Overview

This trial is active, not recruiting.

Conditions depression, anxiety, stress
Treatment mindfulness based cognitive therapy
Sponsor University of Calgary
Collaborator Alberta Centre for Child, Family & Community Research
Start date August 2014
End date April 2017
Trial size 61 participants
Trial identifier NCT02214732, REB13-0860

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
mindfulness based cognitive therapy MBCT
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.
(No Intervention)
Participants in the TAU group access community resources for pregnant women experiencing psychological distress.

Primary Outcomes

Measure
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)

Secondary Outcomes

Measure
Change in Pregnancy Related Anxiety Measure scores from baseline to post-treatment
time frame: Baseline (Week 1), Post-Treatment (Week 10)
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
Change in Positive and Negative Affect Schedule - Extended (PANAS) scores from baseline to 3 months
time frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
Change in Rumination subscale of the Rumination and Reflection Questionnaire scores from baseline to 3 months
time frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
Change in the Five Facet of Mindfulness Questionnaire-Short Form (FFMQ-SF) scores from baseline to 3 months
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
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
time frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
Change in salivary cortisol profile from baseline to 3 months
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
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
time frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
Change in Self-Compassion Scale (SCS) scores from baseline to 3 months
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 Generalized Anxiety Disorder 7-item (GAD-7) scores from baseline to 3 months
time frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title A Randomized Controlled Trial of Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy
Principal investigator Lianne Tomfohr, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Calgary.