<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/NCT01732055</url>
  </required_header>
  <id_info>
    <org_study_id>12-0235</org_study_id>
    <nct_id>NCT01732055</nct_id>
  </id_info>
  <brief_title>Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression</brief_title>
  <official_title>Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Foundation of Hope for Research and Treatment of Mental Illness</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: To compare a novel psychotherapy, Partner-Assisted Interpersonal Psychotherapy&#xD;
      (PA-IPT), with treatment as usual (TAU) in a sample of pregnant women seeking treatment for&#xD;
      Major Depressive Disorder (MDD) at the University of North Carolina at Chapel Hill (UNC-CH)&#xD;
      Perinatal Psychiatry Program.&#xD;
&#xD;
      Participants: 52 women, ages 18-45, who are 16-29 weeks pregnant and experiencing a&#xD;
      depressive episode, and their partners.&#xD;
&#xD;
      Methods: Women and their identified partners will complete a diagnostic interview, complete&#xD;
      measures of depressive symptom severity at baseline, and be randomized to treatment with&#xD;
      PA-IPT or TAU. Women randomized to TAU will be treated by UNC physicians according to the&#xD;
      UNC-CH Perinatal Psychiatry Program's algorithm for treatment of prenatal MDD (usually one of&#xD;
      a number of antidepressant medications, tailored to the individual, although some women may&#xD;
      opt against medication altogether and still be eligible to enroll). Women randomized to&#xD;
      PA-IPT will participate in 8 therapy sessions with their identified partner over a 12-week&#xD;
      period, along with one refresher session at or around 6 weeks postpartum. Women and partners&#xD;
      will be assessed for change in depressive symptoms and relationship satisfaction during&#xD;
      pregnancy at visits 4 and 8, and postpartum at 6-week and 6-month visits.&#xD;
&#xD;
      Hypothesis: The investigators anticipate notable improvement in both groups similar in&#xD;
      magnitude, however it is hypothesized that couples participating in PA-IPT will have higher&#xD;
      relationship satisfaction post-treatment (controlling for baseline satisfaction) than those&#xD;
      receiving TAU.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study ended because recruitment goals unmet and further funding unlikely&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hamilton Rating Scale for Depression-17 item version (HRSD-17)</measure>
    <time_frame>Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum)</time_frame>
    <description>Change from baseline in symptoms of Major Depressive Disorder</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dyadic Adjustment Scale (DAS)</measure>
    <time_frame>Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum)</time_frame>
    <description>Change from baseline in relationship satisfaction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Partner Assisted Interpersonal Psychotherapy</condition>
  <condition>Treatment as Usual</condition>
  <arm_group>
    <arm_group_label>Partner-Assisted Interpersonal Psychotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Partner-Assisted Interpersonal Psychotherapy is an 8-week series of psychotherapy sessions attended by the patient and her identified partner.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment prescribed for subjects by the UNC Perinatal Psychiatry clinic physicians according to the clinic algorithm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Partner-Assisted Interpersonal Psychotherapy</intervention_name>
    <arm_group_label>Partner-Assisted Interpersonal Psychotherapy</arm_group_label>
    <other_name>PA-IPT</other_name>
    <other_name>PAT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as Usual</intervention_name>
    <description>Because treatment(s) are prescribed for subjects by the UNC Perinatal Psychiatry physicians, it is impossible for the investigators to list each potential medication and dosage that might be prescribed to women randomized to this condition. The medication regimens are individual, and some women may opt against medication altogether (and still be eligible to enroll). Women who refuse antidepressant medication will attend visits at the same intervals as those in the study arms for evaluation of safety and symptoms.</description>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <other_name>TAU</other_name>
    <other_name>Watchful Waiting</other_name>
    <other_name>Antidepressant Medication</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females aged 18-45 years&#xD;
&#xD;
          -  16-29 weeks estimated gestational age&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  English or Spanish language literacy&#xD;
&#xD;
          -  In a committed relationship cohabiting for at least 6 months with a Dyadic Adjustment&#xD;
             Scale rating &lt; 90 or with an identified family member or friend residing in the same&#xD;
             home&#xD;
&#xD;
          -  Meet criteria for Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition&#xD;
             Text Revision (DSM-IV) diagnosis of Major Depressive Disorder (MDD)&#xD;
&#xD;
          -  HRSD-17 score is equal or greater than 16 at diagnostic evaluation and randomization&#xD;
&#xD;
          -  Medically healthy and without fetal anomaly according to history&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No identified primary care, nurse midwife, or obstetrical physician to monitor&#xD;
             pregnancy; participant or physician refuses to sign release of information&#xD;
&#xD;
          -  By patient report, history of partner verbal, emotional, or physical abuse&#xD;
&#xD;
          -  Partner unable or unwilling to participate&#xD;
&#xD;
          -  DSM-IV diagnoses of bipolar 1 or 2 or any psychotic episode&#xD;
&#xD;
          -  Substance abuse within the last 6 months&#xD;
&#xD;
          -  Eating Disorder&#xD;
&#xD;
          -  Current use of other therapies for depression including individual psychotherapy,&#xD;
             herbal remedies or other complementary/alternative therapies, antidepressant&#xD;
             medication outside the study protocol&#xD;
&#xD;
          -  Active suicidal ideation&#xD;
&#xD;
          -  Identified partner has DSM-IV diagnoses of bipolar 1 or 2 or any psychotic episode&#xD;
&#xD;
          -  Interpersonal violence or abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna R. Brandon, PhD, MSCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Samantha Meltzer-Brody, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina Hospitals and Clinics</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-7160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Brandon AR, Ceccotti N, Hynan LS, Shivakumar G, Johnson N, Jarrett RB. Proof of concept: Partner-Assisted Interpersonal Psychotherapy for perinatal depression. Arch Womens Ment Health. 2012 Dec;15(6):469-80. doi: 10.1007/s00737-012-0311-1. Epub 2012 Oct 4.</citation>
    <PMID>23053218</PMID>
  </reference>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>January 13, 2014</last_update_submitted>
  <last_update_submitted_qc>January 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Antenatal</keyword>
  <keyword>Major Depressive Disorder</keyword>
  <keyword>Psychotherapy</keyword>
  <keyword>Antidepressant Medication</keyword>
  <keyword>Partners</keyword>
  <keyword>Spouses</keyword>
  <keyword>Interpersonal Psychotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antidepressive Agents</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01732055
org study id: 12-0235
nct id: NCT01732055
lead sponsor: 
collaborator: 
has dmc: No
Purpose: To compare a novel psychotherapy, Partner-Assisted Interpersonal Psychotherapy
      (PA-IPT), with treatment as usual (TAU) in a sample of pregnant women seeking treatment for
      Major Depressive Disorder (MDD) at the University of North Carolina at Chapel Hill (UNC-CH)
      Perinatal Psychiatry Program.

      Participants: 52 women, ages 18-45, who are 16-29 weeks pregnant and experiencing a
      depressive episode, and their partners.

      Methods: Women and their identified partners will complete a diagnostic interview, complete
      measures of depressive symptom severity at baseline, and be randomized to treatment with
      PA-IPT or TAU. Women randomized to TAU will be treated by UNC physicians according to the
      UNC-CH Perinatal Psychiatry Program's algorithm for treatment of prenatal MDD (usually one of
      a number of antidepressant medications, tailored to the individual, although some women may
      opt against medication altogether and still be eligible to enroll). Women randomized to
      PA-IPT will participate in 8 therapy sessions with their identified partner over a 12-week
      period, along with one refresher session at or around 6 weeks postpartum. Women and partners
      will be assessed for change in depressive symptoms and relationship satisfaction during
      pregnancy at visits 4 and 8, and postpartum at 6-week and 6-month visits.

      Hypothesis: The investigators anticipate notable improvement in both groups similar in
      magnitude, however it is hypothesized that couples participating in PA-IPT will have higher
      relationship satisfaction post-treatment (controlling for baseline satisfaction) than those
      receiving TAU.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Hamilton Rating Scale for Depression-17 item version (HRSD-17)
time frame: Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum)
description: Change from baseline in symptoms of Major Depressive Disorder
measure: Dyadic Adjustment Scale (DAS)
time frame: Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum)
description: Change from baseline in relationship satisfaction
arm group label: Partner-Assisted Interpersonal Psychotherapy
arm group type: Active Comparator
description: Partner-Assisted Interpersonal Psychotherapy is an 8-week series of psychotherapy sessions attended by the patient and her identified partner.
arm group label: Treatment as Usual
arm group type: Other
description: Treatment prescribed for subjects by the UNC Perinatal Psychiatry clinic physicians according to the clinic algorithm.
intervention type: Behavioral
intervention name: Partner-Assisted Interpersonal Psychotherapy
arm group label: Partner-Assisted Interpersonal Psychotherapy
other name: PA-IPT
other name: PAT
intervention type: Other
intervention name: Treatment as Usual
description: Because treatment(s) are prescribed for subjects by the UNC Perinatal Psychiatry physicians, it is impossible for the investigators to list each potential medication and dosage that might be prescribed to women randomized to this condition. The medication regimens are individual, and some women may opt against medication altogether (and still be eligible to enroll). Women who refuse antidepressant medication will attend visits at the same intervals as those in the study arms for evaluation of safety and symptoms.
arm group label: Treatment as Usual
other name: TAU
other name: Watchful Waiting
other name: Antidepressant Medication
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anna R. Brandon, PhD, MSCS
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
last name: Samantha Meltzer-Brody, MD, MPH
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
citation: Brandon AR, Ceccotti N, Hynan LS, Shivakumar G, Johnson N, Jarrett RB. Proof of concept: Partner-Assisted Interpersonal Psychotherapy for perinatal depression. Arch Womens Ment Health. 2012 Dec;15(6):469-80. doi: 10.1007/s00737-012-0311-1. Epub 2012 Oct 4.
PMID: 23053218
responsible party type: Sponsor
mesh term: Depression
mesh term: Antidepressive Agents