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<!doctype html> <html lang="en"> <head> <meta charset="utf-8"> <meta http-equiv="X-UA-Compatible" content="IE=edge"> <title>Vanderbilt Clinical Trials</title> <meta name="viewport" content="width=device-width, initial-scale=1"> <link href="/assets/css/bootstrap.min.css?v=0" rel="stylesheet" /> <link href="/assets/css/animate.css?v=0" rel="stylesheet" /> <link href="/assets/css/ct.css?v=1731005942" rel="stylesheet" /> <link href="/assets/css/style.css?v=1731005942" rel="stylesheet" /> <link href="/assets/css/nav.css?v=1731005942" rel="stylesheet" /> <link href="/assets/css/vanderbilt.css?v=1731005942" rel="stylesheet" /> <link href="/theme/styles.css" rel="stylesheet" /> <link href="/assets/css/mobile.css?v=1731005942" rel="stylesheet" /> <link rel="icon" href="/assets/img/trialstoday_logo.png?v=1731005942" /> <link href="/assets/css/ct-print.css?v=1731005942" rel="stylesheet" media="print" /> <link href="https://use.typekit.net/jmk1ury.css" rel="stylesheet" /> </head> <body> <div id="canvas"> <div class="hidden-print"> <div id="header" class="hidden-xs"> <h1> <a href="https://www.vanderbilthealth.com/"> <img src ="/theme/image/logo"/> <span id="title">Vanderbilt Clinical Trials</span> </a> </h1> <nav id="nav"> <ul> <li> <a href="https://www.vanderbilthealth.com/clinicaltrials/">Learn More About Clinical Trials</a> </li> <li> <a href="/">Find a Clinical Trial</a> </li> </ul> </nav> </div> <nav class="navbar navbar-inverse visible-xs"> <div class="container-fluid"> <div class="navbar-header"> <button type="button" class="navbar-toggle collapsed" data-toggle="collapse" data-target="#navbar-collapse" aria-expanded="false"> <span class="sr-only">Toggle navigation</span> <span class="icon-bar"></span> <span class="icon-bar"></span> <span class="icon-bar"></span> </button> <a href="#" class="navbar-brand"><strong>Vanderbilt Clinical Trials</strong></a> </div> <div class="collapse navbar-collapse" id="navbar-collapse"> <ul class="nav navbar-nav"> <li> <a href="https://www.vanderbilthealth.com/clinicaltrials/">Learn More About Clinical Trials</a> </li> <li> <a href="/">Find a Clinical Trial</a> </li> </ul> </div> </div> </nav> </div> <div id="main-container" class="container-fluid"> <h2 class="logo">CBT Enhanced With Social Cognitive Training vs. CBT Only With Depressed Youth</h2> <div class="text-right"> <a href="/list/print/NCT05456035" class="btn btn-primary" target="_blank"><span class="glyphicon glyphicon-print"></span> Print</a> </div> <h3>Purpose</h3> <p>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.</p> <h3>Condition</h3> <ul> <li>Depression</li> </ul> <div role="tabpanel" id="trial-tabs" class="margin-top"> <ul class="nav nav-tabs" role="tablist"> <li role="presentation" class="active"><a href="#eligibility" aria-controls="eligibility" role="tab" data-toggle="tab">Eligibility</a></li> <li role="presentation"><a href="#arms" aria-controls="arms" role="tab" data-toggle="tab">Study Design</a></li> <li role="presentation"><a href="#details" aria-controls="details" role="tab" data-toggle="tab">Contact/Details</a></li> <li role="presentation"><a href="#disclaimer" aria-controls="arms" role="tab" data-toggle="tab">Notice</a></li> </ul> <div class="tab-content"> <div role="tabpanel" class="tab-pane active" id="eligibility"> <style> #nlp-cuis .label:hover{ cursor: default; } #nlp-cuis .label.condition{ background-color: #29559b; } #nlp-cuis .label.medication{ background-color: #5020b2; } </style> <div class="same-page"> <h3>Eligibility</h3> <dl class="dl-horizontal dl-horiontal-wide"> <dt>Eligible Ages</dt> <dd> Between 13 Years and 17 Years </dd> <dt>Eligible Genders</dt><dd>All</dd> <dt>Accepts Healthy Volunteers</dt> <dd> No </dd> </dl> <div class="clearfix"></div> </div> <div class="row"> <div class="col-md-6 same-page"> <div class="panel panel-default"> <div class="panel-heading"> <h3 class="panel-title">Inclusion Criteria</h3> </div> <div class="panel-body"> <ol class="criteria-list"> <li>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</li> </ol> </div> </div> </div> <div class="col-md-6 same-page"> <div class="panel panel-default"> <div class="panel-heading"> <h3 class="panel-title">Exclusion Criteria</h3> </div> <div class="panel-body"> <ul class="criteria-list"> <li>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</li> </ul> </div> </div> </div> </div> </div> <div role="tabpanel" class="tab-pane" id="arms"> <div class="same-page clearfix"> <h3>Study Design</h3> <dl class="dl-horizontal"> <dt>Phase</dt><dd>N/A</dd> <dt>Study Type</dt><dd>Interventional</dd> <dt>Allocation</dt> <dd>Randomized</dd> <dt>Intervention Model</dt> <dd>Parallel Assignment</dd> <dt>Intervention Model Description</dt> <dd>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.</dd> <dt>Primary Purpose</dt> <dd>Treatment</dd> <dt>Masking</dt> <dd>Single (Outcomes Assessor)</dd> <dt>Masking Description</dt> <dd>The individuals who conduct the assessments of the outcome measures will be unaware of to which condition the participant was randomized.</dd> </dl> </div> <div class="same-page"> <h3>Arm Groups</h3> <table class="table table-bordered"> <thead><tr><th width="20%">Arm</th><th width="40%">Description</th><th width="40%">Assigned Intervention</th></tr></thead> <tbody> <tr> <td> <strong>Experimental</strong><br /> <em>Cognitive behavioral therapy plus social cognitive training (CBTSCT)</em> </td> <td> 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. </td> <td> <ul> <li> <strong>Behavioral</strong>: <em>Cognitive behavioral therapy plus social cognitive training (CBTSCT)</em><br /> 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.<br /> Other names: <ul> <li>Cognitive behavioral therapy (CBT)</li> </ul> </li> </ul> </td> </tr> <tr> <td> <strong>Active Comparator</strong><br /> <em>Cognitive behavioral therapy (CBT)</em> </td> <td> 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. </td> <td> <ul> <li> <strong>Behavioral</strong>: <em>Cognitive behavioral therapy plus social cognitive training (CBTSCT)</em><br /> 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.<br /> Other names: <ul> <li>Cognitive behavioral therapy (CBT)</li> </ul> </li> </ul> </td> </tr> </tbody> </table> </div> </div> <div role="tabpanel" class="tab-pane" id="details"> <div class="same-page"> <h3>Recruiting Locations</h3> <div class="panel panel-default"> <div class="panel-body no-padding-bottom"> <div class="row"> <div class="col-md-4 col-sm-6 same-page location tennessee"> <strong>Judy Garber</strong><br /> Nashville, Tennessee 37203-5721<br /> <div class="location-contact"> <u>Contact:</u><br /> Judy Garber, PhD<br /> 615-343-8714<br /> <a href="mailto:jgarber.vanderbilt@gmail.com">jgarber.vanderbilt@gmail.com</a><br /> </div> <br /> </div> </div> </div> </div> </div> <div class="same-page clearfix"> <h3>More Details</h3> <dl class="dl-horizontal"> <dt>Status</dt><dd>Recruiting</dd> <dt>Sponsor</dt><dd>Vanderbilt University</dd> </dl> </div> <div class="same-page"> <h3>Study Contact</h3> Judy Garber, PhD<br /> 615-330-5605<br /> <a href="mailto:judy.garber@vanderbilt.edu">judy.garber@vanderbilt.edu</a> </div> <div class="same-page"> <h3>Detailed Description</h3> <p>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.</p> </div> </div> <div role="tabpanel" class="tab-pane" id="disclaimer"> <div class="same-page clearfix"> <h3>Notice</h3> Study information shown on this site is derived from <a href = "https://clinicaltrials.gov/">ClinicalTrials.gov</a> (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation. </div> </div> </div> </div> <div id="trial-footer"> This study (NCT05456035) was last processed and updated on 8/24/2024 by ClinicalTrials.gov. </div> </div> </div> <div id="footer" class="hidden-print text-center"> <p> For general questions about clinical trials, contact Research Support Services at (615) 322-7343 or <a href="mailto:research.support.services@vumc.org">research.support.services@vumc.org</a> <script type="text/javascript"> var _paq = window._paq || []; _paq.push(['trackPageView']); _paq.push(['enableLinkTracking']); (function() { var u="https://victrstats.app.vumc.org/"; _paq.push(['setTrackerUrl', u+'matomo.php']); _paq.push(['setSiteId', '5']); var d=document, g=d.createElement('script'), s=d.getElementsByTagName('script')[0]; g.type='text/javascript'; g.async=true; g.defer=true; g.src=u+'matomo.js'; s.parentNode.insertBefore(g,s); })(); </script> <noscript><p><img src="https://victrstats.app.vumc.org/matomo.php?idsite=5&rec=1" style="border:0;" alt="" /></p></noscript> </p> </div> <script src="/assets/js/lib/respond.min.js?v=0"></script> <script src="/assets/js/lib/jquery-1.11.0.min.js?v=0"></script> <script src="/assets/js/lib/jquery.countTo.js?v=0"></script> <script src="/assets/js/lib/bootstrap.min.js?v=0"></script> <script src="/assets/js/lib/typeahead-0.11.1.bundle.min.js?v=0"></script> <script src="/assets/js/lib/underscore-min.js?v=0"></script> <script src="/assets/js/lib/backbone-min.js?v=0"></script> <script src="/assets/js/lib/flot/jquery.flot.min.js?v=0"></script> <script src="/assets/js/lib/flot/jquery.flot.time.min.js?v=0"></script> <script src="/assets/js/lib/flot/jquery.flot.resize.min.js?v=0"></script> <script src="/assets/js/lib/flot/jquery.flot.categories.min.js?v=0"></script> <script src="/assets/js/lib/flot/jquery.flot.tooltip.min.js?v=0"></script> <script src="/assets/js/lib/headroom.min.js?v=0"></script> <script src="/assets/js/clinicaltrials.js?v=1731005942"></script> <script src="/assets/js/views/search.js?v=1731005942"></script> <script src="/assets/js/views/guide.js?v=1731005942"></script> <script> var _paq = window._paq = window._paq || []; _paq.push(['trackPageView']); _paq.push(['enableLinkTracking']); (function() { var u="https://victrstats.app.vumc.org/"; _paq.push(['setTrackerUrl', u+'matomo.php']); _paq.push(['setSiteId', '20']); var d=document, g=d.createElement('script'), s=d.getElementsByTagName('script')[0]; g.async=true; g.src=u+'matomo.js'; s.parentNode.insertBefore(g,s); })(); </script> <noscript><p><img src="https://victrstats.app.vumc.org/matomo.php?idsite=20&rec=1" style="border:0;" alt="" /></p></noscript> </body> </html>