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Clinical Trials/NCT03154008
NCT03154008CompletedNot Applicable

Neural Predictors of Response to Cognitive Behavioral Therapy for Adolescent Depression

Vanderbilt University Medical Center1 site in 1 country70 target enrollmentStarted: June 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
70
Locations
1
Primary Endpoint
Clinician-rated improvement

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
14 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Active Treatment

Experimental

Group cognitive behavioral therapy (CBT) for 8 weeks.

Intervention: Cognitive Behavioral Therapy (Behavioral)

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Autumn Kujawa

Assistant Professor

Vanderbilt University

Study Sites (1)

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