Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy

Not Applicable

Completed

• Conditions: Anxiety; Depression; Stress
• Interventions: Behavioral: Mindfulness Based Cognitive Therapy

• Registration Number: NCT02214732
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2014-08-08
• Study First Posted: 2014-08-12
• Primary Completion: 2017-04
• Study Completion: 2017-09
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MBCT + Treatment as Usual (TAU)	Mindfulness Based Cognitive Therapy	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.

Primary Outcome Measures

Name	Time	Method
Change in Edinburgh Postpartum Depression Scale scores from baseline to 3 months follow-up postpartum	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

Name	Time	Method
Change in Perceived Stress Scale (PSS-10) scores from baseline to 3 months	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.
Change in measures of blood pressure (BP) from baseline to 3 months	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.
Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months	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.
Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to 3 months	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.
Change in salivary cortisol profile from baseline to 3 months	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.
Changes in measures of heart rate variability from baseline to 3 months	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.
Change in Pregnancy Related Anxiety Measure scores from baseline to post-treatment	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.

Trial Locations

Locations (2)

Riley Park Maternity Clinic; 🇨🇦 Calgary, Alberta, Canada

University Of Calgary; 🇨🇦 Calgary, Alberta, Canada