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Mindfulness-based Intervention for Postnatal Depression

Primary Purpose

Postnatal Depression

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Mindfulness-based program (MBI-p-R)
Booklet-based psychoeducation
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postnatal Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Queen Mary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-based intervention

Booklet-based psychoeducation group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline Anxiety at 8 weeks
Depression Anxiety Stress Scale, Anxiety subscore 0-42, higher scores mean worse outcome.
Change from 8 weeks Anxiety at 3 months
Depression Anxiety Stress Scale, Anxiety subscore 0-42, higher scores mean worse outcome.
Change from Baseline Stress at 8 weeks
Depression Anxiety Stress Scale, Stress subscore 0-42, higher scores mean worse outcome.
Change from 8 weeks Stress at 3 months
Depression Anxiety Stress Scale, Stress subscore 0-42, higher scores mean worse outcome.
Change from Baseline Executive Function at 8 weeks
Trial Making Test, reaction time is recorded, shorter time means better outcome.
Change from 8 weeks Executive Function at 3 months
Trial Making Test, reaction time is recorded, shorter time means better outcome.
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 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 Baseline Working Memory at 8 weeks
Digit-Span Test, minimum 0, maximum 14, higher scores mean better outcome.
Change from 8 weeks Working Memory at 3 months
Digit-Span Test, minimum 0, maximum 14, higher scores mean better outcome.
Change from Baseline Visual-Motor Coordination at 8 weeks
Digit-Symbol-Coding Test, minimum 0, maximum 133, higher scores mean better outcome.
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 Baseline Role Functioning at 8 weeks
Role Functioning Scale, minimum 4, maximum 38, higher scores mean better outcome.
Change from 8 weeks Role Functioning at 3 months
Role Functioning Scale, minimum 4, maximum 38, higher scores mean better outcome.
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 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 Baseline Sleep Quality at 8 weeks
Pittsburg Sleep Quality Index, minimum 0, maximum 21, higher scores mean worse outcome.
Change from 8 weeks Sleep Quality at 3 months
Pittsburg Sleep Quality Index, minimum 0, maximum 21, higher scores mean worse outcome.
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 8 weeks Mindfulness Levels at 3 months
The Five Facet Mindfulness Questionnaire-Revised, minimum 39, maximum 195, higher scores mean better outcome.

Full Information

First Posted
March 2, 2020
Last Updated
March 30, 2020
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04332146
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postnatal Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based intervention
Arm Type
Experimental
Arm Title
Booklet-based psychoeducation group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based program (MBI-p-R)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Booklet-based psychoeducation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Depression at 8 weeks
Description
The Edinburgh Postnatal Depression Scale, total score 0-30, higher scores mean worse outcome.
Time Frame
Change from baseline to 8 weeks
Title
Change from 8 weeks Depression at 3 months
Description
The Edinburgh Postnatal Depression Scale, total score 0-30, higher scores mean worse outcome.
Time Frame
Change from 8 weeks to 3 months
Secondary Outcome Measure Information:
Title
Change from Baseline Anxiety at 8 weeks
Description
Depression Anxiety Stress Scale, Anxiety subscore 0-42, higher scores mean worse outcome.
Time Frame
Change from baseline to 8 weeks
Title
Change from 8 weeks Anxiety at 3 months
Description
Depression Anxiety Stress Scale, Anxiety subscore 0-42, higher scores mean worse outcome.
Time Frame
Change from 8 weeks to 3 months
Title
Change from Baseline Stress at 8 weeks
Description
Depression Anxiety Stress Scale, Stress subscore 0-42, higher scores mean worse outcome.
Time Frame
Change from baseline to 8 weeks
Title
Change from 8 weeks Stress at 3 months
Description
Depression Anxiety Stress Scale, Stress subscore 0-42, higher scores mean worse outcome.
Time Frame
Change from 8 weeks to 3 months
Title
Change from Baseline Executive Function at 8 weeks
Description
Trial Making Test, reaction time is recorded, shorter time means better outcome.
Time Frame
Change from baseline to 8 weeks
Title
Change from 8 weeks Executive Function at 3 months
Description
Trial Making Test, reaction time is recorded, shorter time means better outcome.
Time Frame
Change from 8 weeks to 3 months
Title
Change from Baseline Attention at 8 weeks
Description
Letter Cancellation Test, correct rate and time are recorded, higher correct rate and shorter time mean better outcome.
Time Frame
Change from baseline to 8 weeks
Title
Change from 8 weeks Attention at 3 months
Description
Letter Cancellation Test, correct rate and time are recorded, higher correct rate and shorter time mean better outcome.
Time Frame
Change from 8 weeks to 3 months
Title
Change from Baseline Working Memory at 8 weeks
Description
Digit-Span Test, minimum 0, maximum 14, higher scores mean better outcome.
Time Frame
Change from baseline to 8 weeks
Title
Change from 8 weeks Working Memory at 3 months
Description
Digit-Span Test, minimum 0, maximum 14, higher scores mean better outcome.
Time Frame
Change from 8 weeks to 3 months
Title
Change from Baseline Visual-Motor Coordination at 8 weeks
Description
Digit-Symbol-Coding Test, minimum 0, maximum 133, higher scores mean better outcome.
Time Frame
Change from baseline to 8 weeks
Title
Change from 8 weeks Visual-Motor Coordination at 3 months
Description
Digit-Symbol-Coding Test, minimum 0, maximum 133, higher scores mean better outcome.
Time Frame
Change from 8 weeks to 3 months
Title
Change from Baseline Role Functioning at 8 weeks
Description
Role Functioning Scale, minimum 4, maximum 38, higher scores mean better outcome.
Time Frame
Change from baseline to 8 weeks
Title
Change from 8 weeks Role Functioning at 3 months
Description
Role Functioning Scale, minimum 4, maximum 38, higher scores mean better outcome.
Time Frame
Change from 8 weeks to 3 months
Title
Change from Baseline Quality of Life at 8 weeks
Description
The Short Form Health Survey, minimum score 0, and maximum score 100, higher scores mean better outcome.
Time Frame
Change from baseline to 8 weeks
Title
Change from 8 weeks Quality of Life at 3 months
Description
The Short Form Health Survey, minimum score 0, and maximum score 100, higher scores mean better outcome.
Time Frame
Change from 8 weeks to 3 months
Title
Change from Baseline Sleep Quality at 8 weeks
Description
Pittsburg Sleep Quality Index, minimum 0, maximum 21, higher scores mean worse outcome.
Time Frame
Change from baseline to 8 weeks
Title
Change from 8 weeks Sleep Quality at 3 months
Description
Pittsburg Sleep Quality Index, minimum 0, maximum 21, higher scores mean worse outcome.
Time Frame
Change from 8 weeks to 3 months
Title
Change from Baseline Mindfulness Levels at 8 weeks
Description
The Five Facet Mindfulness Questionnaire-Revised, minimum 39, maximum 195, higher scores mean better outcome.
Time Frame
Change from baseline to 8 weeks
Title
Change from 8 weeks Mindfulness Levels at 3 months
Description
The Five Facet Mindfulness Questionnaire-Revised, minimum 39, maximum 195, higher scores mean better outcome.
Time Frame
Change from 8 weeks to 3 months
Other Pre-specified Outcome Measures:
Title
Total attendant classes during the 8-week interventions
Description
The number of classes the participants attended during the 8-week period will be recorded
Time Frame
At 8 weeks
Title
Self-practice time
Description
How much time the participants spend for self-practice at home will be recorded
Time Frame
At 8 weeks
Title
Self-practice time
Description
How much time the participants spend for self-practice at home will be recorded
Time Frame
At 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingxia Lin, PhD
Phone
852-39176311
Email
jxlin@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingxia Lin, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingxia Lin, PhD
Phone
852-39176311
Email
jxlin@hku.hk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Mindfulness-based Intervention for Postnatal Depression

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