140 Participants Needed

Value-Affirmation for Grief

(SAGE Trial)

KL
Overseen ByKaiyuan Luo, BS, BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of South Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

KL

Kaiyuan Luo, BS, BA

Principal Investigator

University of South Florida

KS

Kristen Salomon, Ph.D

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

This trial is for individuals experiencing grief. It aims to explore if self-affirmation can help with cardiovascular responses during and after recalling a grief event. Participants should be in good general health, willing to discuss their grief experience, and able to perform the tasks required by the study.

Inclusion Criteria

I am 18 or older and lost a loved one between 2 to 18 months ago.
Participants must also be fluent in English as all procedures will be conducted in English

Exclusion Criteria

I am on medication that could affect my heart or brain function.
I have a history of heart disease or conditions.
Individuals who report being pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants complete questionnaires and have their height and weight measured. Cardiovascular measurement equipment is attached.

1 day
1 visit (in-person)

Intervention

Participants undergo self-affirmation or control task followed by a grief recall interview. Cardiovascular responses are measured.

1 day
1 visit (in-person)

Recovery

Participants sit quietly for a recovery period while cardiovascular measures are taken.

10 minutes

Follow-up

Participants are monitored for cardiovascular recovery and complete additional questionnaires.

2 months

What Are the Treatments Tested in This Trial?

Interventions

  • Value-affirmation

Trial Overview

The study tests whether a self-affirmation intervention can improve heart health during and after participants remember a sad loss. The experiment compares two groups: one practicing self-affirmation techniques and another without such an intervention.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Grief-reducing interventionExperimental Treatment1 Intervention
Group II: Control groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials
433
Recruited
198,000+

Arizona State University

Collaborator

Trials
311
Recruited
109,000+