NCT03154008

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

3 years

First QC Date

May 12, 2017

Last Update Submit

July 21, 2020

Conditions

Adolescent DepressionDepression

Keywords

rewardemotion regulationelectroencephalogramevent-related potentialscognitive behavior therapy

Outcome Measures

Primary Outcomes (2)

  • Depressive symptoms

    Self-reported symptoms on the Mood and Feelings Questionnaire

    past 2 weeks

  • Clinician-rated improvement

    Global improvement rating on the Clinical Global Impression scale

    8 weeks

Study Arms (1)

Active Treatment

EXPERIMENTAL

Group cognitive behavioral therapy (CBT) for 8 weeks.

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

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.

Active Treatment

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

  • 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.

    PMID: 10087688BACKGROUND

MeSH Terms

Conditions

DepressionEmotional Regulation

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-ControlSocial Behavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Autumn Kujawa, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 12, 2017

First Posted

May 15, 2017

Study Start

June 1, 2017

Primary Completion

June 8, 2020

Study Completion

June 8, 2020

Last Updated

July 23, 2020

Record last verified: 2020-07

Locations

US(1)