Back to resultsPredictors of Response to Treatment for Depression (PORT)
Primary Purpose
Adolescent Depression, Depression
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 Adolescent Depression focused on measuring reward, emotion regulation, electroencephalogram, event-related potentials, cognitive behavior therapy
Eligibility Criteria
Inclusion Criteria:
- Participants presenting with major depressive or persistent depressive disorder and moderate severity on the Clinical Global Impressions scale.
- Participants may have comorbid externalizing or anxiety disorders.
- Participants (and parents of minors) fluent in English.
Exclusion Criteria:
- Youth with history of treatment for substance use disorders.
- Youth with intellectual or developmental disabilities (e.g., autism spectrum disorders, pervasive developmental disorders).
- Youth with lifetime schizophrenia, psychosis, or mania.
- Youth with severe current suicidality.
- Youth taking antipsychotic medications or mood stabilizers.
- Youth with recent changes in dosage of antidepressant (adolescents with change in dosage in past 30 days who otherwise meet study criteria will be asked to begin the study once dosage has been stable for 30 days).
- Parent or child not fluent in English.
- Youth who are unable to complete study procedures because of visual or hearing impairments.
- Youth who have recently started outside therapy (past 30 days at time of intake), are engaged in treatment that is determined to be too similar to study therapy (e.g, other CBT groups), or are currently in treatment that is too intensive to allow for participation in study therapy (e.g., partial hospitalization programs)
Sites / Locations
- Vanderbilt University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active Treatment
Arm Description
Group cognitive behavioral therapy (CBT) for 8 weeks.
Outcomes
Primary Outcome Measures
Depressive symptoms
Self-reported symptoms on the Mood and Feelings Questionnaire
Clinician-rated improvement
Global improvement rating on the Clinical Global Impression scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03154008
First Posted
May 12, 2017
Last Updated
July 21, 2020
Sponsor
Vanderbilt University Medical Center
Collaborators
The Klingenstein Third Generation Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03154008
Brief Title
Predictors of Response to Treatment for Depression
Acronym
PORT
Official Title
Neural Predictors of Response to Cognitive Behavioral Therapy for Adolescent Depression
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 8, 2020 (Actual)
Study Completion Date
June 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
The Klingenstein Third Generation Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The current study will examine neurophysiological, specifically event-related potential (ERP), measures of emotional processing as predictors of response to cognitive behavior therapy for adolescent depression.
Detailed Description
Neurophysiological measures (i.e., event-related potentials) of reward responsiveness and regulation of mood-congruent, sad stimuli will be assessed in a sample of adolescents with depression prior to group cognitive behavior therapy (CBT). CBT will follow the Adolescent Coping with Depression Course, an established 16-session group treatment protocol, and consist of behavioral activation, relaxation skills, cognitive therapy, social skills, problem solving, and relapse prevention. Changes in symptoms will be monitored through biweekly self-report and clinician ratings to examine prediction of change in symptoms across CBT. Baseline individual differences in reward responsiveness and emotion regulation will be evaluated as predictors of change in self-reported symptoms and clinician-rated improvement following CBT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Depression, Depression
Keywords
reward, emotion regulation, electroencephalogram, event-related potentials, cognitive behavior therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Treatment
Arm Type
Experimental
Arm Description
Group cognitive behavioral therapy (CBT) for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Cognitive Behavioral Therapy will follow the Adolescent Coping with Depression Course (CWD; Clarke et al., 1999), an established 16-session group treatment protocol, and consist of behavioral activation, relaxation skills, cognitive therapy, social skills, problem solving, and relapse prevention.
Primary Outcome Measure Information:
Title
Depressive symptoms
Description
Self-reported symptoms on the Mood and Feelings Questionnaire
Time Frame
past 2 weeks
Title
Clinician-rated improvement
Description
Global improvement rating on the Clinical Global Impression scale
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants presenting with major depressive or persistent depressive disorder and moderate severity on the Clinical Global Impressions scale.
Participants may have comorbid externalizing or anxiety disorders.
Participants (and parents of minors) fluent in English.
Exclusion Criteria:
Youth with history of treatment for substance use disorders.
Youth with intellectual or developmental disabilities (e.g., autism spectrum disorders, pervasive developmental disorders).
Youth with lifetime schizophrenia, psychosis, or mania.
Youth with severe current suicidality.
Youth taking antipsychotic medications or mood stabilizers.
Youth with recent changes in dosage of antidepressant (adolescents with change in dosage in past 30 days who otherwise meet study criteria will be asked to begin the study once dosage has been stable for 30 days).
Parent or child not fluent in English.
Youth who are unable to complete study procedures because of visual or hearing impairments.
Youth who have recently started outside therapy (past 30 days at time of intake), are engaged in treatment that is determined to be too similar to study therapy (e.g, other CBT groups), or are currently in treatment that is too intensive to allow for participation in study therapy (e.g., partial hospitalization programs)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Autumn Kujawa, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
10087688
Citation
Clarke GN, Rohde P, Lewinsohn PM, Hops H, Seeley JR. Cognitive-behavioral treatment of adolescent depression: efficacy of acute group treatment and booster sessions. J Am Acad Child Adolesc Psychiatry. 1999 Mar;38(3):272-9. doi: 10.1097/00004583-199903000-00014.
Results Reference
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Predictors of Response to Treatment for Depression
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