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Clinical Trials/NCT03154008
NCT03154008
Completed
Not Applicable

Neural Predictors of Response to Cognitive Behavioral Therapy for Adolescent Depression

Vanderbilt University Medical Center1 site in 1 country70 target enrollmentJune 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adolescent Depression
Sponsor
Vanderbilt University Medical Center
Enrollment
70
Locations
1
Primary Endpoint
Clinician-rated improvement
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2017
End Date
June 8, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Autumn Kujawa

Assistant Professor

Vanderbilt University

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)

Outcomes

Primary Outcomes

Clinician-rated improvement

Time Frame: 8 weeks

Global improvement rating on the Clinical Global Impression scale

Depressive symptoms

Time Frame: past 2 weeks

Self-reported symptoms on the Mood and Feelings Questionnaire

Study Sites (1)

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