Major Depressive DisorderNCT05425290
Emotion Regulation Training to Reduce Cardiovascular Disease Risk Among Depressed Young Adults in Southern Mississippi
A study testing Single-session emotion regulation training in people with Major Depressive Disorder and Cardiovascular Diseases, run by University of Southern Mississippi at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Major Depressive Disorder, Cardiovascular Diseases, Inflammation
- What is being tested?
- Single-session emotion regulation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern Mississippi
Hattiesburg, Mississippi, 39406
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Depressive Disorder, Cardiovascular Diseases, Inflammation, Blood Pressure, Heart Rate Variability
- Being tested
- Single-session emotion regulation training
- Medical subject headings
- Depressive Disorder, Major, Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-session emotion regulation trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Not described Receives: Behavioral: Single-session emotion regulation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
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.
Measured: Change from prior to the single-session emotion regulation training to immediately after and 1-week after
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.
Measured: 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)
Emotion Dysregulation, measured by the DERS, will be assessed prior to the training, immediately after, and at the 1-week follow-up visit.
Measured: Change from prior to the single-session emotion regulation training to immediately after and 1-week after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start25 Aug 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Mississippi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425290
- Sponsor's protocol ID
- USMississippi
- Status last verified
- May 2024
- First submitted
- 20 Feb 2022
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Regulation Training to Reduce Cardiovascular Disease Risk Among Depressed Young Adults in Southern Mississippi: A Single-Session Design
- ClinicalTrials.gov ID
- NCT05425290
- Acronym / sponsor ID
- USMississippi
- Conditions
- Major Depressive Disorder, Cardiovascular Diseases, Inflammation, Blood Pressure, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Southern MississippiUniversity, hospital or other
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Single-session emotion regulation training |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-session emotion regulation trainingThe 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. | Behavioural | Intervention Arm |
Primary outcome
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 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 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 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 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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be available upon reasonable request.
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-session emotion regulation training in people with Major Depressive Disorder and Cardiovascular Diseases, run by University of Southern Mississippi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diastolic Blood Pressure (time frame: Change from prior to the single-session emotion regulation training to immediately after and 1-week after). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.