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Trial record 26 of 36 for:    complementary and alternative medicine AND Survey

Efficacy of Yoga for Postpartum Depression

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ClinicalTrials.gov Identifier: NCT02213601
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
University of Iowa

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.

Condition or disease Intervention/treatment Phase
Depression, Postpartum Behavioral: Yoga Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Yoga for Depressed Postpartum Women: A Randomized Controlled Trial
Study Start Date : June 2011
Actual Primary Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Yoga
8-week Gentle Vinyasa Flow yoga intervention
Behavioral: Yoga
No Intervention: Wait-list Control Group



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213601


Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Melissa M Buttner, Ph.D. University of Iowa
Principal Investigator: Michael W O'Hara, Ph.D. University of Iowa

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT02213601     History of Changes
Other Study ID Numbers: 201105725
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: August 11, 2014
Last Verified: August 2014

Keywords provided by University of Iowa:
Yoga
Complementary and Alternative Medicine Interventions
Treatment
Postpartum Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications