Mindfulness-based Intervention for Postnatal Depression

Study Overview
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Brief Summary
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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.

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

Conditions
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Postnatal Depression

Intervention / Treatment
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* Behavioral: Mindfulness-based program (MBI-p-R)
* Behavioral: Booklet-based psychoeducation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based intervention<br> | Behavioral: Mindfulness-based program (MBI-p-R)<br>* 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.<br>|
| Active Comparator: Booklet-based psychoeducation group<br> | Behavioral: Booklet-based psychoeducation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Depression at 8 weeks | The Edinburgh Postnatal Depression Scale, total score 0-30, higher scores mean worse outcome. | 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. | Change from 8 weeks to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Anxiety at 8 weeks | Depression Anxiety Stress Scale, Anxiety subscore 0-42, higher scores mean worse outcome. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Change from 8 weeks to 3 months |