Changes in Brain Function Through Repeated Emotion Regulation Training

NCT04265859 | Unknown

• 1 other identifier: R-HCC-2016-0177
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Beck Depression Inventory - II and State Trait Anxiety Inventory

  Enrollment and repeated again at Visit two (approximately 4 weeks later)

Study Arms (2)

Depressed

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Training; Behavioral: Mindfulness

Healthy Control

OTHER

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

Behavioral: Cognitive Behavioral Training; Behavioral: Mindfulness

Interventions

Cognitive Behavioral Training BEHAVIORAL

The CBT-based regulation training involves using a cognitive strategy that instructs participants to reappraise situations in positive or less negative ways.

Also known as: CBT

Depressed; Healthy Control

Mindfulness BEHAVIORAL

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.

Depressed; Healthy Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael Stevens: lead

Study Sites (1)

Institute of Living/Hartford Hospital

Hartford, Connecticut, 06106, United States

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Michael C Stevens, PhD

  Institute of Living/Hartford Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen L Kesten, MS

CONTACT

(860) 545-7776; Karen.kesten@hhchealth.org

Julie Reid, MS

CONTACT

(860) 545-7788; Julie.reid@hhchealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Research Scientist

Model Details: 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.

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: March 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 2, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)