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Neural Components Underlying the Treatment of Adolescent Depression

Mass General Brigham logo

Mass General Brigham

Status

Completed

Conditions

Major Depressive Disorder

Treatments

Behavioral: Cognitive Behavioral Therapy

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01717508
2011A053424 (Other Grant/Funding Number)
2010A054978 (Other Grant/Funding Number)
K23MH097786 (U.S. NIH Grant/Contract)
2012P001844
2011A051965 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

112 patients

Sex

Female

Ages

13 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

112 participants in 2 patient groups

Cognitive Behavioral Therapy
Other group
Description:
12 weekly sessions of cognitive behavioral therapy
Treatment:
Behavioral: Cognitive Behavioral Therapy
Healthy Controls
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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