Mindfulness-based Intervention for Postnatal Depression

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.

Study Overview

• Status: Unknown
• Conditions: Postnatal Depression
• Intervention / Treatment: Behavioral: Mindfulness-based program (MBI-p-R); Behavioral: Booklet-based psychoeducation

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingxia Lin, PhD; Phone Number: 852-39176311; Email: jxlin@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital
    • Contact: Jingxia Lin, PhD; Phone Number: 852-39176311; Email: jxlin@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-based intervention	Behavioral: Mindfulness-based program (MBI-p-R); 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.
Active Comparator: Booklet-based psychoeducation group	Behavioral: Booklet-based psychoeducation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	At 8 weeks
Self-practice time	How much time the participants spend for self-practice at home will be recorded	At 3 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Jingxia Lin, PhD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: UW17-431

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol, statistical analysis plan and clinical study report will be shared through email.
• IPD Sharing Time Frame: Within one year after the completion of the study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No