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CBT Enhanced With Social Cognitive Training (CBT+SCT)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavior therapy with social cognitive training (CBT+SCT)
CBT-only
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, Treatment

Eligibility Criteria

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

Inclusion Criteria:

  • 12- to 17-years-old
  • diagnosis of a current depressive disorder (e.g., major depressive episode; persistent depressive disorder) or a score on the Children's Depression Rating Scale (CDRS) >= 40

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
  • estimated IQ<80

Sites / Locations

  • Judy Garber
  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT+SCT

CBT-only

Arm Description

Cognitive behavioral therapy plus social cognitive skills training (SCT)

Cognitive behavioral therapy only (without SCT)

Outcomes

Primary Outcome Measures

Faux Pas Recognition Test
The Faux Pas Recognition Task consists of 10 Faux Pas Stories and 10 Control Stories without a faux pas, scoring one point for every correct faux pas perception. The higher score is 20 and lower score 0; domain scores are scaled in a positive direction (i.e. higher scores denote higher theory of mind). Faux Pas Recognition test 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.

Secondary Outcome Measures

Children Depression Rating Scale - Revised
The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression). The CDRS-R is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113. Scores above 35 are considered to represent clinically significant symptoms. We measured depressive symptoms with the CDRS-R as a secondary outcome.

Full Information

First Posted
May 15, 2019
Last Updated
February 28, 2023
Sponsor
Vanderbilt University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03954392
Brief Title
CBT Enhanced With Social Cognitive Training
Acronym
CBT+SCT
Official Title
Social Cognitive Training to Enhance the Efficacy of CBT for Depression in Youth: A Developmental Approach
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

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 study will test the effect of an intervention aimed at enhancing depressed children's social cognitive capacities (e.g., ability to take another's perspective), thereby making treatment of depression in youth more efficient and effective. Participants in both the R61 (N=42) and R33 (N=82) will be youth between 12 and 17 years old currently experiencing a depressive disorder. Youth will be randomized to either an enhanced CBT intervention that teaches social cognitive skills, particularly social perspective taking and theory of mind as compared to CBT only. The primary target is improvement in the social cognitive skills at post treatment in the first trial (R61) and improvements in both social cognitive skills and depressive symptoms at post-treatment and at a 4-month follow-up (R33).
Detailed Description
Depression in youth 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 in order 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). The first RCT (R61) will test the efficacy of an intervention aimed at increasing children's social cognitive (SC) abilities.Youth (ages 12-17; N=42) with depression diagnoses or clinical levels of depressive symptoms (CESD > 20) will be randomized to either the social cognitive training enhanced CBT (SCT-CBT) or CBT only. Pre- and post-treatment evaluations will assess the social cognitions. In the second RCT (R33), we will conduct a replication trial with a new sample of 82 youth (ages 12-17) again randomized to SCT-CBT or CBT only. Youth will be evaluated with regard to the SC abilities (i.e., theory of mind), level of depressive symptoms, and social functioning at baseline, post-treatment, and at a 4-month follow-up (R33). Finally, in the R33 we will test if increases in SC abilities partially account for the relation between treatment condition and decreases in depression. If the SCT-CBT intervention significantly improves children's SC abilities and social functioning and decreases depression, 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, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study has two intervention arms: (1) CBT + SCT 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. We will stratify randomization by gender, age (12-14; 15-17), race/ethnicity (minority status), and medication use.
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
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT+SCT
Arm Type
Experimental
Arm Description
Cognitive behavioral therapy plus social cognitive skills training (SCT)
Arm Title
CBT-only
Arm Type
Active Comparator
Arm Description
Cognitive behavioral therapy only (without SCT)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavior therapy with social cognitive training (CBT+SCT)
Intervention Description
The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. We will conduct individual therapy based on the Coping with Stress manual used in other depression treatment studies with adolescents. In addition, the investigators will teach the teen explicitly about theory of mind and social perspective taking during each session and we will use examples from their own life to help them learn the skills.
Intervention Type
Behavioral
Intervention Name(s)
CBT-only
Intervention Description
The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. The investigators will conduct individual therapy based on the Coping with Stress manual used in other depression treatment studies with adolescents.
Primary Outcome Measure Information:
Title
Faux Pas Recognition Test
Description
The Faux Pas Recognition Task consists of 10 Faux Pas Stories and 10 Control Stories without a faux pas, scoring one point for every correct faux pas perception. The higher score is 20 and lower score 0; domain scores are scaled in a positive direction (i.e. higher scores denote higher theory of mind). Faux Pas Recognition test 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.
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Children Depression Rating Scale - Revised
Description
The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression). The CDRS-R is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113. Scores above 35 are considered to represent clinically significant symptoms. We measured depressive symptoms with the CDRS-R as a secondary outcome.
Time Frame
week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 12- to 17-years-old diagnosis of a current depressive disorder (e.g., major depressive episode; persistent depressive disorder) or a score on the Children's Depression Rating Scale (CDRS) >= 40 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 estimated IQ<80
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy Garber, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Judy Garber
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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CBT Enhanced With Social Cognitive Training

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