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Clinical Trials/NCT03026959
NCT03026959
Completed
N/A

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

Lakehead University1 site in 1 country38 target enrollmentNovember 2016
ConditionsMindfulness

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mindfulness
Sponsor
Lakehead University
Enrollment
38
Locations
1
Primary Endpoint
Altman Self-Rating Mania Scale
Status
Completed
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
May 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dwight Mazmanian

Professor

Lakehead University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Altman Self-Rating Mania Scale

Time Frame: 12 weeks postpartum

Obsessive-Compulsive Inventory-Revised

Time Frame: 12 weeks postpartum

Edinburgh Postnatal Depression Scale

Time Frame: 12 weeks postpartum

Five Facet Mindfulness Questionnaire

Time Frame: 12 weeks postpartum

Hospital Anxiety and Depression Scale - Anxiety Subscale

Time Frame: 12 weeks postpartum

Secondary Outcomes

  • Perceived Stress Scale(12 weeks postpartum)
  • Postpartum Bonding Questionnaire(12 weeks postpartum)
  • World Health Organization Quality of Life Scale(12 weeks postpartum)
  • Brief Resilience Scale(12 weeks postpartum)
  • Multidimensional Scale of Perceived Social Support(12 weeks postpartum)

Study Sites (1)

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