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Changes in Brain Function Through Repeated Emotion Regulation Training

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Training
Mindfulness
Sponsored by
Michael Stevens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institute of Living/Hartford HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Depressed

Healthy Control

Arm Description

Participants in this group will be randomized to receive either the CBT training (n=10) or Mindfulness training (n=10).

Participants in this group will be randomized to receive either the CBT training (n=10) or Mindfulness training (n=10).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
February 10, 2020
Last Updated
July 31, 2023
Sponsor
Michael Stevens
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1. Study Identification

Unique Protocol Identification Number
NCT04265859
Brief Title
Changes in Brain Function Through Repeated Emotion Regulation Training
Official Title
Changes in Brain Function Through Repeated Emotion Regulation Training
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Stevens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Adults having mild-to-moderate levels of depression or who will serve as non-depressed/anxious controls. Participants in each of these study groups then will be randomized into two conditions, each of which will receive 2 assessment/MRI appointments along with 6 sessions of guided practice/training in either 1) Re-interpretation or 2) Mindfulness ER techniques. Immediately after the first and sixth practice sessions, participants also will undergo fMRI so that brain function relative to that stage of practice can be assessed.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Depressed
Arm Type
Experimental
Arm Description
Participants in this group will be randomized to receive either the CBT training (n=10) or Mindfulness training (n=10).
Arm Title
Healthy Control
Arm Type
Other
Arm Description
Participants in this group will be randomized to receive either the CBT training (n=10) or Mindfulness training (n=10).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Training
Other Intervention Name(s)
CBT
Intervention Description
The CBT-based regulation training involves using a cognitive strategy that instructs participants to reappraise situations in positive or less negative ways.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
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.
Primary Outcome Measure Information:
Title
fMRI Brain Scan
Description
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.
Time Frame
Visit one and repeated again at Visit two (approximately 4 weeks later)
Secondary Outcome Measure Information:
Title
Beck Depression Inventory - II and State Trait Anxiety Inventory
Description
Depression and anxiety scales (pre and post scores, as evidenced by a decrease in total scores from each scale)
Time Frame
Enrollment and repeated again at Visit two (approximately 4 weeks later)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen L Kesten, MS
Phone
(860) 545-7776
Email
Karen.kesten@hhchealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Reid, MS
Phone
(860) 545-7788
Email
Julie.reid@hhchealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael C Stevens, PhD
Organizational Affiliation
Institute of Living/Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Living/Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen L Kesten, MS
Phone
860-545-7776
Email
Karen.kesten@hhchealth.org
First Name & Middle Initial & Last Name & Degree
Julie Reid, MS
Phone
(860) 545-7788
Email
Julie.reid@hhchealth.org
First Name & Middle Initial & Last Name & Degree
Michael C Stevens, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Changes in Brain Function Through Repeated Emotion Regulation Training

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