Mindfulness and Maternal Mental Health
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|ClinicalTrials.gov Identifier: NCT03026959|
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : March 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mindfulness||Behavioral: Mindfulness||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|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 2019|
|Estimated Study Completion Date :||November 2019|
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.
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.
- 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 ]
- 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 ]
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
|Contact: Carley Pope, M.Afirstname.lastname@example.org|
|Contact: Dwight Mazmanian, Ph.Demail@example.com|
|Thunder Bay, Ontario, Canada, P7B 5E1|
|Contact: Carley J Pope, M.A. 807-632-7264 firstname.lastname@example.org|
|Contact: Dwight Mazmanian, Ph.D. 807-343-8257 email@example.com|
|Principal Investigator: Dwight Mazmanian, Ph.D.|
|Principal Investigator:||Dwight Mazmanian, Ph.D||Lakehead University|