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

NCT05425290 | Completed DMC

• 1 other identifier: USMississippi
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Cardiovascular Diseases; Inflammation; Blood Pressure; Heart Rate Variability

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Change in Emotion Regulation Questionnaire, Reappraisal subscale (ERQ-R)

  Change from prior to the single-session emotion regulation training to immediately after and 1-week after

• Change in Experiences Questionnaire - Decentering (EQ-D)

  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)

  Change from prior to the single-session emotion regulation training to immediately after and 1-week after

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Behavioral: Single-session emotion regulation training

Interventions

Single-session emotion regulation training BEHAVIORAL

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Southern Mississippi: lead

Study Sites (1)

University of Southern Mississippi

Hattiesburg, Mississippi, 39406, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Cardiovascular Diseases; Inflammation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: June 21, 2022
• Study Start: August 25, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)