (Edinburgh Postnatal Depression Scale) measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety Change from Baseline to Post-Intervention</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Beck Anxiety Inventory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stress Change from Baseline to Post-Intervention</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Perceived Stress Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Daily Stress Scores Change from Baseline to Post-Intervention</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Diary Measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Daily Tobacco Usage Change from Baseline to Post-Intervention</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Diary Measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate Variability Change from Baseline to Post-Intervention</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Maternal heart rate variability measured at rest</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neonatal Outcomes</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>mode of delivery (including any complications), infant well-being, gestational age, and weight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal Heart Rate Change from Baseline to Post-Intervention</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Fetal heart rate measured at rest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Engagement with Craving to Quit</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Engagement with the Craving to Quit app</description>
  </secondary_outcome>
  <other_outcome>
    <measure>CO (carbon monoxide) monitoring Change from Baseline to Post-Intervention</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>breath test</description>
  </other_outcome>
  <other_outcome>
    <measure>MINI (Mini International Neuropsychiatric Interview) Substance Dependence</measure>
    <time_frame>Enrollment</time_frame>
    <description>determine other substance use disorders</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-Reported Mood at each Massage Therapy Session for Intervention Group</measure>
    <time_frame>Up to 3 weeks</time_frame>
    <description>positive and negative mood, including stress</description>
  </other_outcome>
  <other_outcome>
    <measure>Mind-mindedness related to infant</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>Describe your child measure; this will be a narrative statement provided by participants where they are asked to describe their child. These narratives will be scored to ascertain the total number of mind-minded comments included in the narrative.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Tobacco Use</condition>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>Massage Therapy and Mindfulness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the intervention group will receive two prenatal massages a week for a three-week period. They will also be enrolled in the mindfulness-based Craving to Quit® tobacco cessation program during this 3-week period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mindfulness</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will enroll in the mindfulness-based Craving to Quit® tobacco cessation program during the same 3-week period. A massage will be provided upon completion of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prenatal Massage</intervention_name>
    <description>We will utilize moderate pressure Swedish massage (SM) that utilizes long slow strokes known as effleurage and kneading strokes known as petrissage. A specific routine will be performed on each participant with focus on low back, upper back, shoulders, and neck musculature. Consistent moderate pressure, which is lighter than deep tissue massage but deeper than brush strokes, will be used.</description>
    <arm_group_label>Massage Therapy and Mindfulness</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mindfulness</intervention_name>
    <description>The intervention and control group will be enrolled in the Craving to Quit® program, a 21-day mindfulness-based program delivered via a smartphone application (https://www.cravingtoquit.com/). This program uses a mindfulness-based approach to train people to recognize and be aware of their tobacco cravings. The program includes videos, online exercises to complete, and a virtual support community.</description>
    <arm_group_label>Massage Therapy and Mindfulness</arm_group_label>
    <arm_group_label>Mindfulness</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  currently pregnant in third trimester&#xD;
&#xD;
          -  singleton pregnancy&#xD;
&#xD;
          -  aged 18 years or older&#xD;
&#xD;
          -  women smoked before their pregnancy&#xD;
&#xD;
          -  women who currently smoke at least 5 cigarettes per day at enrollment&#xD;
&#xD;
          -  women need access to a smartphone&#xD;
&#xD;
          -  women expressing an interest in learning skills to help decrease tobacco-smoking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  incapable of giving informed consent&#xD;
&#xD;
          -  insufficient English fluency&#xD;
&#xD;
          -  participating in other smoking cessation programs&#xD;
&#xD;
          -  evidencing severe psychiatric symptoms&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Based on biological sex as study of pregnancy</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helena Rutherford, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Paidas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale Child Study Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>January 27, 2020</last_update_submitted>
  <last_update_submitted_qc>January 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Tobacco</keyword>
  <keyword>Massage Therapy</keyword>
  <keyword>Mindfulness</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03276208
org study id: 2000021692
nct id: NCT03276208
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial will examine the contribution of massage therapy and mindfulness to
      tobacco-smoking women in the third trimester of pregnancy.
Massage therapy may be a viable approach to decrease stress during pregnancy that may in turn
      reduce tobacco consumption. Massage therapy may not be sufficient as a stand-alone approach,
      and may be better suited partnered with a cessation approach that targets another mechanism
      of addiction, craving. Therefore, participants (N=60) will be enrolled in the Craving to
      Quit® tobacco cessation program, designed by researchers at Yale, which employs a
      mindfulness-based approach to train participants to recognize and bring cravings into their
      conscious awareness. Each mother will be randomly assigned to a bi-weekly massage
      intervention (n=30) or control (n=30) group. Participants in the intervention group will
      receive two prenatal massages a week for a three-week period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
masking description: During initial telephone screening participants will be randomized to either intervention or control group
measure: Tobacco Use Change from Baseline to Post-Intervention
time frame: Up to 4 weeks
description: Number of cigarettes smoked in past 24 hours
measure: Withdrawal Symptoms Change from Baseline to Post-Intervention
time frame: Up to 4 weeks
description: Mood and Physical Symptoms Scale
measure: Nicotine Dependence Change from Baseline to Post-Intervention
time frame: Up to 4 weeks
description: FTND (Fagerstrom Test for Nicotine Dependence) measure
measure: Depression Change from Baseline to Post-Intervention
time frame: Up to 4 weeks
description: EPDS (Edinburgh Postnatal Depression Scale) measure
measure: Anxiety Change from Baseline to Post-Intervention
time frame: Up to 4 weeks
description: Beck Anxiety Inventory
measure: Stress Change from Baseline to Post-Intervention
time frame: Up to 4 weeks
description: Perceived Stress Scale
measure: Daily Stress Scores Change from Baseline to Post-Intervention
time frame: Up to 4 weeks
description: Diary Measure
measure: Daily Tobacco Usage Change from Baseline to Post-Intervention
time frame: Up to 4 weeks
description: Diary Measure
measure: Heart Rate Variability Change from Baseline to Post-Intervention
time frame: Up to 4 weeks
description: Maternal heart rate variability measured at rest
measure: Neonatal Outcomes
time frame: Up to 2 months
description: mode of delivery (including any complications), infant well-being, gestational age, and weight.
measure: Fetal Heart Rate Change from Baseline to Post-Intervention
time frame: Up to 4 weeks
description: Fetal heart rate measured at rest
measure: Engagement with Craving to Quit
time frame: Up to 4 weeks
description: Engagement with the Craving to Quit app
measure: CO (carbon monoxide) monitoring Change from Baseline to Post-Intervention
time frame: Up to 4 weeks
description: breath test
measure: MINI (Mini International Neuropsychiatric Interview) Substance Dependence
time frame: Enrollment
description: determine other substance use disorders
measure: Self-Reported Mood at each Massage Therapy Session for Intervention Group
time frame: Up to 3 weeks
description: positive and negative mood, including stress
measure: Mind-mindedness related to infant
time frame: Up to 2 months
description: Describe your child measure; this will be a narrative statement provided by participants where they are asked to describe their child. These narratives will be scored to ascertain the total number of mind-minded comments included in the narrative.
arm group label: Massage Therapy and Mindfulness
arm group type: Experimental
description: Participants in the intervention group will receive two prenatal massages a week for a three-week period. They will also be enrolled in the mindfulness-based Craving to Quit® tobacco cessation program during this 3-week period.
arm group label: Mindfulness
arm group type: Active Comparator
description: Participants will enroll in the mindfulness-based Craving to Quit® tobacco cessation program during the same 3-week period. A massage will be provided upon completion of the study.
intervention type: Other
intervention name: Prenatal Massage
description: We will utilize moderate pressure Swedish massage (SM) that utilizes long slow strokes known as effleurage and kneading strokes known as petrissage. A specific routine will be performed on each participant with focus on low back, upper back, shoulders, and neck musculature. Consistent moderate pressure, which is lighter than deep tissue massage but deeper than brush strokes, will be used.
arm group label: Massage Therapy and Mindfulness
intervention type: Other
intervention name: Mindfulness
description: The intervention and control group will be enrolled in the Craving to Quit® program, a 21-day mindfulness-based program delivered via a smartphone application (https://www.cravingtoquit.com/). This program uses a mindfulness-based approach to train people to recognize and be aware of their tobacco cravings. The program includes videos, online exercises to complete, and a virtual support community.
arm group label: Massage Therapy and Mindfulness
arm group label: Mindfulness
criteria: 
gender: Female
gender based: Yes
gender description: Based on biological sex as study of pregnancy
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Helena Rutherford, PhD
role: Principal Investigator
affiliation: Yale University
last name: Michael Paidas, MD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No