Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy

September 13, 2018 updated by: Lianne Tomfohr-Madsen, University of Calgary

A Randomized Controlled Trial of Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy

Anxiety, stress and depression are common during pregnancy and in the postpartum period. The lack of empirically supported, non-pharmaceutical interventions for psychological distress in pregnancy is a significant gap in the literature, especially given many pregnant women's preference for non-pharmaceutical treatments. This study will evaluate the efficacy of Mindfulness Based Cognitive Therapy (MBCT) program in reducing measures of psychological distress (e.g., symptoms of stress, depression and anxiety) in a group of pregnant women endorsing high levels of distress.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • 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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • University of Calgary
      • Calgary, Alberta, Canada, T2N 1B9
        • Riley Park Maternity Clinic

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Eligible women for this study

  • are between 12 and 28 weeks of gestation,
  • are experiencing psychological distress (elevated perinatal anxiety, mild depressive symptoms, or high-levels of self-reported stress)

Exclusion Criteria:

  • current suicidality
  • current substance abuse or dependence
  • experience a current major depressive episode
  • have been diagnosed with bipolar disorder or other disorders that have a psychotic, dissociative, hallucinatory, or delusional component
  • taking prescribed medications that affect sleep or mood

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MBCT + Treatment as Usual (TAU)

Behavioural: Mindfulness Based Cognitive Therapy

Participants in the MBCT group attend an 8 week course of a modified MBCT program for pregnant women, delivered by a licensed clinical psychologist.
Behavioral: Mindfulness Based Cognitive Therapy
The modified MBCT program for pregnant women is an 8-session group intervention that aims to help women change their relationship to the thoughts, feelings, and bodily sensations that can lead to psychological distress. Participants are guided to recognize and disengage from unhelpful mind states characterized by self-perpetuating patterns of ruminative thought. The intervention was modified to address pregnant women's physical and emotional needs, as well as their risk of perinatal mood episodes.
Other Names:
  • MBCT
No Intervention: Treatment as Usual (TAU)
Participants in the TAU group access community resources for pregnant women experiencing psychological distress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Edinburgh Postpartum Depression Scale scores from baseline to 3 months follow-up postpartum
Time Frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum (3 months after the birth of a person's baby)
Symptoms of depression will be assessed using the 10-item, self-report Edinburgh Postpartum Depression Scale (EPDS). The EPDS has been validated against interview schedules and other self-report instruments.
Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum (3 months after the birth of a person's baby)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pregnancy Related Anxiety Measure scores from baseline to post-treatment
Time Frame: Baseline (Week 1), Post-Treatment (Week 10)
The Pregnancy Anxiety Measure, a 10-item instrument will be used to examine the extent to which women are worried about their own and baby's health, labour, delivery and caring their new baby.
Baseline (Week 1), Post-Treatment (Week 10)
Change in Perceived Stress Scale (PSS-10) scores from baseline to 3 months
Time Frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
This questionnaire will be used in assessing the perception of stress. The questions are in regards to participant's feelings and thoughts during the previous month. It was designed to be used in community samples. The items are assessing perceived helplessness and self-efficacy.
Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to 3 months
Time Frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
The PSQI instrument will be used in assessing participant's sleep quality. There are seven components of the PSQI and these are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction.
Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months
Time Frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
Actigraphy monitoring provides objective information on circadian rhythm amplitude, acrophase, as well as indices of sleep efficiency, sleep latency, total sleep time, and number and frequency of awakenings. The use of actigraphy has been demonstrated sensitive to treatment effects, while being less costly and intrusive than polysomnography.
Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
Change in salivary cortisol profile from baseline to 3 months
Time Frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
All samples are assayed for salivary cortisol using a highly sensitive enzyme immunoassay.
Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
Change in measures of blood pressure (BP) from baseline to 3 months
Time Frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
BP data will be collected using an automatic, calibrated, oscillometric BP monitor and a BP cuff on the upper part of the dominant arm.
Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
Changes in measures of heart rate variability from baseline to 3 months
Time Frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
Measures of heart rate (bpm) will be recorded noninvasively using a HIC-2000 Bio-electric Impedance Cardiograph and the Cardiac Output Program, developed by Bio-Impedance Technology.
Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum

Collaborators and Investigators

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

Sponsor

University of Calgary

Collaborators

Alberta Centre for Child, Family & Community Research
Alberta Family Wellness Initiative

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

August 1, 2014

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

August 8, 2014

First Posted (Estimate)

August 12, 2014

Study Record Updates

Last Update Posted (Actual)

September 14, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB13-0860

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.

Clinical Trials on Depression

Clinical Trials on Mindfulness Based Cognitive Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe