Recruiting

CBT vs. CBT

Sponsor:

Vanderbilt University

Code:

NCT05456035

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Interventions

Cognitive behavioral therapy plus social cognitive training (CBTSCT)

Study Details

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

Study ID

NCT05456035

Start date

Oct 10, 2022

Status verified date

Sep, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Participants ages 13- through 17-years-old
2. 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

Study Design

Enrollment

82 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

active comparator: Cognitive behavioral therapy (CBT)

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.

Interventions

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 measure

  • Faux Pas Recognition Test [ Time Frame: after 12 weeks ]
  • Children's Depression Rating Scale-Revised [ Time Frame: after 12 weeks ]

Central Contacts and Locations

Central contacts

Judy Garber, PhD

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

Steven D Hollon, PhD

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

Locations

Judy Garber

Recruiting

Nashville, Tennessee, United States, 37203-5721

Contacts

Judy Garber, PhD

615-343-8714jgarber.vanderbilt@gmail.com

Steven D Hollon, PhD

615-322-3369steven.d.hollon@vanderbilt.edu

Principal Investigator:

Judy Garber, PhD

More Information

Sponsor

Vanderbilt University

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • Depression
  • Adolescents
  • Cognitive behavior therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University on 2025-09-09.