Mood DisordersNCT06275217
Mindful Yoga for Postpartum Depression
A study testing Mindfulness-based yoga program and Psychoeducation in people with Mood Disorders, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Mood Disorders
- What is being tested?
- Mindfulness-based yoga program and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteHong Kong
- Study dates
- 8 Jan 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Mindfulness-based yoga program, Psychoeducation
- Keywords
- Yoga, Mindfulness-based, Postpartum depression, mood symptoms
- Medical subject headings
- Mood Disorders, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based yoga programBehavioural
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.
PsychoeducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 10 weeks, 6 months and 1 year follow-ups.
Secondary outcomes (10)
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.
Measured: Baseline, 10 weeks, 6 months and 1 year follow-ups.
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.
Measured: Baseline, 10 weeks, 6 months and 1 year follow-ups.
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.
Measured: Baseline, 10 weeks, 6 months and 1 year follow-ups.
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.
Measured: Baseline, 10 weeks, 6 months and 1 year follow-ups.
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.
Measured: Baseline, 10 weeks, 6 months and 1 year follow-ups.
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.
Measured: Baseline, 10 weeks, 6 months and 1 year follow-ups.
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.
Measured: Baseline, 10 weeks, 6 months and 1 year follow-ups.
Cortisol concentration level
Measures salivary cortisol concentration at baseline and post-intervention. Higher concentration means higher level of stress and depression.
Measured: Baseline and 10 weeks (post-intervention).
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.
Measured: Baseline and 10 weeks (post-intervention).
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.
Measured: Baseline and 10 weeks (post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start8 Jan 2021
- Primary completion15 Jul 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIN Jingxia Jessie, The Hong Kong Polytechnic University
- Investigators
- Jessie Lin, PhD, Study chair, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275217
- Sponsor's protocol ID
- HMRF17182481
- Status last verified
- Mar 2025
- First submitted
- 17 Jan 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06275217
- Acronym / sponsor ID
- HMRF17182481
- Conditions
- Mood Disorders
- Keywords
- Yoga, Mindfulness-based, Postpartum depression, mood symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful yoga group | Experimental | Behavioral: Mindfulness-based yoga programThe participants in experimental group will receive a 10-week mindfulness-based yoga program, one session per week with 1.5 hours in each session. |
| Psychoeducation group | Active comparator | Other: PsychoeducationThe participants in the psychoeducation group will receive a 10-week psychoeducation program, one session per week with 1.5 hours in each session. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based yoga programThe 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. | Behavioural | Mindful yoga group |
| PsychoeducationKnowledge 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. | Other | Psychoeducation group |
Primary outcome
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.
10 secondary outcomes
Depression Anxiety Stress Scale-Depression
Time frame: Baseline, 10 weeks, 6 months and 1 year follow-ups.
Depression Anxiety Stress Scale-Anxiety
Time frame: Baseline, 10 weeks, 6 months and 1 year follow-ups.
Depression Anxiety Stress Scale-Stress
Time frame: Baseline, 10 weeks, 6 months and 1 year follow-ups.
Pittsburgh Sleep Quality Index
Time frame: Baseline, 10 weeks, 6 months and 1 year follow-ups.
36 Item-Short Form Health Survey Questionnaire
Time frame: Baseline, 10 weeks, 6 months and 1 year follow-ups.
Five Facet Mindfulness Questionnaire
Time frame: Baseline, 10 weeks, 6 months and 1 year follow-ups.
Pregnancy Symptom Inventory
Time frame: Baseline, 10 weeks, 6 months and 1 year follow-ups.
Cortisol concentration level
Time frame: Baseline and 10 weeks (post-intervention).
Physical fitness
Time frame: Baseline and 10 weeks (post-intervention).
Balance
Time frame: Baseline and 10 weeks (post-intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessie Lin, PhD study chair
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based yoga program and Psychoeducation in people with Mood Disorders, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale (time frame: Baseline, 10 weeks, 6 months and 1 year follow-ups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.