Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy
A Randomized Controlled Trial of Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy
1 other identifier
interventional
61
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
Started Aug 2014
Typical duration for not_applicable depression
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 7, 2014
CompletedFirst Posted
Study publicly available on registry
August 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedSeptember 14, 2018
September 1, 2018
2.7 years
August 7, 2014
September 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum (3 months after the birth of a person's baby)
Secondary Outcomes (7)
Change in Pregnancy Related Anxiety Measure scores from baseline to post-treatment
Baseline (Week 1), Post-Treatment (Week 10)
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 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 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 salivary cortisol profile from baseline to 3 months
Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
- +2 more secondary outcomes
Study Arms (2)
MBCT + Treatment as Usual (TAU)
EXPERIMENTALBehavioural: 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.
Treatment as Usual (TAU)
NO INTERVENTIONParticipants in the TAU group access community resources for pregnant women experiencing psychological distress.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Alberta Centre for Child, Family & Community Researchcollaborator
- Alberta Family Wellness Initiativecollaborator
Study Sites (2)
Riley Park Maternity Clinic
Calgary, Alberta, T2N 1B9, Canada
University Of Calgary
Calgary, Alberta, T2N 1N4, Canada
Related Publications (1)
Tomfohr-Madsen LM, Campbell TS, Giesbrecht GF, Letourneau NL, Carlson LE, Madsen JW, Dimidjian S. Mindfulness-based cognitive therapy for psychological distress in pregnancy: study protocol for a randomized controlled trial. Trials. 2016 Oct 13;17(1):498. doi: 10.1186/s13063-016-1601-0.
PMID: 27737714DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lianne Tomfohr-Madsen, PhD
University of Calgary
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Psychology
Study Record Dates
First Submitted
August 7, 2014
First Posted
August 12, 2014
Study Start
August 1, 2014
Primary Completion
April 1, 2017
Study Completion
September 1, 2017
Last Updated
September 14, 2018
Record last verified: 2018-09