Mindfulness and Maternal Mental Health

Sponsor
Lakehead University (Other)
Overall Status
Completed
CT.gov ID
NCT03026959
Collaborator
(none)
38
1
2
29.9
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
The Role of Mindfulness Skills Training in Maternal Mental Health: A Randomized Controlled Trial
Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
May 1, 2019
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
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.

Behavioral: Mindfulness
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.

Outcome Measures

Primary Outcome Measures

  1. Edinburgh Postnatal Depression Scale [12 weeks postpartum]

  2. Hospital Anxiety and Depression Scale - Anxiety Subscale [12 weeks postpartum]

  3. Obsessive-Compulsive Inventory-Revised [12 weeks postpartum]

  4. Altman Self-Rating Mania Scale [12 weeks postpartum]

  5. Five Facet Mindfulness Questionnaire [12 weeks postpartum]

Secondary Outcome Measures

  1. Perceived Stress Scale [12 weeks postpartum]

  2. Brief Resilience Scale [12 weeks postpartum]

  3. Postpartum Bonding Questionnaire [12 weeks postpartum]

  4. World Health Organization Quality of Life Scale [12 weeks postpartum]

  5. Multidimensional Scale of Perceived Social Support [12 weeks postpartum]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lakehead University Thunder Bay Ontario Canada P7B 5E1

Sponsors and Collaborators

  • Lakehead University

Investigators

  • Principal Investigator: Dwight Mazmanian, Ph.D, Lakehead University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dwight Mazmanian, Professor, Lakehead University
ClinicalTrials.gov Identifier:
NCT03026959
Other Study ID Numbers:
  • 083 16-17
First Posted:
Jan 20, 2017
Last Update Posted:
Aug 13, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No

Study Results

No Results Posted as of Aug 13, 2019