50 Participants Needed

Mindfulness for Postpartum Anxiety

Recruiting at 1 trial location
SM
ZB
Overseen ByZoryana Babiy, M.Sc.
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: St. Joseph's Healthcare Hamilton
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a 4-week mindfulness program (mindfulness-based intervention) can help new mothers feel less anxious and more in tune with their bodies after giving birth. It focuses on improving emotion regulation (the ability to manage emotions) and bodily awareness (understanding signals in the body, like a fast heartbeat), which often challenge mothers with postpartum anxiety. Participants will complete surveys and undergo brain scans before and after the program to measure changes. This study suits mothers within a year of giving birth who have anxiety but are not currently in therapy or taking changing medications. As an unphased trial, it offers new mothers the opportunity to explore innovative ways to manage postpartum anxiety and enhance well-being.

What prior data suggests that this mindfulness-based intervention is safe for postpartum anxiety?

Research shows that mindfulness-based programs can be safe and well-tolerated for new mothers. These programs have been found to help reduce stress and anxiety, which is important for postpartum women. For instance, one study found that these programs helped lower feelings of stress and depression. Another study reported that they could ease symptoms of anxiety and depression, especially helping to prevent postpartum depression.

While specific data on negative effects from these programs is lacking, existing research suggests they are generally safe. The mindfulness approach used in these studies did not report significant negative effects, making it a promising option for managing postpartum anxiety.12345

Why are researchers excited about this trial?

Researchers are excited about using a mindfulness-based intervention for postpartum anxiety because it offers a drug-free approach to managing symptoms. Unlike medications such as antidepressants or anti-anxiety drugs, which can have side effects and require time to adjust, mindfulness practices empower individuals to manage anxiety through mental exercises and awareness techniques. This approach not only helps in reducing anxiety but also promotes overall well-being and can be easily incorporated into daily routines. Plus, the potential for immediate implementation and personal empowerment makes mindfulness a promising alternative or complement to traditional treatments.

What evidence suggests that this mindfulness-based intervention might be an effective treatment for postpartum anxiety?

Research has shown that mindfulness-based practices can significantly reduce anxiety, worry, and depression in new mothers. One study found that these practices led to a noticeable drop in anxiety levels. Other studies have demonstrated that mindfulness can enhance self-kindness and mental health, particularly for those who might be more vulnerable. This trial will evaluate a 4-week mindfulness intervention, which participants may receive, to assess its effectiveness in managing postpartum anxiety. This approach is promising because it helps individuals manage emotions better and become more aware of their body's signals, making mindfulness a comprehensive option for addressing both mental and physical symptoms of postpartum anxiety.16789

Who Is on the Research Team?

SM

Sheryl M Green, Ph.D., C.Psych

Principal Investigator

St. Joseph's Healthcare Hamilton

BN

Benicio N Frey, MD, PhD, FRCPC

Principal Investigator

St. Joseph's Healthcare Hamilton

ZB

Zoryana Babiy, M.Sc.

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for new mothers experiencing postpartum anxiety. Participants should be in the first year after delivery and struggling with emotional regulation or recognizing physical signs of anxiety. The study involves brain imaging, so those eligible must be comfortable with undergoing fMRI scans.

Inclusion Criteria

Fluent in English, minimal grade 8 reading level
I am a mother or birthing parent over 18 and within 12 months after giving birth.
My mental health medications have been stable for at least 8 weeks.
See 2 more

Exclusion Criteria

Women with psychotic or current alcohol or substance use disorders
Suffering from severe claustrophobia
Metallic objects in body (metal implants, pacemakers)
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mindfulness Intervention

Participants undergo a 4-week mindfulness intervention targeting anxiety symptoms, emotion regulation, and bodily awareness

4 weeks
Self-report questionnaires and brain imaging at enrolment and immediately post-intervention

Follow-up

Participants are monitored for improvements in anxiety symptoms, emotion regulation, and bodily awareness

4 weeks
Self-report questionnaires administered 4 weeks post-intervention

What Are the Treatments Tested in This Trial?

Interventions

  • Mindfulness-based Intervention
Trial Overview The trial tests a 4-week mindfulness-based intervention aimed at improving symptoms of postpartum anxiety, emotional regulation, and bodily awareness. It includes self-report questionnaires and fMRI to assess changes before and after the intervention, as well as follow-up evaluations.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: 4-week mindfulness interventionExperimental Treatment1 Intervention
Group II: Waitlist treatment as usual controlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials
203
Recruited
26,900+

Citations

Postpartum Outcomes and Formal Mindfulness Practice in ...Completers showed statistically and clinically significant improvements in anxiety, worry and depression, and significant increases in self-compassion and ...
Using an Electronic Mindfulness-based Intervention (eMBI) ...Several earlier studies have found mindfulness-based interventions to be effective in reducing mental distress in pregnant women, especially in those at risk ...
Efficacy of mindfulness-based interventions on perinatal ...Significant improvements were observed in anxiety (SAS: SMD = −0.64, p < 0.05) and neonatal outcomes (Apgar score: SMD = 0.87, p < 0.05).
Effectiveness of a Mindfulness-Based Mobile Intervention ...These findings suggest that mindfulness-based mobile app interventions may help improve mental well-being in pregnant women, potentially by ...
Psychological and Physiological Impact of a Mindfulness ...The purpose of the proposed study is to test the effectiveness of a 4-week mindfulness intervention on anxiety symptoms, ER, and bodily ...
Mindfulness-Based Cognitive Therapy Postpartum Mothers ...Outcomes related to all stress, postpartum blues, mother-infant attachment, and breastfeeding were assessed at baseline and after therapy (on average, 2 ...
Assessing the effectiveness of mindfulness-based programs ...The intervention program effectively reduced postpartum self-perceived stress and depression, suggesting that this program provides acceptable ...
The effect of mindfulness-based interventions during ...MBIs can relieve maternal depressive and anxiety symptoms, especially for the prevention of postpartum depression in healthy pregnant women.
A Mobile Health Mindfulness Intervention for Women With ...This study aims to assess the feasibility, acceptability, and preliminary efficacy of an mHealth mindfulness intervention for postpartum women
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