<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02232438</url>
  </required_header>
  <id_info>
    <org_study_id>6797</org_study_id>
    <nct_id>NCT02232438</nct_id>
  </id_info>
  <brief_title>Psychotherapy for Depressed or Anxious Adolescents With Cancer</brief_title>
  <official_title>Open Trial of Behavioral Activation Therapy for Depressed or Anxious Adolescents With Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York State Psychiatric Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York State Psychiatric Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      At present, there are no established treatments for depression or anxiety in adolescents with&#xD;
      cancer, creating an important clinical and research gap. Fortunately, there is now&#xD;
      substantial evidence documenting the efficacy of psychotherapy in the treatment of depressed&#xD;
      and anxious adolescents in the general population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the high prevalence of depression and anxiety in cancer patients, little is known&#xD;
      about the efficacy of psychotherapy in depressed and anxious adolescents with cancer.&#xD;
&#xD;
      Behavioral activation therapy (BAT) is a brief, manualized therapy that has shown efficacy in&#xD;
      the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in&#xD;
      several controlled trials patients, including adult cancer patients. The goal of this open&#xD;
      label clinical trial is to obtain preliminary evidence of the efficacy of BAT(6 sessions) in&#xD;
      a group of adolescent cancer patients with MDD, GAD or adjustment disorder with mood or&#xD;
      anxiety features.&#xD;
&#xD;
      We will test the efficacy of BAT using the Multidimensional Anxiety Scale for Children at&#xD;
      several time points of the treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No participants enrolled.&#xD;
  </why_stopped>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Multidimensional Anxiety Scale for Children (MASC 2)</measure>
    <time_frame>baseline, and every two weeks till week 10</time_frame>
    <description>10 to 15 minutes of mood assessment.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Behavioral activation therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients treated with Behavioral activation therapy will improve in mood and anxiety symptoms and psychosocial functioning at the end of the 6 weeks of treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral activation therapy</intervention_name>
    <description>Behavioral activation therapy (BAT) is a brief, manualized therapy that has shown efficacy in the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in several controlled trials patients (see review in Dimidjan et al., Ann Rev Clin Psychol, 2010, and Chu, Brian C., et al. Cognitive and Behavioral Practice, 2009.), including adult cancer patients (Hopkoet al., 2009; Hopko et al., 2011).</description>
    <arm_group_label>Behavioral activation therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A primary psychiatric diagnosis of Major Depressive Disorder, Generalized Anxiety&#xD;
             Disorder or Adjustment Disorder with Mood or Anxiety features as defined by DSM-IV.&#xD;
&#xD;
          -  Cancer patients.&#xD;
&#xD;
          -  Parent consent and child assent to participate for patients younger than 18. Patient&#xD;
             consent for subjects 18-21.&#xD;
&#xD;
          -  Diagnosis of cancer (stage 1-4), but healthy enough to complete study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lifetime history of psychosis or bipolar disorder.&#xD;
&#xD;
          -  Current suicide risk.&#xD;
&#xD;
          -  History of substance abuse or dependence in the three months prior to the study.&#xD;
&#xD;
          -  Patients who have ever failed BAT in the context of cancer.&#xD;
&#xD;
          -  Receiving other concurrent therapy for same disorder and patients who are receiving&#xD;
             effective medication for depression.&#xD;
&#xD;
          -  Mental retardation.&#xD;
&#xD;
          -  CNS tumors.&#xD;
&#xD;
          -  Patients undergoing Stem Cell Transplantation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>New York State Psychiatric Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>October 5, 2015</last_update_submitted>
  <last_update_submitted_qc>October 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Psychotherapy</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02232438
org study id: 6797
nct id: NCT02232438
lead sponsor: 
has dmc: Yes
At present, there are no established treatments for depression or anxiety in adolescents with
      cancer, creating an important clinical and research gap. Fortunately, there is now
      substantial evidence documenting the efficacy of psychotherapy in the treatment of depressed
      and anxious adolescents in the general population.
Despite the high prevalence of depression and anxiety in cancer patients, little is known
      about the efficacy of psychotherapy in depressed and anxious adolescents with cancer.

      Behavioral activation therapy (BAT) is a brief, manualized therapy that has shown efficacy in
      the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in
      several controlled trials patients, including adult cancer patients. The goal of this open
      label clinical trial is to obtain preliminary evidence of the efficacy of BAT(6 sessions) in
      a group of adolescent cancer patients with MDD, GAD or adjustment disorder with mood or
      anxiety features.

      We will test the efficacy of BAT using the Multidimensional Anxiety Scale for Children at
      several time points of the treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Multidimensional Anxiety Scale for Children (MASC 2)
time frame: baseline, and every two weeks till week 10
description: 10 to 15 minutes of mood assessment.
arm group label: Behavioral activation therapy
arm group type: Experimental
description: Patients treated with Behavioral activation therapy will improve in mood and anxiety symptoms and psychosocial functioning at the end of the 6 weeks of treatment.
intervention type: Behavioral
intervention name: Behavioral activation therapy
description: Behavioral activation therapy (BAT) is a brief, manualized therapy that has shown efficacy in the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in several controlled trials patients (see review in Dimidjan et al., Ann Rev Clin Psychol, 2010, and Chu, Brian C., et al. Cognitive and Behavioral Practice, 2009.), including adult cancer patients (Hopkoet al., 2009; Hopko et al., 2011).
arm group label: Behavioral activation therapy
criteria: 
gender: All
minimum age: 12 Years
maximum age: 21 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression