Mindful Yoga for Postpartum Depression

Mood Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06275217
• Other study ID #: HMRF17182481
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: The Hong Kong Polytechnic University
• Contact: Jessie Lin, PhD
• Phone: +852 2766 6718
• Email: jx-jessie.lin[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: December 31, 2025
• Est. primary completion date: July 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mood Disorders

Intervention

Behavioral:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Depression Anxiety Stress Scale-Depression	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.	Baseline, 10 weeks, 6 months and 1 year follow-ups.
Secondary	Depression Anxiety Stress Scale-Anxiety	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.	Baseline, 10 weeks, 6 months and 1 year follow-ups.
Secondary	Depression Anxiety Stress Scale-Stress	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.	Baseline, 10 weeks, 6 months and 1 year follow-ups.
Secondary	Pittsburgh Sleep Quality Index	Measures sleep quality. There are 8 components scores, and each component score ranges from 0 to 3. Higher score means worse sleep quality.	Baseline, 10 weeks, 6 months and 1 year follow-ups.
Secondary	36 Item-Short Form Health Survey Questionnaire	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.	Baseline, 10 weeks, 6 months and 1 year follow-ups.
Secondary	Five Facet Mindfulness Questionnaire	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.	Baseline, 10 weeks, 6 months and 1 year follow-ups.
Secondary	Pregnancy Symptom Inventory	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.	Baseline, 10 weeks, 6 months and 1 year follow-ups.
Secondary	Cortisol concentration level	Measures salivary cortisol concentration at baseline and post-intervention. Higher concentration means higher level of stress and depression.	Baseline and 10 weeks (post-intervention).
Secondary	Physical fitness	6-minute walking test is used for physical fitness measure. The total distance walked during 6 minutes is recorded. Higher score means better fitness.	Baseline and 10 weeks (post-intervention).
Secondary	Balance	Single-leg standing test is used to measure the balance. The time to keep the posture is recorded. Higher score means better balance ability.	Baseline and 10 weeks (post-intervention).