Emotion Regulation Training to Reduce Cardiovascular Disease Risk Among Depressed Young Adults in Southern Mississippi

May 11, 2024 updated by: University of Southern Mississippi

Emotion Regulation Training to Reduce Cardiovascular Disease Risk Among Depressed Young Adults in Southern Mississippi: A Single-Session Design

The proposed study will investigate the utility of a single-session emotion regulation training to reduce CVD risk among young adults diagnosed with MDD living in Southern MS. Using an single-arm, non-randomized design, young adults aged 18-29 will undergo a single-session emotion regulation skills training. Before and immediately after the skills training session, participants will supply several biological metrics tied to CVD risk: resting HRV, inflammation (measured via c-reactive protein [CRP]), and blood pressure. Participants will provide the same biological metrics at a one-week follow-up visit to assess short-term sustained gains following the single-session intervention and complete a 7-day ecological momentary assessment (EMA) of their daily emotion regulation skills use and depressive symptoms between these two visits.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cardiovascular disease (CVD) is a leading cause of death in Mississippi, accounting for over a third of deaths within the state. Mississippians face numerous health disparities that enhance disease risk throughout our community. In addition to behavioral factors, several notable biological markers enhance risk for CVD including low resting heart rate variability (HRV), high blood pressure, and inflammation. In Mississippi, an estimated 20.9% of adults meet criteria for depression. Adults experiencing depressive disorders experience high rates of emotion dysregulation, and psychological interventions that include emotion regulation training components are highly efficacious in reducing psychological and physical symptoms associated with depression. Depression, particularly major depressive disorder, is routinely linked with enhanced CVD risk. Understanding and intervening on the relationship between CVD risk factors and depression in young adulthood offers potential to prevent exacerbation of risk later in life. This pilot study will investigate the utility of a single-session emotion regulation training to reduce CVD risk among young adults living in Southern Mississippi who are diagnosed with major depressive disorder (MDD). The study aims are to: 1) examine whether the single-session emotion regulation training promotes changes in biological risk factors for cardiovascular disease immediately following the training and at a 1-week follow-up visit; 2) to assess whether the single-session emotion regulation training reduces depressive symptoms among research subjects; and 3) to test whether use of emotion regulation skills learned during the training in the week following the intervention session promotes greater changes in cardiovascular disease risk factors. Using a lab-based experimental intervention design, young adults will undergo a single-session emotion regulation skills training. Before and after the skills training session, research subjects will supply several physiological metrics tied to CVD risk: resting HRV, c-reactive protein (CRP) levels, and blood pressure. Subjects will provide the same biological metrics at a one-week follow-up visit to assess short-term sustained gains following the single-session intervention. Results from this study offer potential to reduce emotion regulation difficulties associated with major depression, reduce CVD risk factors among young adults in Mississippi, and advance our knowledge of how psychological interventions can improve both psychological and physical risk factors for chronic health conditions among young adults, potentially buffering depression's long-term health impact.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39406
        • University of Southern Mississippi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men and women ages 18-29
  2. Able to speak and read English
  3. Outpatient at the time of participation
  4. Able to provide informed consent
  5. Stable medications for 30 days or more

  6. Appropriate diagnoses:

    • Meets diagnostic criteria for current major depressive disorder

Exclusion Criteria:

  1. Not fluent in English
  2. Not able to provide informed consent
  3. Active suicidal ideation
  4. Presence of autoimmune and/or inflammatory diseases (e.g., rheumatoid arthritis, ulcerative colitis)
  5. Ongoing use of steroids (if use of steroids is temporary, individuals are eligible to participate 30 days after termination)
  6. Medication change in the past 30 days (individuals are eligible to participate 30 days after a medication change and may take advantage of delayed scheduling)
  7. Meets diagnostic criteria for a schizophrenia-spectrum disorder, substance use disorder, and/or bipolar disorder
  8. Presence of a cardiovascular disease (e.g., hypertension) or prescribed cardiovascular medications (e.g., beta blockers, blood pressure medication)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Arm
Behavioral: Single-session emotion regulation training
The single-session emotion regulation skills training will blend psychotherapeutic approaches that emphasize effective ER. First, participants will be taught to adopt a detached (i.e., 'distanced') and nonjudgmental attitude towards an emotional situation. Detachment, or 'distancing' as it will be introduced to participants, will be taught by examining the situation with objectivity or putting spatial or temporal distance between the current moment and the situation. Second, research participants will be taught reframing. Specifically, they will be introduced to the relationship between thoughts and emotions and how to find interpretations that are less upsetting in order to be more effective when upset. Participants will identify elements of a situation that they did not pay attention to or information that was missing, and to reframe their thoughts based on the full picture. The emotion regulation training is expected to take approximately 30-45 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Diastolic Blood Pressure
Time Frame: Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Diastolic blood pressure will be measured prior to the training, immediately afterwards, and during the 1-week follow-up visit
Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Change in Systolic Blood Pressure
Time Frame: Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Systolic blood pressure will be measured prior to the training, immediately afterwards, and during the 1-week follow-up visit
Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Change in Resting Heart Rate Variability (HRV)
Time Frame: Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Resting heart rate variability (HRV) will be measured prior to the training, immediately afterwards, and during the 1-week follow-up visit
Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Change in C-reactive protein (CRP)
Time Frame: Change from prior to the single-session emotion regulation training to immediately after and 1-week after
C-reactive protein (CRP) will be measured prior to the training, immediately afterwards, and during the 1-week follow-up visit
Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Change in Center for Epidemiological Studies - Depression Scale (CESD)
Time Frame: Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Depressive symptoms will be assessed using the CESD prior to the training, immediately afterwards, and at the 1-week follow-up visit. Depressive symptoms will also be assessed during the EMA assessment period.
Change from prior to the single-session emotion regulation training to immediately after and 1-week after

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Emotion Regulation Questionnaire, Reappraisal subscale (ERQ-R)
Time Frame: Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Reappraisal Skills will be measured by the ERQ-R and assessed prior to the training, immediately afterwards, and at the 1-week follow-up visit. Reappraisal skills will also be assessed during the EMA assessment period.
Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Change in Experiences Questionnaire - Decentering (EQ-D)
Time Frame: Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Decentering skills, measured by the EQ-D, will be assessed prior to the training, immediately afterwards, and at the 1-week follow-up visit. Decentering skills will also be assessed during the EMA assessment period.
Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Change in Difficulties with Emotion Regulation Scale (DERS)
Time Frame: Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Emotion Dysregulation, measured by the DERS, will be assessed prior to the training, immediately after, and at the 1-week follow-up visit.
Change from prior to the single-session emotion regulation training to immediately after and 1-week after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern Mississippi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • USMississippi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data will be available upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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