Mindfulness-based Intervention for Postnatal Depression

NCT04332146 | Completed

• 1 other identifier: UW17-431
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Postnatal Depression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (20)

• Change from Baseline Anxiety at 8 weeks

  Change from baseline to 8 weeks

• Change from 8 weeks Anxiety at 3 months

  Change from 8 weeks to 3 months

• Change from Baseline Stress at 8 weeks

  Change from baseline to 8 weeks

• Change from 8 weeks Stress at 3 months

  Change from 8 weeks to 3 months

• Change from Baseline Executive Function at 8 weeks

  Change from baseline to 8 weeks

Other Outcomes (3)

• Total attendant classes during the 8-week interventions

  At 8 weeks

• Self-practice time

  At 8 weeks

• Self-practice time

  At 3 months

Study Arms (2)

Mindfulness-based intervention

EXPERIMENTAL

Behavioral: Mindfulness-based program (MBI-p-R)

Booklet-based psychoeducation group

ACTIVE COMPARATOR

Behavioral: Booklet-based psychoeducation

Interventions

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.

Mindfulness-based intervention

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.

Booklet-based psychoeducation group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Jingxia Lin, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Officer

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: April 2, 2020
• Study Start: November 1, 2017
• Primary Completion: October 31, 2019
• Study Completion: May 31, 2020
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Within one year after the completion of the study.

Locations

HK (1)