Mindfulness-Based Cognitive Therapy for Psychological Distress During Pregnancy
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Pittsburgh
Disqualifiers: Suicidal ideation, Psychosis, Mania, others
No Placebo Group
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?
Is Mindfulness-Based Cognitive Therapy (MBCT) safe for humans?
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.678910
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
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Exclusion Criteria
My symptoms are severe and need more advanced care.
Current psychosis
I have not received treatment for mania.
See 4 more
Trial 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 (Behavioral Intervention)
- TAU (Behavioral Intervention)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based Cognitive Therapy (MBCT)Experimental Treatment1 Intervention
MBCT will be delivered in a group based, videoconference format with 90 minute sessions 1x/week.
Group II: Treatment as Usual (TAU)Active Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Western Psychiatric Institute & ClinicPittsburgh, PA
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Who Is Running the Clinical Trial?
University of PittsburghLead Sponsor
The Pittsburgh FoundationCollaborator
American Psychological FoundationCollaborator
References
The effect of mindfulness-based cognitive therapy for prevention of relapse in recurrent major depressive disorder: a systematic review and meta-analysis. [2022]Mindfulness-based cognitive therapy (MBCT) is a group-based clinical intervention program designed to reduce relapse or recurrence of major depressive disorder (MDD) by means of systematic training in mindfulness meditation combined with cognitive-behavioral methods.
Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. [2023]Mindfulness-based cognitive therapy (MBCT) is an effective group intervention for reducing rates of depression relapse. However, about one-third of graduates experience relapse within 1 year of completing the course.
[Mindfulness-based cognitive therapy is efficient in the treatment of recurrent depression]. [2018]Mindfulness-based cognitive therapy (MBCT) is an evidence-based psychotherapeutic intervention, which integrates elements of cognitive behavioural therapy for depression with the clinical application of mindfulness meditation. MBCT is currently recommended in several national clinical guidelines as a preventative treatment for recurrent major depressive disorder. Over the last fifteen years there has been a growing interest in MBCT and its clinical potential in the prevention of depressive episodes. In this article, we review the current status of the research in the field.
Effects of mindfulness-based cognitive therapy on mental disorders: a systematic review and meta-analysis of randomised controlled trials. [2020]Mindfulness-based cognitive therapy (MBCT) is a programme developed to prevent depression relapse, but has been applied for other disorders. Our objective was to systematically review and meta-analyse the evidence on the effectiveness and safety of MBCT for the treatment of mental disorders.
Mindfulness-based cognitive therapy: a promising new approach to preventing depressive relapse. [2022]Mindfulness-based cognitive therapy (MBCT) was developed as a psychological approach for people at risk for depressive relapse who wish to learn how to stay well in the long-term. In this article we set out the rationale for MBCT, outline the treatment approach, overview the efficacy research to date and look to future challenges.
Protocol for a mechanistic study of mindfulness based cognitive therapy during pregnancy. [2023]Preventive interventions for postpartum depression (PPD) are critical for women at elevated risk of PPD. Mindfulness based cognitive therapy - perinatal depression (MBCT-PD) is a preventive intervention that has been shown to reduce risk for PPD in women with a prior history of depression. The objective of this clinical trial is to examine two potential mechanisms of action of MBCT-PD, emotion regulation and cognitive control, using behavioral and neuroimaging methods.
Staying well during pregnancy and the postpartum: A pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence. [2022]Clinical decision-making regarding the prevention of depression is complex for pregnant women with histories of depression and their health care providers. Pregnant women with histories of depression report preference for nonpharmacological care, but few evidence-based options exist. Mindfulness-based cognitive therapy has strong evidence in the prevention of depressive relapse/recurrence among general populations and indications of promise as adapted for perinatal depression (MBCT-PD). With a pilot randomized clinical trial, our aim was to evaluate treatment acceptability and efficacy of MBCT-PD relative to treatment as usual (TAU).
Effectiveness of mindfulness-based cognitive therapy for comorbid depression and anxiety in pregnancy: a randomized controlled trial. [2020]Pregnant women are at high risk of mood and anxiety disorders, and options for non-pharmacological treatment are limited. Mindfulness-based cognitive therapy (MBCT) has strong evidence among people with mood and anxiety disorders, but limited studies reported the effectiveness of MBCT on perinatal comorbid conditions. This study aimed to examine the effects of an 8-week MBCT intervention on pregnant women with comorbid depression and anxiety. In this randomized controlled study, 38 pregnant women with a diagnosis of depression and varying levels of comorbid anxiety disorders were randomly assigned to either MBCT or a control group. Scores on the Beck Depression Inventory-II, Beck Anxiety Inventory, Emotion Regulation Questionnaire, and Scales of Psychological Wellbeing were used as outcome measures at baseline, after MBCT, and through 1-month follow-up. Intent to treat analyses provided preliminary evidence that MBCT can be effective in reducing depressive and anxiety symptoms and in enhancing the use of adaptive emotion regulation strategies and psychological well-being. Improvements in outcomes were maintained 1 month. Results provide cross-cultural support for MBCT as a treatment for depression and anxiety in pregnant women. This brief and non-pharmacological treatment can be used to improve maternal psychological health.
Effects of a Brief Electronic Mindfulness-Based Intervention on Relieving Prenatal Depression and Anxiety in Hospitalized High-Risk Pregnant Women: Exploratory Pilot Study. [2021]Peripartum depression and anxiety disorders are highly prevalent and are correlated with adverse maternal and neonatal outcomes. Antenatal care in Germany does not yet include structured screening and effective low-threshold treatment options for women facing peripartum depression and anxiety disorders. Mindfulness-based interventions (MBIs) are increasingly becoming a focus of interest for the management of such patients. Studies have shown a decrease in pregnancy-related stress and anxiety in expectant mothers following mindfulness programs.
Postpartum Outcomes and Formal Mindfulness Practice in Mindfulness-Based Cognitive Therapy for Perinatal Women. [2020]Anxiety is common during pregnancy and associated with poorer outcomes for mother and child. Our single-arm pilot study of an eight-week Mindfulness-Based Cognitive Therapy (MBCT) intervention for pregnant women with elevated anxiety showed significant pre- to post-intervention improvements in anxiety, depression, worry, mindfulness, and self-compassion. It remains unclear whether these improvements are maintained post-partum and whether amount of formal mindfulness practice is correlated with outcomes. The current study examined whether 1) improvements in psychosocial outcomes were maintained three months postpartum; 2) women were adherent to formal practice recommendations; and 3) amount of mindfulness practice was correlated with outcomes. Twenty-three pregnant women (Mage=33.5, SD=4.40; 75% White; 71% with Generalized Anxiety Disorder) completed home practice logs throughout the intervention, and self-report measures before and after the intervention and three months postpartum. Results indicated that previously reported post-intervention improvements in anxiety, worry, mindfulness, and self-compassion were maintained postpartum (p's<.05), and reductions in depression further improved (p<.001). Participants were generally adherent to mindfulness practice recommendations during the intervention (54%-80% weekly adherence; M=17.31 total practice hours [SD=7.45]), and many continued practicing one-week post-intervention (91%) and postpartum (55%). Mindfulness practice during the intervention was not significantly correlated with any outcome at post-intervention or postpartum. Mindfulness practice postpartum was only marginally related to improved worry postpartum (p=.05). MBCT may be associated with maintained improvements in psychosocial outcomes for women during pregnancy and postpartum, but the role of mindfulness practice is unclear. Research using larger samples and randomized controlled designs is needed.