NCT05456035 · Vanderbilt University
CBT Enhanced With Social Cognitive Training vs. CBT Only With Depressed Youth
What this study is about
Depression in youth is a serious public health concern for which more personalized treatments are needed. This randomly assigned 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Cognitive behavioral therapy plus social cognitive training (CBTSCT)
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.
Primary outcome measures
Faux Pas Recognition Test
Time frame: after 12 weeks
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.
Children's Depression Rating Scale-Revised
Time frame: after 12 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Nashville, Tennessee
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 9, 2025 · Source of record for eligibility and locations