<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/NCT02992158</url>
  </required_header>
  <id_info>
    <org_study_id>R34MH108818</org_study_id>
    <nct_id>NCT02992158</nct_id>
  </id_info>
  <brief_title>Feasibility of a Behavioral Activation Trial</brief_title>
  <official_title>Feasibility of a Behavioral Activation Trial in Community Mental Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merakey Behavioral Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this project is to train community mental health therapists in behavioral&#xD;
      activation (BA) treatment for major depressive disorder and then to conduct a study examining&#xD;
      the feasibility of evaluating the effectiveness of BA in this setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After finalizing a 9-session BA treatment model for major depressive disorder in the&#xD;
      Community Mental Health Center (CMHC) setting, the final treatment manual will be used to&#xD;
      train clinicians in BA at the CMHC through workshops and training cases.&#xD;
&#xD;
      Upon completion of training and certification of adequate implementation of BA, a total of 80&#xD;
      patients with MDD will be randomly assigned in a 3:1 ratio to 9 sessions of BA or&#xD;
      treatment-as-usual (TAU) at the CMHC. Feasibility will be assessed in terms of (1) percent of&#xD;
      eligible patients who refuse randomization, (2) percent of patients who complete 9 sessions&#xD;
      of BA treatment, (3) percent of BA homework assignments that are completed, (4) percent of&#xD;
      monthly assessments obtained, and (5) patient ratings of credibility and alliance in BA&#xD;
      treatment. The ability of CMHC therapists to adequately implement BA will be assessed by&#xD;
      rating taped sessions on BA adherence and competence scales. In addition to&#xD;
      feasibility/acceptability of BA and TAU, this study is designed to test whether theoretically&#xD;
      important targets of BA change over the course of BA treatment, and whether such changes are&#xD;
      associated with changes in depressive symptoms. The target measures will be assessed at&#xD;
      baseline, month 1, month 2, and month 3. To support the potential role of these targets as&#xD;
      the mechanisms of change in BA, change in the target variables will be examined in relation&#xD;
      to change in depression symptoms. The investigators will also pilot a potential moderator of&#xD;
      treatment effects (trait reward processing, as measured at baseline using the&#xD;
      Effort-Expenditure for Rewards Task) to include this potential moderator in a subsequent&#xD;
      fully-powered study with the long-term goal of identifying the types of patients most&#xD;
      responsive to BA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">November 2019</completion_date>
  <primary_completion_date type="Actual">November 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>percent of eligible patients who refuse randomization</measure>
    <time_frame>assessed at baseline</time_frame>
    <description>We will calculate this value based on our records of patient participation in baseline assessments.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>percent of patients who complete 9 sessions of BA treatment</measure>
    <time_frame>12 weeks</time_frame>
    <description>We will calculate this value based on our records of patient attendance of therapy sessions (tracked each week by a research assistant).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>percent of BA homework assignments that are completed</measure>
    <time_frame>12 weeks</time_frame>
    <description>We will calculate this value based on our records of homework assignment completion (tracked weekly by therapist participants and reported to the research staff).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>percent of monthly assessments obtained</measure>
    <time_frame>12 weeks</time_frame>
    <description>We will calculate this value based on our records of patient assessment attendance (tracked by a research assistant).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Opinions About Treatment questionnaire</measure>
    <time_frame>collected at week 2</time_frame>
    <description>This questionnaire measures patient ratings of the credibility of BA treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief Alliance Inventory</measure>
    <time_frame>collected at weeks 2, 4, 6, and 8</time_frame>
    <description>This questionnaire measures patient ratings of the therapeutic alliance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Behavioral Activation for Depression Scale</measure>
    <time_frame>monthly for 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reward Probability Index</measure>
    <time_frame>monthly for 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hamilton Rating Scale for Depression</measure>
    <time_frame>monthly for 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form Health Survey (SF-36)</measure>
    <time_frame>monthly for 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inventory of Depressive Symptomatology</measure>
    <time_frame>monthly for 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavior and Symptom Identification Scale (BASIS-24)</measure>
    <time_frame>monthly for 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dysfunctional Attitudes Scale</measure>
    <time_frame>monthly for 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Index (questionnaire)</measure>
    <time_frame>monthly for 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Anxiety Inventory</measure>
    <time_frame>monthly for three months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effort Expenditure for Rewards Task (EEfRT)</measure>
    <time_frame>administered once at baseline and once at month 3</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>behavioral activation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The core principles of the BA model are: (1) the key to changing how people feel is helping them change what they do, (2) changes in life can lead to depression, and short-term coping strategies may keep people stuck over time, (3) the clues to figuring out what will be antidepressant for a particular client lie in what precedes and follows the client's important behaviors, (4) structure and scheduling of activities should follow a plan, not a mood, (5) change will be easier when starting small, (6) activities that are naturally reinforcing should be emphasized, (7) the therapist should act as a coach, (8) a problem-solving empirical approach should be emphasized with recognition that all results are useful, (9) patients should be encourages to not just talk, do! (10) possible and actual barriers to activation should be examined. Patients can also receive medications in this arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>treatment-as-usual</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients will receive psychotherapy (and potentially medications) as part of treatment-as-usual provided in the CMHC setting.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>behavioral activation</intervention_name>
    <arm_group_label>behavioral activation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>treatment-as-usual</intervention_name>
    <description>psychotherapy (and potentially medication) as part of treatment-as-usual provided in a community mental health center</description>
    <arm_group_label>treatment-as-usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. confirmed diagnosis of MDD based on the SCID for DSM-IV (or DSM-V, if available),&#xD;
&#xD;
          2. ability to read at least at the 4th grade level,&#xD;
&#xD;
          3. willingness to participate in research,&#xD;
&#xD;
          4. willingness to be audio recorded (for both therapists and patient- participants)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. current or past psychotic disorder, seizure disorder, or clinically significant&#xD;
             organic pathology&#xD;
&#xD;
          2. acute medical problem requiring immediate inpatient treatment,&#xD;
&#xD;
          3. current substance abuse or dependence requiring primary referral to substance abuse&#xD;
             program,&#xD;
&#xD;
          4. significant suicidal risk/ideation requiring immediate referral or suicidal gesture&#xD;
             within the last 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be shared via the Research Domain Criteria Database (RDoCdb), part of the NIMH Data Archive (NDA). All feasibility and outcome data will be shared.</ipd_description>
  </patient_data>
  <!-- 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/NCT02992158
org study id: R34MH108818
nct id: NCT02992158
lead sponsor: 
collaborator: 
has dmc: Yes
The goal of this project is to train community mental health therapists in behavioral
      activation (BA) treatment for major depressive disorder and then to conduct a study examining
      the feasibility of evaluating the effectiveness of BA in this setting.
After finalizing a 9-session BA treatment model for major depressive disorder in the
      Community Mental Health Center (CMHC) setting, the final treatment manual will be used to
      train clinicians in BA at the CMHC through workshops and training cases.

      Upon completion of training and certification of adequate implementation of BA, a total of 80
      patients with MDD will be randomly assigned in a 3:1 ratio to 9 sessions of BA or
      treatment-as-usual (TAU) at the CMHC. Feasibility will be assessed in terms of (1) percent of
      eligible patients who refuse randomization, (2) percent of patients who complete 9 sessions
      of BA treatment, (3) percent of BA homework assignments that are completed, (4) percent of
      monthly assessments obtained, and (5) patient ratings of credibility and alliance in BA
      treatment. The ability of CMHC therapists to adequately implement BA will be assessed by
      rating taped sessions on BA adherence and competence scales. In addition to
      feasibility/acceptability of BA and TAU, this study is designed to test whether theoretically
      important targets of BA change over the course of BA treatment, and whether such changes are
      associated with changes in depressive symptoms. The target measures will be assessed at
      baseline, month 1, month 2, and month 3. To support the potential role of these targets as
      the mechanisms of change in BA, change in the target variables will be examined in relation
      to change in depression symptoms. The investigators will also pilot a potential moderator of
      treatment effects (trait reward processing, as measured at baseline using the
      Effort-Expenditure for Rewards Task) to include this potential moderator in a subsequent
      fully-powered study with the long-term goal of identifying the types of patients most
      responsive to BA.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: percent of eligible patients who refuse randomization
time frame: assessed at baseline
description: We will calculate this value based on our records of patient participation in baseline assessments.
measure: percent of patients who complete 9 sessions of BA treatment
time frame: 12 weeks
description: We will calculate this value based on our records of patient attendance of therapy sessions (tracked each week by a research assistant).
measure: percent of BA homework assignments that are completed
time frame: 12 weeks
description: We will calculate this value based on our records of homework assignment completion (tracked weekly by therapist participants and reported to the research staff).
measure: percent of monthly assessments obtained
time frame: 12 weeks
description: We will calculate this value based on our records of patient assessment attendance (tracked by a research assistant).
measure: Opinions About Treatment questionnaire
time frame: collected at week 2
description: This questionnaire measures patient ratings of the credibility of BA treatment.
measure: Brief Alliance Inventory
time frame: collected at weeks 2, 4, 6, and 8
description: This questionnaire measures patient ratings of the therapeutic alliance.
measure: Behavioral Activation for Depression Scale
time frame: monthly for 3 months
measure: Reward Probability Index
time frame: monthly for 3 months
measure: Hamilton Rating Scale for Depression
time frame: monthly for 3 months
measure: Short Form Health Survey (SF-36)
time frame: monthly for 3 months
measure: Inventory of Depressive Symptomatology
time frame: monthly for 3 months
measure: Behavior and Symptom Identification Scale (BASIS-24)
time frame: monthly for 3 months
measure: Dysfunctional Attitudes Scale
time frame: monthly for 3 months
measure: Quality of Life Index (questionnaire)
time frame: monthly for 3 months
measure: Beck Anxiety Inventory
time frame: monthly for three months
measure: Effort Expenditure for Rewards Task (EEfRT)
time frame: administered once at baseline and once at month 3
arm group label: behavioral activation
arm group type: Experimental
description: The core principles of the BA model are: (1) the key to changing how people feel is helping them change what they do, (2) changes in life can lead to depression, and short-term coping strategies may keep people stuck over time, (3) the clues to figuring out what will be antidepressant for a particular client lie in what precedes and follows the client's important behaviors, (4) structure and scheduling of activities should follow a plan, not a mood, (5) change will be easier when starting small, (6) activities that are naturally reinforcing should be emphasized, (7) the therapist should act as a coach, (8) a problem-solving empirical approach should be emphasized with recognition that all results are useful, (9) patients should be encourages to not just talk, do! (10) possible and actual barriers to activation should be examined. Patients can also receive medications in this arm.
arm group label: treatment-as-usual
arm group type: Other
description: Patients will receive psychotherapy (and potentially medications) as part of treatment-as-usual provided in the CMHC setting.
intervention type: Behavioral
intervention name: behavioral activation
arm group label: behavioral activation
intervention type: Behavioral
intervention name: treatment-as-usual
description: psychotherapy (and potentially medication) as part of treatment-as-usual provided in a community mental health center
arm group label: treatment-as-usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
sharing ipd: Yes
ipd description: Data will be shared via the Research Domain Criteria Database (RDoCdb), part of the NIMH Data Archive (NDA). All feasibility and outcome data will be shared.