Mindful Yoga for Postpartum Depression

NCT06275217 | Recruiting

• 1 other identifier: HMRF17182481
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Mood Disorders

Keywords

Yoga; Mindfulness-based; Postpartum depression; mood symptoms

Outcome Measures

Primary Outcomes (1)

• Edinburgh Postnatal Depression Scale

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

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

Secondary Outcomes (10)

• 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.

Study Arms (2)

Mindful yoga group

EXPERIMENTAL

The participants in experimental group will receive a 10-week mindfulness-based yoga program, one session per week with 1.5 hours in each session.

Behavioral: Mindfulness-based yoga program

Psychoeducation group

ACTIVE COMPARATOR

The participants in the psychoeducation group will receive a 10-week psychoeducation program, one session per week with 1.5 hours in each session.

Other: Psychoeducation

Interventions

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.

Mindful yoga group

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.

Psychoeducation group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Postpartum women with depression.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Mood Disorders; Depression, Postpartum

Condition Hierarchy (Ancestors)

Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder

Study Officials

• Jessie Lin, PhD

  Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

  STUDY CHAIR

Central Study Contacts

Jessie Lin, PhD

CONTACT

+852 2766 6718; jx-jessie.lin@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 23, 2024
• Study Start: January 8, 2021
• Primary Completion: July 15, 2025
• Study Completion: December 31, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

HK (1)