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Completed

NCT Number: NCT02214732

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Stress

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Riley Park Maternity Clinic, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Based Cognitive Therapy

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 12, 2014
Registry last updated
Sep 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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