<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/NCT04426461</url>
  </required_header>
  <id_info>
    <org_study_id>2020-003</org_study_id>
    <secondary_id>R01MH123691</secondary_id>
    <nct_id>NCT04426461</nct_id>
  </id_info>
  <brief_title>Approach-Avoidance, Computational Framework for Predicting Behavioral Therapy Outcome (AAC-BeT)</brief_title>
  <acronym>AAC-BeT</acronym>
  <official_title>An Approach-Avoidance, Computational Framework for Predicting Behavioral Therapy Outcome in Anxiety and Depression (AAC-BeT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laureate Institute for Brain Research, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Laureate Institute for Brain Research, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Depression and anxiety disorders rank in the top ten causes of years lived with disability.&#xD;
      Less than 50% of patients experiencing long-lasting improvements to current gold-standard&#xD;
      treatments. Two gold-standard behavioral interventions include behavioral activation, focused&#xD;
      on enhancing approach behavior towards meaningful activities, and exposure-based therapy,&#xD;
      focused on decreasing avoidance and challenging negative expectations. While these&#xD;
      interventions have divergent treatment targets, there is little knowledge to inform which&#xD;
      strategies should be used in the frequent case of comorbid anxiety and depression.&#xD;
      Approach-avoidance decision-making paradigms focus on assessing responses when faced with&#xD;
      potential rewards and threats, tapping into processes important for both anxiety and&#xD;
      depression as well as behavioral activation and exposure-based therapy.&#xD;
&#xD;
      For this study, investigators will recruit individuals reporting both anxiety and depression&#xD;
      symptoms and randomize them to one of three different interventions: (1) behavioral&#xD;
      activation, (2) exposure-based therapy, and a non-specific therapy approach (3) supportive&#xD;
      therapy. Participants will complete clinical, self-report, behavioral, and functional&#xD;
      magnetic resonance imaging (fMRI) assessments before and after therapy. Investigators will&#xD;
      use a computational approach to model factors that may influence one's behavior during&#xD;
      approach-avoidance decision-making, including drives to avoid threat versus approach reward&#xD;
      and confidence versus uncertainty in one's decisions.&#xD;
&#xD;
      This project will accomplish the following aims (1) Determine how changes in brain and&#xD;
      behavior responses during approach-avoidance conflict relate to changes in mental health&#xD;
      symptoms with the different therapy approaches, (2) Determine the degree to which baseline&#xD;
      brain and behavior responses during approach-avoidance conflict predict response to the&#xD;
      different therapy approaches, above and beyond the influence of demographics and baseline&#xD;
      symptom severity. In addition, by including peripheral blood draws and measures of grace&#xD;
      matter volume, the project will also accomplish the following aims: (1) Determine whether&#xD;
      kynrenine metabolites measures peripherally may be beneficial as a biomarker of treatment&#xD;
      response and (2) determine whether there is an association between change in kynurenine&#xD;
      metabolites and changes in gray matter volume with treatment.&#xD;
&#xD;
      Results will enhance understanding of how different psychotherapy approaches (behavioral&#xD;
      activation, exposure-based therapy) may impact brain responses and decisions when faces with&#xD;
      potential reward versus threat and approach versus avoidance drives. In addition, results&#xD;
      will have important implications concerning the potential for a more personalized approach to&#xD;
      psychotherapy, enhancing knowledge of which types of therapy strategies may be most&#xD;
      beneficial for which individuals.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 11, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2025</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>
    <intervention_model_description>Participants will be randomized to behavioral activation, exposure-based, or supportive therapy according to parallel assignment, stratified by sex (male, female) and symptom severity (mild, moderate, severe).</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Interview-based assessments will be conducted by blinded clinical assessors and participants will be blinded until after completion of all baseline assessments.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Composite score from Hamilton Anxiety Rating Scale (HAM-A) and Hamilton Rating Scale for Depression (HAM-D)</measure>
    <time_frame>Up to 18 weeks after the baseline assessments</time_frame>
    <description>Composite score (averaging of the standardized Z scores) from the Hamilton Anxiety Rating Scale (HAM-A) and Hamilton Rating Scale for Depression (HAM-D). These Z scores will range from -3.0 to +3.0, with greater scores indicating more severe anxiety and depression symptoms or worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quinolinic Acid</measure>
    <time_frame>Up to 18 weeks after the baseline assessments</time_frame>
    <description>Peripheral serum concentration of Quinolinic Acid</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sheehan Disability Scale</measure>
    <time_frame>Up to 18 weeks after the baseline assessments</time_frame>
    <description>Sheehan Disability Scale total score. This score ranges from 0-30, with higher scores indicating greater disability or worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Anxiety Scale</measure>
    <time_frame>Up to 18 weeks after the baseline assessments</time_frame>
    <description>National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Anxiety Scale, which is reported as a T score. The T scores can range from - to 100, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater symptom severity or worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Depression Scale</measure>
    <time_frame>Up to 18 weeks after the baseline assessments</time_frame>
    <description>National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Depression Scale, which is reported as a T score. The T scores can range from - to 100, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater symptom severity or worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kynurenic acid</measure>
    <time_frame>Up to 14 weeks after the baseline assessments</time_frame>
    <description>Peripheral serum concentration of kynurenic acid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of kynurenic acid to quinolinic acid</measure>
    <time_frame>Up to 14 weeks after the baseline assessments</time_frame>
    <description>Ratio of peripheral serum concentration of kynurenic acid to quinolinic acid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of kynurenic acid to tryptophan</measure>
    <time_frame>Up to 18 weeks after the baseline assessments</time_frame>
    <description>Ratio of peripheral serum concentration of kynurenic acid to tryptophan</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Amygdala reactivity to negative outcomes</measure>
    <time_frame>Up to 14 weeks after the baseline assessments.</time_frame>
    <description>Beta coefficient from general linear model for right amygdala region of interest in response to negative image outcome phase of an approach-avoidance conflict decision-making task. Standardized beta coefficients have a range of 0 to 1, with greater values indicating greater amygdala reactivity or worse outcomes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Dorsolateral prefrontal cortex reactivity to conflict decisions</measure>
    <time_frame>Up to 14 weeks after the baseline assessments.</time_frame>
    <description>Beta coefficient from general linear model for right dorsolateral prefrontal region of interest in response to the conflict decision phase of an approach-avoidance conflict decision-making task. Standardized beta coefficients have a range of 0 to 1, with greater values indicating greater dorsolateral prefrontal cortex reactivity.</description>
  </other_outcome>
  <other_outcome>
    <measure>Dorsal striatal reactivity to negative outcomes</measure>
    <time_frame>Up to 14 weeks after the baseline assessments.</time_frame>
    <description>Beta coefficient from general linear model for dorsal striatal region of interest in response to negative image outcome phase of an approach-avoidance conflict decision-making task. Standardized beta coefficients have a range of 0 to 1, with greater values indicating greater striatal reactivity.</description>
  </other_outcome>
  <other_outcome>
    <measure>Decision uncertainty during approach-avoidance conflict decision making</measure>
    <time_frame>Up to 14 weeks after the baseline assessments.</time_frame>
    <description>Decision uncertainty parameter from computational modeling of behavioral responses on the approach avoidance conflict task. Parameter values have a range of 0 to 20, with greater values indicating greater decision uncertainty.</description>
  </other_outcome>
  <other_outcome>
    <measure>Emotional conflict during approach-avoidance conflict decision making</measure>
    <time_frame>Up to 14 weeks after the baseline assessments.</time_frame>
    <description>Emotional conflict parameter from computational modeling of behavioral responses on the approach avoidance conflict task. Parameter values have a range of 0 to 7, with greater values indicating greater conflict.</description>
  </other_outcome>
  <other_outcome>
    <measure>Approach behavior during approach-avoidance conflict decision making</measure>
    <time_frame>Up to 14 weeks after the baseline assessments.</time_frame>
    <description>Average approach behavior on conflict trials of an approach avoidance conflict task. Average approach behavior values have a range of 0 to 10, with greater values indicating greater approach behavior.</description>
  </other_outcome>
  <other_outcome>
    <measure>Bilateral amygdala volume</measure>
    <time_frame>Up to 14 weeks after the baseline assessments.</time_frame>
    <description>Gray matter volume of the bilateral amygdala</description>
  </other_outcome>
  <other_outcome>
    <measure>Bilateral striatal volume</measure>
    <time_frame>Up to 14 weeks after the baseline assessments.</time_frame>
    <description>Gray matter volume of the bilateral striatum</description>
  </other_outcome>
  <other_outcome>
    <measure>Bilateral hippocampal volume</measure>
    <time_frame>Up to 14 weeks after the baseline assessments.</time_frame>
    <description>Gray matter volume of the bilateral striatum</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Behavioral activation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Exposure-based therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Supportive therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral Activation</intervention_name>
    <description>Behavioral activation will be delivered as a 10-week, manualized, behavioral intervention focused on enhancing engagement in meaningful and reinforcing activities.</description>
    <arm_group_label>Behavioral activation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exposure-based therapy</intervention_name>
    <description>Exposure-based therapy will be delivered as a 10-week, manualized, behavioral intervention focused on decreasing avoidance to allow for inhibitory learning and challenging negative expectations.</description>
    <arm_group_label>Exposure-based therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supportive therapy</intervention_name>
    <description>Supportive therapy will be delivered as a 10-week, manualized intervention focused on encouraging patients to talk openly about their thoughts, emotions, and any past or current concerns.</description>
    <arm_group_label>Supportive therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  score &gt;55 on both the PROMIS Anxiety and PROMIS Depression scales&#xD;
&#xD;
          -  score &gt;5 on any one item of the SDS&#xD;
&#xD;
          -  able to provide informed consent&#xD;
&#xD;
          -  report of anxiety and depressive symptoms as areas of clinical concern&#xD;
&#xD;
          -  sufficient English proficiency to complete procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  significant or unstable physical or mental health conditions (e.g., immediate suicidal&#xD;
             intent) requiring medical attention&#xD;
&#xD;
          -  history of bipolar, psychotic, cognitive, obsessive compulsive disorder, posttraumatic&#xD;
             stress disorder (PTSD)&#xD;
&#xD;
          -  history of moderate to severe substance use disorder over the past year&#xD;
&#xD;
          -  diagnosis of neurologic disorders&#xD;
&#xD;
          -  MRI contra-indications (e.g., metal in body)&#xD;
&#xD;
          -  uncorrected vision/hearing problems&#xD;
&#xD;
          -  current, regular benzodiazepine use&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robin L Aupperle, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Laureate Institute for Brain Research</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mallory Cannon, M.S.</last_name>
    <phone>918-581-4885</phone>
    <email>neurocatt@laureateinstitute.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Robin L Aupperle, PhD</last_name>
    <phone>918-502-5744</phone>
    <email>raupperle@laureateinstitute.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Laureate Institute for Brain Research</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mallory Cannon, BA</last_name>
      <phone>918-581-4885</phone>
      <email>neurocatt@laureateinstitute.org</email>
    </contact>
    <contact_backup>
      <last_name>Robin Aupperle, PhD</last_name>
      <phone>918-502-5744</phone>
      <email>raupperle@laureateinstitute.org</email>
    </contact_backup>
    <investigator>
      <last_name>Robin L Aupperle, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Santiago J, Akeman E, Kirlic N, Clausen AN, Cosgrove KT, McDermott TJ, Mathis B, Paulus M, Craske MG, Abelson J, Martell C, Wolitzky-Taylor K, Bodurka J, Thompson WK, Aupperle RL. Protocol for a randomized controlled trial examining multilevel prediction of response to behavioral activation and exposure-based therapy for generalized anxiety disorder. Trials. 2020 Jan 6;21(1):17. doi: 10.1186/s13063-019-3802-9.</citation>
    <PMID>31907032</PMID>
  </reference>
  <reference>
    <citation>Aupperle RL, Melrose AJ, Francisco A, Paulus MP, Stein MB. Neural substrates of approach-avoidance conflict decision-making. Hum Brain Mapp. 2015 Feb;36(2):449-62. doi: 10.1002/hbm.22639. Epub 2014 Sep 15.</citation>
    <PMID>25224633</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>March 10, 2023</last_update_submitted>
  <last_update_submitted_qc>March 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</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>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After publication of results from the primary aims of this project, we intend to make the data used in publications (e.g., self-report, behavior, and neuroimaging data) accessible in a public database. These data will be stripped of patient identifiers and will comply with HIPAA requirements for publicly accessible datasets. User registration will be required to access or download files. As part of the registration process, users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Immediately after publication of results from the primary aims of this project.</ipd_time_frame>
    <ipd_access_criteria>User registration will be required to access or download files. As part of the registration process, users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.</ipd_access_criteria>
  </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/NCT04426461
org study id: 2020-003
secondary id: R01MH123691
nct id: NCT04426461
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Depression and anxiety disorders rank in the top ten causes of years lived with disability.
      Less than 50% of patients experiencing long-lasting improvements to current gold-standard
      treatments. Two gold-standard behavioral interventions include behavioral activation, focused
      on enhancing approach behavior towards meaningful activities, and exposure-based therapy,
      focused on decreasing avoidance and challenging negative expectations. While these
      interventions have divergent treatment targets, there is little knowledge to inform which
      strategies should be used in the frequent case of comorbid anxiety and depression.
      Approach-avoidance decision-making paradigms focus on assessing responses when faced with
      potential rewards and threats, tapping into processes important for both anxiety and
      depression as well as behavioral activation and exposure-based therapy.

      For this study, investigators will recruit individuals reporting both anxiety and depression
      symptoms and randomize them to one of three different interventions: (1) behavioral
      activation, (2) exposure-based therapy, and a non-specific therapy approach (3) supportive
      therapy. Participants will complete clinical, self-report, behavioral, and functional
      magnetic resonance imaging (fMRI) assessments before and after therapy. Investigators will
      use a computational approach to model factors that may influence one's behavior during
      approach-avoidance decision-making, including drives to avoid threat versus approach reward
      and confidence versus uncertainty in one's decisions.

      This project will accomplish the following aims (1) Determine how changes in brain and
      behavior responses during approach-avoidance conflict relate to changes in mental health
      symptoms with the different therapy approaches, (2) Determine the degree to which baseline
      brain and behavior responses during approach-avoidance conflict predict response to the
      different therapy approaches, above and beyond the influence of demographics and baseline
      symptom severity. In addition, by including peripheral blood draws and measures of grace
      matter volume, the project will also accomplish the following aims: (1) Determine whether
      kynrenine metabolites measures peripherally may be beneficial as a biomarker of treatment
      response and (2) determine whether there is an association between change in kynurenine
      metabolites and changes in gray matter volume with treatment.

      Results will enhance understanding of how different psychotherapy approaches (behavioral
      activation, exposure-based therapy) may impact brain responses and decisions when faces with
      potential reward versus threat and approach versus avoidance drives. In addition, results
      will have important implications concerning the potential for a more personalized approach to
      psychotherapy, enhancing knowledge of which types of therapy strategies may be most
      beneficial for which individuals.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized to behavioral activation, exposure-based, or supportive therapy according to parallel assignment, stratified by sex (male, female) and symptom severity (mild, moderate, severe).
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
masking description: Interview-based assessments will be conducted by blinded clinical assessors and participants will be blinded until after completion of all baseline assessments.
measure: Composite score from Hamilton Anxiety Rating Scale (HAM-A) and Hamilton Rating Scale for Depression (HAM-D)
time frame: Up to 18 weeks after the baseline assessments
description: Composite score (averaging of the standardized Z scores) from the Hamilton Anxiety Rating Scale (HAM-A) and Hamilton Rating Scale for Depression (HAM-D). These Z scores will range from -3.0 to +3.0, with greater scores indicating more severe anxiety and depression symptoms or worse outcome.
measure: Quinolinic Acid
time frame: Up to 18 weeks after the baseline assessments
description: Peripheral serum concentration of Quinolinic Acid
measure: Sheehan Disability Scale
time frame: Up to 18 weeks after the baseline assessments
description: Sheehan Disability Scale total score. This score ranges from 0-30, with higher scores indicating greater disability or worse outcome.
measure: National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Anxiety Scale
time frame: Up to 18 weeks after the baseline assessments
description: National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Anxiety Scale, which is reported as a T score. The T scores can range from - to 100, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater symptom severity or worse outcome.
measure: National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Depression Scale
time frame: Up to 18 weeks after the baseline assessments
description: National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Depression Scale, which is reported as a T score. The T scores can range from - to 100, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater symptom severity or worse outcome.
measure: Kynurenic acid
time frame: Up to 14 weeks after the baseline assessments
description: Peripheral serum concentration of kynurenic acid
measure: Ratio of kynurenic acid to quinolinic acid
time frame: Up to 14 weeks after the baseline assessments
description: Ratio of peripheral serum concentration of kynurenic acid to quinolinic acid
measure: Ratio of kynurenic acid to tryptophan
time frame: Up to 18 weeks after the baseline assessments
description: Ratio of peripheral serum concentration of kynurenic acid to tryptophan
measure: Amygdala reactivity to negative outcomes
time frame: Up to 14 weeks after the baseline assessments.
description: Beta coefficient from general linear model for right amygdala region of interest in response to negative image outcome phase of an approach-avoidance conflict decision-making task. Standardized beta coefficients have a range of 0 to 1, with greater values indicating greater amygdala reactivity or worse outcomes.
measure: Dorsolateral prefrontal cortex reactivity to conflict decisions
time frame: Up to 14 weeks after the baseline assessments.
description: Beta coefficient from general linear model for right dorsolateral prefrontal region of interest in response to the conflict decision phase of an approach-avoidance conflict decision-making task. Standardized beta coefficients have a range of 0 to 1, with greater values indicating greater dorsolateral prefrontal cortex reactivity.
measure: Dorsal striatal reactivity to negative outcomes
time frame: Up to 14 weeks after the baseline assessments.
description: Beta coefficient from general linear model for dorsal striatal region of interest in response to negative image outcome phase of an approach-avoidance conflict decision-making task. Standardized beta coefficients have a range of 0 to 1, with greater values indicating greater striatal reactivity.
measure: Decision uncertainty during approach-avoidance conflict decision making
time frame: Up to 14 weeks after the baseline assessments.
description: Decision uncertainty parameter from computational modeling of behavioral responses on the approach avoidance conflict task. Parameter values have a range of 0 to 20, with greater values indicating greater decision uncertainty.
measure: Emotional conflict during approach-avoidance conflict decision making
time frame: Up to 14 weeks after the baseline assessments.
description: Emotional conflict parameter from computational modeling of behavioral responses on the approach avoidance conflict task. Parameter values have a range of 0 to 7, with greater values indicating greater conflict.
measure: Approach behavior during approach-avoidance conflict decision making
time frame: Up to 14 weeks after the baseline assessments.
description: Average approach behavior on conflict trials of an approach avoidance conflict task. Average approach behavior values have a range of 0 to 10, with greater values indicating greater approach behavior.
measure: Bilateral amygdala volume
time frame: Up to 14 weeks after the baseline assessments.
description: Gray matter volume of the bilateral amygdala
measure: Bilateral striatal volume
time frame: Up to 14 weeks after the baseline assessments.
description: Gray matter volume of the bilateral striatum
measure: Bilateral hippocampal volume
time frame: Up to 14 weeks after the baseline assessments.
description: Gray matter volume of the bilateral striatum
arm group label: Behavioral activation
arm group type: Experimental
arm group label: Exposure-based therapy
arm group type: Experimental
arm group label: Supportive therapy
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Behavioral Activation
description: Behavioral activation will be delivered as a 10-week, manualized, behavioral intervention focused on enhancing engagement in meaningful and reinforcing activities.
arm group label: Behavioral activation
intervention type: Behavioral
intervention name: Exposure-based therapy
description: Exposure-based therapy will be delivered as a 10-week, manualized, behavioral intervention focused on decreasing avoidance to allow for inhibitory learning and challenging negative expectations.
arm group label: Exposure-based therapy
intervention type: Behavioral
intervention name: Supportive therapy
description: Supportive therapy will be delivered as a 10-week, manualized intervention focused on encouraging patients to talk openly about their thoughts, emotions, and any past or current concerns.
arm group label: Supportive therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Robin L Aupperle, PhD
role: Principal Investigator
affiliation: Laureate Institute for Brain Research
last name: Mallory Cannon, M.S.
phone: 918-581-4885
email: neurocatt@laureateinstitute.org
last name: Robin L Aupperle, PhD
phone: 918-502-5744
email: raupperle@laureateinstitute.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
citation: Santiago J, Akeman E, Kirlic N, Clausen AN, Cosgrove KT, McDermott TJ, Mathis B, Paulus M, Craske MG, Abelson J, Martell C, Wolitzky-Taylor K, Bodurka J, Thompson WK, Aupperle RL. Protocol for a randomized controlled trial examining multilevel prediction of response to behavioral activation and exposure-based therapy for generalized anxiety disorder. Trials. 2020 Jan 6;21(1):17. doi: 10.1186/s13063-019-3802-9.
PMID: 31907032
citation: Aupperle RL, Melrose AJ, Francisco A, Paulus MP, Stein MB. Neural substrates of approach-avoidance conflict decision-making. Hum Brain Mapp. 2015 Feb;36(2):449-62. doi: 10.1002/hbm.22639. Epub 2014 Sep 15.
PMID: 25224633
responsible party type: Sponsor
mesh term: Depression
sharing ipd: Yes
ipd description: After publication of results from the primary aims of this project, we intend to make the data used in publications (e.g., self-report, behavior, and neuroimaging data) accessible in a public database. These data will be stripped of patient identifiers and will comply with HIPAA requirements for publicly accessible datasets. User registration will be required to access or download files. As part of the registration process, users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd time frame: Immediately after publication of results from the primary aims of this project.
ipd access criteria: User registration will be required to access or download files. As part of the registration process, users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.