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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how Mindfulness-Based Cognitive Therapy (MBCT) helps pregnant women manage their thoughts and emotions to reduce psychological distress. The goal is to see if MBCT improves mental health during pregnancy and if these benefits last after childbirth. Mindfulness-Based Cognitive Therapy (MBCT) has been shown to be effective in reducing depression and anxiety in pregnant women.

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.

What data supports the effectiveness of the treatment Mindfulness-Based Cognitive Therapy for Psychological Distress During Pregnancy?

Research shows that Mindfulness-Based Cognitive Therapy (MBCT) is effective in reducing relapse rates in people with major depressive disorder, suggesting it could help manage psychological distress during pregnancy by using similar mindfulness and cognitive-behavioral techniques. ^{1 2 3 4 5}

Is Mindfulness-Based Cognitive Therapy (MBCT) safe for humans?

Research on Mindfulness-Based Cognitive Therapy (MBCT) has primarily focused on its effectiveness in preventing depression relapse, but it is generally considered safe for humans. No significant safety concerns have been reported in studies evaluating MBCT for mental disorders. ^{1 2 3 4 6}

How is Mindfulness-Based Cognitive Therapy different from other treatments for psychological distress during pregnancy?

Mindfulness-Based Cognitive Therapy (MBCT) is unique because it combines mindfulness practices with cognitive therapy techniques to help pregnant women manage emotions and thoughts, reducing the risk of postpartum depression without using medication. It is particularly appealing to those who prefer non-drug options and has shown promise in maintaining improvements in anxiety and depression during and after pregnancy. ^{6 7 8 9 10}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. [2023]

3. Denmark pubmed.ncbi.nlm.nih.gov

[Mindfulness-based cognitive therapy is efficient in the treatment of recurrent depression]. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based cognitive therapy on mental disorders: a systematic review and meta-analysis of randomised controlled trials. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: a promising new approach to preventing depressive relapse. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Protocol for a mechanistic study of mindfulness based cognitive therapy during pregnancy. [2023]

7. United States 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. [2022]

8. Austria pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness-based cognitive therapy for comorbid depression and anxiety in pregnancy: a randomized controlled trial. [2020]

9. Canada 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. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Postpartum Outcomes and Formal Mindfulness Practice in Mindfulness-Based Cognitive Therapy for Perinatal Women. [2020]