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Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy

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ClinicalTrials.gov Identifier: NCT02214732
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : September 14, 2018
Sponsor:
Collaborators:
Alberta Centre for Child, Family & Community Research
Alberta Family Wellness Initiative
Information provided by (Responsible Party):
Lianne Tomfohr-Madsen, University of Calgary

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Stress Behavioral: Mindfulness Based Cognitive Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy
Study Start Date : August 2014
Actual Primary Completion Date : April 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: MBCT

No Intervention: Treatment as Usual (TAU)
Participants in the TAU group access community resources for pregnant women experiencing psychological distress.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214732


Locations
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Canada, Alberta
Riley Park Maternity Clinic
Calgary, Alberta, Canada, T2N 1B9
University Of Calgary
Calgary, Alberta, Canada, T2N 1N4
Sponsors and Collaborators
University of Calgary
Alberta Centre for Child, Family & Community Research
Alberta Family Wellness Initiative
Investigators
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Principal Investigator: Lianne Tomfohr-Madsen, PhD University of Calgary

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lianne Tomfohr-Madsen, Assistant Professor of Psychology, University of Calgary
ClinicalTrials.gov Identifier: NCT02214732    
Other Study ID Numbers: REB13-0860
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Keywords provided by Lianne Tomfohr-Madsen, University of Calgary:
Pregnancy
Postpartum
Mindfulness Based Cognitive Therapy
Depression
Anxiety
Stress
MBCT
Actigraphy
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms