Neural Components Underlying the Treatment of Adolescent Depression

Examination of the Neural Components Underlying the Treatment of Adolescent Major Depression

The goal of the study is to examine how cognitive behavioral therapy (CBT), a common treatment for adolescent depression, affects brain functioning. Depressed adolescents will complete an initial assessment consisting of an interview, questionnaires, computer tasks, and an EEG recording. EEG (electroencephalography) measures brain activity by recording the electrical activity along the scalp caused by the firing of neurons within the brain. They will then complete 12 sessions of cognitive behavioral therapy, which will be 50 minutes long and held once a week for 12 weeks. Before their third therapy session, participants will complete a computer task while EEG data are recorded. After completing the treatment, the participants will complete a final assessment, which will include questionnaires, computer tasks, and an EEG recording. They will also complete follow-up assessments over the phone 1, 3, and 6 months after completing the treatment.

This study will also include healthy control participants. They will complete an initial assessment consisting of an interview, questionnaires, computer tasks, and an EEG recording. Three weeks later, they will return to complete a behavioral task while EEG data are recorded. Twelve weeks after the initial assessment, they will complete a final assessment, which will include questionnaires, computer tasks, and an EEG recording.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy

Detailed Description

The purpose of the study is to examine the impact of individual cognitive behavioral therapy (CBT) for adolescent depression on neural functioning. Specifically, the study will utilize Brent and Poling's (1997) cognitive behavioral therapy (CBT) manual (Cognitive Therapy Treatment Manual for Depressed and Suicidal Youth), and investigators will examine pre- to post- neural activity patterns for children and adolescents who receive individual CBT for depression. Electroencephalography (EEG) techniques will be utilized to assess treatment-related effects on brain activity (i.e., anterior cingulate cortex and dorsolateral prefrontal cortex functioning). Neural activity patterns will also be compared to non-depressed, healthy controls.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria, Major Depressive Disorder Participants:

• Ages 13-18 years at time of initial assessment
• Female
• Current major depressive disorder (MDD) diagnosed according to the K-SADS Axis I semi-structured interview
• English as first language or English fluency

Exclusion Criteria, Major Depressive Disorder Participants:

• Male
• Mania/Hypomania
• Current anxiety disorders [e.g., Panic Disorder (PD), Generalized Anxiety Disorder (GAD), Obsessive Compulsive Disorder (OCD)]
• Eating Disorders
• Substance Abuse/Dependency
• Conduct Disorder/Antisocial Disorder
• ADHD
• Psychosis
• Mental Retardation
• Organic Brain Syndrome
• Current Psychotherapy Treatment
• Medical & neurological illness (head injury, loss of consciousness for more than 5 minutes, seizures)
• Current use of psychotropic medication for treatment of MDD with the exception of SSRIs (selective serotonin reuptake inhibitors)
• Active suicidality

Inclusion Criteria, Healthy Control Participants:

• Ages 13-18 years at time of initial assessment
• Female
• English as first language or English fluency

Exclusion Criteria, Healthy Control Participants (in addition to the exclusion criteria of the MDD group):

• Elevated depressive symptoms as assessed in phone screen

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cognitive Behavioral Therapy; 12 weekly sessions of cognitive behavioral therapy	Behavioral: Cognitive Behavioral Therapy; 12 sessions of cognitive behavioral therapy
No Intervention: Healthy Controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG Activity	EEG and ERP measures collected during resting state and behavioral tasks	12 weeks

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Randy P Auerbach, PhD, McLean Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: October 23, 2012
• First Submitted That Met QC Criteria: October 26, 2012
• First Posted (Estimate): October 30, 2012

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: depression; adolescent; MDD; major depressive disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 2012P001844; 2011A053424 (Other Grant/Funding Number: Harvard Medical School); 2011A051965 (Other Grant/Funding Number: McLean Hospital); 2010A054978 (Other Grant/Funding Number: Katz Family Foundation); K23MH097786 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No