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CBT Enhanced With Social Cognitive Training (CBT+SCT)

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ClinicalTrials.gov Identifier: NCT03954392
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : February 15, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Judith Garber, Vanderbilt University

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).

Condition or disease Intervention/treatment Phase
Depression Behavioral: Cognitive behavior therapy with social cognitive training (CBT+SCT) Behavioral: CBT-only Not Applicable

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,

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (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
Primary Purpose: Treatment
Official Title: Social Cognitive Training to Enhance the Efficacy of CBT for Depression in Youth: A Developmental Approach
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CBT+SCT
Cognitive behavioral therapy plus social cognitive skills training (SCT)
Behavioral: Cognitive behavior therapy with social cognitive training (CBT+SCT)
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.

Active Comparator: CBT-only
Cognitive behavioral therapy only (without SCT)
Behavioral: CBT-only
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 Measures :
  1. Faux Pas Recognition Test (measured in both the R61 and R33) [ Time Frame: week 12 ]
    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 FP contains 10 Faux Pas and 10 control stories without a faux pas. Order of the stories is random. Stories are followed by 8 questions.

  2. Children Depression Rating Scale (CDRS) [R33] [ Time Frame: week 12 ]
    In the second RCT (R33), depression will be another primary outcome measured with the CDRS, which is an interview with the parent and teen, separately, about the youth's depressive symptoms during the last two weeks.


Other Outcome Measures:
  1. Patient Health Questionnaire 9 (PHQ9) [ Time Frame: week 12 ]
    Self-report measure of the 9 main depressive symptoms that define a depressive episode



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954392


Contacts
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Contact: Judy Garber, PhD 615-343-8714 jgarber.vanderbilt@gmail.com
Contact: Steven D Hollon, PhD 615-322-3369 steven.d.hollon@vanderbilt.edu

Locations
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United States, Tennessee
Judy Garber Recruiting
Nashville, Tennessee, United States, 37203
Contact: Judy Garber, PhD    615-343-8714    jgarber.vanderbilt@gmail.com   
Principal Investigator: Judy Garber, PhD         
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37203
Contact: Judy Garber    615-343-8714    jgarber.vanderbilt@gmail.com   
Sponsors and Collaborators
Vanderbilt University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Judy Garber, PhD Vanderbilt University
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Responsible Party: Judith Garber, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT03954392    
Other Study ID Numbers: R61MH115125 ( U.S. NIH Grant/Contract )
1R61MH115125-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Judith Garber, Vanderbilt University:
Depression
Adolescents
Treatment
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders