Dataset Information

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

ABSTRACT:

Objective

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.

Method

This baseline protocol describes a randomized control trial (RCT) with two arms, MBCT-PD and treatment as usual (TAU). We plan on enrolling 74 females with a prior history of a major depressive episode, with 37 participants randomized to each arm. Participants in the MBCT-PD arm will receive MBCT-PD during pregnancy, and the TAU group will receive standard prenatal care. All participants will complete the Center for Epidemiological Studies Depression Scale - Revised (CESD-R), Emotion Regulation Questionnaire (ERQ), and classic Stroop task at multiple points from pregnancy through six months postpartum. Participants will also complete an fMRI scan at six weeks postpartum.

Results

All primary outcomes are collected at six weeks postpartum. Primary behavioral outcomes include: depressive symptoms on the CESD-R, cognitive reappraisal on the ERQ, and Stroop task performance. In parallel, the primary neurobiological outcomes include whole-brain activation during fMRI tasks when participants 1) regulate emotional responding and 2) engage cognitive control.

Conclusions

This results of this innovative RCT will help identify potential behavioral and neurobiological mechanisms of action of preventive interventions for PPD for in-depth examination in larger scale RCTs. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

SUBMITTER: Mackiewicz Seghete KL

PROVIDER: S-EPMC7869507 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Publications

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

Mackiewicz Seghete Kristen L KL Graham Alice M AM Lapidus Jodi A JA Jackson Evelyn L A ELA Doyle Olivia J OJ Feryn Alicia B AB Moore Lucille A LA Goodman Sherryl H SH Dimidjian Sona S

Health psychology : official journal of the Division of Health Psychology, American Psychological Association 20200901 9

<h4>Objective</h4>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.<h4>Metho ...[more]

PMID: 32833477

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Project description:Clinically significant psychological distress in pregnancy is common, with epidemiological research suggesting that between 15 and 25 % of pregnant women experience elevated symptoms of stress, anxiety, and depression. Untreated psychological distress in pregnancy is associated with poor obstetrical outcomes, changes in maternal physiology, elevated incidence of child physical and psychological disorders, and is predictive of maternal postpartum mood disorders. Despite the wide-ranging impact of antenatal psychological distress on mothers and their children, there is a gap in our knowledge about the most effective treatments that are available for psychological distress experienced in pregnancy. Additionally, no trials have focused on potential physiological changes that may occur as a result of receiving mindfulness training in pregnancy. The proposed trial will determine the effectiveness of an 8-week modified Mindfulness-based Cognitive Therapy (MBCT) intervention delivered during pregnancy.A randomized controlled trial (RCT) design with repeated measures will be used to evaluate the effectiveness of MBCT to treat psychological distress in pregnancy. A sample of 60 consenting pregnant women aged 18 years and above will be enrolled and randomized to the experimental (MBCT) or control (treatment as usual) condition. Primary (e.g., symptoms of stress, depression, and anxiety), secondary (cortisol, blood pressure (BP), heart rate variability (HRV), and sleep) and other outcome data (e.g., psychological diagnoses) will be collected via a combination of laboratory visits and at-home assessments from both groups at baseline (T1), immediately following the intervention (T2), and at 3 months postpartum (T3). Descriptive statistics will be used to describe sample characteristics. Data will be analyzed using an intention-to-treat approach. Hierarchical linear models will be used to test intervention effects on primary and secondary outcomes.The trial is expected to improve knowledge about evidence-based treatments for psychological distress experienced in pregnancy and to evaluate the potential impact of mindfulness-based interventions on maternal physiology.ClinicalTrials.gov: NCT02214732 , registered on 7 August 2014. Protocol Version 2.0., 5 September 2016.

Project description:BACKGROUND:Chronic pain is one of the most prevalent and disabling symptoms associated with multiple sclerosis (MS). Individuals with MS are interested in nonpharmacologic pain management approaches. Cognitive-behavioral therapy (CBT) is efficacious in improving MS-related pain outcomes. Mindfulness-based cognitive therapy (MBCT) is a promising, alternative approach. Little is known about moderators of these treatments' outcomes, however. This article describes the study protocol for the first randomized controlled trial comparing MBCT, CBT, and usual care and examining treatment effect moderators in individuals with chronic pain and MS. METHODS:We will conduct a single-center, randomized, single blind, parallel-group trial comparing MBCT, CBT, and usual care in adults with MS and chronic pain. Both interventions will be delivered via eight group sessions using videoconferencing technology. Primary (average pain intensity) and secondary outcomes (including pain interference, depressive symptoms, fatigue, and sleep) will be assessed pre-treatment, mid-treatment, post-treatment, and at 6-month follow up. Potential treatment moderators will be assessed pre-treatment. We hypothesize that participants randomly assigned to MBCT or CBT will report significantly greater reductions in average pain intensity than participants assigned to usual care at post-treatment (primary study endpoint) and 6-month follow up. We also hypothesize that mindfulness, pain catastrophizing, and behavioral activation pre-treatment will moderate response to both active treatments, but not response to usual care. DISCUSSION:Findings will provide important new information about the efficacy and moderators of two nonpharmacologic pain management approaches delivered using technology to overcome common barriers to treatment access. The knowledge gained may lead to better patient-treatment matching and, ultimately, better pain treatment outcomes in MS. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03782246. Registered on 20 December 2018.

Project description:Healthcare workers experience higher levels of work-related stress and higher rates of sickness absence than workers in other sectors. Psychological approaches have potential in providing healthcare workers with the knowledge and skills to recognise stress and to manage stress effectively. The strongest evidence for effectiveness in reducing stress in the workplace is for stress-management courses based on cognitive behavioural therapy (CBT) principles and mindfulness-based interventions (MBIs). However, research examining effects of these interventions on sickness absence (an objective indicator of stress) and compassion for others (an indicator of patient care) is limited, as is research on brief CBT stress-management courses (which may be more widely accessible) and on MBIs adapted for workplace settings.This protocol is for two randomised controlled trials with participant preference between the two trials and 1:1 allocation to intervention or wait-list within the preferred choice. The first trial is examining a one-day CBT stress-management workshop and the second trial an 8-session Mindfulness-Based Cognitive Therapy for Life (MBCT-L) course, with both trials comparing intervention to wait-list. The primary outcome for both trials is stress post-intervention with secondary outcomes being sickness absence, compassion for others, depression symptoms, anxiety symptoms, wellbeing, work-related burnout, self-compassion, presenteeism, and mindfulness (MBCT-L only). Both trials aim to recruit 234 staff working in the National Health Service in the UK.This trial will examine whether a one-day CBT stress-management workshop and an 8-session MBCT-L course are effective at reducing healthcare staff stress and other mental health outcomes compared to wait-list, and, whether these interventions are effective at reducing sickness absence and presenteeism and at enhancing wellbeing, self-compassion, mindfulness and compassion for others. Findings will help inform approaches offered to reduce healthcare staff stress and other key variables. A note of caution is that individual-level approaches should only be part of the solution to reducing healthcare staff stress within a broader focus on organisational-level interventions and support.ISRCTN Registry, ISRCTN11723441 . Registered on 16 June 2017. Protocol Version 1: 24 April 2017. Trial Sponsor: Sussex Partnership NHS Foundation Trust (ResearchGovernance@sussexpartnership.nhs.uk).

Project description:BACKGROUND:Depression has serious personal, family and economic consequences. It is estimated that it will cost £12.15 billion to the economy each year in England by 2026. Improving access to psychological therapies (IAPT) is the National Health Service talking therapies service in England for adults experiencing anxiety or depression. Over 1 million people are referred to IAPT every year, over half experiencing depression. Where symptoms of depression are mild to moderate, people are typically offered cognitive behavioural therapy (CBT) self-help (CBT-SH) supported by a psychological well-being practitioner. The problem is that over half of people who complete treatment for depression in IAPT remain depressed despite receiving National Institute of Health and Care Excellent recommended treatment. Furthermore, less than half of IAPT service users complete treatment. This study seeks to investigate the effectiveness of an alternative to CBT-SH. Mindfulness-based cognitive therapy (MBCT) differs from CBT in focus, approach and practice, and may be more effective with a higher number of treatment completions. METHODS/DESIGN:This is a definitive randomised controlled trial comparing supported MBCT self-help (MBCT-SH) with CBT-SH for adults experiencing mild to moderate depression being treated in IAPT services. We will recruit 410 participants experiencing mild to moderate depression from IAPT services and randomise these to receive either an MBCT-based self-help workbook or a CBT-based self-help workbook. Participants will be asked to complete their workbook within 16?weeks, with six support sessions with a psychological well-being practitioner. The primary outcome is depression symptom severity on treatment completion. Secondary outcomes are treatment completion rates and measures of generalized anxiety, well-being, functioning and mindfulness. An exploratory non-inferiority analysis will be conducted in the event the primary hypothesis is not supported. A semi-structured interview with participants will guide understanding of change processes. DISCUSSION:If the findings from this randomised controlled trial demonstrate that MBCT-SH is more effective than CBT-SH for adults experiencing depression, this will provide evidence for policy makers and lead to changes to clinical practice in IAPT services, leading to greater choice of self-help treatment options and better outcomes for service users. If the exploratory non-inferiority analysis is conducted and this indicates non-inferiority of MBCT-SH in comparison to CBT-SH this will also be of interest to policy makers when seeking to increase service user choice of self-help treatment options for depression. TRIAL REGISTRATION:Current Controlled Trial registration number: ISRCTN 13495752. Registered on 31 August 2017 (www.isrctn.com/ISRCTN13495752).

Project description:Introduction Anxiety and depression are among the most common non-motor PD symptoms. People with PD have experienced additional stress and social isolation during the COVID-19 pandemic. Caregivers of people with PD may experience significant caregiver burden. MBCT can prevent the relapse of depression and improve anxiety symptoms. Few studies have explored its benefits for people with PD; none have included caregivers. This study aimed to investigate the feasibility and effectiveness of a mindfulness-based cognitive therapy (MBCT) intervention in reducing anxiety and/or depression in people with Parkinson's disease (PD) and their caregivers. The study was registered on ClinicalTrials.gov (NCT04469049) and it was conducted entirely online. Methods Peoplewith PD or parkinsonism and mild-to-moderate anxiety and/or depressive symptoms and caregivers of people with PD were recruited from neurology clinics, support groups, and online. 3 MBCT groups were conducted in Zoom from November 2020 to June 2021, using a previously adapted MBCT protocol, further modified for online delivery during the pandemic. Caregivers could also enter MBCT groups or complete pre- and post- surveys without joining groups. Data collected included demographic and clinical variables, pre- and post-MBCT behavioral measures (GAD-7, PHQ-9, Five Facet Mindfulness Questionnaire: FFMQ-15), home practice time, and satisfaction surveys. Descriptive statistics were used to summarize participant characteristics, home practice time, and satisfaction survey responses. Pre- and post-MBCT behavioral measure scores were compared using mixed-effect models. Results See attached tables. All 27 participants who entered MBCT groups completed the intervention, except for one man with PD (n = 22 people with PD/parkinsonism, n = 4 caregivers). Attendance and participant satisfaction were high. MBCT completers had significant anxiety (GAD-7) and depression (PHQ-9) score reductions and FFMQ-15 total and Observing and Non-reactivity subscale score increases (all p’s < 0.05). Completers with PD/parkinsonism and anxiety (n = 14) had a significant GAD-7 score reduction; those with PD/parkinsonism and depression (n = 13) had a significant PHQ-9 score reduction (both p’s < 0.05). Completers with PD/parkinsonism also had a significant FFMQ-15 Observing subscale score increase (p < 0.05). The caregiver sample was too small to be analyzed. Conclusions Online MBCT is feasible and may be effective in reducing anxiety and/or depression in people with PD. Results should be replicated in studies with larger samples and control groups. Please note, this study built on the previous pilot trial presented in poster #1101 at the 2021 AAGP Virtual Annual Meeting. This was a different study and it also included caregivers. This research was funded by This study was supported by the Mount Zion Health Fund.

Dataset Information

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

Objective

Method

Results

Conclusions

Publications

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

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