Mindfulness-based Intervention for Postnatal Depression

Not Applicable

• Conditions: Postnatal Depression
• Interventions: Behavioral: Mindfulness-based program (MBI-p-R); Behavioral: Booklet-based psychoeducation

• Registration Number: NCT04332146
• Lead Sponsor: The University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2020-03
• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-30
• Last Update Submitted: 2020-03-30
• Study First Posted: 2020-04-02
• Last Update Posted: 2020-04-02
• Primary Completion: 2020-07
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-based intervention	Mindfulness-based program (MBI-p-R)	-
Booklet-based psychoeducation group	Booklet-based psychoeducation	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline Depression at 8 weeks	Change from baseline to 8 weeks	The Edinburgh Postnatal Depression Scale, total score 0-30, higher scores mean worse outcome.
Change from 8 weeks Depression at 3 months	Change from 8 weeks to 3 months	The Edinburgh Postnatal Depression Scale, total score 0-30, higher scores mean worse outcome.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Anxiety at 8 weeks	Change from baseline to 8 weeks	Depression Anxiety Stress Scale, Anxiety subscore 0-42, higher scores mean worse outcome.
Change from 8 weeks Anxiety at 3 months	Change from 8 weeks to 3 months	Depression Anxiety Stress Scale, Anxiety subscore 0-42, higher scores mean worse outcome.
Change from Baseline Stress at 8 weeks	Change from baseline to 8 weeks	Depression Anxiety Stress Scale, Stress subscore 0-42, higher scores mean worse outcome.
Change from 8 weeks Stress at 3 months	Change from 8 weeks to 3 months	Depression Anxiety Stress Scale, Stress subscore 0-42, higher scores mean worse outcome.
Change from Baseline Executive Function at 8 weeks	Change from baseline to 8 weeks	Trial Making Test, reaction time is recorded, shorter time means better outcome.
Change from 8 weeks Executive Function at 3 months	Change from 8 weeks to 3 months	Trial Making Test, reaction time is recorded, shorter time means better outcome.
Change from Baseline Attention at 8 weeks	Change from baseline to 8 weeks	Letter Cancellation Test, correct rate and time are recorded, higher correct rate and shorter time mean better outcome.
Change from 8 weeks Visual-Motor Coordination at 3 months	Change from 8 weeks to 3 months	Digit-Symbol-Coding Test, minimum 0, maximum 133, higher scores mean better outcome.
Change from 8 weeks Attention at 3 months	Change from 8 weeks to 3 months	Letter Cancellation Test, correct rate and time are recorded, higher correct rate and shorter time mean better outcome.
Change from Baseline Working Memory at 8 weeks	Change from baseline to 8 weeks	Digit-Span Test, minimum 0, maximum 14, higher scores mean better outcome.
Change from 8 weeks Working Memory at 3 months	Change from 8 weeks to 3 months	Digit-Span Test, minimum 0, maximum 14, higher scores mean better outcome.
Change from Baseline Role Functioning at 8 weeks	Change from baseline to 8 weeks	Role Functioning Scale, minimum 4, maximum 38, higher scores mean better outcome.
Change from 8 weeks Role Functioning at 3 months	Change from 8 weeks to 3 months	Role Functioning Scale, minimum 4, maximum 38, higher scores mean better outcome.
Change from Baseline Visual-Motor Coordination at 8 weeks	Change from baseline to 8 weeks	Digit-Symbol-Coding Test, minimum 0, maximum 133, higher scores mean better outcome.
Change from Baseline Quality of Life at 8 weeks	Change from baseline to 8 weeks	The Short Form Health Survey, minimum score 0, and maximum score 100, higher scores mean better outcome.
Change from 8 weeks Quality of Life at 3 months	Change from 8 weeks to 3 months	The Short Form Health Survey, minimum score 0, and maximum score 100, higher scores mean better outcome.
Change from Baseline Sleep Quality at 8 weeks	Change from baseline to 8 weeks	Pittsburg Sleep Quality Index, minimum 0, maximum 21, higher scores mean worse outcome.
Change from 8 weeks Sleep Quality at 3 months	Change from 8 weeks to 3 months	Pittsburg Sleep Quality Index, minimum 0, maximum 21, higher scores mean worse outcome.
Change from Baseline Mindfulness Levels at 8 weeks	Change from baseline to 8 weeks	The Five Facet Mindfulness Questionnaire-Revised, minimum 39, maximum 195, higher scores mean better outcome.
Change from 8 weeks Mindfulness Levels at 3 months	Change from 8 weeks to 3 months	The Five Facet Mindfulness Questionnaire-Revised, minimum 39, maximum 195, higher scores mean better outcome.

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong