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OpenTrials
Completed

NCT Number: NCT03026959

Mindfulness and Maternal Mental Health

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lakehead University

Thunder Bay, Ontario, P7B 5E1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Lakehead University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 20, 2017
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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