Postnatal DepressionNCT04332146
Mindfulness-based Intervention for Postnatal Depression
A study testing Mindfulness-based program (MBI-p-R) and Booklet-based psychoeducation in people with Postnatal Depression, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Postnatal psychopathology have adverse impact on both mothers and infants. Few postnatal women with depressive symptoms receive treatment, and pharmacological intervention has not been well accepted due to the medication side-effects. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postnatal Depression
- What is being tested?
- Mindfulness-based program (MBI-p-R) and Booklet-based psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2017to 31 May 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged from 18 and above
- The Edinburgh Postnatal Depression Scale cut-off score of >=9
- At least 6 weeks, and up to one and half years after childbirth
- Cantonese-speaking Chinese
Who cannot join
- Severe physical illness (myocardial infarction, hypertension, fracture, spinal problems in which yoga may be contraindicated), and seizure disorders.
- Comorbid substance dependence
- Women with psychotic depression, severe eating disorders, actively suicidal or obsessive-compulsive disorders
- Known pregnancy
- A history of bipolar disorder, schizophrenia, brain trauma or organic brain disease, mental retardation, or antisocial personality disorder
- Practice of mindfulness (in forms of Tai Chi, Qi gong or yoga etc.) more than twice a week during the previous three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impacts of Mindfulness-based Intervention on Symptoms and Cognition in Chinese Women With Postnatal Depressive Symptoms - A Randomized Controlled Clinical Trial
Postnatal psychopathology have adverse impact on both mothers and infants. Few postnatal women with depressive symptoms receive treatment, and pharmacological intervention has not been well accepted due to the medication side-effects. Recently, mindfulness-based interventions were found to be beneficial for symptoms in perinatal and antenatal women with depression. These non-pharmacological interventions require less resources and are more feasible for postnatal women to practice at home. To date, no randomized controlled trial has examined mindfulness-based intervention program as a treatment for women with postnatal depression. The proposed randomized controlled trial aims to examine the effects of an 8-week mindfulness-based intervention program on symptom and cognition for postnatal females with depressive symptoms.
A total of 70 postnatal women with depressive symptoms will be recruited from the psychiatric outpatient clinics in Hong Kong, and will be randomized into two groups: 1) an 8-week mindfulness-based intervention program (n=35); 2) a booklet-based psychoeducation control group (n=35). All participants will be assessed for depression, anxiety, stress, cognition, role functioning, quality of life, sleep quality and mindfulness ability at the baseline, 8 weeks, and 3 months after intervention. The intervention sessions will be held once weekly lasting 90 minutes for 8 weeks.
The investigators primarily hypothesize that participants in the mindfulness-based intervention group will improve depressive symptom after 8 weeks compared with the control group. Secondary, the mindfulness-based intervention will improve anxiety, stress, cognitive functions, sleep quality, quality of life and mindfulness ability.
- Conditions
- Postnatal Depression
- Being tested
- Mindfulness-based program (MBI-p-R), Booklet-based psychoeducation
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based program (MBI-p-R)Behavioural
The MBI-p-R was developed in line with the model of Mindfulness-based Stress Reducation (MBSR) proposed by Kabat-Zinn. It will be conducted for 1.5 hours for each session, once a week for 8 weeks. There are four key operational components to be included in each session: engagement and introduction, mindfulness practices, daily life application, and consolidation of learning.
Booklet-based psychoeducationBehavioural
The participants in the control group will be provided a booklet at baseline, including general information in handling every day stress by a new mother, as well as a record for their weekly activities. The contents covered a range of topics including work-stress, balanced diet, physical exercise, sleeping quality, bonding with baby and the treatment for depression. The participants will be contacted by phone call and/or whatsapp weekly for a short talk based on the record and content on the booklet. They will also be asked to record their daily life weekly for discussion.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based intervention | Experimental | Not described Receives: Behavioral: Mindfulness-based program (MBI-p-R) |
| Booklet-based psychoeducation group | Active comparator | Not described Receives: Behavioral: Booklet-based psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Depression at 8 weeks
The Edinburgh Postnatal Depression Scale, total score 0-30, higher scores mean worse outcome.
Measured: Change from baseline to 8 weeks
Change from 8 weeks Depression at 3 months
The Edinburgh Postnatal Depression Scale, total score 0-30, higher scores mean worse outcome.
Measured: Change from 8 weeks to 3 months
Secondary outcomes (20)
Change from Baseline Anxiety at 8 weeks
Depression Anxiety Stress Scale, Anxiety subscore 0-42, higher scores mean worse outcome.
Measured: Change from baseline to 8 weeks
Change from 8 weeks Anxiety at 3 months
Depression Anxiety Stress Scale, Anxiety subscore 0-42, higher scores mean worse outcome.
Measured: Change from 8 weeks to 3 months
Change from Baseline Stress at 8 weeks
Depression Anxiety Stress Scale, Stress subscore 0-42, higher scores mean worse outcome.
Measured: Change from baseline to 8 weeks
Change from 8 weeks Stress at 3 months
Depression Anxiety Stress Scale, Stress subscore 0-42, higher scores mean worse outcome.
Measured: Change from 8 weeks to 3 months
Change from Baseline Executive Function at 8 weeks
Trial Making Test, reaction time is recorded, shorter time means better outcome.
Measured: Change from baseline to 8 weeks
Change from 8 weeks Executive Function at 3 months
Trial Making Test, reaction time is recorded, shorter time means better outcome.
Measured: Change from 8 weeks to 3 months
Change from Baseline Attention at 8 weeks
Letter Cancellation Test, correct rate and time are recorded, higher correct rate and shorter time mean better outcome.
Measured: Change from baseline to 8 weeks
Change from 8 weeks Attention at 3 months
Letter Cancellation Test, correct rate and time are recorded, higher correct rate and shorter time mean better outcome.
Measured: Change from 8 weeks to 3 months
Change from Baseline Working Memory at 8 weeks
Digit-Span Test, minimum 0, maximum 14, higher scores mean better outcome.
Measured: Change from baseline to 8 weeks
Change from 8 weeks Working Memory at 3 months
Digit-Span Test, minimum 0, maximum 14, higher scores mean better outcome.
Measured: Change from 8 weeks to 3 months
Change from Baseline Visual-Motor Coordination at 8 weeks
Digit-Symbol-Coding Test, minimum 0, maximum 133, higher scores mean better outcome.
Measured: Change from baseline to 8 weeks
Change from 8 weeks Visual-Motor Coordination at 3 months
Digit-Symbol-Coding Test, minimum 0, maximum 133, higher scores mean better outcome.
Measured: Change from 8 weeks to 3 months
Change from Baseline Role Functioning at 8 weeks
Role Functioning Scale, minimum 4, maximum 38, higher scores mean better outcome.
Measured: Change from baseline to 8 weeks
Change from 8 weeks Role Functioning at 3 months
Role Functioning Scale, minimum 4, maximum 38, higher scores mean better outcome.
Measured: Change from 8 weeks to 3 months
Change from Baseline Quality of Life at 8 weeks
The Short Form Health Survey, minimum score 0, and maximum score 100, higher scores mean better outcome.
Measured: Change from baseline to 8 weeks
Change from 8 weeks Quality of Life at 3 months
The Short Form Health Survey, minimum score 0, and maximum score 100, higher scores mean better outcome.
Measured: Change from 8 weeks to 3 months
Change from Baseline Sleep Quality at 8 weeks
Pittsburg Sleep Quality Index, minimum 0, maximum 21, higher scores mean worse outcome.
Measured: Change from baseline to 8 weeks
Change from 8 weeks Sleep Quality at 3 months
Pittsburg Sleep Quality Index, minimum 0, maximum 21, higher scores mean worse outcome.
Measured: Change from 8 weeks to 3 months
Change from Baseline Mindfulness Levels at 8 weeks
The Five Facet Mindfulness Questionnaire-Revised, minimum 39, maximum 195, higher scores mean better outcome.
Measured: Change from baseline to 8 weeks
Change from 8 weeks Mindfulness Levels at 3 months
The Five Facet Mindfulness Questionnaire-Revised, minimum 39, maximum 195, higher scores mean better outcome.
Measured: Change from 8 weeks to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Nov 2017
- Primary completion31 Oct 2019
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal DepressionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jingxia Lin, The University of Hong Kong
- Investigators
- Jingxia Lin, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332146
- Sponsor's protocol ID
- UW17-431
- Status last verified
- Jan 2026
- First submitted
- 2 Mar 2020
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, statistical analysis plan and clinical study report will be shared through email.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impacts of Mindfulness-based Intervention on Symptoms and Cognition in Chinese Women With Postnatal Depressive Symptoms - A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04332146
- Acronym / sponsor ID
- UW17-431
- Conditions
- Postnatal Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 2 Apr 2020 (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.
Postnatal psychopathology have adverse impact on both mothers and infants. Few postnatal women with depressive symptoms receive treatment, and pharmacological intervention has not been well accepted due to the medication side-effects. Recently, mindfulness-based interventions were found to be beneficial for symptoms in perinatal and antenatal women with depression. These non-pharmacological interventions require less resources and are more feasible for postnatal women to practice at home. To date, no randomized controlled trial has examined mindfulness-based intervention program as a treatment for women with postnatal depression. The proposed randomized controlled trial aims to examine the effects of an 8-week mindfulness-based intervention program on symptom and cognition for postnatal females with depressive symptoms.
A total of 70 postnatal women with depressive symptoms will be recruited from the psychiatric outpatient clinics in Hong Kong, and will be randomized into two groups: 1) an 8-week mindfulness-based intervention program (n=35); 2) a booklet-based psychoeducation control group (n=35). All participants will be assessed for depression, anxiety, stress, cognition, role functioning, quality of life, sleep quality and mindfulness ability at the baseline, 8 weeks, and 3 months after intervention. The intervention sessions will be held once weekly lasting 90 minutes for 8 weeks.
The investigators primarily hypothesize that participants in the mindfulness-based intervention group will improve depressive symptom after 8 weeks compared with the control group. Secondary, the mindfulness-based intervention will improve anxiety, stress, cognitive functions, sleep quality, quality of life and mindfulness ability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based intervention | Experimental | Behavioral: Mindfulness-based program (MBI-p-R) |
| Booklet-based psychoeducation group | Active comparator | Behavioral: Booklet-based psychoeducation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Females aged from 18 and above
- The Edinburgh Postnatal Depression Scale cut-off score of >=9
- At least 6 weeks, and up to one and half years after childbirth
- Cantonese-speaking Chinese
Key exclusion criteria (6 listed)
- Severe physical illness (myocardial infarction, hypertension, fracture, spinal problems in which yoga may be contraindicated), and seizure disorders.
- Comorbid substance dependence
- Women with psychotic depression, severe eating disorders, actively suicidal or obsessive-compulsive disorders
- Known pregnancy
- A history of bipolar disorder, schizophrenia, brain trauma or organic brain disease, mental retardation, or antisocial personality disorder
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 program (MBI-p-R)The MBI-p-R was developed in line with the model of Mindfulness-based Stress Reducation (MBSR) proposed by Kabat-Zinn. It will be conducted for 1.5 hours for each session, once a week for 8 weeks. There are four key operational components to be included in each session: engagement and introduction, mindfulness practices, daily life application, and consolidation of learning. | Behavioural | Mindfulness-based intervention |
| Booklet-based psychoeducationThe participants in the control group will be provided a booklet at baseline, including general information in handling every day stress by a new mother, as well as a record for their weekly activities. The contents covered a range of topics including work-stress, balanced diet, physical exercise, sleeping quality, bonding with baby and the treatment for depression. The participants will be contacted by phone call and/or whatsapp weekly for a short talk based on the record and content on the booklet. They will also be asked to record their daily life weekly for discussion. | Behavioural | Booklet-based psychoeducation group |
Primary outcome
Change from Baseline Depression at 8 weeks
Time frame: Change from baseline to 8 weeks
The Edinburgh Postnatal Depression Scale, total score 0-30, higher scores mean worse outcome.
Change from 8 weeks Depression at 3 months
Time frame: Change from 8 weeks to 3 months
The Edinburgh Postnatal Depression Scale, total score 0-30, higher scores mean worse outcome.
20 secondary outcomes
Change from Baseline Anxiety at 8 weeks
Time frame: Change from baseline to 8 weeks
Change from 8 weeks Anxiety at 3 months
Time frame: Change from 8 weeks to 3 months
Change from Baseline Stress at 8 weeks
Time frame: Change from baseline to 8 weeks
Change from 8 weeks Stress at 3 months
Time frame: Change from 8 weeks to 3 months
Change from Baseline Executive Function at 8 weeks
Time frame: Change from baseline to 8 weeks
Change from 8 weeks Executive Function at 3 months
Time frame: Change from 8 weeks to 3 months
Change from Baseline Attention at 8 weeks
Time frame: Change from baseline to 8 weeks
Change from 8 weeks Attention at 3 months
Time frame: Change from 8 weeks to 3 months
Change from Baseline Working Memory at 8 weeks
Time frame: Change from baseline to 8 weeks
Change from 8 weeks Working Memory at 3 months
Time frame: Change from 8 weeks to 3 months
Change from Baseline Visual-Motor Coordination at 8 weeks
Time frame: Change from baseline to 8 weeks
Change from 8 weeks Visual-Motor Coordination at 3 months
Time frame: Change from 8 weeks to 3 months
Change from Baseline Role Functioning at 8 weeks
Time frame: Change from baseline to 8 weeks
Change from 8 weeks Role Functioning at 3 months
Time frame: Change from 8 weeks to 3 months
Change from Baseline Quality of Life at 8 weeks
Time frame: Change from baseline to 8 weeks
Change from 8 weeks Quality of Life at 3 months
Time frame: Change from 8 weeks to 3 months
Change from Baseline Sleep Quality at 8 weeks
Time frame: Change from baseline to 8 weeks
Change from 8 weeks Sleep Quality at 3 months
Time frame: Change from 8 weeks to 3 months
Change from Baseline Mindfulness Levels at 8 weeks
Time frame: Change from baseline to 8 weeks
Change from 8 weeks Mindfulness Levels at 3 months
Time frame: Change from 8 weeks to 3 months
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 27 Jan 2026.
- Individual participant dataSharing planned: Yes. The study protocol, statistical analysis plan and clinical study report will be shared through email.
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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.
Jingxia Lin, PhD principal investigator
The University of Hong Kong
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 program (MBI-p-R) and Booklet-based psychoeducation in people with Postnatal Depression, run by The University of Hong Kong 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 4 inclusion and 6 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 27 Jan 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?
Change from Baseline Depression at 8 weeks (time frame: Change from baseline to 8 weeks). The study lists 2 primary outcomes in all. 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 27 Jan 2026.