Changes in Brain Function Through Repeated Emotion Regulation Training

July 31, 2023 updated by: Michael Stevens
This is a pilot study that will investigate how two psychotherapies (re-interpretation and mindfulness) alter brain function. This information will be used to gain understanding of how repeated emotion regulation practices influence the brain and to develop a focused, tactic-based emotional regulation remediation approach for treatment of ADHD.

Study Overview

Status

Status

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

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

The goal of this pilot study is to collect preliminary data that will allow the investigators to formulate theories about ER-related brain function change during intervention-like training that will be tested in larger, externally-funded grant proposals submitted to the National Institutes of Health. The investigators are not especially interested in any existing specific, manualized therapeutic technique. Existing ER-based psychotherapies typically incorporate a variety of related interventions, not all of which focus on the ER component itself. Instead, the investigators will focus on the "building blocks" of such therapies, i.e., the ER interventions themselves and their effect on negative emotional reactions. Here, the investigators ask a specific question - How does ER-elicited brain function change with repeated sessions of guided practice of various ER techniques? In other words, does increasing familiarity or mastery of ER skills through practice change brain function, and how? There are logical hypotheses about the likely nature of brain function changes that can be gleaned from prior neuroimaging research. For instance, if prefrontal cortex activation is important to ER, perhaps practice simply increases such activation. However, pilot work for the current NIMH R01 suggests instead that ER practice might work by enhancing the functional integration among key frontolimbic regions. Complicating such hypotheses is the recognition that different ER tactics engage many distinct brain regions depending on which approach is employed. So a participant's individual brain function differences prior to ER training might be a potent determinant for what sorts of neural changes result from repeated practice. Because all these issues must be evaluated through the lens of a preliminary study before any coherent theoretical model can be formulated, a pilot study is proposed here. Not only will this provide empirical data upon which to base future research, conducting such a pilot will showcase any methodological hurdles or challenges that need to be overcome in order to successfully conduct a larger-scale study.

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 (Estimated)

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.
40

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Institute of Living/Hartford Hospital
        • Contact:
        • Principal Investigator:
          • Michael C Stevens, PhD
        • Contact:

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Ages 18-50
  • Right-handed
  • High-school level of education (11th grade attainment for 18 year-olds is acceptable if they haven't completed their final year yet)
  • >8th grade English reading level to complete self-report evaluations (most are only available in English).
  • For the depressed group, elevated scores on the Beck Depression Inventory - II to validate depressive symptoms.

Exclusion Criteria:

  • Head injury sufficient to have caused >30 minutes lost consciousness
  • Past or current CNS disease (e.g., MS, epilepsy, tumor, etc.)
  • Brain lesion identified by MR (structural MR scans will be reviewed by a radiologist for the presence of clinical neuropathology that may affect cognitive task performance)
  • Hypertension or juvenile-onset diabetes (current treatment with antihypertensives or insulin)
  • Current pregnancy (menstruating females will be tested)
  • DSM-IV Axis I lifetime history of Bipolar disorder, PTSD, OCD, psychotic disorder, Tourette's disorder, or any Pervasive Developmental Disorder (e.g., Autistic disorder, PDD NOS, etc.)
  • For the depressed group, current PTSD
  • Current DSM-IV substance dependence, ADHD, Conduct Disorder, MDD
  • Any current psychotropic medications

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: Randomized
  • Interventional Model: Parallel 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: Depressed
Participants in this group will be randomized to receive either the CBT training (n=10) or Mindfulness training (n=10).
Behavioral: Cognitive Behavioral Training
The CBT-based regulation training involves using a cognitive strategy that instructs participants to reappraise situations in positive or less negative ways.
Other Names:
  • CBT
Behavioral: Mindfulness
The MBT-based regulation training involves using a mindfulness strategy that instructs participants to notice and accept their feelings without judgment or intent to act upon them.
Other: Healthy Control
Participants in this group will be randomized to receive either the CBT training (n=10) or Mindfulness training (n=10).
Behavioral: Cognitive Behavioral Training
The CBT-based regulation training involves using a cognitive strategy that instructs participants to reappraise situations in positive or less negative ways.
Other Names:
  • CBT
Behavioral: Mindfulness
The MBT-based regulation training involves using a mindfulness strategy that instructs participants to notice and accept their feelings without judgment or intent to act upon them.

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
fMRI Brain Scan
Time Frame: Visit one and repeated again at Visit two (approximately 4 weeks later)
fMRI-assessed brain function data, examined either to detect any changes in activation amplitude ("level of activity") in a priori ER-linked brain regions-of-interest (ROIs) or changes in the degree of functional connectivity among them.
Visit one and repeated again at Visit two (approximately 4 weeks later)

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
Beck Depression Inventory - II and State Trait Anxiety Inventory
Time Frame: Enrollment and repeated again at Visit two (approximately 4 weeks later)
Depression and anxiety scales (pre and post scores, as evidenced by a decrease in total scores from each scale)
Enrollment and repeated again at Visit two (approximately 4 weeks later)

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.
Michael Stevens

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael C Stevens, PhD, Institute of Living/Hartford Hospital

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.
March 1, 2021

Primary Completion (Estimated)

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.
October 1, 2023

Study Completion (Estimated)

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.
October 1, 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 10, 2020

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.
February 10, 2020

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.
February 12, 2020

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.
August 2, 2023

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.
July 31, 2023

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.
August 1, 2022

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.
  • R-HCC-2016-0177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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