N/A
N=45
CBT Enhanced With Social Cognitive Training
Depression
Bottom Line
View on ClinicalTrials.gov: NCT03954392 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Faux Pas Recognition Test — 0.901; 0.854 score on a scale — p=< 0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive behavior therapy with social cognitive training (CBT+SCT) (Behavioral); CBT-only (Behavioral)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Faux Pas Recognition Test |
0.901; 0.854 | < 0.05 sig |
| SECONDARY Children Depression Rating Scale - Revised |
23.74; 34.59 | < 0.05 sig |
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).
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
Data sourced from ClinicalTrials.gov (NCT03954392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.