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Mindfulness in High Risk Pregnancies

Primary Purpose

Stress, Anxiety, Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress focused on measuring Mindfulness, Antepartum, High Risk Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pregnant mothers admitted to the antepartum ward at the Lois Hole Hospital for risk of preterm delivery (< 34 weeks GA) are eligible for the study.
  • if they speak, read and write English,
  • if their inpatient stay is anticipated to be at least 4 weeks following recruitment
  • if they are willing and able to attend the mindfulness sessions.

Exclusion Criteria:

  • if they are experiencing current mental illness issues
  • if they are experiencing current or prior substance abuse

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Mindfulness Intervention

    Control

    Arm Description

    Mindfulness training

    Standard of Care

    Outcomes

    Primary Outcome Measures

    Change in stress symptoms
    using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of stress symptoms. Minimum score is 0. Maximum score is 21.
    Change in anxiety symptoms
    using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). Minimum score is 0. Maximum score is 21. And using the Pregnancy Related Anxiety Scale. Scores for individual question range from 1 (Not at all) to 5 (Very much). Minimum score is 10. Maximum score is 50. A high score in both scales means a high level of anxiety symptoms.
    Change in depression symptoms
    using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of depression symptoms. Minimum score is 0. Maximum score is 21.
    Change in mindful awareness
    using the Mindfulness Attention Awareness Scale. Scores for individual question range from 1 (Almost Never) to 6 (Almost Always). Minimum score is 15. Maximum score is 90. And using Toronto Mindfulness Scale. Scores for individual question range from 0 (Not at all) to 4 (Very much). This scale has 2 subscales. Minimum score is 0. Maximum score is 24 for the first subscale and 28 for the second subscale. A high score in both scales (and subscales)means a high mindful awareness level.

    Secondary Outcome Measures

    Mindfulness practice
    Duration of mindfulness practice
    Gestational age
    Gestational age of the newborn (in weeks and days) at the time of delivery

    Full Information

    First Posted
    July 28, 2020
    Last Updated
    December 16, 2022
    Sponsor
    University of Alberta
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04496115
    Brief Title
    Mindfulness in High Risk Pregnancies
    Official Title
    The Impact of Mindfulness on Prenatal Depression, Anxiety and Stress in Mothers at Risk of Preterm Delivery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Alberta

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Anxiety, depression and stress are common during pregnancy. These have been found to negatively impact mother and child outcomes. When anxiety, depression, and stress are present in pregnant women, it is therefore important to manage them to improve the outcome of the mother and her child. Although pregnancy itself has been shown to increase anxiety, depression and stress, these issues are further elevated in high-risk pregnancy groups. Mothers at risk of preterm delivery (less than 37 weeks gestational age), have been found to have higher rates of depression, anxiety and stress compared to uncomplicated term pregnancies. In addition, anxiety, depression and stress symptoms themselves increase the risk for preterm delivery, creating a vicious cycle for this high-risk group. Mindfulness is a tool that has been during pregnancy to reduce depression, anxiety, and stress. Many studies have found mindfulness to be an appropriate management option in normal term pregnancies. To date, there have been no studies that have looked at Mindfulness as a tool for mothers admitted due to risk of preterm delivery. This study will explore the impact of teaching mindfulness skills to inpatient mothers at risk of preterm delivery and studying its effects on maternal depression, anxiety, and stress. This study involves providing Mindfulness strategies during the mother's inpatient admission for the risk of preterm delivery for four consecutive weeks. Participants will be enrolled through informed consent. All participants will be given pre and post participation questionnaires to examine the impact of mindfulness on anxiety, depression and stress. The participants will also be encouraged to maintain a weekly mindfulness log. The results of this research may lead to future studies looking at the impact of mindfulness practice for high-risk pregnancies. This will also help open up the possibility of offering such courses for inpatient and outpatient high-risk pregnancies in the future.
    Detailed Description
    BACKGROUND Anxiety and depression are two of the most common psychological symptoms that manifest in pregnant women. A recent systematic review found the prevalence of prenatal anxiety to be 18.2% in the first trimester, 19.1% in the second trimester and 24.6% in the third trimester. A separate systematic review found rates of depression in the prenatal period to be 16.4%. These symptoms have been found to negatively impact maternal health as well as fetal and childhood development. It is therefore imperative that anxiety and depression be assessed in all pregnant mothers and to further implement interventions to improve outcomes for both the mother and fetus. Pregnant mothers with admission to an inpatient ward due to increased risk for preterm delivery have been found to experience elevated levels of anxiety, depression and stress compared to term pregnancies. Furthermore, increased anxiety and depression have been linked to the risk of preterm labor, creating a vicious cycle. A 2017 study that assessed anxiety and depression in a population of pregnant mothers at risk of preterm labor found 35.1% to have anxiety and 69.8% having depressive symptoms. By managing the psychological symptoms experienced in this cohort of pregnant mothers, the rationale is that the risks associated with them might be reduced, providing improved maternal and fetal outcomes. There have been several studies that have assessed the benefits of mindfulness as a tool in reducing anxiety, stress and depression specifically in pregnancy. A 2016 meta-analysis found that mindfulness-based interventions are effective at reducing pregnancy related depression, stress, and anxiety. A randomized controlled trial assessed pregnant women with high levels of stress and anxiety after six weeks of mindfulness practice with results demonstrating larger decreases in pregnancy specific anxiety as compared to the control group. Mindfulness has been implemented as an intervention prior to delivery with encouraging results. It has also been used in the post-partum period in environments such as the Neonatal Intensive Care Unit (NICU), where parental anxiety, depression and stress are elevated due to admission of their newborn after birth. Recent studies have shown that when mindfulness is used in the NICU environment, it assists with reduction of depressive, anxiety and trauma symptoms as well as improving maternal sleep Mindfulness also helped mothers deal with acute stressors more appropriately and promoted awareness and reduced stress related emotions. To date, there have been no studies that have looked at Mindfulness as a tool for mothers admitted due to risk of preterm delivery. The study being proposed here, would assess the impact of mindfulness in the prenatal period, in a group of mothers who are experiencing elevated levels of depression, anxiety and stress due to the risk of preterm delivery. HYPOTHESIS The investigators hypothesize that pregnant women will experience less depression, anxiety and stress with mindfulness and will increase their mindful awareness. MATERIALS AND METHODS This study is a non blinded, prospective randomized controlled trial. Following recruitment of participants, randomization into either the mindfulness group or the control group will occur. Mindfulness Group (MG) Participants within the mindfulness group will be instructed by a mindfulness practitioner/coach once a week for four weeks in one-on-one sessions. Weekly journals will be provided to measure adherence. Optional mindfulness audio files may be used to continue mindfulness practice in between guided mindfulness sessions. Control Group (CG) Participants within the control group will receive care as usual without any additional mindfulness techniques provided during the four-week period. Instruments General Demographic Form: A researcher created maternal demographic data form (age, educational level, number of gestations, parity, prior experience with mindfulness, history of depression and anxiety) to be completed by the mother at enrolment. Depression, Anxiety and Stress Scale: 21 item Depression, Anxiety, Stress Scale to be completed by the mother at enrolment and at the end of the four weeks. Pregnancy Related Anxiety Scale: 10 item Pregnancy Related Anxiety Scale to be completed by the mother at enrolment and at the end of the four weeks. Mindfulness Scales: 15 item Mindfulness Attention Awareness Scale and the 13 item Toronto Mindfulness Scale will be completed by the mother at enrolment and at the end of the four weeks. Mindfulness Weekly Journal: Document recording the duration of mindfulness practice every day during the four-week intervention to assess adherence. COVID-19 info There will be in-person recruitment and data collection, but all in-person interactions will be put on hold until social distancing requirements have been lifted. DATA ANALYSIS Study data will be managed using Research Electronic Data Capture, a secure, web-based software platform, hosted at the University of Alberta. Group demographics were compared with t-test, chi-square and Mann-Whitney U as appropriate. The scores of the four questionnaires will be analyzed with the Wilcoxon Signed-Rank test for within group comparison and the Mann-Whitney U test for between group comparisons. The Spearman correlation test will be used in the mindfulness group for correlation between the mindfulness scores and the stress, anxiety and depression scores. 2-tailed p-values will be used.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress, Anxiety, Depression, Mindfulness
    Keywords
    Mindfulness, Antepartum, High Risk Pregnancy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mindfulness Intervention
    Arm Type
    Experimental
    Arm Description
    Mindfulness training
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Standard of Care
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness
    Intervention Description
    Mindfulness training
    Primary Outcome Measure Information:
    Title
    Change in stress symptoms
    Description
    using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of stress symptoms. Minimum score is 0. Maximum score is 21.
    Time Frame
    Change from recruitment to 4 weeks after
    Title
    Change in anxiety symptoms
    Description
    using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). Minimum score is 0. Maximum score is 21. And using the Pregnancy Related Anxiety Scale. Scores for individual question range from 1 (Not at all) to 5 (Very much). Minimum score is 10. Maximum score is 50. A high score in both scales means a high level of anxiety symptoms.
    Time Frame
    Change from recruitment to 4 weeks after
    Title
    Change in depression symptoms
    Description
    using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of depression symptoms. Minimum score is 0. Maximum score is 21.
    Time Frame
    Change from recruitment to 4 weeks after
    Title
    Change in mindful awareness
    Description
    using the Mindfulness Attention Awareness Scale. Scores for individual question range from 1 (Almost Never) to 6 (Almost Always). Minimum score is 15. Maximum score is 90. And using Toronto Mindfulness Scale. Scores for individual question range from 0 (Not at all) to 4 (Very much). This scale has 2 subscales. Minimum score is 0. Maximum score is 24 for the first subscale and 28 for the second subscale. A high score in both scales (and subscales)means a high mindful awareness level.
    Time Frame
    Change from recruitment to 4 weeks after
    Secondary Outcome Measure Information:
    Title
    Mindfulness practice
    Description
    Duration of mindfulness practice
    Time Frame
    4 weeks
    Title
    Gestational age
    Description
    Gestational age of the newborn (in weeks and days) at the time of delivery
    Time Frame
    variable (less than 20 weeks from recruitment)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pregnant mothers admitted to the antepartum ward at the Lois Hole Hospital for risk of preterm delivery (< 34 weeks GA) are eligible for the study. if they speak, read and write English, if their inpatient stay is anticipated to be at least 4 weeks following recruitment if they are willing and able to attend the mindfulness sessions. Exclusion Criteria: if they are experiencing current mental illness issues if they are experiencing current or prior substance abuse
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marc-Antoine Landry, MD
    Phone
    780-613-5861
    Email
    marc-antoine.landry@ualberta.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marc-Antoine Landry, MD
    Organizational Affiliation
    University of Alberta
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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