Depression, PostpartumNCT02213601

Efficacy of Yoga for Postpartum Depression

A study testing Yoga in people with Depression, Postpartum, run by University of Iowa at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Depression, Postpartum
What is being tested?: Yoga
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 1 siteUnited States
Study dates: Jun 2011to Oct 2012
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Iowa
Iowa City, Iowa, 52242

Other trials in United States

About this study

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

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.

Conditions: Depression, Postpartum
Being tested: Yoga
Keywords: Yoga, Complementary and Alternative Medicine Interventions, Treatment, Postpartum Depression
Medical subject headings: Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

YogaBehavioural

Study groups in NCT02213601
Study group	Role	What they receive
Yoga	Experimental	8-week Gentle Vinyasa Flow yoga intervention Receives: Behavioral: Yoga
Wait-list Control Group	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Oct 2012

First posted11 Aug 2014 (estimated)
Study startJun 2011
Primary completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Depression, PostpartumStudies of the same condition, open and under way.
More trials run by University of IowaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02213601
Sponsor's protocol ID: 201105725
Status last verified: Aug 2014
First submitted: 7 Aug 2014
Last updated: 11 Aug 2014
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 12724244
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.
PubMed 16231095
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.
PubMed 15241664
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.
PubMed 18692251
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.
PubMed 16260528
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.
PubMed 19278385
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.
PubMed 11074869
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.
PubMed 20098228
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.
PubMed 20400694
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.
PubMed 17325108
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.
PubMed 23706890
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.
PubMed 15229064
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.
PubMed 20346624
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.
PubMed 12715264
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.
PubMed 25886805

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depression, Postpartum trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Yoga for Depressed Postpartum Women: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02213601
Acronym / sponsor ID: 201105725
Conditions: Depression, Postpartum
Keywords: Yoga, Complementary and Alternative Medicine Interventions, Treatment, Postpartum Depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: University of IowaUniversity, hospital or other
Study start: Jun 2011
Primary completion: Oct 2012 (actual)
First posted: 11 Aug 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Yoga	Experimental	Behavioral: Yoga8-week Gentle Vinyasa Flow yoga intervention
Wait-list Control Group	No intervention	–

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Yoga	Behavioural	Yoga

Primary outcome

Change from baseline in depression on the 17-item Hamilton Depression Rating Scale (HDRS) at week 8
Time frame: Baseline, 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.

4 secondary outcomes

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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
Background: PubMed 12724244Cooper 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.
Background: PubMed 16231095Da 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.
Background: PubMed 15241664Dennis 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.
Background: PubMed 18692251Freeman 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.
Background: PubMed 16260528Gavin 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.
Background: PubMed 19278385Goodman 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.
Background: PubMed 11074869O'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.
Background: PubMed 20098228Uebelacker 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.
Background: PubMed 20400694Uebelacker 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.
Background: PubMed 17325108Wu 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.
Background: PubMed 23706890Kinser 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.
Background: PubMed 15229064Wisner 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Melissa M Buttner, Ph.D. principal investigator

University of Iowa

Michael W O'Hara, Ph.D. principal investigator

University of Iowa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Yoga in people with Depression, Postpartum, run by University of Iowa at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in depression on the 17-item Hamilton Depression Rating Scale (HDRS) at week 8 (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02213601, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2014.