CBT Enhanced With Social Cognitive Training

Depression Clinical Trial

— CBT+SCT  

Official title:

Social Cognitive Training to Enhance the Efficacy of CBT for Depression in Youth: A Developmental Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03954392
• Other study ID #: R61MH115125
• Secondary ID: 1R61MH115125-01A
• Status: Completed
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2023
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 30, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Judy Garber	Nashville	Tennessee
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	week 12
Secondary	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.	week 12