Predictors of Response to Treatment for Depression

Not Applicable

Completed

• Conditions: Depression; Adolescent Depression
• Interventions: Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT03154008
• Lead Sponsor: Vanderbilt University Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-12
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-15
• Study Start: 2017-06-01
• Primary Completion: 2020-06-08
• Study Completion: 2020-06-08
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Treatment	Cognitive Behavioral Therapy	Group cognitive behavioral therapy (CBT) for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Clinician-rated improvement	8 weeks	Global improvement rating on the Clinical Global Impression scale
Depressive symptoms	past 2 weeks	Self-reported symptoms on the Mood and Feelings Questionnaire

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States