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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
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.
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.
Queen Mary Hospital
Hong Kong, Hong Kong
Change from Baseline Depression at 8 weeks
The Edinburgh Postnatal Depression Scale, total score 0-30, higher scores mean worse outcome.
Time frame: 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.
Time frame: Change from 8 weeks to 3 months
Change from Baseline Anxiety at 8 weeks
Depression Anxiety Stress Scale, Anxiety subscore 0-42, higher scores mean worse outcome.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from 8 weeks to 3 months
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