Clinical trial NCT05456035: 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
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: Depression
Adolescents
Cognitive behavior therapy
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-07-13
Enrollment: 82
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Faux Pas Recognition Test
timeFrame: after 12 weeks
measure: Children's Depression Rating Scale-Revised
timeFrame: after 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Judy Garber
state: Tennessee
Study officials:
References: