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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
61
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.
Riley Park Maternity Clinic
Calgary, Alberta, Canada
University Of Calgary
Calgary, Alberta, Canada
Change in Edinburgh Postpartum Depression Scale scores from baseline to 3 months follow-up postpartum
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.
Time frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum (3 months after the birth of a person's baby)
Change in Pregnancy Related Anxiety Measure scores from baseline to post-treatment
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.
Time frame: Baseline (Week 1), Post-Treatment (Week 10)
Change in Perceived Stress Scale (PSS-10) scores from baseline to 3 months
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
Change in salivary cortisol profile from baseline to 3 months
All samples are assayed for salivary cortisol using a highly sensitive enzyme immunoassay.
Time frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
Change in measures of blood pressure (BP) from baseline to 3 months
BP data will be collected using an automatic, calibrated, oscillometric BP monitor and a BP cuff on the upper part of the dominant arm.
Time frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
Changes in measures of heart rate variability from baseline to 3 months
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.
Time frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
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