Predictors of Response to Treatment for Depression

Depression Clinical Trial

— PORT  

Official title:

Neural Predictors of Response to Cognitive Behavioral Therapy for Adolescent Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03154008
• Other study ID #: 00007070
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: June 8, 2020

Study information

• Verified date: July 2020
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 8, 2020
• Est. primary completion date: June 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adolescent Depression
• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	The Klingenstein Third Generation Foundation

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms	Self-reported symptoms on the Mood and Feelings Questionnaire	past 2 weeks
Primary	Clinician-rated improvement	Global improvement rating on the Clinical Global Impression scale	8 weeks