NCT05456035 CBT Enhanced With Social Cognitive Training vs. CBT Only With Depressed Youth
| NCT ID | NCT05456035 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2022-10-10 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 82 participants in total. It began in 2022-10-10 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05456035 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 17 Years, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05456035 currently recruiting?
Yes, NCT05456035 is actively recruiting participants. Contact the research team at judy.garber@vanderbilt.edu for enrollment information.
Where is the NCT05456035 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT05456035 clinical trial?
NCT05456035 is sponsored by Vanderbilt University. The trial plans to enroll 82 participants.
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