Mindfulness and Maternal Mental Health

The Role of Mindfulness Skills Training in Maternal Mental Health: A Randomized Controlled Trial

There is preliminary empirical support for the use of mindfulness interventions during the perinatal period; suggesting that mindfulness training may be an effective treatment approach for reducing depression and anxiety symptoms during pregnancy and reducing anxiety, stress, and psychological distress during the postpartum period. To extend on these findings, the purpose of this research is to evaluate the effectiveness of a brief mindfulness-based program in protecting maternal mental health and well-being using a randomized controlled trial.

Study Overview

• Status: Completed
• Conditions: Mindfulness
• Intervention / Treatment: Behavioral: Mindfulness

Detailed Description

Based on the results reported in the existing literature that show that formal mindfulness-based practice is effective for improving mental health status and preventing depressive symptom relapse, this research aims to evaluate the effectiveness of a brief mindfulness-based program, offered during pregnancy, in reducing mothers' psychological symptoms during pregnancy and the postpartum period. A brief program has the advantage being more economical to facilitate compared to full-length programs and also requires a shorter commitment from pregnant women, who are also attempting to manage multiple other new and existing demands (e.g., obstetrics appointments, work).

As emerging research suggests that women are particularly vulnerable to increased depressive, anxious, obsessive, compulsive, and hypomanic symptoms during the perinatal period these are the main psychological symptoms that will be assessed. As well, perceived stress and psychological resiliency will also be assessed for in order to examine changes in these domains in relation to mindfulness engagement. Furthermore, as a reduction in maternal psychological symptoms has been reported to have implications for mother-infant bond, the mother's interpersonal functioning, and maternal quality of life, the investigators will also assess to see if there are corresponding changes in these domains related to mindfulness engagement.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Thunder Bay, Ontario, Canada, P7B 5E1
      • Lakehead University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• pregnant, age 18 years and older, able and willing to attend the study site for the four group sessions.

Exclusion Criteria:

• presence of a current severe mental health condition or mental heath difficulties that would be better addressed through another form of therapy, active major medical illness including significant obstetric complications, inability to give informed consent, inability to speak or understand English, at high risk for delivery before reaching full term (38 weeks gestation), or previous completion of a structured mindfulness-based program.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mindfulness Group; Participants assigned to the mindfulness group will attend four weekly sessions that are each 1.5 hours in length. The sessions will follow the structure described by Short, Mazmanian, Ozen, & Bédard (2015). The structure is designed to first enhance learners' foundation skills in mindfulness and progresses into teaching learners more advanced mindfulness skills.	Behavioral: Mindfulness; The mindfulness intervention follows the structure described by Short, Mazmanian, Ozen, & Bédard, (2015).
NO_INTERVENTION: Social (control) Group; Participants assigned to the social group will also attend four weekly sessions that are each 1.5 hours in length. Each session will have participants focus on a creative tasks while permitting task related discussion. In this way the format is designed to parallel the mindfulness group, where participants engage in a new activity each week and have an opportunity to discuss the activities with the group without engaging in any formal intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Edinburgh Postnatal Depression Scale	12 weeks postpartum
Hospital Anxiety and Depression Scale - Anxiety Subscale	12 weeks postpartum
Obsessive-Compulsive Inventory-Revised	12 weeks postpartum
Altman Self-Rating Mania Scale	12 weeks postpartum
Five Facet Mindfulness Questionnaire	12 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Time Frame
Perceived Stress Scale	12 weeks postpartum
Brief Resilience Scale	12 weeks postpartum
Postpartum Bonding Questionnaire	12 weeks postpartum
World Health Organization Quality of Life Scale	12 weeks postpartum
Multidimensional Scale of Perceived Social Support	12 weeks postpartum

Collaborators and Investigators

• Sponsor: Lakehead University
• Investigators: Principal Investigator: Dwight Mazmanian, Ph.D, Lakehead University

Publications and helpful links

General Publications

• Bedard M, Felteau M, Marshall S, Cullen N, Gibbons C, Dubois S, Maxwell H, Mazmanian D, Weaver B, Rees L, Gainer R, Klein R, Moustgaard A. Mindfulness-based cognitive therapy reduces symptoms of depression in people with a traumatic brain injury: results from a randomized controlled trial. J Head Trauma Rehabil. 2014 Jul-Aug;29(4):E13-22. doi: 10.1097/HTR.0b013e3182a615a0.
• Davey HL, Tough SC, Adair CE, Benzies KM. Risk factors for sub-clinical and major postpartum depression among a community cohort of Canadian women. Matern Child Health J. 2011 Oct;15(7):866-75. doi: 10.1007/s10995-008-0314-8. Epub 2008 Feb 7.
• Helmes E, Ward BG. Mindfulness-based cognitive therapy for anxiety symptoms in older adults in residential care. Aging Ment Health. 2017 Mar;21(3):272-278. doi: 10.1080/13607863.2015.1111862. Epub 2015 Nov 13.
• O'Hara MW, Wisner KL. Perinatal mental illness: definition, description and aetiology. Best Pract Res Clin Obstet Gynaecol. 2014 Jan;28(1):3-12. doi: 10.1016/j.bpobgyn.2013.09.002. Epub 2013 Oct 7.
• Pope CJ, Sharma V, Mazmanian D. Recognition, diagnosis and treatment of postpartum bipolar depression. Expert Rev Neurother. 2014 Jan;14(1):19-28. doi: 10.1586/14737175.2014.846219. Epub 2013 Nov 26.
• Russell EJ, Fawcett JM, Mazmanian D. Risk of obsessive-compulsive disorder in pregnant and postpartum women: a meta-analysis. J Clin Psychiatry. 2013 Apr;74(4):377-85. doi: 10.4088/JCP.12r07917.
• Short MM, Mazmanian D, Ozen LJ, Bédard M. Four days of mindfulness meditation training for graduate students: A pilot study examining effects on mindfulness, self-regulation, and executive function. J Contemplative Inq. 2015; 2(1). http://journal.contemplativeinquiry.org/index.php/joci/article/view/13

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ACTUAL): May 1, 2019
• Study Completion (ACTUAL): May 1, 2019

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: January 18, 2017
• First Posted (ESTIMATE): January 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 083 16-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO