Postnatal Depression Clinical Trial
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | September 2021 |
Est. primary completion date | July 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Queen Mary Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | Self-practice time | How much time the participants spend for self-practice at home will be recorded | At 8 weeks | |
Other | Self-practice time | How much time the participants spend for self-practice at home will be recorded | At 3 months | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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