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Neural Components Underlying the Treatment of Adolescent Depression

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01717508
Enrollment
112
Registered
2012-10-30
Start date
2012-10-31
Completion date
2019-06-30
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

MDD, depression, major depressive disorder, adolescent

Brief summary

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.

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy

12 sessions of cognitive behavioral therapy

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Mclean Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
13 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
EEG Activity12 weeksEEG and ERP measures collected during resting state and behavioral tasks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026