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.

Using development and psychopathology principles to inform the Research Domain Criteria (RDoC) framework

“…Developmental psychopathology researchers may come closer to identifying causal mechanisms through intervention research (Davis, Hankin, Swales, & Hoffman, 2018;Mackiewicz Seghete et al, 2020). By including putative biological mechanisms in intervention design (Cicchetti & Gunnar, 2008), researchers can determine if their intervention targets change the biological mechanism of interest (Fisher, Gunnar, Dozier, Bruce, & Pears, 2006).…”

Using early phase studies to advance intervention research: The science of behavior change.

“…Mackiewicz Seghete and colleagues report on a protocol for a mechanistic study of Mindfulness Based Cognitive Therapy (MBCT) during pregnancy to ultimately prevent depression (Mackiewicz Seghete et al, 2020). The hypothesized mechanisms of action include emotion regulation by patient report as well as secondary emotional arousal and reactivity assessed by MRI scans of whole-brain activation when participants (a) regulate emotional responding and (b) engage in cognitive control.…”

Toward an open mechanistic science of behavior change.

“…The 10 articles in this commentary illustrate the considerable breadth and depth of thought involved in conducting a robust mechanistic science of behavior change (Birk et al, 2020; Brewer, Roy, Deluty, Liu, & Hoge, 2020; Dong et al, 2020; Halbert et al, 2020; Leahey et al, 2020; Mackiewicz Seghete et al, 2020; McHugh, Nguyen, Fitzmaurice, & Dillon, 2020; Otto et al, 2020; Scioli et al, 2020; Wilson et al, 2020). There are a wide range of different populations being supported (e.g., patients with acute coronary syndrome, parent/adolescent dyads, African American women breast cancer survivors, adults experiencing opioid use disorder), intervention strategies (e.g., mindfulness, delay discounting tasks, affect labeling, exercise), mechanisms (e.g., fear of recurrence, delay discounting, stress reactivity, neuropeptide Y, self-regulation), and behaviors/health outcomes (e.g., physical activity, sleep, worry, medication adherence).…”

“…The articles collectively display a diversity of thought on intervention operations, control condition selection, and measurement batteries of the theorized mechanisms of action under investigation. For example, Brewer et al (2020), Otto et al (2020), and Mackiewicz Seghete’s et al (2020) articles all advance mindfulness interventions but with different intervention operations and hypotheses postulated for each (in part as each is focused on distinct populations and different targeted mechanisms). In terms of control conditions, while many researchers chose a treatment-as-usual or similar clinical variant, others, such as Birk et al (2020), chose very tight mechanistic-oriented control conditions, with that research group going so far as to include a sham control condition for their theorized mechanism of cognitive bias modification.…”

“…In terms of control conditions, while many researchers chose a treatment-as-usual or similar clinical variant, others, such as Birk et al (2020), chose very tight mechanistic-oriented control conditions, with that research group going so far as to include a sham control condition for their theorized mechanism of cognitive bias modification. Notably, several articles (i.e., Halbert et al, 2020; Mackiewicz Seghete et al, 2020; McHugh et al, 2020; Otto et al, 2020) use a mixture of physiological, cognitive testing, and/or self-report measures to study interrelated mechanisms, including the use of laboratory-based manipulations to study issues like stress-reactivity. Such multidimensional, multicomponent assessment batteries reflect the often-complex nature of the phenomena being studied.…”