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NCT Number: NCT06275217

Mindful Yoga for Postpartum Depression

This is a parallel-group randomized controlled trial. A total of 198 postpartum women with depressive symptoms (EPDS scores≥8 at baseline) will be recruited and randomized into two groups: 10-week mindful yoga intervention and 10-week psychoeducation program. Clinical assessment of depression, self-report questionnaires and salivary cortisol tests will be performed at baseline, after 10-week intervention, and at 6-month and 12-month follow-ups. The investigators expected that the mindful yoga intervention will reduce depression after 10 weeks compared to psychoeducation. The mindful yoga intervention will further reduce anxiety, stress, improve quality of life and sleep, and steepen diurnal cortisol slopes. These effects will be maintained for at least six months.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

Location status: Recruiting

Location contact

Jessie JX Lin, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Postpartum women aged 18-60 years old.
  • The scores of EPDS ≥ 10.
  • At least 6 week and up to 1 year after childbirth.
  • Giving birth to a single full-term healthy baby (gestation between 37-41 weeks, body weight > 2.5kg, APGAR score at 5 minutes > 7).
  • Fewer than 10 hours of yoga/Qi gong/Tai Chi or mindfulness/meditation practice in the previous 3 months.

Exclusion criteria

  • Severe complications after delivery, or their infants are admitted to NICU.
  • Regular psychiatric follow-up.
  • Currently taking antipsychotic drugs.
  • Known pragnancy, or other contraindications to physical exercise (e.g., wound healing situation) according to the body examination by O&G clinicians at 6 weeks after delivery.

Treatment and study plan

Mindfulness-based yoga program

Behavioral

The intervention includes mindfulness-based components and yoga practice. Once a week for 10 weeks, with 1.5 hours in each session (30 minutes mindfulness-based practice and 1 hour yoga practice). A well-trained research personnel will facilitate the mindfulness-based section, and a qualified yoga instructor will facilitate the yoga section.

Psychoeducation

Other

Knowledge of perinatal mental health, stress-related management, postnatal nutrition, exercise habit and sleep hygiene will be provided to the participants in the psychoeducation group. It is a group-based intervention delivered in hybrid mode including face-to-face and online group-based class. Once a week for 10 weeks, with 1.5 hour in each session.

Primary outcomes

  1. Edinburgh Postnatal Depression Scale

    Time frame: Baseline, 10 weeks, 6 months and 1 year follow-ups.

    Measures postnatal depression. Each item scores 0-3, and the total score ranges from 0 to 30. Higher score means worse depressive symptoms.

Secondary outcomes

  1. Depression Anxiety Stress Scale-Depression

    Time frame: Baseline, 10 weeks, 6 months and 1 year follow-ups.

    Measures depressive symptoms. Each item scores 0-3, the total score for depression ranges from 0 to 21. Higher score means worse symptoms of depression.

  2. Depression Anxiety Stress Scale-Anxiety

    Time frame: Baseline, 10 weeks, 6 months and 1 year follow-ups.

    Measures anxiety symptoms. Each item scores 0-3, the total score for anxiety ranges from 0 to 21. Higher score means worse symptoms of anxiety.

  3. Depression Anxiety Stress Scale-Stress

    Time frame: Baseline, 10 weeks, 6 months and 1 year follow-ups.

    Measures stress symptoms. Each item scores 0-3, the total score for stress ranges from 0 to 21. Higher score means worse symptoms of stress.

  4. Pittsburgh Sleep Quality Index

    Time frame: Baseline, 10 weeks, 6 months and 1 year follow-ups.

    Measures sleep quality. There are 8 components scores, and each component score ranges from 0 to 3. Higher score means worse sleep quality.

  5. 36 Item-Short Form Health Survey Questionnaire

    Time frame: Baseline, 10 weeks, 6 months and 1 year follow-ups.

    Measures quality of life including physical and mental health. Each item scores 0-100. There are eight subscores ranging from 0 to 100. Higher score means better quality of life.

  6. Five Facet Mindfulness Questionnaire

    Time frame: Baseline, 10 weeks, 6 months and 1 year follow-ups.

    Measures the level of mindfulness ability. Each item scores 1-5, and the total score ranges from 42 to 210. Higher score means better mindfulness ability.

  7. Pregnancy Symptom Inventory

    Time frame: Baseline, 10 weeks, 6 months and 1 year follow-ups.

    Measures physical pain and fatigue of postpartum women. Each item scores 0-3. The total score ranges from 0 to 24. Higher score means worse pregnancy symptoms.

  8. Cortisol concentration level

    Time frame: Baseline and 10 weeks (post-intervention).

    Measures salivary cortisol concentration at baseline and post-intervention. Higher concentration means higher level of stress and depression.

  9. Physical fitness

    Time frame: Baseline and 10 weeks (post-intervention).

    6-minute walking test is used for physical fitness measure. The total distance walked during 6 minutes is recorded. Higher score means better fitness.

  10. Balance

    Time frame: Baseline and 10 weeks (post-intervention).

    Single-leg standing test is used to measure the balance. The time to keep the posture is recorded. Higher score means better balance ability.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessie Lin, PhD

CONTACT

[email protected]

+852 2766 6718

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

The Effects of a Mindful Yoga Program on Mood Symptoms and Stress for Postpartum Women With Depressive Symptoms: a Randomized Controlled Clinical Trial

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2024
Registry last updated
Mar 18, 2025

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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