Trial Outcomes & Findings for Neural Mechanisms of Enhancing Emotion Regulation in Bereaved Spouses (NCT NCT04822194)

Last Updated: 2025-07-09

Results Overview

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".

Recruitment status

COMPLETED

Study phase

Target enrollment

75 participants

Primary outcome timeframe

Sessions 1 (baseline/initial session), 2, 3, 4, and 5, which were conducted approximately every 2-3 days over the course of 2 weeks.

Results posted on

2025-07-09

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	38	37
Overall Study Did Not Receive Emotion Regulation Training	4	0
Overall Study Discontinued Training	2	4
Overall Study Lost to Long Term Follow-up	5	7
Overall Study COMPLETED	27	26
Overall Study NOT COMPLETED	11	11

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	5	4
Overall Study Technical issues with MR scanner	1	0
Overall Study Lost to Follow-up	5	7

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Distancing n=29 Participants 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.	Reinterpretation n=32 Participants 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.	Total n=61 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=29 Participants	0 Participants n=32 Participants	0 Participants n=61 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=29 Participants	11 Participants n=32 Participants	22 Participants n=61 Participants
Age, Categorical >=65 years	18 Participants n=29 Participants	21 Participants n=32 Participants	39 Participants n=61 Participants
Age, Continuous	67.90 years STANDARD_DEVIATION 13.48 • n=29 Participants	67.22 years STANDARD_DEVIATION 9.98 • n=32 Participants	67.54 years STANDARD_DEVIATION 11.68 • n=61 Participants
Sex: Female, Male Female	20 Participants n=29 Participants	21 Participants n=32 Participants	41 Participants n=61 Participants
Sex: Female, Male Male	9 Participants n=29 Participants	11 Participants n=32 Participants	20 Participants n=61 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=29 Participants	5 Participants n=32 Participants	9 Participants n=61 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=29 Participants	25 Participants n=32 Participants	49 Participants n=61 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=29 Participants	2 Participants n=32 Participants	3 Participants n=61 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=29 Participants	0 Participants n=32 Participants	0 Participants n=61 Participants
Race (NIH/OMB) Asian	1 Participants n=29 Participants	0 Participants n=32 Participants	1 Participants n=61 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=29 Participants	0 Participants n=32 Participants	0 Participants n=61 Participants
Race (NIH/OMB) Black or African American	4 Participants n=29 Participants	2 Participants n=32 Participants	6 Participants n=61 Participants
Race (NIH/OMB) White	21 Participants n=29 Participants	28 Participants n=32 Participants	49 Participants n=61 Participants
Race (NIH/OMB) More than one race	0 Participants n=29 Participants	1 Participants n=32 Participants	1 Participants n=61 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=29 Participants	1 Participants n=32 Participants	4 Participants n=61 Participants
Region of Enrollment United States	29 participants n=29 Participants	32 participants n=32 Participants	61 participants n=61 Participants
Self-reported Negative Affect	1.98 units on a scale STANDARD_DEVIATION 0.45 • n=29 Participants	2.05 units on a scale STANDARD_DEVIATION 0.49 • n=32 Participants	2.02 units on a scale STANDARD_DEVIATION 0.46 • n=61 Participants
Respiratory Sinus Arrhythmia	3.04 ln(ms) STANDARD_DEVIATION 0.78 • n=21 Participants • 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.	2.99 ln(ms) STANDARD_DEVIATION 0.78 • n=24 Participants • 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.	3.01 ln(ms) STANDARD_DEVIATION 0.769 • n=45 Participants • 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.
Neural Activity Look Neutral Trials	0.09 units on a scale STANDARD_DEVIATION 0.03 • n=27 Participants • Two participants were excluded due to excessive motion artifacts (over 2 mm/degrees).	0.10 units on a scale STANDARD_DEVIATION 0.03 • n=32 Participants • Two participants were excluded due to excessive motion artifacts (over 2 mm/degrees).	0.10 units on a scale STANDARD_DEVIATION 0.03 • n=59 Participants • Two participants were excluded due to excessive motion artifacts (over 2 mm/degrees).
Neural Activity Look Negative Trials	0.12 units on a scale STANDARD_DEVIATION 0.03 • n=27 Participants • Two participants were excluded due to excessive motion artifacts (over 2 mm/degrees).	0.13 units on a scale STANDARD_DEVIATION 0.03 • n=32 Participants • Two participants were excluded due to excessive motion artifacts (over 2 mm/degrees).	0.13 units on a scale STANDARD_DEVIATION 0.03 • n=59 Participants • Two participants were excluded due to excessive motion artifacts (over 2 mm/degrees).
Neural Activity Reappraise Negative Trials	0.12 units on a scale STANDARD_DEVIATION 0.03 • n=27 Participants • Two participants were excluded due to excessive motion artifacts (over 2 mm/degrees).	0.12 units on a scale STANDARD_DEVIATION 0.04 • n=32 Participants • Two participants were excluded due to excessive motion artifacts (over 2 mm/degrees).	0.12 units on a scale STANDARD_DEVIATION 0.04 • n=59 Participants • Two participants were excluded due to excessive motion artifacts (over 2 mm/degrees).
Neural Activity Composite Score	0.11 units on a scale STANDARD_DEVIATION 0.03 • n=27 Participants • Two participants were excluded due to excessive motion artifacts (over 2 mm/degrees).	0.11 units on a scale STANDARD_DEVIATION 0.04 • n=32 Participants • Two participants were excluded due to excessive motion artifacts (over 2 mm/degrees).	0.11 units on a scale STANDARD_DEVIATION 0.04 • n=59 Participants • Two participants were excluded due to excessive motion artifacts (over 2 mm/degrees).
Grief Rumination Utrecht Grief Rumination Scale (UGRS) Meaning Subscale	11.17 score on a scale STANDARD_DEVIATION 2.96 • n=29 Participants	12.47 score on a scale STANDARD_DEVIATION 2.49 • n=32 Participants	11.85 score on a scale STANDARD_DEVIATION 2.78 • n=61 Participants
Grief Rumination Utrecht Grief Rumination Scale (UGRS) Relationships Subscale	6.86 score on a scale STANDARD_DEVIATION 3.37 • n=29 Participants	6.00 score on a scale STANDARD_DEVIATION 3.03 • n=32 Participants	6.41 score on a scale STANDARD_DEVIATION 3.20 • n=61 Participants
Grief Rumination Utrecht Grief Rumination Scale (UGRS) Counterfactuals Subscale	7.41 score on a scale STANDARD_DEVIATION 4.00 • n=29 Participants	7.25 score on a scale STANDARD_DEVIATION 3.55 • n=32 Participants	7.33 score on a scale STANDARD_DEVIATION 3.74 • n=61 Participants
Grief Rumination Utrecht Grief Rumination Scale (UGRS) Injustice Subscale	6.79 score on a scale STANDARD_DEVIATION 3.17 • n=29 Participants	6.41 score on a scale STANDARD_DEVIATION 3.50 • n=32 Participants	6.59 score on a scale STANDARD_DEVIATION 3.32 • n=61 Participants
Grief Rumination Utrecht Grief Rumination Scale (UGRS) Reactions Subscale	9.10 score on a scale STANDARD_DEVIATION 3.00 • n=29 Participants	9.22 score on a scale STANDARD_DEVIATION 2.89 • n=32 Participants	9.16 score on a scale STANDARD_DEVIATION 2.92 • n=61 Participants
Grief Rumination Utrecht Grief Rumination Scale (UGRS) Composite score	41.34 score on a scale STANDARD_DEVIATION 10.54 • n=29 Participants	41.34 score on a scale STANDARD_DEVIATION 11.07 • n=32 Participants	41.34 score on a scale STANDARD_DEVIATION 10.73 • n=61 Participants
Grief Rumination Inventory for Complicated Grief (ICG)	27.93 score on a scale STANDARD_DEVIATION 9.36 • n=29 Participants	31.31 score on a scale STANDARD_DEVIATION 12.10 • n=32 Participants	29.70 score on a scale STANDARD_DEVIATION 10.93 • n=61 Participants
Depressive Symptoms	26 score on a scale STANDARD_DEVIATION 8.45 • n=29 Participants	23.5 score on a scale STANDARD_DEVIATION 10.29 • n=32 Participants	24.7 score on a scale STANDARD_DEVIATION 9.47 • n=61 Participants
Perceived Stress	17.7 score on a scale STANDARD_DEVIATION 5.74 • n=29 Participants	15.9 score on a scale STANDARD_DEVIATION 7.48 • n=32 Participants	16.8 score on a scale STANDARD_DEVIATION 6.72 • n=61 Participants

PRIMARY outcome

Timeframe: Sessions 1 (baseline/initial session), 2, 3, 4, and 5, which were conducted approximately every 2-3 days over the course of 2 weeks.

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".

Outcome measures

Outcome measures
Measure	Distancing n=29 Participants 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.	Reinterpretation n=32 Participants 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.
Self-reported Negative Affect Session 2 Negative Affect	1.88 score on a scale Standard Error 0.07	1.91 score on a scale Standard Error 0.06
Self-reported Negative Affect Session 3 Negative Affect	1.70 score on a scale Standard Error 0.06	1.89 score on a scale Standard Error 0.06
Self-reported Negative Affect Session 4 Negative Affect	1.63 score on a scale Standard Error 0.06	1.85 score on a scale Standard Error 0.07
Self-reported Negative Affect Session 5 Negative Affect	1.63 score on a scale Standard Error 0.06	1.83 score on a scale Standard Error 0.06

PRIMARY outcome

Timeframe: Sessions 1 (baseline/initial session), 2, 3, 4, and 5, which were conducted approximately every 2-3 days over the course of 2 weeks.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Distancing n=29 Participants 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.	Reinterpretation n=32 Participants 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.
Respiratory Sinus Arrhythmia Session 2	2.80 ln(ms) Standard Error 0.12	2.72 ln(ms) Standard Error 0.11
Respiratory Sinus Arrhythmia Session 3	2.90 ln(ms) Standard Error 0.12	2.95 ln(ms) Standard Error 0.14
Respiratory Sinus Arrhythmia Session 4	3.05 ln(ms) Standard Error 0.15	2.84 ln(ms) Standard Error 0.13
Respiratory Sinus Arrhythmia Session 5	3.09 ln(ms) Standard Error 0.16	2.84 ln(ms) Standard Error 0.12

PRIMARY outcome

Timeframe: Sessions 1 (baseline/initial session) and 5, which were conducted approximately 2 weeks apart.

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.

Outcome measures

Outcome measures
Measure	Distancing n=27 Participants 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.	Reinterpretation n=32 Participants 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.
Neural Activity Reappraise Negative Trials	0.11 units on a scale Standard Error 0.01	0.13 units on a scale Standard Error 0.01
Neural Activity Look Neutral Trials	0.09 units on a scale Standard Error 0.01	0.10 units on a scale Standard Error 0.005
Neural Activity Look Negative Trials	0.13 units on a scale Standard Error 0.01	0.14 units on a scale Standard Error 0.01
Neural Activity Composite Score	0.11 units on a scale Standard Error 0.004	0.12 units on a scale Standard Error 0.003

PRIMARY outcome

Timeframe: Sessions 1 (baseline/initial session) and 5, which were conducted approximately 2 weeks apart, and at the 1- and 2-month follow-ups.