Effectiveness of a Mindfulness and Compassion Intervention for Pregnant Women and Their Partners for the Prevention of Stress and Depression During Pregnancy and Breastfeeding

December 1, 2019 updated by: Javier Garcia Campayo

Effectiveness of a Mindfulness and Compassion Group Intervention Applied to Pregnant Women and Their Partners to Decrease Stress, Negative Affect and Depression During Pregnancy and Breastfeeding. Controlled and Randomized Study

The aim of this study is to assess a mindfulness and compassion group intervention for pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of stress, negative affect and depression in pregnancy and breastfeeding. This group intervention will also be compared with a Treatment as usual (TAU) group consisting in a childbirth education class taught by the Health Center midwife. The principal hypothesis is that the mindfulness and compassion intervention will be more effective than TAU.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of this study is to assess a mindfulness and compassion group intervention for pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of stress, negative affect and depression in pregnancy and breastfeeding.

There will be two groups:

  1. A face to face mindfulness and compassion intervention for pregnant women in their second trimester of pregnancy and their partners in group format (8 weeks) based in the Mindfulness Based Childbirth and Parenting program from Nancy Bardacke. This group will also receive in their third trimester of pregnancy the childbirth education classes taught by midwives (6-8 weeks) that every pregnant woman normally attends to in the National Health Care System in Spain (TAU).
  2. A control group that will receive only the childbirth education class by midwives (TAU) group consisting in a childbirth education class taught by the Health Center midwife at the third trimester of pregnancy.

Each group will be composed of 60 participants with a total sample of 120. The principal hypothesis is that the mindfulness and compassion intervention will be more effective than TAU in the decrease of stress, negative affect and depression and in the increase of positive affect during pregnancy and breastfeeding.

The differences between the intervention and control group will be analyzed. Finally, a qualitative study will be conducted.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valladolid, Spain, 47013
        • Universidad Nacional de Educación a Distancia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Be at least 18 years old
  • Willingness to participate in the study and signing informed consent
  • Ability to understand and write Spanish.
  • Women will be in their 6 to 25 weeks of pregnancy.
  • All women eligible will be accepted with our without their partner.

Exclusion Criteria:

  • Any diagnose of disease that may affect central nervous system (brain pathology, traumatic brain injury, dementia, etc.),
  • Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.),
  • Any medical, infectious or degenerative disease that may affect mood, presence of delusional ideas or hallucinations consistent or not with mood, and suicide risk
  • Currently taking psychopharmacological medication or under psychopharmacological treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
TAU + mindfulness applied face to face 8 sessions of 120 minutes/session Mindfulness and Compassion based intervention applied in groups of 12-15 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months.
Behavioral: Mindfulness
TAU + mindfulness applied face to face 8 sessions of 120 minutes/session Mindfulness and Compassion based intervention applied in groups of 12-15 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months.
No Intervention: No intervention
Usual medical treatment (TAU) In this group the midwife will apply the usual treatment (childbirth education class in the third trimester of pregnancy).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Edinburgh postnatal depression scale (EPDS)
Time Frame: Baseline
In the mindfulness and compassion based intervention group
Baseline
Edinburgh postnatal depression scale (EPDS)
Time Frame: Baseline
In the TAU control group
Baseline
Edinburgh postnatal depression scale (EPDS)
Time Frame: Post-treatment 8 weeks from baseline in intervention group
Post-treatment 8 weeks from baseline in intervention group
Edinburgh postnatal depression scale (EPDS)
Time Frame: Post-treatment 8 weeks from baseline in TAU control group
Post-treatment 8 weeks from baseline in TAU control group
Edinburgh postnatal depression scale (EPDS)
Time Frame: Post-partum 3 months follow up in 8 weeks intervention group
Post-partum 3 months follow up in 8 weeks intervention group
Edinburgh postnatal depression scale (EPDS)
Time Frame: Post-partum 3 months follow up in TAU control group
Post-partum 3 months follow up in TAU control group
Edinburgh postnatal depression scale (EPDS)
Time Frame: Post-partum 6 months follow up in 8 weeks intervention group
Post-partum 6 months follow up in 8 weeks intervention group
Edinburgh postnatal depression scale (EPDS)
Time Frame: Post-partum 6 months follow up in TAU control group
Post-partum 6 months follow up in TAU control group

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sociodemographic data Gender, age, marital status, education, occupation, economical level
Time Frame: Baseline
In the mindfulness-based intervention applied face-to-face and TAU control group
Baseline
M.I.N.I. International Neuropsychiatric Interview
Time Frame: baseline applied in TAU and in intervention group
only if needed
baseline applied in TAU and in intervention group
Client service receipt inventory (CSRI)
Time Frame: Baseline
In the mindfulness-based intervention applied face-to-face and TAU control group
Baseline
Client service receipt inventory (CSRI)
Time Frame: Post-partum 6 months follow up in 8 weeks intervention group
Post-partum 6 months follow up in 8 weeks intervention group
Client service receipt inventory (CSRI)
Time Frame: Post-partum 6 months follow up in TAU control group
Post-partum 6 months follow up in TAU control group
Medical data regarding delivery and breastfeeding
Time Frame: 2 months after delivery
In the mindfulness-based intervention applied face-to-face and TAU control group
2 months after delivery
Perceived Stress Scale (PSS)
Time Frame: Baseline
In the mindfulness and compassion based intervention group
Baseline
Perceived Stress Scale (PSS)
Time Frame: Baseline
In the TAU control group
Baseline
Perceived Stress Scale (PSS)
Time Frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
Post-treatment 8 weeks from baseline in 8 weeks intervention group
Perceived Stress Scale (PSS)
Time Frame: Post-treatment 8 weeks from baseline in TAU control group
Post-treatment 8 weeks from baseline in TAU control group
Perceived Stress Scale (PSS)
Time Frame: Post-partum 3 months follow up in 8 weeks intervention group
Post-partum 3 months follow up in 8 weeks intervention group
Perceived Stress Scale (PSS)
Time Frame: Post-partum 3 months follow up in TAU control group
Post-partum 3 months follow up in TAU control group
Perceived Stress Scale (PSS)
Time Frame: Post-partum 6 months follow up in 8 weeks intervention group
Post-partum 6 months follow up in 8 weeks intervention group
Perceived Stress Scale (PSS)
Time Frame: Post-partum 6 weeks follow up in TAU control group
Post-partum 6 weeks follow up in TAU control group
Positive and negative affect (PANAS)
Time Frame: Baseline
In the mindfulness and compassion based intervention group
Baseline
Positive and negative affect (PANAS)
Time Frame: Baseline
In the TAU control group
Baseline
Positive and negative affect (PANAS)
Time Frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
Post-treatment 8 weeks from baseline in 8 weeks intervention group
Positive and negative affect (PANAS)
Time Frame: Post-treatment 8 weeks from baseline in TAU control group
Post-treatment 8 weeks from baseline in TAU control group
Positive and negative affect (PANAS)
Time Frame: Post-partum 3 months follow up in 8 weeks intervention group
Post-partum 3 months follow up in 8 weeks intervention group
Positive and negative affect (PANAS)
Time Frame: Post-partum 3 months follow up in TAU control group
Post-partum 3 months follow up in TAU control group
Positive and negative affect (PANAS)
Time Frame: Post-partum 6 months follow up in 8 weeks intervention group
Post-partum 6 months follow up in 8 weeks intervention group
Positive and negative affect (PANAS)
Time Frame: Post-partum 6 months follow up in TAU control group
Post-partum 6 months follow up in TAU control group
Five Facets and factors of mindfulness (FFMQ)
Time Frame: Baseline
In the mindfulness and compassion based intervention group
Baseline
Five Facets and factors of mindfulness (FFMQ)
Time Frame: Baseline
In the TAU control group
Baseline
Five Facets and factors of mindfulness (FFMQ)
Time Frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
Post-treatment 8 weeks from baseline in 8 weeks intervention group
Five Facets and factors of mindfulness (FFMQ)
Time Frame: Post-treatment 8 weeks from baseline in TAU control group
Post-treatment 8 weeks from baseline in TAU control group
Five Facets and factors of mindfulness (FFMQ)
Time Frame: Post-partum 3 months follow up in 8 weeks intervention group
Post-partum 3 months follow up in 8 weeks intervention group
Five Facets and factors of mindfulness (FFMQ)
Time Frame: Post-partum 3 months follow up in TAU control group
Post-partum 3 months follow up in TAU control group
Five Facets and factors of mindfulness (FFMQ)
Time Frame: Post-partum 6 months follow up in 8 weeks intervention group
Post-partum 6 months follow up in 8 weeks intervention group
Five Facets and factors of mindfulness (FFMQ)
Time Frame: Post-partum 6 months follow up in TAU control group
Post-partum 6 months follow up in TAU control group
Self Compassion Scale (SCS)
Time Frame: Baseline
In the mindfulness and compassion based intervention group
Baseline
Self Compassion Scale (SCS)
Time Frame: Baseline
In the TAU control group
Baseline
Self Compassion Scale (SCS)
Time Frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
In the mindfulness and compassion based intervention group
Post-treatment 8 weeks from baseline in 8 weeks intervention group
Self Compassion Scale (SCS)
Time Frame: Post-treatment 8 weeks from baseline in TAU control group
Post-treatment 8 weeks from baseline in TAU control group
Self Compassion Scale (SCS)
Time Frame: Post-partum 3 months follow up in 8 weeks intervention group
Post-partum 3 months follow up in 8 weeks intervention group
Self Compassion Scale (SCS)
Time Frame: Post-partum 3 months follow up in TAU control group
Post-partum 3 months follow up in TAU control group
Self Compassion Scale (SCS)
Time Frame: Post-partum 6 months follow up in 8 weeks intervention group
Post-partum 6 months follow up in 8 weeks intervention group
Self Compassion Scale(SCS)
Time Frame: Post-partum 6 months follow up in TAU control group
Post-partum 6 months follow up in TAU control group
Parental Evaluation Scale (EEP)
Time Frame: Post-partum 3 months follow up in 8 weeks intervention group
Post-partum 3 months follow up in 8 weeks intervention group
Parental Evaluation Scale (EEP)
Time Frame: Post-partum 3 months follow up in TAU control group
Post-partum 3 months follow up in TAU control group
Parental Evaluation Scale (EEP)
Time Frame: Post-partum 6 months follow up in 8 weeks intervention group
Post-partum 6 months follow up in 8 weeks intervention group
Parental Evaluation Scale (EEP)
Time Frame: Post-partum 6 months follow up in TAU control group
Post-partum 6 months follow up in TAU control group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Javier Garcia Campayo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad Nacional de Educación a Distancia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 2, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 50/2014/04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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