Cardiovascular Effects of Grieving

NCT07356635 | Recruiting

• 1 other identifier: STUDY008302
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Self-affirmation (SA) theory proposes that people are motivated to maintain a positive self-image of being worthy, stable, and capable. Self-affirmation (SA) manipulations have been shown to effectively increase self-worth as well as reduce cardiovascular reactivity while enhancing cardiovascular recovery in response to stress. While SA is discussed as a way to alleviate grief, its effect on cardiovascular reactivity (CVR) and recovery to grief recall has yet to be studied within laboratory settings. This study proposes an experimental design to examine how an in-lab manipulation promoting self-affirmation can improve patients' cardiovascular responses during and after a grief recall procedure. The investigators hypothesized that grief severity (a continuous variable) interacts with condition (a categorical variable with two levels, i.e., SA intervention vs. control) to predict CV reactivity and recovery as outcomes. Primary Objective 1: To investigate effects of self-affirmation intervention on cardiovascular responses among grieving participants during and after grief recall. Secondary Objective 1: To investigate the relationship of grief severity with psychological stress.

Conditions

Grief; Cardiovascular Health; Emotion

Keywords

grief; cardiovascular reactivity; cardiovascular health; heart rate variability; psychophysiology; self-affirmation; value-affirmation; stress; mourning

Outcome Measures

Primary Outcomes (12)

• Hypothesis 1: There will be a main effect of self-affirmation condition on CV reactivity and recovery to the grief recall task

  A series of one-way ANCOVAs will be conducted to compare measures of cardiovascular reactivity and recovery between the self-affirmation and control conditions, controlling for gender, race, and baseline values, using a significance level of α = .05. CV reactivity will be operationalized as the difference between CV during grief recall and CV baseline measures. CV recovery will be operationalized as the difference between CV recovery measures and CV baseline measures.

  Two months after the last participant data collection.

• Hypothesis 2: Grief severity (as measured by the PG-13 Questionnaire) will moderate the effect of the self-affirmation condition on cardiovascular reactivity and recovery.

  A series of multiple regression analyses will be conducted separately for HR, SBP, DBP and HF-HRV on reactivity and recovery. Predictor variables will include grief severity (PG-13 scores), experimental condition (value-affirmation vs. control, dummy-coded), and the condition x Grief Severity interaction. Dependent variables will be cardiovascular reactivity and recovery. A significant interaction would support the hypothesis that the effect of self-affirmation on reactivity and/or recovery is dependent on grief levels. It is predicted that the stress-buffering effect of self-affirmation will be strongest for individuals with high grief severity, evidenced by a smaller HR, SBP, and HF-HRV compared to the control group. The method calculating recovery would be the same as the method used in H1.

  Two months after the last participant.

• Hypothesis 3 (Exploratory): There will be a mediated moderation effect: the self-report measurement of self-worth mediates the change in cardiovascular reactivity, moderated by grief severity.

  A moderated mediation analysis with Hayes PROCESS model will be conducted to explore whether the effect of value-affirmation on cardiovascular reactivity is mediated by changes in self-worth and moderated by grief severity. Change in self-worth will be operationalized by the difference in scores on the Self-Worth Questionnaire (SWQ) taken at timepoint 2 and 3 (right before and after the grief recall). The research team hypothesized that the self-worth variable will mediate the relationship between experimental condition and cardiovascular reactivity, with the relationship between self-worth and reactivity moderated by the participant's level of grief severity.

  Two months after the last participant data collection.

• Hypothesis 4-1: Grief is related to psychological stress among young adult grieving participants: depression

  To test the hypothesis that grief severity is positively associated with participant's level of depression, a bivariate correlation will be conducted. Grief severity, as measured by scores on the prolonged grief (PG-13) questionnaire, will serve as the predictor variable. PG-13 includes 13 questions with a minimum value of 13 and a maximum value of 65, while higher value indicates higher level of grief. The outcome variable will be the scores of the Beck Depression Inventory (BDI). The BDI scale includes 21 questions with a minimum value of 0 and a maximum value of 63, where higher value indicates higher levels of depression. The research team proposed that participants scoring higher on PG-13 would also score higher in BDI, indicating greater vulnerability to depression.

  Two months after the last participant.

• Hypothesis 4-2: Grief is related to psychological stress among young adult grieving participants: anxiety

  To test the hypothesis that grief severity is positively associated with participant's anxiety level, a bivariate correlation will be conducted. Grief severity, as measured by scores on the prolonged grief (PG-13) questionnaire, will serve as the predictor variable. PG-13 includes 13 questions with a minimum value of 13 and a maximum value of 65, while higher value indicates higher level of grief. The outcome variable will be the scores of the Generalized Anxiety Disorder-7 scale (GAD-7). The GAD-7 scale includes 7 questions with a minimum value of 0 and a maximum value of 21, where higher value indicates higher levels of anxiety. The research team proposed that participants scoring higher on PG-13 would also score higher in GAD-7, indicating greater vulnerability to anxiety.

  Two months after the last participant.

• Hypothesis 4-3: Grief is related to psychological stress among young adult grieving participants: worries

  To test the hypothesis that grief severity is positively associated with participant's worriness level, a bivariate correlation will be conducted. Grief severity, as measured by scores on the prolonged grief (PG-13) questionnaire, will serve as the predictor variable. PG-13 includes 13 questions with a minimum value of 13 and a maximum value of 65, while higher value indicates higher level of grief. The outcome variable will be the scores of the Penn State Worry Questionnaire (PSWQ). The PSWQ scale includes 16 questions with a minimum value of 16 and a maximum value of 80, where higher value indicates higher levels of worriness. The research team proposed that participants scoring higher on PG-13 would also score higher in PSWQ, indicating greater levels of worriness.

  Two months after the last participant.

• Hypothesis 4-4: Grief is related to psychological stress among young adult grieving participants: perceived stress

  To test the hypothesis that grief severity is positively associated with participant's sleep quality, a bivariate correlation will be conducted. Grief severity, as measured by scores on the prolonged grief (PG-13) questionnaire, will serve as the predictor variable. PG-13 includes 13 questions with a minimum value of 13 and a maximum value of 65, while higher value indicates higher level of grief. The outcome variable will be the scores of the Perceived Stress Scale (PSS-10). PSS-10 scale includes 10 questions with a minimum value of 0 and a maximum value of 40, where higher value indicates higher levels of daily stress experienced within the last month. The research team proposed that participants scoring higher on PG-13 would also score higher in PSS, indicating greater levels of perceived stress.

  Two months after the last participant.

• Hypothesis 4-5: Grief is related to psychological stress among young adult grieving participants: sleep quality

  To test the hypothesis that grief severity is positively associated with participant's sleep disturbance, a bivariate correlation will be conducted. Grief severity, as measured by scores on the Prolonged Grief (PG-13) questionnaire, will serve as the predictor variable. PG-13 includes 13 questions with a minimum value of 13 and a maximum value of 65, while higher value indicates higher level of grief. The outcome variable will be the scores of the Pittsburgh Sleep Quality Index (PSQI). PSQI includes a mixture of likert-scale questions and short-answer questions that is transferrable to scores, with a minimum value of 0 and a maximum value of 21, where higher value indicates worst sleeping quality. The research team proposed that participants scoring higher on PG-13 would also score higher in PSQI, indicating greater levels of sleep disturbance.

  Two months after the last participant.

• Hypothesis 4-6: Grief is related to psychological stress among young adult grieving participants: Post-traumatic Stress Disorder

  To test the hypothesis that grief severity is positively associated with participant's PTSD symptoms, a bivariate correlation will be conducted. Grief severity, as measured by scores on the Prolonged Grief (PG-13) questionnaire, will serve as the predictor variable. PG-13 includes 13 questions with a minimum value of 13 and a maximum value of 65, while higher value indicates higher level of grief. The outcome variable will be the scores of the PTSD Checklist for DSM-5 (PCL-5). PCL-5 includes 20 questions with a minimum value of 0 and a maximum value of 80, where higher value indicates higher PTSD symptoms. The research team proposed that participants scoring higher on PG-13 would also score higher in PCL-5, indicating greater levels PTSD symptoms.

  Two months after the last participant.

• Hypothesis 5-1 (exploratory): Grief Severity is associated with meaning violation

  To test the hypothesis that grief severity is associated with higher meaning violation, linear regression will be conducted. Grief severity, as measured by scores on the prolonged grief (PG-13) questionnaire, will serve as the predictor variable. PG-13 includes 13 questions with a minimum value of 13 and a maximum value of 65, while higher value indicates higher level of grief. The outcome variable will be the scores of the Global Meaning Violation Scale (GMVS). GMVS includes 13 questions with a minimum value of 0 and a maximum value of 78, where higher value indicates higher levels meaning violation brought by the death event. The research team proposed that participants scoring higher on PG-13 would also score higher on GMVS, indicating higher level of meaning violation.

  Two months after the last participant.

• Hypothesis 5-2 (exploratory): Grief Severity is associated with perceived inclusion

  To test the hypothesis that grief severity is associated with higher inclusion of others in one's self, a linear regression will be conducted. Grief severity, as measured by scores on the prolonged grief (PG-13) questionnaire, will serve as the predictor variable. PG-13 includes 13 questions with a minimum value of 13 and a maximum value of 65, while higher value indicates higher level of grief. The outcome variable will be the scores of the Inclusion of Others in the Self Scale (IOS). IOS includes 2 subscales, each with a minimum value of 0 and a maximum value of 7, where higher value indicates higher levels of inclusion of other person or other group members to the self.

  Two months after the last participant.

• Hypothesis 5-3 (exploratory): Grief Severity is associated with complicated relationship

  To test the hypothesis that grief severity is associated with complicated relationship, a linear regression will be conducted. Grief severity, as measured by scores on the prolonged grief (PG-13) questionnaire, will serve as the predictor variable. PG-13 includes 13 questions with a minimum value of 13 and a maximum value of 65, while higher value indicates higher level of grief. The outcome variable will be the scores of the Social Relationship Index (SRI). SRI includes short-answer questions and likert-scale selections, with a minimum value of 4 and a maximum value of 24, where higher value indicates more complicated relationship.

  Two months after the last participant.

Study Arms (2)

Grief-reducing intervention

EXPERIMENTAL

Participants will be randomly assigned to either a self-affirming task or a non-affirming neutral task prior to engaging in grief recall.

Behavioral: Value-affirmation

Control group

NO INTERVENTION

Participants will be randomly assigned to either a self-affirming task or a non-affirming neutral task prior to engaging in grief recall. Participants in no-affirmation control group will be asked to rank their top 12 favorite jellybean flavors and write about the 3rd and 4th favorite flavor for 10 minutes. This control task has also been tested to propose same amount of workload without promoting participants' self-worth.

Interventions

Value-affirmation BEHAVIORAL

Participants who are randomly assigned to the value-affirmation condition will be presented with 11 values and qualities to rank in order of importance from 1 to 11. Values presented including: being creative / artistic, government or politics, independence, learning and gaining knowledge, athletic ability, belonging to a group (such as your community, cultural group, or school club), music, career, spiritual or religious values, sense of humor. Participants will then be asked to write about their top-ranked value/quality and how it makes them feel good about themselves for 10 minutes.

Also known as: self-affirmation

Grief-reducing intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18 and older who have experienced the death of family member and/or friend within the last 2 to 18 months.
• Participants must also be fluent in English as all procedures will be conducted in English.

You may not qualify if:

• \- Individuals with a history of cardiovascular disease or disorders, those who report being pregnant, or are taking medication which may alter/affect cardiovascular and/or cognitive processes.

Sponsors & Collaborators

• University of South Florida: lead
• Arizona State University: collaborator

Study Sites (1)

University of South Florida, Psychology and Communication Sciences and Disorders Lab Building

Tampa, Florida, 33620, United States

RECRUITING

Related Publications (21)

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  BACKGROUND

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  BACKGROUND

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  PMID: 19652695 BACKGROUND

• Park, C. L., Riley, K. E., George, L. S., Gutierrez, I. A., Hale, A. E., Cho, D., & Braun, T. D. (2016). Global Meaning Violation Scale (GMVS) [Database record]. APA PsycTests. https://doi.org/10.1037/t65154-000

  BACKGROUND

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  BACKGROUND

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  PMID: 12148458 BACKGROUND

• Saavedra Perez HC, Direk N, Milic J, Ikram MA, Hofman A, Tiemeier H. The Impact of Complicated Grief on Diurnal Cortisol Levels Two Years After Loss: A Population-Based Study. Psychosom Med. 2017 May;79(4):426-433. doi: 10.1097/PSY.0000000000000422.

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  PMID: 26541373 BACKGROUND

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  PMID: 13688369 RESULT

Study Officials

• Kristen Salomon, Ph.D

  University of South Florida

  STUDY DIRECTOR

• Kaiyuan Luo, BS, BA

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaiyuan Luo, BS, BA

CONTACT

412-708-9227; kluo@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to either value-affirmation treatment or control condition.

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 21, 2026
• Study Start: October 16, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (1)