Neural Components Underlying the Treatment of Adolescent Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD, depression, major depressive disorder, adolescent
Eligibility 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
Sites / Locations
- McLean Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Cognitive Behavioral Therapy
Healthy Controls
Arm Description
12 weekly sessions of cognitive behavioral therapy
Outcomes
Primary Outcome Measures
EEG Activity
EEG and ERP measures collected during resting state and behavioral tasks
Secondary Outcome Measures
Full Information
NCT ID
NCT01717508
First Posted
October 23, 2012
Last Updated
February 21, 2020
Sponsor
Mclean Hospital
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01717508
Brief Title
Neural Components Underlying the Treatment of Adolescent Depression
Official Title
Examination of the Neural Components Underlying the Treatment of Adolescent Major Depression
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
MDD, depression, major depressive disorder, adolescent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral Therapy
Arm Type
Other
Arm Description
12 weekly sessions of cognitive behavioral therapy
Arm Title
Healthy Controls
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
12 sessions of cognitive behavioral therapy
Primary Outcome Measure Information:
Title
EEG Activity
Description
EEG and ERP measures collected during resting state and behavioral tasks
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randy P Auerbach, PhD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neural Components Underlying the Treatment of Adolescent Depression
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