<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/NCT03837392</url>
  </required_header>
  <id_info>
    <org_study_id>202002658</org_study_id>
    <nct_id>NCT03837392</nct_id>
  </id_info>
  <brief_title>Efficacy of Brief Acceptance and Commitment Therapy (ACT) for Perinatal Anxiety</brief_title>
  <official_title>A Pilot Study Examining the Efficacy of Brief Acceptance and Commitment Therapy (ACT) for Perinatal Anxiety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</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 protocol will test the hypothesis that Acceptance and Commitment Therapy (ACT) is&#xD;
      effective in reducing anxiety and depressive symptoms during the perinatal and postpartum&#xD;
      periods. Participants should expect their participation in the study to last 9-12 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study's major theme is &quot;to examine the efficacy of a brief Acceptance and Commitment&#xD;
      Therapy (ACT) intervention in treating perinatal anxiety symptoms, as compared to a&#xD;
      supportive control condition.&quot;&#xD;
&#xD;
      The perinatal and postpartum periods are known to be a vulnerable time for the development of&#xD;
      mental health symptomatology, with approximately 7% of women developing postpartum depression&#xD;
      in the first three months following childbirth. One known predictor of postpartum depression&#xD;
      is perinatal anxiety and distress. The impact of postpartum depression extends beyond the&#xD;
      mother, whose distress and daily functioning are affected, with adverse effects on infant&#xD;
      development and care. The need for interventions and preventive interventions has been widely&#xD;
      indicated for over two decades.&#xD;
&#xD;
      This protocol will describe two conditions, the effects of which will be contrasted to&#xD;
      determine the efficacy of ACT in treating anxiety and depressive symptoms among perinatal&#xD;
      women. The ACT condition will be compared to a supportive psychoeducation intervention. The&#xD;
      effects of the intervention will be determined in terms of self-report measures (anxiety and&#xD;
      depressive symptoms, flexibility, mindfulness, social satisfaction) and diagnostic interviews&#xD;
      (depression, anxiety). The impact of trauma history and psychodiagnostic history will be&#xD;
      examined as moderating factors and/or covariates in the examination of the intervention's&#xD;
      efficacy.&#xD;
&#xD;
      This protocol will test the hypothesis that ACT is effective in reducing anxiety and&#xD;
      depressive symptoms during the perinatal and postpartum periods. Second, the investigators&#xD;
      will examine the intergenerational impact of the intervention on the offspring via offspring&#xD;
      birth outcomes, as reported in the electronic medical record. Finally, the investigators will&#xD;
      explore mediators and moderators of the treatment outcomes. This work will advance the&#xD;
      understanding of the impact of brief interventions on perinatal well-being and improve the&#xD;
      ability to disseminate empirically supported interventions for pregnant mothers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">January 31, 2023</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Inventory of Mood and Anxiety Symptoms (IMAS-R) scores from Baseline</measure>
    <time_frame>Past 1 month</time_frame>
    <description>The IMAS-R provides continuous and diagnostic scores on mood, anxiety, and distress symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Five Facet Mindfulness Questionnaire</measure>
    <time_frame>up to 12 month</time_frame>
    <description>This assessment is a 39-item measure where the scale is from 1 (never or rarely true) to 5 (very often or always true). FFMQ measures five facets of mindfulness with respect to one's own experience: observing (8 items), describing (8 items), acting with (8 items), non-judging (8 items), and non-reacting (7 items).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Acceptance and Action Questionnaire (AAQ-2) from Baseline</measure>
    <time_frame>up to 12 month</time_frame>
    <description>AAQ-2 will be used to measure psychological inflexibility, avoidance behavior, and maladaptive coping. This is a 7 item measure with a scale of 1 (never true) to 7 (always true). Lower scores indicate lesser experiential avoidance.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Differences in Infant Birth Outcomes</measure>
    <time_frame>After delivery</time_frame>
    <description>Infant birth outcomes will be obtained from medical records</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Post Partum Depression</condition>
  <condition>Perinatal Depression</condition>
  <condition>Post Partum Anxiety</condition>
  <condition>Perinatal Anxiety</condition>
  <arm_group>
    <arm_group_label>Acceptance and Commitment Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acceptance and Commitment Therapy (ACT) - participants in this arm will take part in an online ACT + psychoeducation intervention. The intervention will provide psychoeducation surrounding perinatal anxiety and depression as well as on engaging social support and coping strategies. The ACT portion of the intervention will focus on developing psychological flexibility, which is defined as behaviorally pursuing one's values even in the presence of barriers (e.g., thoughts, emotions). Following the online intervention, the participants will be contacted for two phone coaching calls -- each lasting about 30-45 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supportive Psychoeducation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group - participants in this arm will take part in an online psychoeducation and support intervention. This intervention will focus on psychoeducation surrounding perinatal anxiety and depression, as well as on engaging social support and coping strategies. Following the online intervention, the participants will be contacted for two phone coaching calls -- each lasting about 30-45 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Baseline Assessment (18-26 weeks pregnant)</intervention_name>
    <description>At baseline, participants will complete several interviews and questionnaires online and via phone to determine psychological history, current functioning, history of trauma, coping styles, and demographic variables.</description>
    <arm_group_label>Acceptance and Commitment Therapy</arm_group_label>
    <arm_group_label>Supportive Psychoeducation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Online Intervention and Phone Coaching Interventions</intervention_name>
    <description>ACT is a cognitive-behavioral therapy that seeks to promote psychological flexibility. The active comparator is the Supportive Control. Two phone coaching sessions will occur 2- and 4-weeks post-intervention in both conditions.</description>
    <arm_group_label>Acceptance and Commitment Therapy</arm_group_label>
    <arm_group_label>Supportive Psychoeducation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum</intervention_name>
    <description>The follow-up assessments at 34-36 weeks pregnancy and 4-weeks postpartum will be completed via REDCap, an online secure survey platform in order to reduce participant burden.</description>
    <arm_group_label>Acceptance and Commitment Therapy</arm_group_label>
    <arm_group_label>Supportive Psychoeducation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Follow Up Assessments: 8 weeks postpartum</intervention_name>
    <description>The follow-up assessment at 8-weeks postpartum will be completed via phone.</description>
    <arm_group_label>Acceptance and Commitment Therapy</arm_group_label>
    <arm_group_label>Supportive Psychoeducation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult women (ages 18-45) who are between 18-26 weeks pregnant&#xD;
&#xD;
          2. Fluency in English&#xD;
&#xD;
          3. Ability to give informed consent and comply with study procedures (including phone and&#xD;
             internet access)&#xD;
&#xD;
          4. Elevated GAD-7 score (10+)&#xD;
&#xD;
          5. Women must be receiving prenatal care&#xD;
&#xD;
          6. Singleton pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prisoners&#xD;
&#xD;
          2. Inability to give informed consent and comply with study procedures&#xD;
&#xD;
          3. Past/current mania, past/current psychoses (assessed with Psychosis Screening&#xD;
             Questionnaire)&#xD;
&#xD;
          4. No therapy appointments in last 60 days (not currently in psychotherapy).&#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_official>
    <last_name>Emily B K Thomas, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Emily Thomas</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Mental Health</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>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <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/NCT03837392
org study id: 202002658
nct id: NCT03837392
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This protocol will test the hypothesis that Acceptance and Commitment Therapy (ACT) is
      effective in reducing anxiety and depressive symptoms during the perinatal and postpartum
      periods. Participants should expect their participation in the study to last 9-12 months.
The study's major theme is "to examine the efficacy of a brief Acceptance and Commitment
      Therapy (ACT) intervention in treating perinatal anxiety symptoms, as compared to a
      supportive control condition."

      The perinatal and postpartum periods are known to be a vulnerable time for the development of
      mental health symptomatology, with approximately 7% of women developing postpartum depression
      in the first three months following childbirth. One known predictor of postpartum depression
      is perinatal anxiety and distress. The impact of postpartum depression extends beyond the
      mother, whose distress and daily functioning are affected, with adverse effects on infant
      development and care. The need for interventions and preventive interventions has been widely
      indicated for over two decades.

      This protocol will describe two conditions, the effects of which will be contrasted to
      determine the efficacy of ACT in treating anxiety and depressive symptoms among perinatal
      women. The ACT condition will be compared to a supportive psychoeducation intervention. The
      effects of the intervention will be determined in terms of self-report measures (anxiety and
      depressive symptoms, flexibility, mindfulness, social satisfaction) and diagnostic interviews
      (depression, anxiety). The impact of trauma history and psychodiagnostic history will be
      examined as moderating factors and/or covariates in the examination of the intervention's
      efficacy.

      This protocol will test the hypothesis that ACT is effective in reducing anxiety and
      depressive symptoms during the perinatal and postpartum periods. Second, the investigators
      will examine the intergenerational impact of the intervention on the offspring via offspring
      birth outcomes, as reported in the electronic medical record. Finally, the investigators will
      explore mediators and moderators of the treatment outcomes. This work will advance the
      understanding of the impact of brief interventions on perinatal well-being and improve the
      ability to disseminate empirically supported interventions for pregnant mothers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in Inventory of Mood and Anxiety Symptoms (IMAS-R) scores from Baseline
time frame: Past 1 month
description: The IMAS-R provides continuous and diagnostic scores on mood, anxiety, and distress symptoms.
measure: Change in Five Facet Mindfulness Questionnaire
time frame: up to 12 month
description: This assessment is a 39-item measure where the scale is from 1 (never or rarely true) to 5 (very often or always true). FFMQ measures five facets of mindfulness with respect to one's own experience: observing (8 items), describing (8 items), acting with (8 items), non-judging (8 items), and non-reacting (7 items).
measure: Change in Acceptance and Action Questionnaire (AAQ-2) from Baseline
time frame: up to 12 month
description: AAQ-2 will be used to measure psychological inflexibility, avoidance behavior, and maladaptive coping. This is a 7 item measure with a scale of 1 (never true) to 7 (always true). Lower scores indicate lesser experiential avoidance.
measure: Differences in Infant Birth Outcomes
time frame: After delivery
description: Infant birth outcomes will be obtained from medical records
arm group label: Acceptance and Commitment Therapy
arm group type: Experimental
description: Acceptance and Commitment Therapy (ACT) - participants in this arm will take part in an online ACT + psychoeducation intervention. The intervention will provide psychoeducation surrounding perinatal anxiety and depression as well as on engaging social support and coping strategies. The ACT portion of the intervention will focus on developing psychological flexibility, which is defined as behaviorally pursuing one's values even in the presence of barriers (e.g., thoughts, emotions). Following the online intervention, the participants will be contacted for two phone coaching calls -- each lasting about 30-45 minutes.
arm group label: Supportive Psychoeducation
arm group type: Active Comparator
description: Control group - participants in this arm will take part in an online psychoeducation and support intervention. This intervention will focus on psychoeducation surrounding perinatal anxiety and depression, as well as on engaging social support and coping strategies. Following the online intervention, the participants will be contacted for two phone coaching calls -- each lasting about 30-45 minutes.
intervention type: Diagnostic Test
intervention name: Baseline Assessment (18-26 weeks pregnant)
description: At baseline, participants will complete several interviews and questionnaires online and via phone to determine psychological history, current functioning, history of trauma, coping styles, and demographic variables.
arm group label: Acceptance and Commitment Therapy
arm group label: Supportive Psychoeducation
intervention type: Behavioral
intervention name: Online Intervention and Phone Coaching Interventions
description: ACT is a cognitive-behavioral therapy that seeks to promote psychological flexibility. The active comparator is the Supportive Control. Two phone coaching sessions will occur 2- and 4-weeks post-intervention in both conditions.
arm group label: Acceptance and Commitment Therapy
arm group label: Supportive Psychoeducation
intervention type: Diagnostic Test
intervention name: Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum
description: The follow-up assessments at 34-36 weeks pregnancy and 4-weeks postpartum will be completed via REDCap, an online secure survey platform in order to reduce participant burden.
arm group label: Acceptance and Commitment Therapy
arm group label: Supportive Psychoeducation
intervention type: Diagnostic Test
intervention name: Follow Up Assessments: 8 weeks postpartum
description: The follow-up assessment at 8-weeks postpartum will be completed via phone.
arm group label: Acceptance and Commitment Therapy
arm group label: Supportive Psychoeducation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Emily B K Thomas, PhD
role: Principal Investigator
affiliation: University of Iowa
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Iowa
investigator full name: Emily Thomas
investigator title: Clinical Assistant Professor
mesh term: Depression, Postpartum
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Anxiety Disorders
sharing ipd: No