search
Back to results

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

Primary Purpose

Major Depressive Disorder, Cardiovascular Diseases, Inflammation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single-session emotion regulation training
Sponsored by
University of Southern Mississippi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Southern MississippiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Arm

Arm Description

Outcomes

Primary Outcome Measures

Change in Diastolic Blood Pressure
Diastolic blood pressure will be measured prior to the training, immediately afterwards, and during the 1-week follow-up visit
Change in Systolic Blood Pressure
Systolic blood pressure will be measured prior to the training, immediately afterwards, and during the 1-week follow-up visit
Change in Resting Heart Rate Variability (HRV)
Resting heart rate variability (HRV) will be measured prior to the training, immediately afterwards, and during the 1-week follow-up visit
Change in C-reactive protein (CRP)
C-reactive protein (CRP) will be measured prior to the training, immediately afterwards, and during the 1-week follow-up visit
Change in Center for Epidemiological Studies - Depression Scale (CESD)
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.

Secondary Outcome Measures

Change in Emotion Regulation Questionnaire, Reappraisal subscale (ERQ-R)
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 in Experiences Questionnaire - Decentering (EQ-D)
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 in Difficulties with Emotion Regulation Scale (DERS)
Emotion Dysregulation, measured by the DERS, will be assessed prior to the training, immediately after, and at the 1-week follow-up visit.

Full Information

First Posted
February 20, 2022
Last Updated
July 19, 2023
Sponsor
University of Southern Mississippi
search

1. Study Identification

Unique Protocol Identification Number
NCT05425290
Brief Title
Emotion Regulation Training to Reduce Cardiovascular Disease Risk Among Depressed Young Adults in Southern Mississippi
Official Title
Emotion Regulation Training to Reduce Cardiovascular Disease Risk Among Depressed Young Adults in Southern Mississippi: A Single-Session Design
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Mississippi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Cardiovascular Diseases, Inflammation, Blood Pressure, Heart Rate Variability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Single-session emotion regulation training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Diastolic Blood Pressure
Description
Diastolic blood pressure will be measured prior to the training, immediately afterwards, and during the 1-week follow-up visit
Time Frame
Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Title
Change in Systolic Blood Pressure
Description
Systolic blood pressure will be measured prior to the training, immediately afterwards, and during the 1-week follow-up visit
Time Frame
Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Title
Change in Resting Heart Rate Variability (HRV)
Description
Resting heart rate variability (HRV) will be measured prior to the training, immediately afterwards, and during the 1-week follow-up visit
Time Frame
Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Title
Change in C-reactive protein (CRP)
Description
C-reactive protein (CRP) will be measured prior to the training, immediately afterwards, and during the 1-week follow-up visit
Time Frame
Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Title
Change in Center for Epidemiological Studies - Depression Scale (CESD)
Description
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.
Time Frame
Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Secondary Outcome Measure Information:
Title
Change in Emotion Regulation Questionnaire, Reappraisal subscale (ERQ-R)
Description
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.
Time Frame
Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Title
Change in Experiences Questionnaire - Decentering (EQ-D)
Description
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.
Time Frame
Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Title
Change in Difficulties with Emotion Regulation Scale (DERS)
Description
Emotion Dysregulation, measured by the DERS, will be assessed prior to the training, immediately after, and at the 1-week follow-up visit.
Time Frame
Change from prior to the single-session emotion regulation training to immediately after and 1-week after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women ages 18-29 Able to speak and read English Outpatient at the time of participation Able to provide informed consent Stable medications for 30 days or more Appropriate diagnoses: Meets diagnostic criteria for current major depressive disorder Exclusion Criteria: Not fluent in English Not able to provide informed consent Active suicidal ideation Presence of autoimmune and/or inflammatory diseases (e.g., rheumatoid arthritis, ulcerative colitis) Ongoing use of steroids (if use of steroids is temporary, individuals are eligible to participate 30 days after termination) 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) Meets diagnostic criteria for a schizophrenia-spectrum disorder, substance use disorder, and/or bipolar disorder Presence of a cardiovascular disease (e.g., hypertension) or prescribed cardiovascular medications (e.g., beta blockers, blood pressure medication)
Facility Information:
Facility Name
University of Southern Mississippi
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39406
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan E Renna, PhD
Phone
601-266-6742
Email
megan.renna@usm.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data will be available upon reasonable request.

Learn more about this trial

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

We'll reach out to this number within 24 hrs