Efficacy of Yoga for Postpartum Depression

Depression, Postpartum Clinical Trial

Official title:

Efficacy of Yoga for Depressed Postpartum Women: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213601
• Other study ID #: 201105725
• Status: Completed
• Phase: N/A
• First received: August 7, 2014
• Last updated: August 7, 2014
• Start date: June 2011

Study information

• Verified date: August 2014
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder

Intervention

Behavioral:
• Yoga

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

Da Costa D, Dritsa M, Rippen N, Lowensteyn I, Khalifé S. Health-related quality of life in postpartum depressed women. Arch Womens Ment Health. 2006 Mar;9(2):95-102. Epub 2005 Oct 18. — View 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. Epub 2004 Jun 15. — View 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. Review. — View 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. Review. — View 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. — View 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. — View Citation

Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from baseline in panic symptoms on the Inventory of Depression and Anxiety Symptoms Panic Scale (IDAS) at week 8	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.	Baseline, Week 8	No
Secondary	Change from baseline in social anxiety symptoms on the Inventory of Depression and Anxiety Symptoms Social Anxiety Scale (IDAS) at week 8	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.	Baseline, Week 8	No
Secondary	Change from baseline in traumatic intrusion symptoms on the Inventory of Depression and Anxiety Symptoms Traumatic Intrusions Scale (IDAS) at week 8	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.	Baseline, Week 8	No
Secondary	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	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.	Baseline, Week 8	No