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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05425290
• Other study ID #: USMississippi
• Status: Completed
• Phase: N/A
• Start date: August 25, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: University of Southern Mississippi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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)

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Diseases
• Depressive Disorder
• Depressive Disorder, Major
• Heart Rate Variability
• Inflammation
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of Southern Mississippi	Hattiesburg	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Mississippi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 from prior to the single-session emotion regulation training to immediately after and 1-week after
Primary	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 from prior to the single-session emotion regulation training to immediately after and 1-week after
Primary	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 from prior to the single-session emotion regulation training to immediately after and 1-week after
Primary	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 from prior to the single-session emotion regulation training to immediately after and 1-week after
Primary	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.	Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Secondary	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 from prior to the single-session emotion regulation training to immediately after and 1-week after
Secondary	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 from prior to the single-session emotion regulation training to immediately after and 1-week after
Secondary	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.	Change from prior to the single-session emotion regulation training to immediately after and 1-week after