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Completed

NCT Number: NCT03154008

Predictors of Response to Treatment for Depression

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.

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Key information

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University

Nashville, Tennessee, 37203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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 outcomes

  1. Depressive symptoms

    Time frame: past 2 weeks

    Self-reported symptoms on the Mood and Feelings Questionnaire

  2. Clinician-rated improvement

    Time frame: 8 weeks

    Global improvement rating on the Clinical Global Impression scale

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • The Klingenstein Third Generation Foundation

Registry information

Official study title

Neural Predictors of Response to Cognitive Behavioral Therapy for Adolescent Depression

Acronym: PORT

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 15, 2017
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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