Neural Components Underlying the Treatment of Adolescent Depression

NCT ID: NCT01717508

Last Updated: 2020-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive Behavioral Therapy

12 weekly sessions of cognitive behavioral therapy

Group Type OTHER

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

12 sessions of cognitive behavioral therapy

Healthy Controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive Behavioral Therapy

12 sessions of cognitive behavioral therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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


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

Exclusion Criteria

* 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


* Elevated depressive symptoms as assessed in phone screen
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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Randy P. Auerbach

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Randy P Auerbach, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

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McLean Hospital

Belmont, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2011A053424

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2011A051965

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2010A054978

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

K23MH097786

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2012P001844

Identifier Type: -

Identifier Source: org_study_id

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