xml: <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/NCT06038786</url>
    </required_header>
    <id_info>
      <org_study_id>2016P002351</org_study_id>
      <nct_id>NCT06038786</nct_id>
    </id_info>
    <brief_title>Resiliency Training on the College Campus</brief_title>
    <official_title>Resiliency Training on the College Campus</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Massachusetts General Hospital</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>
        This is a waitlist controlled study examining the initial efficacy of Resilience Training&#xD;
        among college students at an elevated risk for a severe mental illness.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2018</start_date>
    <completion_date type="Actual">March 1, 2020</completion_date>
    <primary_completion_date type="Actual">November 26, 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>
      <intervention_model_description>Waitlist controlled design</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Peters Delusions Inventory</measure>
      <time_frame>Baseline, 4-weeks, 12 months</time_frame>
      <description>The Peters Delusions Inventory (PDI) is a brief 21-item survey using non-stigmatizing and non-clinical language to obtain ratings of common delusional experiences (e.g. paranoia, grandiosity, ideas of reference) and perceptual aberrations (e.g. experiences of being controlled; thought insertion, withdrawal, and echoing). The PDI also captures conviction, preoccupation, and distress related to the delusions. This scale is scored from 0-21, with higher scores indicating more presence of these delusions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Beck Depression Inventory</measure>
      <time_frame>Baseline, 4-weeks, 12 months</time_frame>
      <description>The Beck Depression Inventory (BDI) is a 21-item self-report assessment obtaining ratings of one's level of depression on a Likert scale of 0-63, with higher scores indicating more depressive symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Spielberger State-Trait Anxiety Inventory</measure>
      <time_frame>Baseline, 4-weeks, 12 months</time_frame>
      <description>The Spielberger State-Trait Anxiety Inventory (STAI) is a 20-item self-report scale obtaining ratings of one's anxiety, both those that are trait like and ongoing, and those that are state like and temporary. Scores range from 0-120, with higher scores indicate higher levels of anxiety symptoms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Connor-Davidson Resilience Scale</measure>
      <time_frame>Baseline, 4-weeks, 12 months</time_frame>
      <description>The Connor-Davidson Resilience Scale (CD-RISC) is a 25-item self-report scale obtaining ratings of one's level of coping and emotional resilience. It is rated on a scale of 0-100, with higher scores indicate one has more coping skills and more emotional resilience.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Five Facet Mindfulness Questionnaire</measure>
      <time_frame>Baseline, 4-weeks, 12 months</time_frame>
      <description>The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item self-report survey that obtains ratings of one's capacity for mindfulness. It contains 5 sub scales, although this study only used the total score. It is scored on a 0-195 scale, though a mean score is taken ranging from 0-5, with higher scores indicate greater capacity for mindfulness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interpersonal Reactivity Index</measure>
      <time_frame>Baseline, 4-weeks, 12 months</time_frame>
      <description>The Interpersonal Reactivity Index (IRI) is a 28-item self-report scale that measures one's ability to experience empathy for another person. The scale has 4 sub scales, yet this study utilized only two of them: the empathic concern and perspective taking subscales. It is scored on a 0-140 scale, with higher ratings indicate more ability for empathy.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">107</enrollment>
    <condition>Psychotic Disorders</condition>
    <condition>Mood Disorders</condition>
    <condition>Anxiety Disorders</condition>
    <arm_group>
      <arm_group_label>Resilience Training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants obtained Resilience Training, a 4 session, 1.5 hour group intervention delivering the following skills: mindfulness, mentalization, and self-compassion.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>A 4-6 week waitlist during which participants did not receive any treatment. They would then obtain Resilience Training following their waitlist period.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Resilience Training</intervention_name>
      <description>A 4 session group-based behavioral intervention which delivers the following skills: mindfulness, metallization, and self-compassion.</description>
      <arm_group_label>Resilience Training</arm_group_label>
      <arm_group_label>Waitlist</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 18-30 years old&#xD;
  &#xD;
            2. Enrolled in undergraduate program at the college or university where the intervention&#xD;
               takes place&#xD;
  &#xD;
            3. Students who endorse delusion-like experiences (DLEs): Peter's et al. Delusion&#xD;
               Inventory (PDI) score &gt; 4 and/or&#xD;
  &#xD;
            4. Students with mild to moderate depressive symptoms: Beck Depression Inventory (BDI)&#xD;
               score ≥ 6&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Inability to provide informed consent&#xD;
  &#xD;
            2. Not proficient in English&#xD;
  &#xD;
            3. Current self-reported Diagnostic Statistical Manual 5 (DSM-5) diagnosis with active&#xD;
               symptoms (such as active psychotic symptoms, current suicidality, serious active&#xD;
               alcohol or substance use, marked deterioration in functioning over the prior month)&#xD;
               determined by clinical interview with participant, or self-report of a psychiatric&#xD;
               diagnosis that necessitates close monitoring or individual therapy and/or inpatient or&#xD;
               partial hospitalization&#xD;
  &#xD;
            4. Current enrollment in psychological or behavioral health treatment.&#xD;
  &#xD;
            5. Current use of psychotropic medications (other than stimulants) prescribed by a&#xD;
               physician.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Daphne Holt, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Massachusetts General Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Massachusetts General Hospital</name>
        <address>
          <city>Charlestown</city>
          <state>Massachusetts</state>
          <zip>02129</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Daphne Holt</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anxiety Disorders</mesh_term>
      <mesh_term>Psychotic Disorders</mesh_term>
      <mesh_term>Mood Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>We plan to submit the full, yet de-identified dataset to Mendeley Data: https://data.mendeley.com at publication of this manuscript.</ipd_description>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Study data will be come available once manuscripts are published.</ipd_time_frame>
      <ipd_access_criteria>Data shared will be coded, with no PHI included.</ipd_access_criteria>
      <ipd_url>http://data.mendeley.com</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038786
  org study id: 2016P002351
  nct id: NCT06038786
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a waitlist controlled study examining the initial efficacy of Resilience Training
        among college students at an elevated risk for a severe mental illness.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Waitlist controlled design
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Peters Delusions Inventory
  time frame: Baseline, 4-weeks, 12 months
  description: The Peters Delusions Inventory (PDI) is a brief 21-item survey using non-stigmatizing and non-clinical language to obtain ratings of common delusional experiences (e.g. paranoia, grandiosity, ideas of reference) and perceptual aberrations (e.g. experiences of being controlled; thought insertion, withdrawal, and echoing). The PDI also captures conviction, preoccupation, and distress related to the delusions. This scale is scored from 0-21, with higher scores indicating more presence of these delusions.
  measure: Beck Depression Inventory
  time frame: Baseline, 4-weeks, 12 months
  description: The Beck Depression Inventory (BDI) is a 21-item self-report assessment obtaining ratings of one's level of depression on a Likert scale of 0-63, with higher scores indicating more depressive symptoms.
  measure: Spielberger State-Trait Anxiety Inventory
  time frame: Baseline, 4-weeks, 12 months
  description: The Spielberger State-Trait Anxiety Inventory (STAI) is a 20-item self-report scale obtaining ratings of one's anxiety, both those that are trait like and ongoing, and those that are state like and temporary. Scores range from 0-120, with higher scores indicate higher levels of anxiety symptoms.
  measure: Connor-Davidson Resilience Scale
  time frame: Baseline, 4-weeks, 12 months
  description: The Connor-Davidson Resilience Scale (CD-RISC) is a 25-item self-report scale obtaining ratings of one's level of coping and emotional resilience. It is rated on a scale of 0-100, with higher scores indicate one has more coping skills and more emotional resilience.
  measure: Five Facet Mindfulness Questionnaire
  time frame: Baseline, 4-weeks, 12 months
  description: The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item self-report survey that obtains ratings of one's capacity for mindfulness. It contains 5 sub scales, although this study only used the total score. It is scored on a 0-195 scale, though a mean score is taken ranging from 0-5, with higher scores indicate greater capacity for mindfulness.
  measure: Interpersonal Reactivity Index
  time frame: Baseline, 4-weeks, 12 months
  description: The Interpersonal Reactivity Index (IRI) is a 28-item self-report scale that measures one's ability to experience empathy for another person. The scale has 4 sub scales, yet this study utilized only two of them: the empathic concern and perspective taking subscales. It is scored on a 0-140 scale, with higher ratings indicate more ability for empathy.
  arm group label: Resilience Training
  arm group type: Experimental
  description: Participants obtained Resilience Training, a 4 session, 1.5 hour group intervention delivering the following skills: mindfulness, mentalization, and self-compassion.
  arm group label: Waitlist
  arm group type: Placebo Comparator
  description: A 4-6 week waitlist during which participants did not receive any treatment. They would then obtain Resilience Training following their waitlist period.
  intervention type: Behavioral
  intervention name: Resilience Training
  description: A 4 session group-based behavioral intervention which delivers the following skills: mindfulness, metallization, and self-compassion.
  arm group label: Resilience Training
  arm group label: Waitlist
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: No
  last name: Daphne Holt, MD, PhD
  role: Principal Investigator
  affiliation: Massachusetts General Hospital
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Daphne Holt
  investigator title: Associate Professor
  mesh term: Anxiety Disorders
  mesh term: Psychotic Disorders
  mesh term: Mood Disorders
  sharing ipd: Yes
  ipd description: We plan to submit the full, yet de-identified dataset to Mendeley Data: https://data.mendeley.com at publication of this manuscript.
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Study data will be come available once manuscripts are published.
  ipd access criteria: Data shared will be coded, with no PHI included.
  ipd url: http://data.mendeley.com