NCT02213601

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2014

Completed
Last Updated

August 11, 2014

Status Verified

August 1, 2014

Enrollment Period

1.3 years

First QC Date

August 7, 2014

Last Update Submit

August 7, 2014

Conditions

Depression, Postpartum

Keywords

YogaComplementary and Alternative Medicine InterventionsTreatmentPostpartum Depression

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in depression on the 17-item Hamilton Depression Rating Scale (HDRS) at week 8

    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.

    Baseline, Week 8

Secondary Outcomes (4)

  • Change from baseline in panic symptoms on the Inventory of Depression and Anxiety Symptoms Panic Scale (IDAS) at week 8

    Baseline, Week 8

  • Change from baseline in social anxiety symptoms on the Inventory of Depression and Anxiety Symptoms Social Anxiety Scale (IDAS) at week 8

    Baseline, Week 8

  • Change from baseline in traumatic intrusion symptoms on the Inventory of Depression and Anxiety Symptoms Traumatic Intrusions Scale (IDAS) at week 8

    Baseline, Week 8

  • 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

    Baseline, Week 8

Study Arms (2)

Yoga

EXPERIMENTAL

8-week Gentle Vinyasa Flow yoga intervention

Behavioral: Yoga

Wait-list Control Group

NO INTERVENTION

Interventions

YogaBEHAVIORAL
Yoga

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Score of 12 or greater on the 17-item Hamilton Depressing Rating Scale
  • Participant must reside within a 30 mile radius of the yoga studios
  • ≥ 6 weeks postpartum if delivery was either complicated and/or involved a cesarean section

You may not qualify if:

  • Current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, alcohol or drug abuse/dependence (except nicotine), or anorexia in the past year
  • Acute suicidal or homicidal risk
  • Current mental health treatment, including psychotropic medications or psychotherapy with a certified therapist
  • St. John's Wort or Fish oil
  • Practiced yoga at a studio with a certified yoga instructor within the past month
  • Significant medical disorder (e.g., seizure disorder) that is contraindicated for exercise in postpartum women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (15)

  • 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: 12724244BACKGROUND

  • 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: 16231095BACKGROUND

  • 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: 15241664BACKGROUND

  • 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: 18692251BACKGROUND

  • 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: 16260528BACKGROUND

  • 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: 19278385BACKGROUND

  • 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: 11074869BACKGROUND

  • 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: 20098228BACKGROUND

  • 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: 20400694BACKGROUND

  • 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: 17325108BACKGROUND

  • 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: 23706890BACKGROUND

  • 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: 15229064BACKGROUND

  • 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.

    PMID: 20346624BACKGROUND

  • 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: 12715264BACKGROUND

  • Buttner MM, Brock RL, O'Hara MW, Stuart S. Efficacy of yoga for depressed postpartum women: A randomized controlled trial. Complement Ther Clin Pract. 2015 May;21(2):94-100. doi: 10.1016/j.ctcp.2015.03.003. Epub 2015 Apr 1.

    PMID: 25886805DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Yoga

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Melissa M Buttner, Ph.D.

    University of Iowa

    PRINCIPAL INVESTIGATOR

  • Michael W O'Hara, Ph.D.

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2014

First Posted

August 11, 2014

Study Start

June 1, 2011

Primary Completion

October 1, 2012

Last Updated

August 11, 2014

Record last verified: 2014-08

Locations

US(1)