DepressionNCT05456035
CBT Enhanced With Social Cognitive Training vs. CBT Only With Depressed Youth
A study testing Cognitive behavioral therapy plus social cognitive training (CBTSCT) in people with Depression, run by Vanderbilt University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive behavioral therapy plus social cognitive training (CBTSCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2022to 31 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants ages 13- through 17-years-old
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Judy Garber
Nashville, Tennessee, 37203-5721
Judy Garber, PhD, 615-343-8714, jgarber.vanderbilt@gmail.com
Steven D Hollon, PhD, 615-322-3369, steven.d.hollon@vanderbilt.edu
About this study
Official title: Social Cognitive Training to Enhance the Efficacy of CBT forDepression in Youth: A Developmental Approach (R33)
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Cognitive behavioral therapy plus social cognitive training (CBTSCT)
- Keywords
- Depression, Adolescents, Cognitive behavior therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy plus social cognitive training (CBTSCT)Behavioural
Also called Cognitive behavioral therapy (CBT)
The study has two intervention arms to which depressed adolescents will be randomized: (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 social cognitive training component.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy plus social cognitive training (CBTSCT) | Experimental | The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. We will conduct individual therapy with depressed adolescents using modules from the Coping with Stress manual used in other depression treatment studies with adolescents. In addition, therapists will teach teens explicitly about theory of mind and social perspective taking during each session and will use examples from the teen's own life to help them learn the skills. Receives: Behavioral: Cognitive behavioral therapy plus social cognitive training (CBTSCT) |
| Cognitive behavioral therapy (CBT) | Active comparator | The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. Therapists will conduct individual therapy sessions with depressed adolescents using modules from the Coping with Stress manual. Social cognitive training will not be provided to teens in this condition. Receives: Behavioral: Cognitive behavioral therapy plus social cognitive training (CBTSCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faux Pas Recognition Test
Faux Pas Recognition test (FPRT) 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. FPRT contains 8 Faux Pas and 8 control stories without a faux pas. Stories are followed by 8 questions. Higher scores mean better theory of mind.
Measured: after 12 weeks
Children's Depression Rating Scale-Revised
In the R33 RCT, depression will be another primary outcome measured with the CDRS-R, which is a clinical interview with the parent and teen separately, about the youth's depressive symptoms during the last two weeks. Higher scores mean more depressive symptoms.
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start10 Oct 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Judith Garber, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456035
- Sponsor's protocol ID
- R33MH115125
- Other IDs
- R33MH115125-03
- Status last verified
- Oct 2026
- First submitted
- 1 Jul 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No