Cardiovascular Effects of Grieving
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of South Florida
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Value-affirmation
BehavioralParticipants 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Grief-reducing interventionExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Two months after the last participant data collection.2
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.
Time frame
Two months after the last participant.3
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.
Time frame
Two months after the last participant data collection.4
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.
Time frame
Two months after the last participant.Sponsors and contacts
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University of South Florida
Lead sponsor
Arizona State University
Collaborator
Source ClinicalTrials.gov