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Mindfulness and Maternal Mental Health

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ClinicalTrials.gov Identifier: NCT03026959
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Mindfulness 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Role of Mindfulness Skills Training in Maternal Mental Health: A Randomized Controlled Trial
Study Start Date : November 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Edinburgh Postnatal Depression Scale [ Time Frame: 12 weeks postpartum ]
  2. Hospital Anxiety and Depression Scale - Anxiety Subscale [ Time Frame: 12 weeks postpartum ]
  3. Obsessive-Compulsive Inventory-Revised [ Time Frame: 12 weeks postpartum ]
  4. Altman Self-Rating Mania Scale [ Time Frame: 12 weeks postpartum ]
  5. Five Facet Mindfulness Questionnaire [ Time Frame: 12 weeks postpartum ]

Secondary Outcome Measures :
  1. Perceived Stress Scale [ Time Frame: 12 weeks postpartum ]
  2. Brief Resilience Scale [ Time Frame: 12 weeks postpartum ]
  3. Postpartum Bonding Questionnaire [ Time Frame: 12 weeks postpartum ]
  4. World Health Organization Quality of Life Scale [ Time Frame: 12 weeks postpartum ]
  5. Multidimensional Scale of Perceived Social Support [ Time Frame: 12 weeks postpartum ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant, age 18 years and older, able and willing to attend the study site for the four group sessions, between 14 and 33 weeks gestation (inclusive) as of the first intervention group or comparison group session.

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 use of any psychotropic medication at baseline, 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026959


Contacts
Contact: Carley Pope, M.A 807-632-7264 cpope@lakeheadu.ca
Contact: Dwight Mazmanian, Ph.D 807-343-8257 dwight.mazmanian@lakeheadu.ca

Locations
Canada, Ontario
Lakehead University Recruiting
Thunder Bay, Ontario, Canada, P7B 5E1
Contact: Carley J Pope, M.A.    807-632-7264    cpope@lakeheadu.ca   
Contact: Dwight Mazmanian, Ph.D.    807-343-8257    dwight.mazmanian@lakeheadu.ca   
Principal Investigator: Dwight Mazmanian, Ph.D.         
Sponsors and Collaborators
Lakehead University
Investigators
Principal Investigator: Dwight Mazmanian, Ph.D Lakehead University
More Information

Publications:
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

Responsible Party: Dwight Mazmanian, Associate Professor, Lakehead University
ClinicalTrials.gov Identifier: NCT03026959     History of Changes
Other Study ID Numbers: 083 16-17
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided