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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-based intervention | Experimental |
| |
| Booklet-based psychoeducation group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total attendant classes during the 8-week interventions | The number of classes the participants attended during the 8-week period will be recorded | At 8 weeks |
| Self-practice time | How much time the participants spend for self-practice at home will be recorded |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jingxia Lin, PhD | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | Hong Kong |
The study protocol, statistical analysis plan and clinical study report will be shared through email.
Within one year after the completion of the study.
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| 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. |
|
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 |
| At 8 weeks |
| Self-practice time | How much time the participants spend for self-practice at home will be recorded | At 3 months |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |