Changes in Brain Function Through Repeated Emotion Regulation Training

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: Recruiting
• Conditions: Depression
• Intervention / Treatment: Behavioral: Cognitive Behavioral Training; Behavioral: Mindfulness

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: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen L Kesten, MS; Phone Number: (860) 545-7776; Email: Karen.kesten@hhchealth.org
• Study Contact Backup: Name: Julie Reid, MS; Phone Number: (860) 545-7788; Email: Julie.reid@hhchealth.org

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Recruiting
      • Institute of Living/Hartford Hospital
      • Contact: Karen L Kesten, MS; Phone Number: 860-545-7776; Email: Karen.kesten@hhchealth.org
      • Principal Investigator: Michael C Stevens, PhD
      • Contact: Julie Reid, MS; Phone Number: (860) 545-7788; Email: Julie.reid@hhchealth.org

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
fMRI Brain Scan	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

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory - II and State Trait Anxiety Inventory	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

• Sponsor: Michael Stevens
• Investigators: Principal Investigator: Michael C Stevens, PhD, Institute of Living/Hartford Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): October 1, 2023

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID 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