Clinical trial NCT03154008: Predictors of Response to Treatment for Depression
Official title: Neural Predictors of Response to Cognitive Behavioral Therapy for Adolescent Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Depression
Depression
Keywords: reward
emotion regulation
electroencephalogram
event-related potentials
cognitive behavior therapy
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: The Klingenstein Third Generation Foundation
First posted: 2017-05-15
Enrollment: 70
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Depressive symptoms
timeFrame: past 2 weeks
measure: Clinician-rated improvement
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Autumn Kujawa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.