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Clinical Trials/NCT06275217
NCT06275217
Recruiting
Not Applicable

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

The Hong Kong Polytechnic University1 site in 1 country198 target enrollmentJanuary 8, 2021
ConditionsMood Disorders

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mood Disorders
Sponsor
The Hong Kong Polytechnic University
Enrollment
198
Locations
1
Primary Endpoint
Edinburgh Postnatal Depression Scale
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 8, 2021
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

LIN Jingxia Jessie

Assistant Professor

The Hong Kong Polytechnic University

Eligibility Criteria

Inclusion Criteria

  • Postpartum women aged 18-60 years old.
  • The scores of EPDS ≥
  • 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.

Outcomes

Primary Outcomes

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

  • Depression Anxiety Stress Scale-Depression(Baseline, 10 weeks, 6 months and 1 year follow-ups.)
  • Depression Anxiety Stress Scale-Anxiety(Baseline, 10 weeks, 6 months and 1 year follow-ups.)
  • Depression Anxiety Stress Scale-Stress(Baseline, 10 weeks, 6 months and 1 year follow-ups.)
  • Pittsburgh Sleep Quality Index(Baseline, 10 weeks, 6 months and 1 year follow-ups.)
  • 36 Item-Short Form Health Survey Questionnaire(Baseline, 10 weeks, 6 months and 1 year follow-ups.)
  • Pregnancy Symptom Inventory(Baseline, 10 weeks, 6 months and 1 year follow-ups.)
  • Cortisol concentration level(Baseline and 10 weeks (post-intervention).)
  • Balance(Baseline and 10 weeks (post-intervention).)
  • Five Facet Mindfulness Questionnaire(Baseline, 10 weeks, 6 months and 1 year follow-ups.)
  • Physical fitness(Baseline and 10 weeks (post-intervention).)

Study Sites (1)

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