Mindfulness-Based Cognitive Therapy for Psychological Distress During Pregnancy

Overseen By Shannon Donofry, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Suicidal ideation, Psychosis, Mania, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Mindfulness-Based Cognitive Therapy (MBCT) can help pregnant individuals manage psychological distress. Participants will either join weekly group mindfulness sessions online or receive usual care, which includes information and resources for support. The goal is to understand how mindfulness can improve mental well-being during pregnancy. Individuals who are 12 to 30 weeks pregnant, experiencing mild distress, and have internet access might find this trial suitable. As an unphased study, this trial offers a unique opportunity to contribute to understanding the benefits of mindfulness during pregnancy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Mindfulness-Based Cognitive Therapy (MBCT) is generally safe and well-tolerated during pregnancy. Studies have found that MBCT can significantly reduce depression and anxiety in pregnant women. For instance, one study found that pregnant women who participated in MBCT experienced fewer symptoms of depression compared to those who did not.

No reports of serious side effects from MBCT suggest it is a low-risk option. MBCT combines mindfulness exercises with techniques from cognitive therapy. Often conducted in groups, it helps people manage their thoughts and feelings better. This therapy is available in various formats, including online versions, to enhance accessibility.

Overall, while researchers continue to study MBCT, current evidence suggests it is a safe and effective way to support mental health during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Mindfulness-Based Cognitive Therapy (MBCT) is unique because it offers a structured, group-based approach to managing psychological distress during pregnancy through videoconference sessions. Unlike traditional options like individual therapy or medication, MBCT integrates mindfulness practices to help expectant mothers develop skills to handle stress and emotions. Researchers are excited about MBCT because it provides a flexible, accessible format that could make mental health support more available and engaging for pregnant women, potentially improving outcomes without the need for medication.

What evidence suggests that Mindfulness-Based Cognitive Therapy is effective for psychological distress during pregnancy?

Research has shown that Mindfulness-Based Cognitive Therapy (MBCT), which participants in this trial may receive, can reduce worry, anxiety, and depression symptoms in pregnant women. Studies have found that MBCT helps women cope better by encouraging awareness and acceptance of their thoughts, which is especially helpful during pregnancy. In past research, pregnant women who used MBCT reported feeling less stressed and more in control of their emotions. The therapy is also available in digital formats, making it easier to access and supporting its effectiveness in reducing stress during pregnancy. Overall, MBCT offers a promising way to improve mental well-being for expectant mothers. ^{3 6 7 8 9}

Who Is on the Research Team?

Michele Levine, PhD

Principal Investigator

University of Pittsburgh Medical Center

Shannon Donofry, PhD

Principal Investigator

University of Pittsburgh-Psychology and (primarily) AHN Psychiatry & Behavioral Health Institute

Are You a Good Fit for This Trial?

This trial is for pregnant individuals in the U.S. between 12 and 30 weeks along, experiencing mild psychological distress. They must have internet or cellular access. It's not for those with severe mental health issues like untreated mania, current psychosis, active substance abuse, or suicidal thoughts.

Inclusion Criteria

Reporting at least mild psychological distress (based on self-report)

Access to high-speed internet or cellular network access

Pregnancy between 12 and 30 weeks gestation

Exclusion Criteria

My symptoms are severe and need more advanced care.

Current psychosis

I have not received treatment for mania.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Mindfulness-Based Cognitive Therapy (MBCT) delivered in a group-based, videoconference format with 90-minute sessions once a week

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for changes in psychological functioning and well-being

3 months

What Are the Treatments Tested in This Trial?

Interventions

• MBCT
• TAU

Trial Overview The study compares Mindfulness-Based Cognitive Therapy (MBCT) to usual treatment methods during pregnancy and postpartum to understand how MBCT improves well-being and manages psychological distress during these periods.

How Is the Trial Designed?

Group I: Mindfulness-Based Cognitive Therapy (MBCT) Experimental Treatment 1 Intervention

MBCT will be delivered in a group based, videoconference format with 90 minute sessions 1x/week.

Group II: Treatment as Usual (TAU) Active Control 1 Intervention

TAU, or the control group, provides information about the benefits of mindfulness in pregnancy, offers referrals for psychotherapy in the community, and involves monthly phone or videoconference calls to maintain engagement.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

The Pittsburgh Foundation

Collaborator

Trials

8

Recruited

470+

American Psychological Foundation

Collaborator

Trials

20

Recruited

2,200+

Published Research Related to This Trial

An 8-week mindfulness-based cognitive therapy (MBCT) intervention significantly reduced depressive and anxiety symptoms in 38 pregnant women with comorbid conditions, showing its potential as a non-pharmacological treatment option.

The benefits of MBCT were maintained one month after the intervention, indicating its effectiveness in enhancing emotional regulation and overall psychological well-being during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness-based cognitive therapy for comorbid depression and anxiety in pregnancy: a randomized controlled trial. Zemestani, M., Fazeli Nikoo, Z.[2020]

Mindfulness-based cognitive therapy (MBCT) is designed specifically for individuals at risk of depressive relapse, helping them learn strategies to maintain long-term mental wellness.

The article reviews existing research on the effectiveness of MBCT, highlighting its potential as a valuable psychological intervention for preventing future episodes of depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: a promising new approach to preventing depressive relapse. Williams, JM., Kuyken, W.[2022]

A pilot study involving 68 high-risk pregnant women showed that a 1-week electronic mindfulness-based intervention (eMBI) significantly reduced state anxiety levels, indicating its potential effectiveness in managing anxiety during hospitalization.

Despite the reduction in anxiety, the study found no significant changes in depression scores after the intervention, highlighting that while eMBIs can help with anxiety, they may not be as effective for depression in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Brief Electronic Mindfulness-Based Intervention on Relieving Prenatal Depression and Anxiety in Hospitalized High-Risk Pregnant Women: Exploratory Pilot Study. Goetz, M., Schiele, C., Müller, M., et al.[2021]

Mindfulness-based cognitive therapy (MBCT) significantly reduces the risk of relapse or recurrence of major depressive disorder (MDD) by 34%, based on a meta-analysis of six randomized controlled trials involving 593 participants.

For patients with three or more previous episodes of MDD, MBCT offers a 43% reduction in relapse risk and is at least as effective as maintenance antidepressant medication, highlighting its potential as a valuable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mindfulness-based cognitive therapy for prevention of relapse in recurrent major depressive disorder: a systematic review and meta-analysis. Piet, J., Hougaard, E.[2022]

Mindfulness-based cognitive therapy adapted for perinatal depression (MBCT-PD) was found to be acceptable and well-received by pregnant women with histories of depression, showing higher satisfaction and completion rates compared to treatment as usual (TAU).

Participants in the MBCT-PD group experienced significantly lower rates of depressive relapse and reduced depressive symptoms over the 6 months postpartum, indicating its efficacy in preventing depression during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staying well during pregnancy and the postpartum: A pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence. Dimidjian, S., Goodman, SH., Felder, JN., et al.[2022]

The study is a randomized control trial involving 74 women with a history of major depression, comparing the effectiveness of mindfulness-based cognitive therapy for perinatal depression (MBCT-PD) against standard prenatal care.

The trial aims to explore how MBCT-PD influences emotion regulation and cognitive control, using behavioral assessments and neuroimaging to identify mechanisms that could help prevent postpartum depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a mechanistic study of mindfulness based cognitive therapy during pregnancy. Mackiewicz Seghete, KL., Graham, AM., Lapidus, JA., et al.[2023]

An eight-week Mindfulness-Based Cognitive Therapy (MBCT) intervention for 23 pregnant women significantly improved anxiety, depression, worry, mindfulness, and self-compassion, with these benefits maintained three months postpartum.

Participants generally adhered to mindfulness practice recommendations during the intervention, but the amount of mindfulness practice did not significantly correlate with the psychosocial outcomes, suggesting that MBCT may be effective regardless of practice frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum Outcomes and Formal Mindfulness Practice in Mindfulness-Based Cognitive Therapy for Perinatal Women. Luberto, CM., Park, ER., Goodman, JH.[2020]

Mindfulness-based cognitive therapy (MBCT) is highly valued by participants, with many describing it as 'life changing,' but about one-third of graduates still experience depression relapse within a year after completing the course.

Participants expressed a strong desire for additional support after MBCT, suggesting that a maintenance program could help them sustain mindfulness practices and reduce the risk of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. Siwik, CJ., Adler, SR., Moran, PJ., et al.[2023]

Mindfulness-based cognitive therapy (MBCT) is recognized as an effective psychotherapeutic intervention that combines cognitive behavioral therapy with mindfulness meditation, specifically aimed at preventing recurrent major depressive disorder.

Over the past fifteen years, MBCT has gained significant attention and is now recommended in various national clinical guidelines for its potential to prevent depressive episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness-based cognitive therapy is efficient in the treatment of recurrent depression]. Velden, AM., Piet, J., Møller, AB., et al.[2018]

Mindfulness-based cognitive therapy (MBCT) significantly reduces the rate of depression relapse by 40% in patients with three or more previous episodes of depression, based on a systematic review of 11 studies.

The evidence suggests that MBCT is effective for treating mental disorders, particularly in preventing relapse, although the overall methodological quality of the studies was moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based cognitive therapy on mental disorders: a systematic review and meta-analysis of randomised controlled trials. Galante, J., Iribarren, SJ., Pearce, PF.[2020]

Citations

1. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1601-0

Mindfulness-based cognitive therapy for psychological ... MBCT in pregnancy has been shown to reduce worry, anxiety, and comorbid symptoms of depression in pregnant women with clinically elevated ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10015792/

Adapting Mindfulness-Based Cognitive Therapy for Perinatal ... MBCT-PD is a preventive perinatal group intervention that promotes awareness, distress tolerance, acceptance, and coping skills for managing thoughts and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722916300025

An Open Trial of Web-Based Mindfulness-Based Cognitive ... The current study examined the feasibility and preliminary outcomes of MMB among pregnant women at risk for depressive relapse. Results provide support for MMB ...

4. mdpi.com mdpi.com/1660-4601/21/5/622

Mindfulness in Pregnancy and Postpartum: Protocol of a ... Research suggests that Mindfulness-Based Cognitive Therapy (MBCT) can effectively mitigate psychological distress, although few studies have evaluated MBCT in ...

5. kp-scalresearch.org kp-scalresearch.org/ResearchStudies/digital-mindfulness-based-cognitive-therapy-for-perinatal-depression/

Digital Mindfulness Based Cognitive Therapy for Perinatal ... A digital adaptation of MBCT for pregnant women, Mindful Mood Balance for Moms (MMBFM), was recently developed to overcome access barriers to in-person groups ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5064936/

Mindfulness-based cognitive therapy for psychological ... When compared to a TAU control group, women who receive MBCT during pregnancy will, on average, experience lower symptoms of depression, worry, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03809572

Mindfulness Based Cognitive Therapy (MBCT) During ... The study is a pilot randomized control trial of a validated intervention, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnancy, developed to ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032724003586

Effects of mindfulness-based interventions (MBIs) on ... Mindfulness-based interventions significantly improved depression among pregnant women, especially mindfulness-based cognitive therapy (MBCT).

9. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1572633/full

Effect of mindfulness group therapy on maternal ... Our study found that group mindfulness therapy effectively alleviated depressive symptoms in women with twin pregnancies. Furthermore, the preventive benefits ...