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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):

December 1, 2016
January 20, 2017
January 20, 2017
November 2016
November 2018   (Final data collection date for primary outcome measure)
  • Edinburgh Postnatal Depression Scale [ Time Frame: 12 weeks postpartum ]
  • Hospital Anxiety and Depression Scale - Anxiety Subscale [ Time Frame: 12 weeks postpartum ]
  • Obsessive-Compulsive Inventory-Revised [ Time Frame: 12 weeks postpartum ]
  • Altman Self-Rating Mania Scale [ Time Frame: 12 weeks postpartum ]
  • Five Facet Mindfulness Questionnaire [ Time Frame: 12 weeks postpartum ]
Same as current
No Changes Posted
  • Perceived Stress Scale [ Time Frame: 12 weeks postpartum ]
  • Brief Resilience Scale [ Time Frame: 12 weeks postpartum ]
  • Postpartum Bonding Questionnaire [ Time Frame: 12 weeks postpartum ]
  • World Health Organization Quality of Life Scale [ Time Frame: 12 weeks postpartum ]
  • Multidimensional Scale of Perceived Social Support [ Time Frame: 12 weeks postpartum ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Mindfulness
Behavioral: Mindfulness
The mindfulness intervention follows the structure described by Short, Mazmanian, Ozen, & Bédard, (2015).
  • 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.
    Intervention: Behavioral: Mindfulness
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
124
November 2018
November 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact: Carley Pope, M.A 807-632-7264 cpope@lakeheadu.ca
Contact: Dwight Mazmanian, Ph.D 807-343-8257 dwight.mazmanian@lakeheadu.ca
Canada
 
 
NCT03026959
083 16-17
No
Not Provided
Plan to Share IPD: Undecided
Dwight Mazmanian, Lakehead University
Lakehead University
Not Provided
Principal Investigator: Dwight Mazmanian, Ph.D Lakehead University
Lakehead University
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP