Clinical trial NCT04332146: Mindfulness-based Intervention for Postnatal Depression
Official title: The Impacts of Mindfulness-based Intervention on Symptoms and Cognition in Chinese Women With Postnatal Depressive Symptoms - A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postnatal Depression
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Depression at 8 weeks
timeFrame: Change from baseline to 8 weeks
measure: Change from 8 weeks Depression at 3 months
timeFrame: Change from 8 weeks to 3 months
Secondary outcomes:
measure: Change from Baseline Anxiety at 8 weeks
timeFrame: Change from baseline to 8 weeks
measure: Change from 8 weeks Anxiety at 3 months
timeFrame: Change from 8 weeks to 3 months
measure: Change from Baseline Stress at 8 weeks
timeFrame: Change from baseline to 8 weeks
measure: Change from 8 weeks Stress at 3 months
timeFrame: Change from 8 weeks to 3 months
measure: Change from Baseline Executive Function at 8 weeks
timeFrame: Change from baseline to 8 weeks
measure: Change from 8 weeks Executive Function at 3 months
timeFrame: Change from 8 weeks to 3 months
measure: Change from Baseline Attention at 8 weeks
timeFrame: Change from baseline to 8 weeks
measure: Change from 8 weeks Attention at 3 months
timeFrame: Change from 8 weeks to 3 months
measure: Change from Baseline Working Memory at 8 weeks
timeFrame: Change from baseline to 8 weeks
measure: Change from 8 weeks Working Memory at 3 months
timeFrame: Change from 8 weeks to 3 months
measure: Change from Baseline Visual-Motor Coordination at 8 weeks
timeFrame: Change from baseline to 8 weeks
measure: Change from 8 weeks Visual-Motor Coordination at 3 months
timeFrame: Change from 8 weeks to 3 months
measure: Change from Baseline Role Functioning at 8 weeks
timeFrame: Change from baseline to 8 weeks
measure: Change from 8 weeks Role Functioning at 3 months
timeFrame: Change from 8 weeks to 3 months
measure: Change from Baseline Quality of Life at 8 weeks
timeFrame: Change from baseline to 8 weeks
measure: Change from 8 weeks Quality of Life at 3 months
timeFrame: Change from 8 weeks to 3 months
measure: Change from Baseline Sleep Quality at 8 weeks
timeFrame: Change from baseline to 8 weeks
measure: Change from 8 weeks Sleep Quality at 3 months
timeFrame: Change from 8 weeks to 3 months
measure: Change from Baseline Mindfulness Levels at 8 weeks
timeFrame: Change from baseline to 8 weeks
measure: Change from 8 weeks Mindfulness Levels at 3 months
timeFrame: Change from 8 weeks to 3 months
Other outcomes:
measure: Total attendant classes during the 8-week interventions
timeFrame: At 8 weeks
measure: Self-practice time
timeFrame: At 8 weeks
measure: Self-practice time
timeFrame: At 3 months
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Jingxia Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: