Clinical trial NCT02214732: Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy
Official title: A Randomized Controlled Trial of Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Stress
Keywords: Pregnancy
Postpartum
Mindfulness Based Cognitive Therapy
Depression
Anxiety
Stress
MBCT
Actigraphy
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Centre for Child, Family & Community Research
name: Alberta Family Wellness Initiative
First posted: 2014-08-12
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Edinburgh Postpartum Depression Scale scores from baseline to 3 months follow-up postpartum
timeFrame: 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
timeFrame: Baseline (Week 1), Post-Treatment (Week 10)
measure: Change in Perceived Stress Scale (PSS-10) scores from baseline to 3 months
timeFrame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
measure: Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to 3 months
timeFrame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
measure: Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months
timeFrame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
measure: Change in salivary cortisol profile from baseline to 3 months
timeFrame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
measure: Change in measures of blood pressure (BP) from baseline to 3 months
timeFrame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
measure: Changes in measures of heart rate variability from baseline to 3 months
timeFrame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Riley Park Maternity Clinic
state: Alberta
city: Calgary
country: Canada
facility: University Of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Lianne Tomfohr-Madsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.