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Predictors of Response to Treatment for Depression (PORT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03154008
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : June 17, 2019
The Klingenstein Third Generation Foundation
Information provided by (Responsible Party):
Autumn Kujawa, Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Adolescent Depression Depression Behavioral: Cognitive Behavioral Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neural Predictors of Response to Cognitive Behavioral Therapy for Adolescent Depression
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Active Treatment
Group cognitive behavioral therapy (CBT) for 8 weeks.
Behavioral: Cognitive Behavioral Therapy
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 Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03154008

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Contact: Autumn Kujawa, PhD (615)343-3707

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United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37203
Contact: Autumn Kujawa, PhD    615-322-8141   
Sponsors and Collaborators
Vanderbilt University Medical Center
The Klingenstein Third Generation Foundation
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Principal Investigator: Autumn Kujawa, PhD Vanderbilt University

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Responsible Party: Autumn Kujawa, Assistant Professor, Vanderbilt University Identifier: NCT03154008     History of Changes
Other Study ID Numbers: 00007070
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Autumn Kujawa, Vanderbilt University:
emotion regulation
event-related potentials
cognitive behavior therapy
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders