Neural Components Underlying the Treatment of Adolescent Depression
Examination of the Neural Components Underlying the Treatment of Adolescent Major Depression
5 other identifiers
interventional
112
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable major-depressive-disorder
Started Oct 2012
Longer than P75 for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 23, 2012
CompletedFirst Posted
Study publicly available on registry
October 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedFebruary 24, 2020
February 1, 2020
6.7 years
October 23, 2012
February 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
EEG Activity
EEG and ERP measures collected during resting state and behavioral tasks
12 weeks
Study Arms (2)
Cognitive Behavioral Therapy
OTHER12 weekly sessions of cognitive behavioral therapy
Healthy Controls
NO INTERVENTIONInterventions
12 sessions of cognitive behavioral therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Ages 13-18 years at time of initial assessment
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mclean Hospitallead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
McLean Hospital
Belmont, Massachusetts, 02478, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Randy P Auerbach, PhD
Mclean Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 23, 2012
First Posted
October 30, 2012
Study Start
October 1, 2012
Primary Completion
June 1, 2019
Study Completion
June 30, 2019
Last Updated
February 24, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share