Mindfulness in High Risk Pregnancies

NCT04496115 | Not Yet Recruiting

• 1 other identifier: Pro00102522
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress; Anxiety; Depression; Mindfulness

Keywords

Mindfulness; Antepartum; High Risk Pregnancy

Outcome Measures

Primary Outcomes (4)

• 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 from recruitment to 4 weeks after

• 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 from recruitment to 4 weeks after

• 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 from recruitment to 4 weeks after

• 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.

  Change from recruitment to 4 weeks after

Secondary Outcomes (2)

• Mindfulness practice

  4 weeks

• Gestational age

  variable (less than 20 weeks from recruitment)

Study Arms (2)

Mindfulness Intervention

EXPERIMENTAL

Mindfulness training

Behavioral: Mindfulness

Control

NO INTERVENTION

Standard of Care

Interventions

Mindfulness BEHAVIORAL

Mindfulness training

Mindfulness Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Marc-Antoine Landry, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc-Antoine Landry, MD

CONTACT

780-613-5861; marc-antoine.landry@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 3, 2020
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share