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Neural Mechanisms of Enhancing Emotion Regulation in Bereaved Spouses

Neural Mechanisms of Enhancing Emotion Regulation in Bereaved Spouses

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04822194
Enrollment
75
Registered
2021-03-30
Start date
2022-02-02
Completion date
2024-05-22
Last updated
2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Affect, Bereavement, Depressive Symptoms, Emotions, Grief

Keywords

emotion regulation, bereavement, affective neuroscience, social cognitive neuroscience

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).

Interventions

BEHAVIORALCognitive 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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Bryan Denny
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Participants will be randomized to either the Distancing or Reinterpretation group.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Perceived StressSessions 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.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.
Neural ActivitySessions 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.
Grief RuminationSessions 1 (baseline/initial session) and 5, which were conducted approximately 2 weeks apart, and at the 1- and 2-month follow-ups.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.
Depressive SymptomsSessions 1 (baseline/initial session) and 5, which were conducted approximately 2 weeks apart, and at the 1- and 2-month follow-ups.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.
Self-reported Negative AffectSessions 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.
Respiratory Sinus ArrhythmiaSessions 1 (baseline/initial session), 2, 3, 4, and 5, which were conducted approximately every 2-3 days over the course of 2 weeks.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.

Secondary

MeasureTime frameDescription
Physical HealthSessions 1 (baseline/initial session) and 5, which were conducted approximately 2 weeks apart, and at the 1- and 2-month follow-ups.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.
Inflammatory BiomarkersSessions 0 and 6, which were conducted approximately 2-3 weeks apart.Inflammatory biomarkers (e.g., serum IL-6, sIL-6R, IL-10, and TNF- α) measured via blood draw
Frequency of Reappraisal UsageSessions 1 (baseline/initial session) and 5, which were conducted approximately 2 weeks apart, and at the 1- and 2-month follow-ups.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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
29
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.
32
Total61

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up57
Overall StudyTechnical issues with MR scanner10
Overall StudyWithdrawal by Subject54

Baseline characteristics

CharacteristicDistancingTotalReinterpretation
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
18 Participants39 Participants21 Participants
Age, Categorical
Between 18 and 65 years
11 Participants22 Participants11 Participants
Age, Continuous67.90 years
STANDARD_DEVIATION 13.48
67.54 years
STANDARD_DEVIATION 11.68
67.22 years
STANDARD_DEVIATION 9.98
Depressive Symptoms26 score on a scale
STANDARD_DEVIATION 8.45
24.7 score on a scale
STANDARD_DEVIATION 9.47
23.5 score on a scale
STANDARD_DEVIATION 10.29
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants9 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
24 Participants49 Participants25 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants3 Participants2 Participants
Grief Rumination
Inventory for Complicated Grief (ICG)
27.93 score on a scale
STANDARD_DEVIATION 9.36
29.70 score on a scale
STANDARD_DEVIATION 10.93
31.31 score on a scale
STANDARD_DEVIATION 12.1
Grief Rumination
Utrecht Grief Rumination Scale (UGRS) Composite score
41.34 score on a scale
STANDARD_DEVIATION 10.54
41.34 score on a scale
STANDARD_DEVIATION 10.73
41.34 score on a scale
STANDARD_DEVIATION 11.07
Grief Rumination
Utrecht Grief Rumination Scale (UGRS) Counterfactuals Subscale
7.41 score on a scale
STANDARD_DEVIATION 4
7.33 score on a scale
STANDARD_DEVIATION 3.74
7.25 score on a scale
STANDARD_DEVIATION 3.55
Grief Rumination
Utrecht Grief Rumination Scale (UGRS) Injustice Subscale
6.79 score on a scale
STANDARD_DEVIATION 3.17
6.59 score on a scale
STANDARD_DEVIATION 3.32
6.41 score on a scale
STANDARD_DEVIATION 3.5
Grief Rumination
Utrecht Grief Rumination Scale (UGRS) Meaning Subscale
11.17 score on a scale
STANDARD_DEVIATION 2.96
11.85 score on a scale
STANDARD_DEVIATION 2.78
12.47 score on a scale
STANDARD_DEVIATION 2.49
Grief Rumination
Utrecht Grief Rumination Scale (UGRS) Reactions Subscale
9.10 score on a scale
STANDARD_DEVIATION 3
9.16 score on a scale
STANDARD_DEVIATION 2.92
9.22 score on a scale
STANDARD_DEVIATION 2.89
Grief Rumination
Utrecht Grief Rumination Scale (UGRS) Relationships Subscale
6.86 score on a scale
STANDARD_DEVIATION 3.37
6.41 score on a scale
STANDARD_DEVIATION 3.2
6.00 score on a scale
STANDARD_DEVIATION 3.03
Neural Activity
Composite Score
0.11 units on a scale
STANDARD_DEVIATION 0.03
0.11 units on a scale
STANDARD_DEVIATION 0.04
0.11 units on a scale
STANDARD_DEVIATION 0.04
Neural Activity
Look Negative Trials
0.12 units on a scale
STANDARD_DEVIATION 0.03
0.13 units on a scale
STANDARD_DEVIATION 0.03
0.13 units on a scale
STANDARD_DEVIATION 0.03
Neural Activity
Look Neutral Trials
0.09 units on a scale
STANDARD_DEVIATION 0.03
0.10 units on a scale
STANDARD_DEVIATION 0.03
0.10 units on a scale
STANDARD_DEVIATION 0.03
Neural Activity
Reappraise Negative Trials
0.12 units on a scale
STANDARD_DEVIATION 0.03
0.12 units on a scale
STANDARD_DEVIATION 0.04
0.12 units on a scale
STANDARD_DEVIATION 0.04
Perceived Stress17.7 score on a scale
STANDARD_DEVIATION 5.74
16.8 score on a scale
STANDARD_DEVIATION 6.72
15.9 score on a scale
STANDARD_DEVIATION 7.48
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
4 Participants6 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants4 Participants1 Participants
Race (NIH/OMB)
White
21 Participants49 Participants28 Participants
Region of Enrollment
United States
29 participants61 participants32 participants
Respiratory Sinus Arrhythmia3.04 ln(ms)
STANDARD_DEVIATION 0.78
3.01 ln(ms)
STANDARD_DEVIATION 0.769
2.99 ln(ms)
STANDARD_DEVIATION 0.78
Self-reported Negative Affect1.98 units on a scale
STANDARD_DEVIATION 0.45
2.02 units on a scale
STANDARD_DEVIATION 0.46
2.05 units on a scale
STANDARD_DEVIATION 0.49
Sex: Female, Male
Female
20 Participants41 Participants21 Participants
Sex: Female, Male
Male
9 Participants20 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 380 / 37
other
Total, other adverse events
0 / 380 / 37
serious
Total, serious adverse events
0 / 380 / 37

Outcome results

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.

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
DistancingDepressive SymptomsCenter for Epidemiological Studies Depression scale Session 521.59 score on a scaleStandard Error 2.04
DistancingDepressive SymptomsCenter for Epidemiological Studies Depression scale 1 month follow up18.96 score on a scaleStandard Error 1.63
DistancingDepressive SymptomsCenter for Epidemiological Studies Depression scale 2 month follow up16.77 score on a scaleStandard Error 1.86
ReinterpretationDepressive SymptomsCenter for Epidemiological Studies Depression scale Session 521.78 score on a scaleStandard Error 1.9
ReinterpretationDepressive SymptomsCenter for Epidemiological Studies Depression scale 1 month follow up20.75 score on a scaleStandard Error 1.93
ReinterpretationDepressive SymptomsCenter for Epidemiological Studies Depression scale 2 month follow up18.70 score on a scaleStandard Error 2.07
Comparison: Null hypothesis: no difference between groupsp-value: 0.092Mixed Models Analysis
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.

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
DistancingGrief RuminationUtrecht Grief Rumination Scale Meaning Subscale Session 510.38 score on a scaleStandard Error 0.52
DistancingGrief RuminationUtrecht Grief Rumination Scale Relationships Subscale Session 55.66 score on a scaleStandard Error 0.4
DistancingGrief RuminationUtrecht Grief Rumination Scale Counterfactuals Subscale Session 56.66 score on a scaleStandard Error 0.66
DistancingGrief RuminationUtrecht Grief Rumination Scale Injustice Subscale Session 55.59 score on a scaleStandard Error 0.51
DistancingGrief RuminationUtrecht Grief Rumination Scale Reactions Subscale Session 59.24 score on a scaleStandard Error 0.61
DistancingGrief RuminationUtrecht Grief Rumination Scale Composite Score Session 537.52 score on a scaleStandard Error 1.85
DistancingGrief RuminationUtrecht Grief Rumination Scale Meaning Subscale 1 month follow up9.42 score on a scaleStandard Error 0.45
DistancingGrief RuminationUtrecht Grief Rumination Scale Relationships Subscale 1 month follow up6.08 score on a scaleStandard Error 0.46
DistancingGrief RuminationUtrecht Grief Rumination Scale Counterfactuals Subscale 1 month follow up5.50 score on a scaleStandard Error 0.52
DistancingGrief RuminationUtrecht Grief Rumination Scale Injustice Subscale 1 month follow up5.13 score on a scaleStandard Error 0.51
DistancingGrief RuminationUtrecht Grief Rumination Scale Reactions Subscale 1 month follow up8.04 score on a scaleStandard Error 0.43
DistancingGrief RuminationUtrecht Grief Rumination Scale Composite Score 1 month follow up34.17 score on a scaleStandard Error 1.56
DistancingGrief RuminationUtrecht Grief Rumination Scale Meaning Subscale 2 month follow up8.77 score on a scaleStandard Error 0.53
DistancingGrief RuminationUtrecht Grief Rumination Scale Relationships Subscale 2 month follow up5.55 score on a scaleStandard Error 0.59
DistancingGrief RuminationUtrecht Grief Rumination Scale Counterfactuals Subscale 2 month follow up5.91 score on a scaleStandard Error 0.69
DistancingGrief RuminationUtrecht Grief Rumination Scale Injustice Subscale 2 month follow up4.05 score on a scaleStandard Error 0.31
DistancingGrief RuminationUtrecht Grief Rumination Scale Reactions Subscale 2 month follow up6.95 score on a scaleStandard Error 0.7
DistancingGrief RuminationUtrecht Grief Rumination Scale Composite Score 2 month follow up31.23 score on a scaleStandard Error 2.24
DistancingGrief RuminationInventory for Complicated Grief Session 525.41 score on a scaleStandard Error 1.69
DistancingGrief RuminationInventory for Complicated Grief 1 month follow up23.92 score on a scaleStandard Error 1.77
DistancingGrief RuminationInventory for Complicated Grief 2 month follow up21.41 score on a scaleStandard Error 1.83
ReinterpretationGrief RuminationUtrecht Grief Rumination Scale Reactions Subscale 1 month follow up8.21 score on a scaleStandard Error 0.55
ReinterpretationGrief RuminationUtrecht Grief Rumination Scale Meaning Subscale Session 511.69 score on a scaleStandard Error 0.51
ReinterpretationGrief RuminationInventory for Complicated Grief Session 529.41 score on a scaleStandard Error 2.24
ReinterpretationGrief RuminationUtrecht Grief Rumination Scale Relationships Subscale Session 55.78 score on a scaleStandard Error 0.48
ReinterpretationGrief RuminationUtrecht Grief Rumination Scale Composite Score 1 month follow up35.61 score on a scaleStandard Error 1.95
ReinterpretationGrief RuminationUtrecht Grief Rumination Scale Counterfactuals Subscale Session 56.81 score on a scaleStandard Error 0.59
ReinterpretationGrief RuminationUtrecht Grief Rumination Scale Reactions Subscale 2 month follow up7.39 score on a scaleStandard Error 0.75
ReinterpretationGrief RuminationUtrecht Grief Rumination Scale Injustice Subscale Session 56.59 score on a scaleStandard Error 0.66
ReinterpretationGrief RuminationUtrecht Grief Rumination Scale Meaning Subscale 2 month follow up10.30 score on a scaleStandard Error 0.71
ReinterpretationGrief RuminationUtrecht Grief Rumination Scale Reactions Subscale Session 59.03 score on a scaleStandard Error 0.51
ReinterpretationGrief RuminationInventory for Complicated Grief 2 month follow up27.09 score on a scaleStandard Error 2.55
ReinterpretationGrief RuminationUtrecht Grief Rumination Scale Composite Score Session 539.91 score on a scaleStandard Error 2.05
ReinterpretationGrief RuminationUtrecht Grief Rumination Scale Relationships Subscale 2 month follow up5.17 score on a scaleStandard Error 0.55
ReinterpretationGrief RuminationUtrecht Grief Rumination Scale Meaning Subscale 1 month follow up10.61 score on a scaleStandard Error 0.64
ReinterpretationGrief RuminationUtrecht Grief Rumination Scale Composite Score 2 month follow up34.22 score on a scaleStandard Error 2.89
ReinterpretationGrief RuminationUtrecht Grief Rumination Scale Relationships Subscale 1 month follow up5.11 score on a scaleStandard Error 0.34
ReinterpretationGrief RuminationUtrecht Grief Rumination Scale Counterfactuals Subscale 2 month follow up5.48 score on a scaleStandard Error 0.72
ReinterpretationGrief RuminationUtrecht Grief Rumination Scale Counterfactuals Subscale 1 month follow up6.11 score on a scaleStandard Error 0.57
ReinterpretationGrief RuminationInventory for Complicated Grief 1 month follow up27.32 score on a scaleStandard Error 2.41
ReinterpretationGrief RuminationUtrecht Grief Rumination Scale Injustice Subscale 1 month follow up5.57 score on a scaleStandard Error 0.56
ReinterpretationGrief RuminationUtrecht Grief Rumination Scale Injustice Subscale 2 month follow up5.87 score on a scaleStandard Error 0.71
Comparison: Null hypothesis: no difference between groups. Power analyses of an effect size (d=.70) previously reported for within and between-subjects analyses of questionnaire outcomes (i.e., depressive symptoms, grief rumination, perceived stress, reappraisal usage) indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=0.05) for between-group effects should be achieved with 36 per group.p-value: 0.724Mixed Models Analysis
Comparison: Null hypothesis: no difference between groupsp-value: 0.835Mixed Models Analysis
Comparison: Null hypothesis: no difference between groups.p-value: 0.09Mixed Models Analysis
Comparison: Null hypothesis: no difference between groupsp-value: 0.983Mixed Models Analysis
Comparison: Null hypothesis: no difference between groupsp-value: 0.76Mixed Models Analysis
Comparison: Null hypothesis: no difference between groups.p-value: 0.402Mixed Models Analysis
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.

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

ArmMeasureGroupValue (MEAN)Dispersion
DistancingNeural ActivityLook Neutral Trials0.09 units on a scaleStandard Error 0.01
DistancingNeural ActivityLook Negative Trials0.13 units on a scaleStandard Error 0.01
DistancingNeural ActivityReappraise Negative Trials0.11 units on a scaleStandard Error 0.01
DistancingNeural ActivityComposite Score0.11 units on a scaleStandard Error 0.004
ReinterpretationNeural ActivityComposite Score0.12 units on a scaleStandard Error 0.003
ReinterpretationNeural ActivityLook Neutral Trials0.10 units on a scaleStandard Error 0.005
ReinterpretationNeural ActivityReappraise Negative Trials0.13 units on a scaleStandard Error 0.01
ReinterpretationNeural ActivityLook Negative Trials0.14 units on a scaleStandard Error 0.01
Comparison: Null hypothesis: no difference between groups. Power analyses using a within-subject fMRI effect size estimate for right amygdala affective reactivity from a meta-analysis of Human Connectome Project data of approx. d=.70, applying to between-subjects effects as well, indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=0.05) to detect between-group effects should be achieved with 36 participants per group.p-value: 0.021Mixed Models Analysis
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.

Time frame: 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.

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
DistancingPerceived StressPerceived Stress Scale Session 216.07 score on a scaleStandard Error 1.16
DistancingPerceived StressPerceived Stress Scale Session 315.93 score on a scaleStandard Error 1.04
DistancingPerceived StressPerceived Stress Scale Session 414.52 score on a scaleStandard Error 1.16
DistancingPerceived StressPerceived Stress Scale Session 514.41 score on a scaleStandard Error 1.17
DistancingPerceived StressPerceived Stress Scale 1 month follow up14.29 score on a scaleStandard Error 1.17
DistancingPerceived StressPerceived Stress Scale 2 month follow up13.00 score on a scaleStandard Error 1.2
ReinterpretationPerceived StressPerceived Stress Scale 1 month follow up14.18 score on a scaleStandard Error 1.41
ReinterpretationPerceived StressPerceived Stress Scale Session 215.31 score on a scaleStandard Error 1.38
ReinterpretationPerceived StressPerceived Stress Scale Session 514.28 score on a scaleStandard Error 1.49
ReinterpretationPerceived StressPerceived Stress Scale Session 315.53 score on a scaleStandard Error 1.45
ReinterpretationPerceived StressPerceived Stress Scale 2 month follow up12.91 score on a scaleStandard Error 1.59
ReinterpretationPerceived StressPerceived Stress Scale Session 414.28 score on a scaleStandard Error 1.35
Comparison: Null hypothesis: no difference between groupsp-value: 0.585Mixed Models Analysis
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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
DistancingRespiratory Sinus ArrhythmiaSession 22.80 ln(ms)Standard Error 0.12
DistancingRespiratory Sinus ArrhythmiaSession 32.90 ln(ms)Standard Error 0.12
DistancingRespiratory Sinus ArrhythmiaSession 43.05 ln(ms)Standard Error 0.15
DistancingRespiratory Sinus ArrhythmiaSession 53.09 ln(ms)Standard Error 0.16
ReinterpretationRespiratory Sinus ArrhythmiaSession 52.84 ln(ms)Standard Error 0.12
ReinterpretationRespiratory Sinus ArrhythmiaSession 22.72 ln(ms)Standard Error 0.11
ReinterpretationRespiratory Sinus ArrhythmiaSession 42.84 ln(ms)Standard Error 0.13
ReinterpretationRespiratory Sinus ArrhythmiaSession 32.95 ln(ms)Standard Error 0.14
Comparison: Null hypothesis: no difference between groups. Power analyses using an approximate effect size (d=.70) previously obtained for within and between-subjects analyses of respiratory sinus arrhythmia data indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=.05) to detect between-group effects should be achieved with 36 per group.p-value: 0.741Mixed Models Analysis
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.

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

ArmMeasureGroupValue (MEAN)Dispersion
DistancingSelf-reported Negative AffectSession 2 Negative Affect1.88 score on a scaleStandard Error 0.07
DistancingSelf-reported Negative AffectSession 3 Negative Affect1.70 score on a scaleStandard Error 0.06
DistancingSelf-reported Negative AffectSession 4 Negative Affect1.63 score on a scaleStandard Error 0.06
DistancingSelf-reported Negative AffectSession 5 Negative Affect1.63 score on a scaleStandard Error 0.06
ReinterpretationSelf-reported Negative AffectSession 5 Negative Affect1.83 score on a scaleStandard Error 0.06
ReinterpretationSelf-reported Negative AffectSession 2 Negative Affect1.91 score on a scaleStandard Error 0.06
ReinterpretationSelf-reported Negative AffectSession 4 Negative Affect1.85 score on a scaleStandard Error 0.07
ReinterpretationSelf-reported Negative AffectSession 3 Negative Affect1.89 score on a scaleStandard Error 0.06
Comparison: Null hypothesis: no difference between groups. Power analyses using an approximate effect size (d=.70) previously reported for within and between-subjects behavioral analyses of longitudinal reappraisal training data indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=.05) to detect between-group effects require 36 per group.p-value: 0.053Mixed Models Analysis
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.

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
DistancingFrequency of Reappraisal UsageEmotion Regulation Questionnaire Reappraisal facet score Session 129.86 score on a scaleStandard Error 1.32
DistancingFrequency of Reappraisal UsageEmotion Regulation Questionnaire Reappraisal facet score 1 month follow up32.17 score on a scaleStandard Error 1.31
DistancingFrequency of Reappraisal UsageEmotion Regulation Questionnaire Reappraisal facet score Session 531.48 score on a scaleStandard Error 1.08
DistancingFrequency of Reappraisal UsageEmotion Regulation Questionnaire Reappraisal facet score 2 month follow up31.05 score on a scaleStandard Error 1.46
ReinterpretationFrequency of Reappraisal UsageEmotion Regulation Questionnaire Reappraisal facet score Session 531.69 score on a scaleStandard Error 0.93
ReinterpretationFrequency of Reappraisal UsageEmotion Regulation Questionnaire Reappraisal facet score Session 130.03 score on a scaleStandard Error 1.03
ReinterpretationFrequency of Reappraisal UsageEmotion Regulation Questionnaire Reappraisal facet score 2 month follow up31.28 score on a scaleStandard Error 1.35
ReinterpretationFrequency of Reappraisal UsageEmotion Regulation Questionnaire Reappraisal facet score 1 month follow up31.43 score on a scaleStandard Error 1.09
Comparison: Null hypothesis: no difference between groupsp-value: 0.7Mixed Models Analysis
Secondary

Inflammatory Biomarkers

Inflammatory biomarkers (e.g., serum IL-6, sIL-6R, IL-10, and TNF- α) measured via blood draw

Time frame: Sessions 0 and 6, which were conducted approximately 2-3 weeks apart.

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
DistancingInflammatory BiomarkerssIL-6R Session 65931.06 pg/mLStandard Error 473.53
DistancingInflammatory BiomarkersIL-10 Session 016.60 pg/mLStandard Error 5.19
DistancingInflammatory BiomarkersSerum IL-6 Session 05.10 pg/mLStandard Error 2.24
DistancingInflammatory BiomarkersTNF- α Session 021.02 pg/mLStandard Error 2.27
DistancingInflammatory BiomarkerssIL-6R Session 06050.37 pg/mLStandard Error 424.24
DistancingInflammatory BiomarkersSerum IL-6 Session 65.60 pg/mLStandard Error 1.79
DistancingInflammatory BiomarkersTNF- α Session 623.97 pg/mLStandard Error 2.45
ReinterpretationInflammatory BiomarkerssIL-6R Session 65494.27 pg/mLStandard Error 378.9
ReinterpretationInflammatory BiomarkerssIL-6R Session 05387.61 pg/mLStandard Error 309.64
ReinterpretationInflammatory BiomarkersIL-10 Session 012.60 pg/mLStandard Error 4.94
ReinterpretationInflammatory BiomarkersTNF- α Session 629.05 pg/mLStandard Error 4.24
ReinterpretationInflammatory BiomarkersSerum IL-6 Session 010.34 pg/mLStandard Error 3.44
ReinterpretationInflammatory BiomarkersSerum IL-6 Session 66.11 pg/mLStandard Error 1.63
ReinterpretationInflammatory BiomarkersTNF- α Session 033.53 pg/mLStandard Error 5.01
Comparison: Null hypothesis: no difference between groupsp-value: 0.422ANCOVA
Comparison: Null hypothesis: no difference between groupsp-value: 0.438ANCOVA
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.

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
DistancingPhysical HealthPhysical Function score Session 177.93 score on a scaleStandard Error 5.16
DistancingPhysical HealthPhysical Health score Session 159.48 score on a scaleStandard Error 7.17
DistancingPhysical HealthEmotional Problems score Session 151.72 score on a scaleStandard Error 7.51
DistancingPhysical HealthEnergy score Session 148.45 score on a scaleStandard Error 4.23
DistancingPhysical HealthEmotional Wellbeing score Session 162.07 score on a scaleStandard Error 3.43
DistancingPhysical HealthSocial Function score Session 168.97 score on a scaleStandard Error 4.58
DistancingPhysical HealthEnergy score Session 549.71 score on a scaleStandard Error 4.74
DistancingPhysical HealthPain score Session 176.47 score on a scaleStandard Error 4.39
DistancingPhysical HealthHealth Perceptions score Session 171.55 score on a scaleStandard Error 4.21
DistancingPhysical HealthPhysical Function score Session 580.34 score on a scaleStandard Error 4.39
DistancingPhysical HealthPhysical Health score Session 565.52 score on a scaleStandard Error 7.59
DistancingPhysical HealthEmotional Problems score Session 557.47 score on a scaleStandard Error 7
DistancingPhysical HealthEmotional Wellbeing score Session 563.17 score on a scaleStandard Error 3.54
DistancingPhysical HealthSocial Function score Session 570.69 score on a scaleStandard Error 4.49
DistancingPhysical HealthPain score Session 578.88 score on a scaleStandard Error 4.02
DistancingPhysical HealthHealth Perceptions score Session 571.21 score on a scaleStandard Error 4.04
DistancingPhysical HealthPhysical Function score 1 month follow up78.75 score on a scaleStandard Error 4.57
DistancingPhysical HealthPhysical Health Physical Health score 1 month follow up62.50 score on a scaleStandard Error 8.64
DistancingPhysical HealthEmotional Problems score 1 month follow up68.06 score on a scaleStandard Error 7.89
DistancingPhysical HealthEnergy score 1 month follow up57.71 score on a scaleStandard Error 3.91
DistancingPhysical HealthEmotional Wellbeing score 1 month follow up68.17 score on a scaleStandard Error 2.84
DistancingPhysical HealthSocial Function score 1 month follow up81.77 score on a scaleStandard Error 3.36
DistancingPhysical HealthPain score 1 month follow up75.63 score on a scaleStandard Error 4.46
DistancingPhysical HealthHealth Perceptions score 1 month follow up75.00 score on a scaleStandard Error 4.13
DistancingPhysical HealthPhysical Function score 2 month follow up79.77 score on a scaleStandard Error 5.06
DistancingPhysical HealthPhysical Health score 2 month follow up70.45 score on a scaleStandard Error 8.8
DistancingPhysical HealthEmotional Problems score 2 month follow up80.30 score on a scaleStandard Error 6.45
DistancingPhysical HealthEnergy score 2 month follow up55.23 score on a scaleStandard Error 5.07
DistancingPhysical HealthEmotional Wellbeing score 2 month follow up72.36 score on a scaleStandard Error 3.36
DistancingPhysical HealthSocial Function score 2 month follow up81.82 score on a scaleStandard Error 4.17
DistancingPhysical HealthPain score 2 month follow up76.70 score on a scaleStandard Error 4.97
DistancingPhysical HealthHealth Perceptions Score 2 month follow up73.41 score on a scaleStandard Error 3.93
ReinterpretationPhysical HealthHealth Perceptions Score 2 month follow up73.04 score on a scaleStandard Error 4.26
ReinterpretationPhysical HealthPhysical Function score Session 183.71 score on a scaleStandard Error 4.21
ReinterpretationPhysical HealthPhysical Function score 1 month follow up85.36 score on a scaleStandard Error 3.66
ReinterpretationPhysical HealthPhysical Health score Session 167.74 score on a scaleStandard Error 6.58
ReinterpretationPhysical HealthPhysical Function score 2 month follow up84.78 score on a scaleStandard Error 4.75
ReinterpretationPhysical HealthEmotional Problems score Session 146.24 score on a scaleStandard Error 7.98
ReinterpretationPhysical HealthPhysical Health Physical Health score 1 month follow up66.07 score on a scaleStandard Error 7.84
ReinterpretationPhysical HealthEnergy score Session 149.68 score on a scaleStandard Error 3.67
ReinterpretationPhysical HealthEmotional Wellbeing score 2 month follow up69.74 score on a scaleStandard Error 3.51
ReinterpretationPhysical HealthEmotional Wellbeing score Session 164.65 score on a scaleStandard Error 3.37
ReinterpretationPhysical HealthEmotional Problems score 1 month follow up48.81 score on a scaleStandard Error 7.76
ReinterpretationPhysical HealthPhysical Health score 2 month follow up66.30 score on a scaleStandard Error 8.11
ReinterpretationPhysical HealthSocial Function score Session 178.63 score on a scaleStandard Error 4.61
ReinterpretationPhysical HealthEnergy score 1 month follow up55.54 score on a scaleStandard Error 3.94
ReinterpretationPhysical HealthPain score Session 171.53 score on a scaleStandard Error 4.05
ReinterpretationPhysical HealthPain score 2 month follow up76.96 score on a scaleStandard Error 4.69
ReinterpretationPhysical HealthHealth Perceptions score Session 171.94 score on a scaleStandard Error 3.19
ReinterpretationPhysical HealthEmotional Wellbeing score 1 month follow up68.57 score on a scaleStandard Error 3.82
ReinterpretationPhysical HealthPhysical Function score Session 583.44 score on a scaleStandard Error 4.14
ReinterpretationPhysical HealthEmotional Problems score 2 month follow up65.22 score on a scaleStandard Error 7.97
ReinterpretationPhysical HealthPhysical Health score Session 571.09 score on a scaleStandard Error 5.84
ReinterpretationPhysical HealthSocial Function score 1 month follow up77.68 score on a scaleStandard Error 4.56
ReinterpretationPhysical HealthEmotional Problems score Session 545.83 score on a scaleStandard Error 7.14
ReinterpretationPhysical HealthEnergy score Session 552.50 score on a scaleStandard Error 4.07
ReinterpretationPhysical HealthSocial Function score 2 month follow up80.43 score on a scaleStandard Error 4.43
ReinterpretationPhysical HealthEmotional Wellbeing score Session 564.88 score on a scaleStandard Error 3.46
ReinterpretationPhysical HealthPain score 1 month follow up78.13 score on a scaleStandard Error 3.97
ReinterpretationPhysical HealthSocial Function score Session 575.39 score on a scaleStandard Error 4.58
ReinterpretationPhysical HealthEnergy score 2 month follow up57.83 score on a scaleStandard Error 4.47
ReinterpretationPhysical HealthPain score Session 575.70 score on a scaleStandard Error 4.43
ReinterpretationPhysical HealthHealth Perceptions score 1 month follow up72.32 score on a scaleStandard Error 3.38
ReinterpretationPhysical HealthHealth Perceptions score Session 573.59 score on a scaleStandard Error 3.49
Comparison: Null hypothesis: no difference between groupsp-value: 0.452Mixed Models Analysis
Comparison: Null hypothesis: no difference between groupsp-value: 0.65Mixed Models Analysis
Comparison: Null hypothesis: no difference between groupsp-value: 0.224Mixed Models Analysis
Comparison: Null hypothesis: no difference between groups.p-value: 0.696Mixed Models Analysis
Comparison: Null hypothesis: no difference in groupsp-value: 0.256Mixed Models Analysis
Comparison: Null hypothesis: no difference between groupsp-value: 0.984Mixed Models Analysis
Comparison: Null hypothesis: no difference between groupsp-value: 0.363Mixed Models Analysis
Comparison: Null hypothesis: no difference between groupsp-value: 0.045Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026