<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/NCT03275961</url>
  </required_header>
  <id_info>
    <org_study_id>16-007944</org_study_id>
    <nct_id>NCT03275961</nct_id>
  </id_info>
  <brief_title>Stress Management and Resiliency Training (SMART) Integrated Into Treatment of Major Depression</brief_title>
  <official_title>Stress Management and Resiliency Training (SMART) Integrated Into Comprehensive Treatment of Major Depression: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      The investigators are doing this research study to find out if the Stress Management and&#xD;
      Resiliency Training (SMART) therapy will help subjects with their major depression treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose to conduct an initial feasibility study in a sample of patients in&#xD;
      treatment for major depression using SMART. The intervention will be weekly group therapy&#xD;
      session of SMART for 8 weeks duration. Once enrolled, participants will complete a Structured&#xD;
      Clinical Interview for Diagnosis (SCID). The SCID will primarily serve to confirm a diagnosis&#xD;
      of Major Depressive Disorder. Each study intervention group (3-4 groups) will be composed of&#xD;
      6-8 research participants per group. There will be no comparison group. The investigators aim&#xD;
      to assess adherence with goal of 75% completion of the 8 sessions of SMART and of the&#xD;
      homework assignments. Resilience will be measured with the Connor-Davidson resilience scale.&#xD;
      Secondary outcomes will include subjective and objective clinical rating scales for major&#xD;
      depression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2016</start_date>
  <completion_date type="Actual">October 15, 2018</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Connor-Davidson Resilience Scale Score</measure>
    <time_frame>baseline, 8 weeks</time_frame>
    <description>The Connor-Davidson Resilience Scale (CD-RISC), a 25-item scale, was developed to measure resiliency. CD-RISC has been evaluated and has been found to have good internal consistency (α = .89), test-retest reliability (intraclass correlation coefficient = .87), and positive correlation with multiple related measures with ability to distinguish between participants with lesser and greater resilience. The scores can range from 0 to 100. The mean score in a general population sample was 80.7 and in psychiatric outpatients 68. A positive change with increasing scores will indicate improvement in resilience.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Hamilton Rating Scale for Depression Score</measure>
    <time_frame>baseline, 8 weeks</time_frame>
    <description>The Hamilton Rating Scale for Depression (HAMD-17) is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17 score ranges from 0 (not ill) to 52 (severely ill). A negative change indicates improvement in the subject's depression/anxiety symptoms, and a positive change indicates a worsening of the subject's depression/anxiety symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Health Questionnaire-9 Score</measure>
    <time_frame>baseline, 8 weeks</time_frame>
    <description>The Patient Health Questionnaire (PHQ) is a self-administered 9-item scale which scores each of the 9 DSM-V criteria as &quot;0&quot; (not at all) to &quot;3&quot; (nearly every day). PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 6-10,11-15, 16-20, and &gt;20 represented mild, moderate, moderately severe, and severe depression, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quick Inventory of Depressive Symptoms Score</measure>
    <time_frame>baseline, 8 weeks</time_frame>
    <description>The 16-item Quick Inventory of Depressive Symptomatology (QIDS) designed to assess the severity of depressive symptoms. The QIDS assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) to diagnose a major depressive episode. The scores can range from 0 to 27, with 0 being no depression to 27 being very severe depression. Increasing scores indicate worsening depression and decreasing scores indicate improving depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Generalized Anxiety Disorder-7 Score</measure>
    <time_frame>baseline, 8 weeks</time_frame>
    <description>Generalized Anxiety Disorder 7 (GAD-7) is a 7 item self-report scale which scores the symptoms of generalized anxiety disorder (GAD) from &quot;0&quot;( not at all) to &quot;3&quot;( nearly every day). Cut points of 5, 10, and 15 represent mild, moderate, and severe levels of anxiety on the GAD-7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Perceived Stress Scale Score</measure>
    <time_frame>baseline, 8 weeks</time_frame>
    <description>The Perceived Stress Scale is a 10 item self-administered scale that measures the degree to which one's life are appraised as stressful. The scores can range from 0( no stress) to 40( very high stress). Scores between 0-13 are considered low stress, 14-26- moderate stress and 27-40- high stress. A decreasing trend of scores would indicate improvement in perceived stress levels.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Depressed Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will undergo an 8 week behavioral program with Stress Management and Resiliency Training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stress Management and Resiliency Training</intervention_name>
    <description>Subjects will undergo an 8 week behavioral program. Treatment will consist of weekly group therapy sessions in small groups with core practices to apply the principles of SMART.</description>
    <arm_group_label>Depressed Subjects</arm_group_label>
    <other_name>SMART</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Attending the Mayo Clinic Depression Center and Behavioral Health Clinic at Mayo&#xD;
             Clinic Health System, Austin, Minnesota&#xD;
&#xD;
          -  DSM-V diagnostic confirmation of major depressive disorder (MDD)&#xD;
&#xD;
          -  Baseline PHQ-9 scores in the range of ≥6-≤19, and HAMD-17 score 8-18, or QIDS-C16&#xD;
             score of 6-20&#xD;
&#xD;
          -  Able to speak English&#xD;
&#xD;
          -  Participants will continue taking any prescribed medications from their clinical&#xD;
             treatment team&#xD;
&#xD;
          -  Patients with co-morbid secondary diagnoses of persistent depressive disorder and&#xD;
             generalized anxiety disorders will be included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with bipolar disorder&#xD;
&#xD;
          -  Active psychosis&#xD;
&#xD;
          -  Active suicidal ideations&#xD;
&#xD;
          -  Active substance abuse meeting criteria for substance use disorders except nicotine&#xD;
&#xD;
          -  Obsessive compulsive disorder&#xD;
&#xD;
          -  Active Panic disorder with agoraphobia, other phobic disorder&#xD;
&#xD;
          -  Active Posttraumatic stress disorder&#xD;
&#xD;
          -  Active Severe personality disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashok Seshadri, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>November 13, 2018</last_update_submitted>
  <last_update_submitted_qc>November 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Ashok Seshadri</investigator_full_name>
    <investigator_title>Consultant, Instructor in Psychiatry</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03275961
org study id: 16-007944
nct id: NCT03275961
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators are doing this research study to find out if the Stress Management and
      Resiliency Training (SMART) therapy will help subjects with their major depression treatment.
The investigators propose to conduct an initial feasibility study in a sample of patients in
      treatment for major depression using SMART. The intervention will be weekly group therapy
      session of SMART for 8 weeks duration. Once enrolled, participants will complete a Structured
      Clinical Interview for Diagnosis (SCID). The SCID will primarily serve to confirm a diagnosis
      of Major Depressive Disorder. Each study intervention group (3-4 groups) will be composed of
      6-8 research participants per group. There will be no comparison group. The investigators aim
      to assess adherence with goal of 75% completion of the 8 sessions of SMART and of the
      homework assignments. Resilience will be measured with the Connor-Davidson resilience scale.
      Secondary outcomes will include subjective and objective clinical rating scales for major
      depression.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Connor-Davidson Resilience Scale Score
time frame: baseline, 8 weeks
description: The Connor-Davidson Resilience Scale (CD-RISC), a 25-item scale, was developed to measure resiliency. CD-RISC has been evaluated and has been found to have good internal consistency (α = .89), test-retest reliability (intraclass correlation coefficient = .87), and positive correlation with multiple related measures with ability to distinguish between participants with lesser and greater resilience. The scores can range from 0 to 100. The mean score in a general population sample was 80.7 and in psychiatric outpatients 68. A positive change with increasing scores will indicate improvement in resilience.
measure: Change in Hamilton Rating Scale for Depression Score
time frame: baseline, 8 weeks
description: The Hamilton Rating Scale for Depression (HAMD-17) is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17 score ranges from 0 (not ill) to 52 (severely ill). A negative change indicates improvement in the subject's depression/anxiety symptoms, and a positive change indicates a worsening of the subject's depression/anxiety symptoms.
measure: Change in Patient Health Questionnaire-9 Score
time frame: baseline, 8 weeks
description: The Patient Health Questionnaire (PHQ) is a self-administered 9-item scale which scores each of the 9 DSM-V criteria as "0" (not at all) to "3" (nearly every day). PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 6-10,11-15, 16-20, and >20 represented mild, moderate, moderately severe, and severe depression, respectively.
measure: Change in Quick Inventory of Depressive Symptoms Score
time frame: baseline, 8 weeks
description: The 16-item Quick Inventory of Depressive Symptomatology (QIDS) designed to assess the severity of depressive symptoms. The QIDS assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) to diagnose a major depressive episode. The scores can range from 0 to 27, with 0 being no depression to 27 being very severe depression. Increasing scores indicate worsening depression and decreasing scores indicate improving depression.
measure: Change in Generalized Anxiety Disorder-7 Score
time frame: baseline, 8 weeks
description: Generalized Anxiety Disorder 7 (GAD-7) is a 7 item self-report scale which scores the symptoms of generalized anxiety disorder (GAD) from "0"( not at all) to "3"( nearly every day). Cut points of 5, 10, and 15 represent mild, moderate, and severe levels of anxiety on the GAD-7.
measure: Change in Perceived Stress Scale Score
time frame: baseline, 8 weeks
description: The Perceived Stress Scale is a 10 item self-administered scale that measures the degree to which one's life are appraised as stressful. The scores can range from 0( no stress) to 40( very high stress). Scores between 0-13 are considered low stress, 14-26- moderate stress and 27-40- high stress. A decreasing trend of scores would indicate improvement in perceived stress levels.
arm group label: Depressed Subjects
arm group type: Experimental
description: Subjects will undergo an 8 week behavioral program with Stress Management and Resiliency Training.
intervention type: Behavioral
intervention name: Stress Management and Resiliency Training
description: Subjects will undergo an 8 week behavioral program. Treatment will consist of weekly group therapy sessions in small groups with core practices to apply the principles of SMART.
arm group label: Depressed Subjects
other name: SMART
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ashok Seshadri, M.D.
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Ashok Seshadri
investigator title: Consultant, Instructor in Psychiatry
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No