A Randomized Controlled Trial of Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- University of Calgary
- Enrollment
- 61
- Locations
- 2
- Primary Endpoint
- Change in Edinburgh Postpartum Depression Scale scores from baseline to 3 months follow-up postpartum
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Lianne Tomfohr-Madsen
Assistant Professor of Psychology
University of Calgary
Eligibility 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
Outcomes
Primary Outcomes
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
- 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)
- Change in measures of blood pressure (BP) from baseline to 3 months(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(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(Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum)
- Change in salivary cortisol profile from baseline to 3 months(Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum)
- Changes in measures of heart rate variability from baseline to 3 months(Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum)
- Change in Pregnancy Related Anxiety Measure scores from baseline to post-treatment(Baseline (Week 1), Post-Treatment (Week 10))