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Completed

NCT Number: NCT02213601

Efficacy of Yoga for Postpartum Depression

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.

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Key information

Conditions

Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga

Behavioral

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
First posted
Aug 11, 2014
Registry last updated
Aug 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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