Mindfulness and Maternal Mental Health

Mindfulness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026959
• Other study ID #: 083 16-17
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: May 2019

Study information

• Verified date: August 2019
• Source: Lakehead University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mindfulness

Intervention

Behavioral:
• Mindfulness
The mindfulness intervention follows the structure described by Short, Mazmanian, Ozen, & Bédard, (2015).

Locations

Country	Name	City	State
Canada	Lakehead University	Thunder Bay	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lakehead University

Country where clinical trial is conducted

Canada, 

References & Publications (7)

Bédard 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edinburgh Postnatal Depression Scale		12 weeks postpartum
Primary	Hospital Anxiety and Depression Scale - Anxiety Subscale		12 weeks postpartum
Primary	Obsessive-Compulsive Inventory-Revised		12 weeks postpartum
Primary	Altman Self-Rating Mania Scale		12 weeks postpartum
Primary	Five Facet Mindfulness Questionnaire		12 weeks postpartum
Secondary	Perceived Stress Scale		12 weeks postpartum
Secondary	Brief Resilience Scale		12 weeks postpartum
Secondary	Postpartum Bonding Questionnaire		12 weeks postpartum
Secondary	World Health Organization Quality of Life Scale		12 weeks postpartum
Secondary	Multidimensional Scale of Perceived Social Support		12 weeks postpartum