Clinical trial NCT04822194: Neural Mechanisms of Enhancing Emotion Regulation in Bereaved Spouses
Official title: Neural Mechanisms of Enhancing Emotion Regulation in Bereaved Spouses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Affect
Bereavement
Emotions
Depressive Symptoms
Grief
Keywords: emotion regulation
bereavement
affective neuroscience
social cognitive neuroscience
Lead sponsor: William Marsh Rice University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-03-30
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either the "Distancing" or "Reinterpretation" group.
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the underlying mechanisms of a novel emotion regulation intervention among recently bereaved spouses. More specifically, this study examines how thinking about an emotional stimulus in a more adaptive way can affect the relationship between psychological stress, psychophysiological biomarkers of adaptive cardiac response, and brain activity. The emotion regulation strategy targeted is reappraisal, specifically reappraisal-by-distancing (i.e., thinking about a negative situation in a more objective, impartial way) versus reappraisal-by-reinterpretation (i.e., thinking about a better outcome for a negative situation than what initially seemed apparent).

The study seeks to determine if relatively brief, focused reappraisal training in bereaved spouses will result in reduction of self-reported negative affect, increases in respiratory sinus arrhythmia (RSA; a measure of heart rate variability reflecting adaptive cardiac vagal tone), reduction in blood-based inflammatory biomarkers, and changes in neural activity over time. Reappraisal-by-distancing is expected to lead to greater changes in these variables relative to reappraisal-by-reinterpretation. Additionally, it is expected that across time decreases in self-reported negative affect, increases in RSA, reductions in blood-based inflammatory biomarker levels, and changes in neural activity will in turn lead to reductions in depressive symptoms and grief rumination. Finally, it is expected that distancing training will lead to reductions in depressive symptoms and grief rumination that are mediated by changes in the targeted neurobiological and behavioral mechanisms.

Detailed description: The objective of this study is to use an experimental medicine approach to evaluate the basic psychological, psychophysiological, and neural mechanisms underlying a novel cognitive emotion regulation intervention aimed at improving psychological outcomes (e.g., reducing depressive symptoms and grief rumination) in recently bereaved spouses. Cognitive reappraisal (i.e. the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way) represents a highly promising target for psychological intervention in bereavement. Reappraisal can be operationalized via two primary tactics: psychological distancing (i.e. appraising an emotional stimulus as an objective, impartial observer) and reinterpretation (i.e. imagining a better outcome than what initially seemed apparent). The current study builds upon promising preliminary work to investigate the effectiveness and underlying neurobiological mechanisms of a novel, five-session cognitive reappraisal intervention in bereaved spouses.

Recently bereaved participants (i.e. approximately 6 months post-spousal loss) will be randomly assigned to receive training in either distancing or reinterpretation, with five sessions occurring every 1-3 days, with longitudinal collection of affective, psychophysiological, physiological (i.e., blood draws to assess inflammatory biomarkers) and functional magnetic resonance imaging (fMRI) data. Follow-up questionnaire assessments will occur at one- and two-months post-intervention. The study aims to mechanistically relate changes in psychological, psychophysiological, physiological, and neural function during a novel emotion regulation intervention never before implemented in this stressed, high risk group. This research represents a Phase I, Stage I clinical trial. The primary endpoints are the assessments of the psychological, psychophysiological, physiological, and neural mechanisms mediating behavior change as a function of the cognitive emotion regulation intervention. The secondary endpoint is testing the efficacy of the intervention via assessment of psychological outcomes (i.e., the behavior change, as represented in changes in depressive symptoms, stress, and grief rumination).

Eligibility criteria: Inclusion Criteria:

* Recent loss of romantic partner within the past 5-7 months
* At least 18 years of age
* Minimum score of 25 on the Inventory for Complicated Grief
* Must be able to speak, read, and write in English
* Must be eligible to safely complete MRI scanning

Exclusion Criteria:

* Death of a second close family member/friend in the past year
* Currently receiving psychotherapy
* Diagnosed with obstructive pulmonary and/or heart disease, diabetes, liver failure, or kidney failure
* Significant visual, auditory, or cognitive impairment
* Divorced within the last year
* Prior participation in a similar emotion regulation training protocol in Dr. Denny's lab
* Any contraindication of MRI scanning (e.g., pregnancy, presence of any non-removable metal on or in the body, implanted medical devices, tattoos, medication patches, orthodontic braces or permanent retainers, hearing aids, history of claustrophobia or breathing disorders)

Primary outcomes:
measure: Change in self-reported negative affect
timeFrame: At each training session immediately after emotion regulation task, approximately every 2-3 days for 2 weeks.
measure: Change in respiratory sinus arrhythmia
timeFrame: At baseline and at final training session, approximately 2 weeks post-baseline
measure: Change in neural activity
timeFrame: During emotion regulation task at baseline and at final training session, approximately 2 weeks post-baseline
measure: Change in grief rumination
timeFrame: At baseline, final training session (approximately 2 weeks post-baseline), and at 1 and 2 months post-intervention
measure: Change in depressive symptoms
timeFrame: At baseline, final training session (approximately 2 weeks post-baseline), and at 1 and 2 months post-intervention
measure: Change in perceived stress
timeFrame: At baseline, final training session (approximately 2 weeks post-baseline), and at 1 and 2 months post-intervention
Secondary outcomes:
measure: Frequency of reappraisal usage
timeFrame: At baseline, final training session (approximately 2 weeks post-baseline), and at 1 and 2 months post-intervention
measure: Physical health
timeFrame: At baseline, final training session (approximately 2 weeks post-baseline), and at 1 and 2 months post-intervention
measure: Inflammatory biomarkers
timeFrame: Prior to baseline and following the final training session (approximately 2 weeks post-baseline)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Rice University
state: Texas
Study officials:
affiliation: William Marsh Rice University
name: Bryan Denny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Denny BT, Ochsner KN. Behavioral effects of longitudinal training in cognitive reappraisal. Emotion. 2014 Apr;14(2):425-33. doi: 10.1037/a0035276. Epub 2013 Dec 23.
citation: Denny BT. Getting better over time: A framework for examining the impact of emotion regulation training. Emotion. 2020 Feb;20(1):110-114. doi: 10.1037/emo0000641.
citation: Fagundes CP, Brown RL, Chen MA, Murdock KW, Saucedo L, LeRoy A, Wu EL, Garcini LM, Shahane AD, Baameur F, Heijnen C. Grief, depressive symptoms, and inflammation in the spousally bereaved. Psychoneuroendocrinology. 2019 Feb;100:190-197. doi: 10.1016/j.psyneuen.2018.10.006. Epub 2018 Oct 11.
citation: Bonanno GA, Kaltman S. Toward an integrative perspective on bereavement. Psychol Bull. 1999 Nov;125(6):760-76. doi: 10.1037/0033-2909.125.6.760.
citation: Denny BT, Inhoff MC, Zerubavel N, Davachi L, Ochsner KN. Getting Over It: Long-Lasting Effects of Emotion Regulation on Amygdala Response. Psychol Sci. 2015 Sep;26(9):1377-88. doi: 10.1177/0956797615578863. Epub 2015 Jul 31.
citation: Ochsner KN, Silvers JA, Buhle JT. Functional imaging studies of emotion regulation: a synthetic review and evolving model of the cognitive control of emotion. Ann N Y Acad Sci. 2012 Mar;1251:E1-24. doi: 10.1111/j.1749-6632.2012.06751.x.
citation: Fagundes CP, Murdock KW, LeRoy A, Baameur F, Thayer JF, Heijnen C. Spousal bereavement is associated with more pronounced ex vivo cytokine production and lower heart rate variability: Mechanisms underlying cardiovascular risk? Psychoneuroendocrinology. 2018 Jul;93:65-71. doi: 10.1016/j.psyneuen.2018.04.010. Epub 2018 Apr 13.