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

NCT05456035 | Recruiting DMC

• 2 other identifiers: R33MH115125R33MH115125-03
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Keywords

Depression; Adolescents; Cognitive behavior therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  after 12 weeks

Study Arms (2)

Cognitive behavioral therapy plus social cognitive training (CBTSCT)

EXPERIMENTAL

The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. We will conduct individual therapy with depressed adolescents using modules from the Coping with Stress manual used in other depression treatment studies with adolescents. In addition, therapists will teach teens explicitly about theory of mind and social perspective taking during each session and will use examples from the teen's own life to help them learn the skills.

Behavioral: Cognitive behavioral therapy plus social cognitive training (CBTSCT)

Cognitive behavioral therapy (CBT)

ACTIVE COMPARATOR

The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. Therapists will conduct individual therapy sessions with depressed adolescents using modules from the Coping with Stress manual. Social cognitive training will not be provided to teens in this condition.

Behavioral: Cognitive behavioral therapy plus social cognitive training (CBTSCT)

Interventions

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.

Also known as: Cognitive behavioral therapy (CBT)

Cognitive behavioral therapy (CBT); Cognitive behavioral therapy plus social cognitive training (CBTSCT)

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Judy Garber

Nashville, Tennessee, 37203-5721, United States

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Judy Garber, PhD

CONTACT

615-330-5605; judy.garber@vanderbilt.edu

Steven D Hollon, PhD

CONTACT

615-373-2422; steven.d.hollon@vanderbilt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The individuals who conduct the assessments of the outcome measures will be unaware of to which condition the participant was randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology and Human Development

Model Details: The study has two intervention arms: (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 SCT training component. Adolescents are randomized to either condition.

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 13, 2022
• Study Start: October 10, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)