<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/NCT02972112</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-16-GA-0155-CTIL</org_study_id>
    <nct_id>NCT02972112</nct_id>
  </id_info>
  <brief_title>Ultrashort Cognitive Behavioral Intervention for Tokophobia- A Prospective Randomized Single Blinded Controlled Trial</brief_title>
  <official_title>Ultrashort Cognitive Behavioral Intervention for Tokophobia- A Prospective Randomized Single Blinded Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <brief_summary>
    <textblock>
      Women in their 3rd trimester, represent a unique segment of the tokophobic population. In&#xD;
      these cases help is needed within a very short and limited period of time. To date, no&#xD;
      specific treatment targets this population in order to ameliorate the anxiety and to provide&#xD;
      these women and their newborns with better obstetric and psychiatric outcomes. The present&#xD;
      study investigates an accessible individual two session intervention conducted by midwives&#xD;
      skilled in CBT (cognitive behavioral therapy) . This intervention is designed to enable&#xD;
      stronger emotional regulation and increase of their capacity to accept unexpected changes&#xD;
      during labor and feelings of control. The investigators expect this psychological adjustment&#xD;
      to lead to a better course of delivery, less interventions including caesarian sections, and&#xD;
      subjective birth experience.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2019</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>Diagnostic</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pregnancy-Related Anxiety Questionnaire</measure>
    <time_frame>In the end of second session of intervention- up to 4 weeks from screening</time_frame>
    <description>a widely used instrument to assess and identify pregnancy-specific anxiety in women</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Specific Phobia</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>will receive 2 sessions of 90 minutes each of a cognitive behavioral protocol for the treatment of Tokophobia administered by a CBT trained midwife.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>will receive 2 sessions of a delivery preparation course (practice as usual).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT</intervention_name>
    <description>novel cognitive behavioral protocol for the treatment of tokophobia</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham</intervention_name>
    <description>standard birth preparation sessions.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Hebrew speaking pregnant women week 32 + 0 to 37 + 0&#xD;
&#xD;
          2. fulfilling the criteria for a specific phobia diagnosed by SCID (Structured Clinical&#xD;
             Interview for the Diagnostic) in accordance with DSM-V (Diagnostic and Statistical&#xD;
             Manual) and the Fear of Vaginal Delivery Questionnaire (FDQ).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Women who suffer from a psychotic disorder, PTSD or suicidal ideation&#xD;
&#xD;
          2. High risk pregnancies&#xD;
&#xD;
          3. Alcoholism or drug abuse and dependence.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Gabi Aisenberg Romano, PhD</last_name>
    <phone>052-4262816</phone>
    <email>gabiar@tlvmc.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02972112
org study id: TASMC-16-GA-0155-CTIL
nct id: NCT02972112
lead sponsor: 
Women in their 3rd trimester, represent a unique segment of the tokophobic population. In
      these cases help is needed within a very short and limited period of time. To date, no
      specific treatment targets this population in order to ameliorate the anxiety and to provide
      these women and their newborns with better obstetric and psychiatric outcomes. The present
      study investigates an accessible individual two session intervention conducted by midwives
      skilled in CBT (cognitive behavioral therapy) . This intervention is designed to enable
      stronger emotional regulation and increase of their capacity to accept unexpected changes
      during labor and feelings of control. The investigators expect this psychological adjustment
      to lead to a better course of delivery, less interventions including caesarian sections, and
      subjective birth experience.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Pregnancy-Related Anxiety Questionnaire
time frame: In the end of second session of intervention- up to 4 weeks from screening
description: a widely used instrument to assess and identify pregnancy-specific anxiety in women
arm group label: Study group
arm group type: Active Comparator
description: will receive 2 sessions of 90 minutes each of a cognitive behavioral protocol for the treatment of Tokophobia administered by a CBT trained midwife.
arm group label: Control group
arm group type: Sham Comparator
description: will receive 2 sessions of a delivery preparation course (practice as usual).
intervention type: Behavioral
intervention name: CBT
description: novel cognitive behavioral protocol for the treatment of tokophobia
arm group label: Study group
intervention type: Other
intervention name: Sham
description: standard birth preparation sessions.
arm group label: Control group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Gabi Aisenberg Romano, PhD
phone: 052-4262816
email: gabiar@tlvmc.gov.il
facility: 
country: Israel
responsible party type: Sponsor