<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/NCT02213601</url>
  </required_header>
  <id_info>
    <org_study_id>201105725</org_study_id>
    <nct_id>NCT02213601</nct_id>
  </id_info>
  <brief_title>Efficacy of Yoga for Postpartum Depression</brief_title>
  <official_title>Efficacy of Yoga for Depressed Postpartum Women: A Randomized Controlled Trial</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this project is to compare the efficacy of an 8-week yoga intervention, relative&#xD;
      to a wait-list control (WLC) condition, for improving psychological functioning and&#xD;
      health-related quality of life in depressed postpartum women. It was hypothesized that the&#xD;
      yoga intervention would be significantly more efficacious than the wait-list control&#xD;
      condition in reducing symptoms of depression and anxiety, and improving health-related&#xD;
      quality of life, at the end of the 8-week yoga intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <primary_completion_date type="Actual">October 2012</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in depression on the 17-item Hamilton Depression Rating Scale (HDRS) at week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>The Hamilton Depression Rating Scale (HDRS) is a validated and reliable measure of the severity of depressive symptoms, and is used extensively in depression treatment studies. The 17-item HDRS is sensitive to treatment change in the postpartum population, and is a valid indicator of depression severity in postpartum depression despite the overlap between somatic HDRS items and typical experiences of postpartum women.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in panic symptoms on the Inventory of Depression and Anxiety Symptoms Panic Scale (IDAS) at week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item factor analytically derived, multidimensional inventory that uses a 5-point Likert scale to assess symptoms of depression and anxiety over the past 2 weeks (1 = not at all to 5 = extremely). The IDAS has strong internal consistency reliability, with median coefficient alphas greater than .80, and has been validated for use in a postpartum sample. The Panic scale is an 8-item measure that assesses symptoms traditionally linked to anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in social anxiety symptoms on the Inventory of Depression and Anxiety Symptoms Social Anxiety Scale (IDAS) at week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item factor analytically derived, multidimensional inventory that uses a 5-point Likert scale to assess symptoms of depression and anxiety over the past 2 weeks (1 = not at all to 5 = extremely). The IDAS has strong internal consistency reliability, with median coefficient alphas greater than .80, and has been validated for use in a postpartum sample. The Social Anxiety scale is a 5-item measure that assesses symptoms traditionally linked to anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in traumatic intrusion symptoms on the Inventory of Depression and Anxiety Symptoms Traumatic Intrusions Scale (IDAS) at week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item factor analytically derived, multidimensional inventory that uses a 5-point Likert scale to assess symptoms of depression and anxiety over the past 2 weeks (1 = not at all to 5 = extremely). The IDAS has strong internal consistency reliability, with median coefficient alphas greater than .80, and has been validated for use in a postpartum sample. The Traumatic Intrusions scale is a 4-item measure that assesses symptoms traditionally linked to anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in health-related quality of life symptoms on the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) at week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) is a well-validated measure of Health-related Quality of Life and consists of 36 items reflecting 8 domains of health: 1) role-limiting physical, 2) role-limiting emotional, 3) physical functioning, 4) social functioning, 5) mental health, 6) energy and vitality, 7) pain, and 8) general health perceptions.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Depression, Postpartum</condition>
  <arm_group>
    <arm_group_label>Yoga</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8-week Gentle Vinyasa Flow yoga intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga</intervention_name>
    <arm_group_label>Yoga</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Score of 12 or greater on the 17-item Hamilton Depressing Rating Scale&#xD;
&#xD;
          -  Participant must reside within a 30 mile radius of the yoga studios&#xD;
&#xD;
          -  ≥ 6 weeks postpartum if delivery was either complicated and/or involved a cesarean&#xD;
             section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or past diagnosis of bipolar disorder, schizophrenia or other psychotic&#xD;
             disorder, alcohol or drug abuse/dependence (except nicotine), or anorexia in the past&#xD;
             year&#xD;
&#xD;
          -  Acute suicidal or homicidal risk&#xD;
&#xD;
          -  Current mental health treatment, including psychotropic medications or psychotherapy&#xD;
             with a certified therapist&#xD;
&#xD;
          -  St. John's Wort or Fish oil&#xD;
&#xD;
          -  Practiced yoga at a studio with a certified yoga instructor within the past month&#xD;
&#xD;
          -  Significant medical disorder (e.g., seizure disorder) that is contraindicated for&#xD;
             exercise in postpartum women&#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>Melissa M Buttner, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael W O'Hara, Ph.D.</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>
  <reference>
    <citation>Cooper PJ, Murray L, Wilson A, Romaniuk H. Controlled trial of the short- and long-term effect of psychological treatment of post-partum depression. I. Impact on maternal mood. Br J Psychiatry. 2003 May;182:412-9.</citation>
    <PMID>12724244</PMID>
  </reference>
  <reference>
    <citation>Da Costa D, Dritsa M, Rippen N, Lowensteyn I, Khalife S. Health-related quality of life in postpartum depressed women. Arch Womens Ment Health. 2006 Mar;9(2):95-102. doi: 10.1007/s00737-005-0108-6. Epub 2005 Oct 18.</citation>
    <PMID>16231095</PMID>
  </reference>
  <reference>
    <citation>Dennis CL. Influence of depressive symptomatology on maternal health service utilization and general health. Arch Womens Ment Health. 2004 Jul;7(3):183-91. doi: 10.1007/s00737-004-0053-9. Epub 2004 Jun 15.</citation>
    <PMID>15241664</PMID>
  </reference>
  <reference>
    <citation>Freeman MP. Complementary and alternative medicine for perinatal depression. J Affect Disord. 2009 Jan;112(1-3):1-10. doi: 10.1016/j.jad.2008.06.017. Epub 2008 Aug 8.</citation>
    <PMID>18692251</PMID>
  </reference>
  <reference>
    <citation>Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db.</citation>
    <PMID>16260528</PMID>
  </reference>
  <reference>
    <citation>Goodman JH. Women's attitudes, preferences, and perceived barriers to treatment for perinatal depression. Birth. 2009 Mar;36(1):60-9. doi: 10.1111/j.1523-536X.2008.00296.x.</citation>
    <PMID>19278385</PMID>
  </reference>
  <reference>
    <citation>O'Hara MW, Stuart S, Gorman LL, Wenzel A. Efficacy of interpersonal psychotherapy for postpartum depression. Arch Gen Psychiatry. 2000 Nov;57(11):1039-45. doi: 10.1001/archpsyc.57.11.1039.</citation>
    <PMID>11074869</PMID>
  </reference>
  <reference>
    <citation>Uebelacker LA, Epstein-Lubow G, Gaudiano BA, Tremont G, Battle CL, Miller IW. Hatha yoga for depression: critical review of the evidence for efficacy, plausible mechanisms of action, and directions for future research. J Psychiatr Pract. 2010 Jan;16(1):22-33. doi: 10.1097/01.pra.0000367775.88388.96.</citation>
    <PMID>20098228</PMID>
  </reference>
  <reference>
    <citation>Uebelacker LA, Tremont G, Epstein-Lubow G, Gaudiano BA, Gillette T, Kalibatseva Z, Miller IW. Open trial of Vinyasa yoga for persistently depressed individuals: evidence of feasibility and acceptability. Behav Modif. 2010 May;34(3):247-64. doi: 10.1177/0145445510368845. Epub 2010 Apr 16.</citation>
    <PMID>20400694</PMID>
  </reference>
  <reference>
    <citation>Wu P, Fuller C, Liu X, Lee HC, Fan B, Hoven CW, Mandell D, Wade C, Kronenberg F. Use of complementary and alternative medicine among women with depression: results of a national survey. Psychiatr Serv. 2007 Mar;58(3):349-56. doi: 10.1176/ps.2007.58.3.349.</citation>
    <PMID>17325108</PMID>
  </reference>
  <reference>
    <citation>Kinser PA, Bourguignon C, Whaley D, Hauenstein E, Taylor AG. Feasibility, acceptability, and effects of gentle Hatha yoga for women with major depression: findings from a randomized controlled mixed-methods study. Arch Psychiatr Nurs. 2013 Jun;27(3):137-47. doi: 10.1016/j.apnu.2013.01.003. Epub 2013 Apr 9.</citation>
    <PMID>23706890</PMID>
  </reference>
  <reference>
    <citation>Wisner KL, Perel JM, Peindl KS, Hanusa BH, Piontek CM, Findling RL. Prevention of postpartum depression: a pilot randomized clinical trial. Am J Psychiatry. 2004 Jul;161(7):1290-2. doi: 10.1176/appi.ajp.161.7.1290.</citation>
    <PMID>15229064</PMID>
  </reference>
  <reference>
    <citation>Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; Consolidated Standards of Reporting Trials Group. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010 Aug;63(8):e1-37. doi: 10.1016/j.jclinepi.2010.03.004. Epub 2010 Mar 25. Erratum In: J Clin Epidemiol. 2012 Mar;65(3):351.</citation>
    <PMID>20346624</PMID>
  </reference>
  <reference>
    <citation>Ross LE, Gilbert Evans SE, Sellers EM, Romach MK. Measurement issues in postpartum depression part 1: anxiety as a feature of postpartum depression. Arch Womens Ment Health. 2003 Feb;6(1):51-7. doi: 10.1007/s00737-002-0155-1.</citation>
    <PMID>12715264</PMID>
  </reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>August 7, 2014</last_update_submitted>
  <last_update_submitted_qc>August 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Yoga</keyword>
  <keyword>Complementary and Alternative Medicine Interventions</keyword>
  <keyword>Treatment</keyword>
  <keyword>Postpartum Depression</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>
  <!-- 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/NCT02213601
org study id: 201105725
nct id: NCT02213601
lead sponsor: 
has dmc: No
The aim of this project is to compare the efficacy of an 8-week yoga intervention, relative
      to a wait-list control (WLC) condition, for improving psychological functioning and
      health-related quality of life in depressed postpartum women. It was hypothesized that the
      yoga intervention would be significantly more efficacious than the wait-list control
      condition in reducing symptoms of depression and anxiety, and improving health-related
      quality of life, at the end of the 8-week yoga intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline in depression on the 17-item Hamilton Depression Rating Scale (HDRS) at week 8
time frame: Baseline, Week 8
description: The Hamilton Depression Rating Scale (HDRS) is a validated and reliable measure of the severity of depressive symptoms, and is used extensively in depression treatment studies. The 17-item HDRS is sensitive to treatment change in the postpartum population, and is a valid indicator of depression severity in postpartum depression despite the overlap between somatic HDRS items and typical experiences of postpartum women.
measure: Change from baseline in panic symptoms on the Inventory of Depression and Anxiety Symptoms Panic Scale (IDAS) at week 8
time frame: Baseline, Week 8
description: The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item factor analytically derived, multidimensional inventory that uses a 5-point Likert scale to assess symptoms of depression and anxiety over the past 2 weeks (1 = not at all to 5 = extremely). The IDAS has strong internal consistency reliability, with median coefficient alphas greater than .80, and has been validated for use in a postpartum sample. The Panic scale is an 8-item measure that assesses symptoms traditionally linked to anxiety.
measure: Change from baseline in social anxiety symptoms on the Inventory of Depression and Anxiety Symptoms Social Anxiety Scale (IDAS) at week 8
time frame: Baseline, Week 8
description: The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item factor analytically derived, multidimensional inventory that uses a 5-point Likert scale to assess symptoms of depression and anxiety over the past 2 weeks (1 = not at all to 5 = extremely). The IDAS has strong internal consistency reliability, with median coefficient alphas greater than .80, and has been validated for use in a postpartum sample. The Social Anxiety scale is a 5-item measure that assesses symptoms traditionally linked to anxiety.
measure: Change from baseline in traumatic intrusion symptoms on the Inventory of Depression and Anxiety Symptoms Traumatic Intrusions Scale (IDAS) at week 8
time frame: Baseline, Week 8
description: The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item factor analytically derived, multidimensional inventory that uses a 5-point Likert scale to assess symptoms of depression and anxiety over the past 2 weeks (1 = not at all to 5 = extremely). The IDAS has strong internal consistency reliability, with median coefficient alphas greater than .80, and has been validated for use in a postpartum sample. The Traumatic Intrusions scale is a 4-item measure that assesses symptoms traditionally linked to anxiety.
measure: Change from baseline in health-related quality of life symptoms on the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) at week 8
time frame: Baseline, Week 8
description: The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) is a well-validated measure of Health-related Quality of Life and consists of 36 items reflecting 8 domains of health: 1) role-limiting physical, 2) role-limiting emotional, 3) physical functioning, 4) social functioning, 5) mental health, 6) energy and vitality, 7) pain, and 8) general health perceptions.
arm group label: Yoga
arm group type: Experimental
description: 8-week Gentle Vinyasa Flow yoga intervention
arm group label: Wait-list Control Group
arm group type: No Intervention
intervention type: Behavioral
intervention name: Yoga
arm group label: Yoga
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Melissa M Buttner, Ph.D.
role: Principal Investigator
affiliation: University of Iowa
last name: Michael W O'Hara, Ph.D.
role: Principal Investigator
affiliation: University of Iowa
facility: 
country: United States
citation: Cooper PJ, Murray L, Wilson A, Romaniuk H. Controlled trial of the short- and long-term effect of psychological treatment of post-partum depression. I. Impact on maternal mood. Br J Psychiatry. 2003 May;182:412-9.
PMID: 12724244
citation: Da Costa D, Dritsa M, Rippen N, Lowensteyn I, Khalife S. Health-related quality of life in postpartum depressed women. Arch Womens Ment Health. 2006 Mar;9(2):95-102. doi: 10.1007/s00737-005-0108-6. Epub 2005 Oct 18.
PMID: 16231095
citation: Dennis CL. Influence of depressive symptomatology on maternal health service utilization and general health. Arch Womens Ment Health. 2004 Jul;7(3):183-91. doi: 10.1007/s00737-004-0053-9. Epub 2004 Jun 15.
PMID: 15241664
citation: Freeman MP. Complementary and alternative medicine for perinatal depression. J Affect Disord. 2009 Jan;112(1-3):1-10. doi: 10.1016/j.jad.2008.06.017. Epub 2008 Aug 8.
PMID: 18692251
citation: Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db.
PMID: 16260528
citation: Goodman JH. Women's attitudes, preferences, and perceived barriers to treatment for perinatal depression. Birth. 2009 Mar;36(1):60-9. doi: 10.1111/j.1523-536X.2008.00296.x.
PMID: 19278385
citation: O'Hara MW, Stuart S, Gorman LL, Wenzel A. Efficacy of interpersonal psychotherapy for postpartum depression. Arch Gen Psychiatry. 2000 Nov;57(11):1039-45. doi: 10.1001/archpsyc.57.11.1039.
PMID: 11074869
citation: Uebelacker LA, Epstein-Lubow G, Gaudiano BA, Tremont G, Battle CL, Miller IW. Hatha yoga for depression: critical review of the evidence for efficacy, plausible mechanisms of action, and directions for future research. J Psychiatr Pract. 2010 Jan;16(1):22-33. doi: 10.1097/01.pra.0000367775.88388.96.
PMID: 20098228
citation: Uebelacker LA, Tremont G, Epstein-Lubow G, Gaudiano BA, Gillette T, Kalibatseva Z, Miller IW. Open trial of Vinyasa yoga for persistently depressed individuals: evidence of feasibility and acceptability. Behav Modif. 2010 May;34(3):247-64. doi: 10.1177/0145445510368845. Epub 2010 Apr 16.
PMID: 20400694
citation: Wu P, Fuller C, Liu X, Lee HC, Fan B, Hoven CW, Mandell D, Wade C, Kronenberg F. Use of complementary and alternative medicine among women with depression: results of a national survey. Psychiatr Serv. 2007 Mar;58(3):349-56. doi: 10.1176/ps.2007.58.3.349.
PMID: 17325108
citation: Kinser PA, Bourguignon C, Whaley D, Hauenstein E, Taylor AG. Feasibility, acceptability, and effects of gentle Hatha yoga for women with major depression: findings from a randomized controlled mixed-methods study. Arch Psychiatr Nurs. 2013 Jun;27(3):137-47. doi: 10.1016/j.apnu.2013.01.003. Epub 2013 Apr 9.
PMID: 23706890
citation: Wisner KL, Perel JM, Peindl KS, Hanusa BH, Piontek CM, Findling RL. Prevention of postpartum depression: a pilot randomized clinical trial. Am J Psychiatry. 2004 Jul;161(7):1290-2. doi: 10.1176/appi.ajp.161.7.1290.
PMID: 15229064
citation: Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; Consolidated Standards of Reporting Trials Group. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010 Aug;63(8):e1-37. doi: 10.1016/j.jclinepi.2010.03.004. Epub 2010 Mar 25. Erratum In: J Clin Epidemiol. 2012 Mar;65(3):351.
PMID: 20346624
citation: Ross LE, Gilbert Evans SE, Sellers EM, Romach MK. Measurement issues in postpartum depression part 1: anxiety as a feature of postpartum depression. Arch Womens Ment Health. 2003 Feb;6(1):51-7. doi: 10.1007/s00737-002-0155-1.
PMID: 12715264
responsible party type: Sponsor
mesh term: Depression, Postpartum
mesh term: Depression
mesh term: Depressive Disorder