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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG061597-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Distancing | Experimental | Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction in which detailed instructions for implementation of the distancing strategy is explained (i.e. appraising an emotional stimulus as an objective, impartial observer). |
|
| Reinterpretation | Active Comparator | Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction in which detailed instructions for implementation of the reinterpretation strategy is explained (i.e. imagining a better outcome than what initially seemed apparent). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Emotion Regulation Training | Behavioral | Cognitive emotion regulation training via cognitive reappraisal involves the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal to down-regulate negative emotion can be operationalized via two tactics: psychological distancing and reinterpretation. The current study will randomly assign participants to receive a brief course of reappraisal training using either psychological distancing or reinterpretation. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Negative Affect | Self-reported negative affect data collected during the emotion regulation task on a 1-4 scale, with 1 meaning "not negative at all" and 4 meaning "very negative". | Sessions 1 (baseline/initial session), 2, 3, 4, and 5, which were conducted approximately every 2-3 days over the course of 2 weeks. |
| Respiratory Sinus Arrhythmia | Heart rate variability, or variability in time intervals between heart beats, as measured by the log of the root mean square of the successive RR interval differences (ln(RMSSD)). RR intervals are interbeat intervals between consecutive heartbeats. Average ranges for ln(RMSSD) for 30 to over 75 years of age range from 3.2 to 3.9 for women and 3.2 to 3.8 for men. | Sessions 1 (baseline/initial session), 2, 3, 4, and 5, which were conducted approximately every 2-3 days over the course of 2 weeks. |
| Neural Activity | Picture Induced Negative Emotion Signature (PINES) is an independently-defined, validated whole-brain neural pattern map for negative appraisal, with positive weights for areas like the amygdala and insula. PINES Correspondence Scores (PCS) are correlation coefficients derived for each trial type (Look Neutral, Look Negative, Reappraise Negative) per participant by correlating each participant's whole-brain pattern during the task to PINES. PCS correlation coefficients range from -1 to 1, and higher values reflect greater correlation to PINES and thus greater negative affect. | Sessions 1 (baseline/initial session) and 5, which were conducted approximately 2 weeks apart. |
| Grief Rumination | Grief rumination assessed via Utrecht Grief Rumination Scale (UGRS) and the Inventory for Complicated Grief (ICG). UGRS items are rated from 1 (never) to 5 (very often). Scores range from 15 to 75; higher numbers represent higher grief rumination. These are summed from 3-item subscales Reactions, Injustice, Counterfactuals, Meaning, and Relationships, which all have score ranges of 3-15. Higher scores represent greater grief rumination. The ICG assesses grief via 19 first-person statements on a scale of 0 (Never) to 4 (Always) with a range from 0-76. Higher numbers reflect greater grief. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Reappraisal Usage | Overall reappraisal usage frequency assessed via the Emotion Regulation Questionnaire Reappraisal facet score. Participants report using a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). Reappraisal facet scores may range from 6-42. Higher scores represent greater habitual reappraisal usage. | Sessions 1 (baseline/initial session) and 5, which were conducted approximately 2 weeks apart, and at the 1- and 2-month follow-ups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bryan Denny, Ph.D. | William Marsh Rice University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rice University | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24364856 | Background | 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. | |
| 31961188 | Background | 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. |
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Pursuant to the NIH Data Sharing Policy, we have created a Data Sharing Plan for the proposed research. Under this plan, and pursuant to IRB regulations, fully de-identified raw data (defined below) will be made publicly available. Available data will include a compendium of de-identified training condition assignments; raw (i.e. individual subject-by-condition level) negative affect self-reports; questionnaire data; raw heart rate variability data; and raw subject-level brain data (i.e. unpreprocessed functional and structural MRI data, converted to the widely-sharable Brain Imaging Data Structure [BIDS] standard).
De-identified data will be made available after the analysis process is complete and research manuscripts are finalized. There is no fixed end date for data access.
Data will be publicly available on OpenNeuro (https://openneuro.org), a free, open- science neuroinformatics data repository.
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| ID | Title | Description |
|---|---|---|
| FG000 | Distancing | Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction in which detailed instructions for implementation of the distancing strategy is explained (i.e. appraising an emotional stimulus as an objective, impartial observer). Cognitive Emotion Regulation Training: Cognitive emotion regulation training via cognitive reappraisal involves the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal to down-regulate negative emotion can be operationalized via two tactics: psychological distancing and reinterpretation. The current study will randomly assign participants to receive a brief course of reappraisal training using either psychological distancing or reinterpretation. |
| FG001 | Reinterpretation | Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction in which detailed instructions for implementation of the reinterpretation strategy is explained (i.e. imagining a better outcome than what initially seemed apparent). Cognitive Emotion Regulation Training: Cognitive emotion regulation training via cognitive reappraisal involves the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal to down-regulate negative emotion can be operationalized via two tactics: psychological distancing and reinterpretation. The current study will randomly assign participants to receive a brief course of reappraisal training using either psychological distancing or reinterpretation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Of the 27 participants to complete distancing protocol, 3 were excluded from analysis due to incorrect task or scan parameters. The 5 lost to follow-up after completion of active intervention were added for a total of 29 distancing participants. Of the 26 participants to complete the reinterpretation protocol, 1 was excluded from analysis due to incorrect task parameters. The 7 lost to follow-up after completion of active intervention were added for a total of 32 reinterpretation participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Distancing | Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction in which detailed instructions for implementation of the distancing strategy is explained (i.e. appraising an emotional stimulus as an objective, impartial observer). Cognitive Emotion Regulation Training: Cognitive emotion regulation training via cognitive reappraisal involves the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal to down-regulate negative emotion can be operationalized via two tactics: psychological distancing and reinterpretation. The current study will randomly assign participants to receive a brief course of reappraisal training using either psychological distancing or reinterpretation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Self-reported Negative Affect | Self-reported negative affect data collected during the emotion regulation task on a 1-4 scale, with 1 meaning "not negative at all" and 4 meaning "very negative". | Posted | Mean | Standard Error | score on a scale | Sessions 1 (baseline/initial session), 2, 3, 4, and 5, which were conducted approximately every 2-3 days over the course of 2 weeks. |
|
3 months
A Serious Adverse Event is a clinical event occurring subsequent to the administration of an agent or intervention which can be characterized as fatal, life-threatening, permanently disabling, requiring hospitalization, or an overdose.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Distancing | Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction in which detailed instructions for implementation of the distancing strategy is explained (i.e. appraising an emotional stimulus as an objective, impartial observer). Cognitive Emotion Regulation Training: Cognitive emotion regulation training via cognitive reappraisal involves the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal to down-regulate negative emotion can be operationalized via two tactics: psychological distancing and reinterpretation. The current study will randomly assign participants to receive a brief course of reappraisal training using either psychological distancing or reinterpretation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bryan Denny | Rice University | 713-348-8257 | bryan.denny@rice.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 21, 2025 | May 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 21, 2025 | May 21, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 15, 2023 | Apr 29, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
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Participants will be randomized to either the "Distancing" or "Reinterpretation" group.
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|
| Sessions 1 (baseline/initial session) and 5, which were conducted approximately 2 weeks apart, and at the 1- and 2-month follow-ups. |
| Depressive Symptoms | Symptoms of depression assessed via the Center for Epidemiological Studies Depression (CES-D) scale, which asks participants to rate how often in the past week they have experience symptoms of depression, ranging from 0 (Rarely or none of the time) to 3 (Most of the time). Scores range from 0 to 60, with higher scores indicating higher levels of depressive symptoms. | Sessions 1 (baseline/initial session) and 5, which were conducted approximately 2 weeks apart, and at the 1- and 2-month follow-ups. |
| Perceived Stress | Perceived stress assessed via the Perceived Stress Scale (PSS), consisting of 10 self-reported items asking participants how often they felt or thought a certain way, ranging from 0 (Never) to 4 (Very Often). Total range is 0 to 40, with higher scores indicate higher levels of perceived stress. | Sessions 1 (baseline/initial session), 2, 3, 4, and 5, which were conducted approximately every 2-3 days over the course of 2 weeks, and at the 1- and 2- month follow-up. |
| Physical Health | Physical health and quality of life assessed via the RAND 36-Item Short Form Health Survey (SF-36) which assesses 8 subscales: physical functioning, social functioning, role limitations due to physical health problems, body pain, role limitations due to personal or emotional problems, emotional well-being, energy/fatigue, and general health perceptions. Each subscale ranges from 0 to 100, higher scores referring to more adaptive health outcomes. | Sessions 1 (baseline/initial session) and 5, which were conducted approximately 2 weeks apart, and at the 1- and 2-month follow-ups. |
| Inflammatory Biomarkers | Inflammatory biomarkers (e.g., serum IL-6, sIL-6R, IL-10, and TNF- α) measured via blood draw | Sessions 0 and 6, which were conducted approximately 2-3 weeks apart. |
| 30368120 | Background | 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. |
| 10589301 | Background | 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. |
| 26231911 | Background | 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. |
| 23025352 | Background | 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. |
| 29702444 | Background | 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. |
| Lost to Follow-up |
|
| BG001 | Reinterpretation | Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction in which detailed instructions for implementation of the reinterpretation strategy is explained (i.e. imagining a better outcome than what initially seemed apparent). Cognitive Emotion Regulation Training: Cognitive emotion regulation training via cognitive reappraisal involves the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal to down-regulate negative emotion can be operationalized via two tactics: psychological distancing and reinterpretation. The current study will randomly assign participants to receive a brief course of reappraisal training using either psychological distancing or reinterpretation. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Self-reported Negative Affect | Self-reported negative affect data collected during the emotion regulation task on a 1-4 scale, with 1 meaning "not negative at all" and 4 meaning "very negative". | Mean | Standard Deviation | units on a scale |
|
| Respiratory Sinus Arrhythmia | Heart rate variability, or variability in time intervals between heart beats, as measured by the log of root mean square of the successive RR interval differences. RR intervals are interbeat intervals between consecutive heartbeats. | Participants that had low quality data (e.g., motion artifacts), recordings that were too short to analyze (less than 150 seconds), or had no recording files available were excluded from analysis. | Mean | Standard Deviation | ln(ms) |
|
| Neural Activity | Picture Induced Negative Emotion Signature (PINES) is an independently-defined, validated whole-brain neural pattern map for negative appraisal, with positive weights for areas like the amygdala and insula. PINES Correspondence Scores (PCS) are correlation coefficients derived for each trial type (Look Neutral, Look Negative, Reappraise Negative) per participant by correlating each participant's whole-brain pattern during the task to PINES. PCS correlation coefficients range from -1 to 1, and higher values reflect greater correlation to PINES and thus greater negative affect. | Two participants were excluded due to excessive motion artifacts (over 2 mm/degrees). | Mean | Standard Deviation | units on a scale |
|
| Grief Rumination | Grief rumination assessed via Utrecht Grief Rumination Scale (UGRS) and the Inventory for Complicated Grief (ICG). UGRS items are rated from 1 (never) to 5 (very often). Scores range from 15 to 75; higher numbers represent higher grief rumination. These are summed from 3-item subscales Reactions, Injustice, Counterfactuals, Meaning, and Relationships, which all have score ranges of 3-15. Higher scores represent greater grief rumination. The ICG assesses grief via 19 first-person statements on a scale of 0 (Never) to 4 (Always) with a range from 0-76. Higher numbers reflect greater grief. | Mean | Standard Deviation | score on a scale |
|
| Depressive Symptoms | Symptoms of depression assessed via the Center for Epidemiological Studies Depression (CES-D) scale, which asks participants to rate how often in the past week they have experience symptoms of depression, ranging from 0 (Rarely or none of the time) to 3 (Most of the time). Scores range from 0 to 60, with higher scores indicating higher levels of depressive symptoms. | Mean | Standard Deviation | score on a scale |
|
| Perceived Stress | Perceived stress assessed via the Perceived Stress Scale (PSS), which consists of 10 self-report items asking participants how often they felt or thought a certain way, ranging from 0 (Never) to 4 (Very Often) with total scores ranging from 0-40. Higher scores indicate higher levels of perceived stress. | Mean | Standard Deviation | score on a scale |
|
| OG001 | Reinterpretation | Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction in which detailed instructions for implementation of the reinterpretation strategy is explained (i.e. imagining a better outcome than what initially seemed apparent). Cognitive Emotion Regulation Training: Cognitive emotion regulation training via cognitive reappraisal involves the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal to down-regulate negative emotion can be operationalized via two tactics: psychological distancing and reinterpretation. The current study will randomly assign participants to receive a brief course of reappraisal training using either psychological distancing or reinterpretation. |
|
|
|
| Primary | Respiratory Sinus Arrhythmia | Heart rate variability, or variability in time intervals between heart beats, as measured by the log of the root mean square of the successive RR interval differences (ln(RMSSD)). RR intervals are interbeat intervals between consecutive heartbeats. Average ranges for ln(RMSSD) for 30 to over 75 years of age range from 3.2 to 3.9 for women and 3.2 to 3.8 for men. | Participants that had low quality data (e.g., motion artifacts), recordings that were too short to analyze (less than 150 seconds), or had no recording files available were excluded from analysis. | Posted | Mean | Standard Error | ln(ms) | Sessions 1 (baseline/initial session), 2, 3, 4, and 5, which were conducted approximately every 2-3 days over the course of 2 weeks. |
|
|
|
|
| Primary | Neural Activity | Picture Induced Negative Emotion Signature (PINES) is an independently-defined, validated whole-brain neural pattern map for negative appraisal, with positive weights for areas like the amygdala and insula. PINES Correspondence Scores (PCS) are correlation coefficients derived for each trial type (Look Neutral, Look Negative, Reappraise Negative) per participant by correlating each participant's whole-brain pattern during the task to PINES. PCS correlation coefficients range from -1 to 1, and higher values reflect greater correlation to PINES and thus greater negative affect. | Posted | Mean | Standard Error | units on a scale | Sessions 1 (baseline/initial session) and 5, which were conducted approximately 2 weeks apart. |
|
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|
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| Primary | Grief Rumination | Grief rumination assessed via Utrecht Grief Rumination Scale (UGRS) and the Inventory for Complicated Grief (ICG). UGRS items are rated from 1 (never) to 5 (very often). Scores range from 15 to 75; higher numbers represent higher grief rumination. These are summed from 3-item subscales Reactions, Injustice, Counterfactuals, Meaning, and Relationships, which all have score ranges of 3-15. Higher scores represent greater grief rumination. The ICG assesses grief via 19 first-person statements on a scale of 0 (Never) to 4 (Always) with a range from 0-76. Higher numbers reflect greater grief. | Participants either dropped out or stopped responding during the follow-ups, leading to attrition that lowered our participant number during the 1 and 2 month follow-ups. | Posted | Mean | Standard Error | score on a scale | Sessions 1 (baseline/initial session) and 5, which were conducted approximately 2 weeks apart, and at the 1- and 2-month follow-ups. |
|
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|
|
| Primary | Depressive Symptoms | Symptoms of depression assessed via the Center for Epidemiological Studies Depression (CES-D) scale, which asks participants to rate how often in the past week they have experience symptoms of depression, ranging from 0 (Rarely or none of the time) to 3 (Most of the time). Scores range from 0 to 60, with higher scores indicating higher levels of depressive symptoms. | Participants either dropped out or stopped responding during the follow-ups, leading to attrition that lowered our participant number during the 1 and 2 month follow-ups. | Posted | Mean | Standard Error | score on a scale | Sessions 1 (baseline/initial session) and 5, which were conducted approximately 2 weeks apart, and at the 1- and 2-month follow-ups. |
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| Primary | Perceived Stress | Perceived stress assessed via the Perceived Stress Scale (PSS), consisting of 10 self-reported items asking participants how often they felt or thought a certain way, ranging from 0 (Never) to 4 (Very Often). Total range is 0 to 40, with higher scores indicate higher levels of perceived stress. | Participants either dropped out or stopped responding during the follow-ups, leading to attrition that lowered our participant number during the 1 and 2 month follow-ups. | Posted | Mean | Standard Error | score on a scale | Sessions 1 (baseline/initial session), 2, 3, 4, and 5, which were conducted approximately every 2-3 days over the course of 2 weeks, and at the 1- and 2- month follow-up. |
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| Secondary | Frequency of Reappraisal Usage | Overall reappraisal usage frequency assessed via the Emotion Regulation Questionnaire Reappraisal facet score. Participants report using a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). Reappraisal facet scores may range from 6-42. Higher scores represent greater habitual reappraisal usage. | Participants either dropped out or stopped responding during the follow-ups, leading to attrition that lowered our participant number during the 1 and 2 month follow-ups. | Posted | Mean | Standard Error | score on a scale | Sessions 1 (baseline/initial session) and 5, which were conducted approximately 2 weeks apart, and at the 1- and 2-month follow-ups. |
|
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| Secondary | Physical Health | Physical health and quality of life assessed via the RAND 36-Item Short Form Health Survey (SF-36) which assesses 8 subscales: physical functioning, social functioning, role limitations due to physical health problems, body pain, role limitations due to personal or emotional problems, emotional well-being, energy/fatigue, and general health perceptions. Each subscale ranges from 0 to 100, higher scores referring to more adaptive health outcomes. | Participants either dropped out or stopped responding during the follow-ups, leading to attrition that lowered our participant number during the 1 and 2 month follow-ups. | Posted | Mean | Standard Error | score on a scale | Sessions 1 (baseline/initial session) and 5, which were conducted approximately 2 weeks apart, and at the 1- and 2-month follow-ups. |
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| Secondary | Inflammatory Biomarkers | Inflammatory biomarkers (e.g., serum IL-6, sIL-6R, IL-10, and TNF- α) measured via blood draw | Blood biomarkers were a later, secondary addition to the study outcome measures and thus there was not biomarker data collected from each participant. Additionally, attrition from the study accounts for differing participant counts as well. | Posted | Mean | Standard Error | pg/mL | Sessions 0 and 6, which were conducted approximately 2-3 weeks apart. |
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| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Reinterpretation | Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction in which detailed instructions for implementation of the reinterpretation strategy is explained (i.e. imagining a better outcome than what initially seemed apparent). Cognitive Emotion Regulation Training: Cognitive emotion regulation training via cognitive reappraisal involves the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal to down-regulate negative emotion can be operationalized via two tactics: psychological distancing and reinterpretation. The current study will randomly assign participants to receive a brief course of reappraisal training using either psychological distancing or reinterpretation. | 0 | 37 | 0 | 37 | 0 | 37 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Session 3 |
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| Session 4 |
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| Session 5 |
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| Reappraise Negative Trials |
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| Composite Score |
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| Utrecht Grief Rumination Scale Relationships Subscale Session 5 |
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| Utrecht Grief Rumination Scale Counterfactuals Subscale Session 5 |
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| Utrecht Grief Rumination Scale Injustice Subscale Session 5 |
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| Utrecht Grief Rumination Scale Reactions Subscale Session 5 |
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| Utrecht Grief Rumination Scale Composite Score Session 5 |
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| Utrecht Grief Rumination Scale Meaning Subscale 1 month follow up |
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| Utrecht Grief Rumination Scale Relationships Subscale 1 month follow up |
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| Utrecht Grief Rumination Scale Counterfactuals Subscale 1 month follow up |
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| Utrecht Grief Rumination Scale Injustice Subscale 1 month follow up |
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| Utrecht Grief Rumination Scale Reactions Subscale 1 month follow up |
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| Utrecht Grief Rumination Scale Composite Score 1 month follow up |
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| Utrecht Grief Rumination Scale Meaning Subscale 2 month follow up |
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| Utrecht Grief Rumination Scale Relationships Subscale 2 month follow up |
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| Utrecht Grief Rumination Scale Counterfactuals Subscale 2 month follow up |
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| Utrecht Grief Rumination Scale Injustice Subscale 2 month follow up |
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| Utrecht Grief Rumination Scale Reactions Subscale 2 month follow up |
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| Utrecht Grief Rumination Scale Composite Score 2 month follow up |
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| Inventory for Complicated Grief Session 5 |
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| Inventory for Complicated Grief 1 month follow up |
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| Inventory for Complicated Grief 2 month follow up |
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| Null hypothesis: no difference between groups | Mixed Models Analysis | Ran linear mixed model on counterfactuals adjusted for covariates, p-value above reflects group by session interaction. | 0.835 | Superiority |
| Null hypothesis: no difference between groups. | Mixed Models Analysis | Ran linear mixed model on injustice adjusted for covariates, p-value above reflects group by session interaction. | 0.090 | Superiority |
| Null hypothesis: no difference between groups | Mixed Models Analysis | Ran linear mixed model on meaning adjusted for covariates, p-value above reflects group by session interaction. | 0.983 | Superiority |
| Null hypothesis: no difference between groups | Mixed Models Analysis | Ran linear mixed model on reaction adjusted for covariates, p-value above reflects group by session interaction. | 0.760 | Superiority |
| Null hypothesis: no difference between groups. | Mixed Models Analysis | Ran linear mixed model on relations adjusted for covariates, p-value above reflects group by session interaction. | 0.402 | Superiority |
| Center for Epidemiological Studies Depression scale 1 month follow up |
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| Center for Epidemiological Studies Depression scale 2 month follow up |
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| Perceived Stress Scale Session 3 |
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| Perceived Stress Scale Session 4 |
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| Perceived Stress Scale Session 5 |
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| Perceived Stress Scale 1 month follow up |
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| Perceived Stress Scale 2 month follow up |
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| Emotion Regulation Questionnaire Reappraisal facet score Session 5 |
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| Emotion Regulation Questionnaire Reappraisal facet score 1 month follow up |
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| Emotion Regulation Questionnaire Reappraisal facet score 2 month follow up |
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| Physical Health score Session 1 |
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| Emotional Problems score Session 1 |
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| Energy score Session 1 |
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| Emotional Wellbeing score Session 1 |
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| Social Function score Session 1 |
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| Pain score Session 1 |
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| Health Perceptions score Session 1 |
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| Physical Function score Session 5 |
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| Physical Health score Session 5 |
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| Emotional Problems score Session 5 |
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| Energy score Session 5 |
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| Emotional Wellbeing score Session 5 |
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| Social Function score Session 5 |
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| Pain score Session 5 |
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| Health Perceptions score Session 5 |
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| Physical Function score 1 month follow up |
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| Physical Health Physical Health score 1 month follow up |
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| Emotional Problems score 1 month follow up |
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| Energy score 1 month follow up |
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| Emotional Wellbeing score 1 month follow up |
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| Social Function score 1 month follow up |
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| Pain score 1 month follow up |
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| Health Perceptions score 1 month follow up |
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| Physical Function score 2 month follow up |
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| Physical Health score 2 month follow up |
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| Emotional Problems score 2 month follow up |
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| Energy score 2 month follow up |
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| Emotional Wellbeing score 2 month follow up |
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| Social Function score 2 month follow up |
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| Pain score 2 month follow up |
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| Health Perceptions Score 2 month follow up |
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Null hypothesis: no difference between groups
| Mixed Models Analysis |
Ran linear mixed model on emotional well-being adjusted for covariates, p-value reflects group by session interaction |
| 0.452 |
| Superiority |
| Null hypothesis: no difference between groups | Mixed Models Analysis | Ran a linear mixed model on energy adjusted for covariates, p-value above reflects group by session interaction. | 0.650 | Superiority |
| Null hypothesis: no difference between groups | Mixed Models Analysis | Ran linear mixed model on general health perceptions adjusted for covariates, p-value above reflects group by session interaction. | 0.224 | Superiority |
| Null hypothesis: no difference in groups | Mixed Models Analysis | Ran linear mixed model on pain adjusted for covariates, p-value above reflects group by session interaction. | 0.256 | Superiority |
| Null hypothesis: no difference between groups | Mixed Models Analysis | Ran linear mixed model on physical function adjusted for covariates, p-value above reflects group by session interaction. | 0.984 | Superiority |
| Null hypothesis: no difference between groups | Mixed Models Analysis | Ran linear mixed model on physical health adjusted for covariates, p-value above reflects group by session interaction. | 0.363 | Superiority |
| Null hypothesis: no difference between groups | Mixed Models Analysis | Ran linear mixed model on social functioning adjusted for covariates, p-value above reflects group by session interaction. | 0.045 | Superiority |
| Serum IL-6 Session 0 |
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| TNF- α Session 0 |
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| sIL-6R Session 0 |
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| Serum IL-6 Session 6 |
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| TNF- α Session 6 |
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| sIL-6R Session 6 |
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| ANCOVA |
Ran a repeated measures ANCOVA of TNFα, p-value above reflects time by ER group interaction effect. |
| 0.438 |
| Superiority |