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

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy plus social cognitive training (CBTSCT)
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Adolescents, Cognitive behavior therapy

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Judy GarberRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive behavioral therapy plus social cognitive training (CBTSCT)

Cognitive behavioral therapy (CBT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 1, 2022
Last Updated
August 17, 2023
Sponsor
Vanderbilt University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05456035
Brief Title
CBT Enhanced With Social Cognitive Training vs. CBT Only With Depressed Youth
Official Title
Social Cognitive Training to Enhance the Efficacy of CBT forDepression in Youth: A Developmental Approach (R33)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Depression in adolescents is a recurrent and impairing disorder. Although some treatments have shown modest effects in children and adolescents (e.g., cognitive behavioral therapy - CBT), there remains a critical need to build upon these therapies to reach even more youths with depression. One variable hypothesized to affect children's interpersonal relationships is their level of social cognitive development on abilities particularly relevant to social functioning and CBT (e.g., social perspective taking; theory of mind). This RCT will test the efficacy of an intervention aimed at increasing children's social cognitive (SC) abilities. Adolescents (ages 13-17; N=82) with depression diagnoses or clinical levels of depressive symptoms (PHQ9 >15) will be randomized to either the social cognitive training enhanced CBT (CBTSCT) or CBT only. In the R33 RCT, investigators will conduct a trial aimed at replicating the results of the R61 with a new sample of 82 youth (ages 13-17) randomized to CBTSCT or CBT only. Youth will be evaluated regarding their social cognitive abilities (i.e., theory of mind), level of depressive symptoms, and social functioning at baseline, post-treatment, and at a 6-month follow-up. Finally, investigators will test if increases in social cognitive abilities partially accounted for the relation between treatment condition and decreases in depression. If the CBTSCT intervention significantly improves participants' social cognitive abilities and decreases depressive symptoms, then this will provide therapists with a more efficient and personalized treatment of depression in youth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Adolescents, Cognitive behavior therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
The individuals who conduct the assessments of the outcome measures will be unaware of to which condition the participant was randomized.
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavioral therapy plus social cognitive training (CBTSCT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive behavioral therapy (CBT)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy plus social cognitive training (CBTSCT)
Other Intervention Name(s)
Cognitive behavioral therapy (CBT)
Intervention Description
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 Information:
Title
Faux Pas Recognition Test
Description
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
Title
Children's Depression Rating Scale-Revised
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judy Garber, PhD
Phone
615-330-5605
Email
judy.garber@vanderbilt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Steven D Hollon, PhD
Phone
615-373-2422
Email
steven.d.hollon@vanderbilt.edu
Facility Information:
Facility Name
Judy Garber
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-5721
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judy Garber, PhD
Phone
615-343-8714
Email
jgarber.vanderbilt@gmail.com
First Name & Middle Initial & Last Name & Degree
Steven D Hollon, PhD
Phone
615-322-3369
Email
steven.d.hollon@vanderbilt.edu
First Name & Middle Initial & Last Name & Degree
Judy Garber, PhD
First Name & Middle Initial & Last Name & Degree
Steven D Hollon, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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