CBT Enhanced With Social Cognitive Training vs. CBT Only With Depressed Youth

ConditionDepression

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age13-17

SponsorVanderbilt University

About this trial

Depression in youth is a serious public health concern for which more personalized treatments are needed. This randomized controlled trial will test the effect of an intervention aimed at enhancing social cognitive capacities (e.g., ability to take another's perspective), thereby making treatment of depression in youth more efficient and effective. Participants in the R33 (N=82) will be youth between ages 13- through 17-years-old currently experiencing depression. Youth will be randomized to either an enhanced CBT intervention that teaches social cognitive skills, particularly social perspective taking and theory of mind (CBTSCT) as compared to CBT only. The primary target is improvement in both social cognitive skills and depressive symptoms at post-treatment and at a 6-month follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants ages 13- through 17-years-old

Youth must have a diagnosis of a current depressive disorder (e.g., major depressive episode; persistent depressive disorder) or a score on the Patient Health Questionnaire (PHQ9) > 15

Disqualifiers

ever met criteria for a diagnosis of bipolar disorder, schizophrenia, autism, or conduct disorder

current alcohol or substance use disorder with significant impairment

imminent risk of suicide

reading level < 4th grade

Trial design

Design model

Parallel

Treatments tested in this trial

Cognitive behavioral therapy plus social cognitive training (CBTSCT)
Behavioral
The study has two intervention arms to which depressed adolescents will be randomized: (1) CBTSCT is cognitive behavioral therapy enhanced with training in social cognitive abilities (e.g., social perspective taking), and (2) CBT only is cognitive behavioral therapy without the additional social cognitive training component.

Treatment groups

82 Participants

are divided into 2 treatment groups

Group A: Cognitive behavioral therapy plus social cognitive training (CBTSCT)Experimental treatment 1 intervention

Group B: Cognitive behavioral therapy (CBT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Faux Pas Recognition Test

Faux Pas Recognition test (FPRT) measures the ability to identify and explain faux pas situations where a character unintentionally insults another person due to lack of knowledge about some key feature of the other character. FPRT contains 8 Faux Pas and 8 control stories without a faux pas. Stories are followed by 8 questions. Higher scores mean better theory of mind.

Time frame

after 12 weeks

Children's Depression Rating Scale-Revised

In the R33 RCT, depression will be another primary outcome measured with the CDRS-R, which is a clinical interview with the parent and teen separately, about the youth's depressive symptoms during the last two weeks. Higher scores mean more depressive symptoms.

Time frame

after 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

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