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Completed

NCT Number: NCT04332146

Mindfulness-based Intervention for Postnatal Depression

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.

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Key information

Conditions

Postnatal Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Mindfulness-based program (MBI-p-R)

Behavioral

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 psychoeducation

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change from Baseline Anxiety at 8 weeks

    Time frame: Change from baseline to 8 weeks

    Depression Anxiety Stress Scale, Anxiety subscore 0-42, higher scores mean worse outcome.

  2. Change from 8 weeks Anxiety at 3 months

    Time frame: Change from 8 weeks to 3 months

    Depression Anxiety Stress Scale, Anxiety subscore 0-42, higher scores mean worse outcome.

  3. Change from Baseline Stress at 8 weeks

    Time frame: Change from baseline to 8 weeks

    Depression Anxiety Stress Scale, Stress subscore 0-42, higher scores mean worse outcome.

  4. Change from 8 weeks Stress at 3 months

    Time frame: Change from 8 weeks to 3 months

    Depression Anxiety Stress Scale, Stress subscore 0-42, higher scores mean worse outcome.

  5. Change from Baseline Executive Function at 8 weeks

    Time frame: Change from baseline to 8 weeks

    Trial Making Test, reaction time is recorded, shorter time means better outcome.

  6. Change from 8 weeks Executive Function at 3 months

    Time frame: Change from 8 weeks to 3 months

    Trial Making Test, reaction time is recorded, shorter time means better outcome.

  7. Change from Baseline Attention at 8 weeks

    Time frame: Change from baseline to 8 weeks

    Letter Cancellation Test, correct rate and time are recorded, higher correct rate and shorter time mean better outcome.

  8. Change from 8 weeks Attention at 3 months

    Time frame: Change from 8 weeks to 3 months

    Letter Cancellation Test, correct rate and time are recorded, higher correct rate and shorter time mean better outcome.

  9. Change from Baseline Working Memory at 8 weeks

    Time frame: Change from baseline to 8 weeks

    Digit-Span Test, minimum 0, maximum 14, higher scores mean better outcome.

  10. Change from 8 weeks Working Memory at 3 months

    Time frame: Change from 8 weeks to 3 months

    Digit-Span Test, minimum 0, maximum 14, higher scores mean better outcome.

  11. Change from Baseline Visual-Motor Coordination at 8 weeks

    Time frame: Change from baseline to 8 weeks

    Digit-Symbol-Coding Test, minimum 0, maximum 133, higher scores mean better outcome.

  12. Change from 8 weeks Visual-Motor Coordination at 3 months

    Time frame: Change from 8 weeks to 3 months

    Digit-Symbol-Coding Test, minimum 0, maximum 133, higher scores mean better outcome.

  13. Change from Baseline Role Functioning at 8 weeks

    Time frame: Change from baseline to 8 weeks

    Role Functioning Scale, minimum 4, maximum 38, higher scores mean better outcome.

  14. Change from 8 weeks Role Functioning at 3 months

    Time frame: Change from 8 weeks to 3 months

    Role Functioning Scale, minimum 4, maximum 38, higher scores mean better outcome.

  15. Change from Baseline Quality of Life at 8 weeks

    Time frame: Change from baseline to 8 weeks

    The Short Form Health Survey, minimum score 0, and maximum score 100, higher scores mean better outcome.

  16. Change from 8 weeks Quality of Life at 3 months

    Time frame: Change from 8 weeks to 3 months

    The Short Form Health Survey, minimum score 0, and maximum score 100, higher scores mean better outcome.

  17. Change from Baseline Sleep Quality at 8 weeks

    Time frame: Change from baseline to 8 weeks

    Pittsburg Sleep Quality Index, minimum 0, maximum 21, higher scores mean worse outcome.

  18. Change from 8 weeks Sleep Quality at 3 months

    Time frame: Change from 8 weeks to 3 months

    Pittsburg Sleep Quality Index, minimum 0, maximum 21, higher scores mean worse outcome.

  19. Change from Baseline Mindfulness Levels at 8 weeks

    Time frame: Change from baseline to 8 weeks

    The Five Facet Mindfulness Questionnaire-Revised, minimum 39, maximum 195, higher scores mean better outcome.

  20. Change from 8 weeks Mindfulness Levels at 3 months

    Time frame: Change from 8 weeks to 3 months

    The Five Facet Mindfulness Questionnaire-Revised, minimum 39, maximum 195, higher scores mean better outcome.

Other outcomes

  1. Total attendant classes during the 8-week interventions

    Time frame: At 8 weeks

    The number of classes the participants attended during the 8-week period will be recorded

  2. Self-practice time

    Time frame: At 8 weeks

    How much time the participants spend for self-practice at home will be recorded

  3. Self-practice time

    Time frame: At 3 months

    How much time the participants spend for self-practice at home will be recorded

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

The Impacts of Mindfulness-based Intervention on Symptoms and Cognition in Chinese Women With Postnatal Depressive Symptoms - A Randomized Controlled Clinical Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Apr 2, 2020
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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