Mindful Yoga for Postpartum Depression

NCT ID: NCT06275217

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-08
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Mindful yoga group

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.

Group Type: EXPERIMENTAL

Mindfulness-based yoga program

Intervention Type: 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 group

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

Group Type: ACTIVE_COMPARATOR

Psychoeducation

Intervention Type: 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.

Interventions

Mindfulness-based yoga program

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.

Intervention Type: BEHAVIORAL

Psychoeducation

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

LIN Jingxia Jessie

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessie Lin, PhD

Role: STUDY_CHAIR

Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

Locations

The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Jessie Lin, PhD

Role: CONTACT

jx-jessie.lin@polyu.edu.hk

+852 2766 6718

Facility Contacts

Jessie JX Lin, PhD

Role: primary

jx-jessie.lin@polyu.edu.hk

Other Identifiers

HMRF17182481

Identifier Type: -

Identifier Source: org_study_id