Clinical trial NCT04265859: Changes in Brain Function Through Repeated Emotion Regulation Training
Official title: Changes in Brain Function Through Repeated Emotion Regulation Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: fMRI Brain Scan
timeFrame: Visit one and repeated again at Visit two (approximately 4 weeks later)
Secondary outcomes:
measure: Beck Depression Inventory - II and State Trait Anxiety Inventory
timeFrame: Enrollment and repeated again at Visit two (approximately 4 weeks later)
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Institute of Living/Hartford Hospital
state: Connecticut
Study officials:
affiliation: Institute of Living/Hartford Hospital
name: Michael C Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
References: