<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/NCT01730261</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 12-1256-3</org_study_id>
    <secondary_id>HSM 12-00760</secondary_id>
    <secondary_id>IF1435434</secondary_id>
    <nct_id>NCT01730261</nct_id>
  </id_info>
  <brief_title>Online Emotional Regulation Group Treatment</brief_title>
  <official_title>Online Emotional Regulation Group Treatment for Individuals With Traumatic Brain Injury (TBI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the feasibility of online delivery of emotional regulation training&#xD;
      to individuals with TBI with emotional dysregulation. 80 subjects with significant emotional&#xD;
      dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions&#xD;
      twice a week for 12 weeks, delivered online in group modality. Attendance and compliance will&#xD;
      be tracked, and outcomes will be monitored using online data collection methods. Treatment&#xD;
      satisfaction and participant subjective experience will also be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will examine the feasibility of online delivery of emotional regulation training&#xD;
      to individuals with Traumatic Brain Injury who also have emotional dysregulation. 80 subjects&#xD;
      with significant emotional dysregulation will be enrolled and will receive 24 60-minute&#xD;
      emotional regulation sessions twice a week for 12 weeks, delivered online via a group meeting&#xD;
      software. Study participation will last 28 weeks: 4 weeks of baseline, 12 weeks of treatment&#xD;
      (24 sessions) and 12 weeks of follow-up. Assessments will be conducted at each of four&#xD;
      timepoints: T1 (baseline), T2 (pre-treatment assessment), T3 (end-of-treatment assessment)&#xD;
      and T4 (follow-up assessment). In addition, a subset of the measures will be administered&#xD;
      bi-weekly for the duration of the study. Assessments will consist of a variety of measures&#xD;
      designed to measure executive functioning, problem solving skills, and quality of life. All&#xD;
      assessments will be completed online, using a web-based data collection. Attendance and&#xD;
      treatment compliance will be tracked, and outcomes will be monitored using online data&#xD;
      collection methods. Treatment satisfaction and participant subjective experience (including&#xD;
      technical difficulties that make access to web-delivered treatment impossible) will also be&#xD;
      assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 1</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>Difficulties in Emotion Regulation Scale(DERS)</measure>
    <time_frame>up to 28 weeks</time_frame>
    <description>36-item self-report questionnaire that focuses on emotional awareness, acceptance, ability to control impulsivity, and flexible use of strategies</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Brain Injury Rehabilitation Trust Regulation of Emotions Questionnaire (BREQ)</measure>
    <time_frame>up to 28 weeks</time_frame>
    <description>32 item self-report questionnaire assessing deficits in emotion regulation, developed specifically to assess emotional dysregulation related to TBI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Problem Solving Inventory</measure>
    <time_frame>up to 28 weeks</time_frame>
    <description>35-item self-report questionnaire assessing problem solving capability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Problem Solving Inventory-Revised: Short Form</measure>
    <time_frame>up to 28 weeks</time_frame>
    <description>25-item self-report questionnaire assessing problem solving in everyday living</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Affect Negative Affect Scale</measure>
    <time_frame>up to 28 weeks</time_frame>
    <description>20-item self-report measure of positive and negative affect within a specified time frame</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with Life Scale</measure>
    <time_frame>T1 (baseline)</time_frame>
    <description>5- item measure of global satisfaction with life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with Life Scale</measure>
    <time_frame>T2 (week 4)</time_frame>
    <description>5- item measure of global satisfaction with life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with Life Scale</measure>
    <time_frame>T3 (week 16)</time_frame>
    <description>5- item measure of global satisfaction with life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with Life Scale</measure>
    <time_frame>T4 (week 28)</time_frame>
    <description>5- item measure of global satisfaction with life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with Therapy and Therapist Scale</measure>
    <time_frame>T3 (week 16)</time_frame>
    <description>12-item scale that assesses satisfaction with treatment and therapist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with Therapy and Therapist Scale</measure>
    <time_frame>T4 (week 28)</time_frame>
    <description>12-item scale that assesses satisfaction with treatment and therapist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Compliance</measure>
    <time_frame>up to 28 weeks</time_frame>
    <description>therapist's ratings of participant on each of the following areas at each session: attendance, participation, homework completion, skill acquisition, skill generalization, ease of use of technology, and interpersonal behavior</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">147</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>Executive Dysfunction</condition>
  <condition>Emotional Dysregulation</condition>
  <arm_group>
    <arm_group_label>Online Emotional Regulation Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 24 treatment sessions, with baseline, post-treatment screening and follow-up screening, and bi-weekly assessments</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Online Emotional Regulation Treatment</intervention_name>
    <description>Emotional Regulation Training (EmReg) is a cognitive-behavioral approach which aims to increase awareness, and self-monitoring of affective states to improve self-regulation. EmReg combines didactic and experiential training, and emphasizes skill acquisition and generalization through examination of incidents of emotional dysregulation in one's life and completion of homework assignments. The treatment is divided into two phases: knowledge provision and practice facilitation. During the knowledge provision phase participants are introduced to the objectives and the main concepts of the treatment, to increase their familiarity with the terminology, and to the emotional regulation skills they acquire during the practice facilitation phase. During the practice facilitation phase participants receive training in emotional regulation skills, which they practice in-session with the guidance of the therapist and feedback from the group, as well as out-of-session as homework assignments.</description>
    <arm_group_label>Online Emotional Regulation Treatment</arm_group_label>
    <other_name>Emotional Regulation Training (EmReg)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented TBI of any severity and being at least 6 months post injury&#xD;
&#xD;
          -  Presence of executive dysfunction, manifested as self-reported difficulties with&#xD;
             emotional and behavioral self-regulation, operationalized as endorsement of 25% or&#xD;
             more of the symptoms on the Difficulties in Emotion Regulation Scale (DERS, Gratz &amp;&#xD;
             Roemer, 2004).&#xD;
&#xD;
          -  Currently aged 18 or older&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  At least low average intellectual functioning, operationalized as a minimum Verbal IQ&#xD;
             score of 80 on the Wechsler Abbreviated Scale of Intelligence&#xD;
&#xD;
          -  Ownership of and relative facility with use of a computer, webcam, and microphone&#xD;
&#xD;
          -  Access to a broadband internet connection at sufficiently high speed to allow&#xD;
             videoconference&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  DSM-IV-TR diagnosis of alcohol or substance abuse within past 6 months&#xD;
&#xD;
          -  DSM-IV-TR of psychosis within past 6 months&#xD;
&#xD;
          -  High suicidality, operationalized as a score of 17 or higher on the Mini International&#xD;
             Neuropsychiatric Interview (M.I.N.I., Sheehan et al., 2008)&#xD;
&#xD;
        Participation in this study will not preclude participation in other treatments.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wayne Gordon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</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>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>October 1, 2015</last_update_submitted>
  <last_update_submitted_qc>October 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Traumatic Brain Injury</keyword>
  <keyword>TBI</keyword>
  <keyword>Executive Dysfunction</keyword>
  <keyword>Emotional Regulation</keyword>
  <keyword>Problem Solving</keyword>
  <keyword>Self-regulation</keyword>
  <keyword>Cognitive Rehabilitation</keyword>
  <keyword>Metacognitive Strategies</keyword>
  <keyword>Cognitive-behavioral therapy</keyword>
  <keyword>Online Therapy</keyword>
  <keyword>Group therapy</keyword>
  <keyword>Group videoconference</keyword>
  <keyword>Telehealth</keyword>
  <keyword>Telerehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</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/NCT01730261
org study id: GCO 12-1256-3
secondary id: HSM 12-00760
secondary id: IF1435434
nct id: NCT01730261
lead sponsor: 
has dmc: No
This study will examine the feasibility of online delivery of emotional regulation training
      to individuals with TBI with emotional dysregulation. 80 subjects with significant emotional
      dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions
      twice a week for 12 weeks, delivered online in group modality. Attendance and compliance will
      be tracked, and outcomes will be monitored using online data collection methods. Treatment
      satisfaction and participant subjective experience will also be assessed.
This study will examine the feasibility of online delivery of emotional regulation training
      to individuals with Traumatic Brain Injury who also have emotional dysregulation. 80 subjects
      with significant emotional dysregulation will be enrolled and will receive 24 60-minute
      emotional regulation sessions twice a week for 12 weeks, delivered online via a group meeting
      software. Study participation will last 28 weeks: 4 weeks of baseline, 12 weeks of treatment
      (24 sessions) and 12 weeks of follow-up. Assessments will be conducted at each of four
      timepoints: T1 (baseline), T2 (pre-treatment assessment), T3 (end-of-treatment assessment)
      and T4 (follow-up assessment). In addition, a subset of the measures will be administered
      bi-weekly for the duration of the study. Assessments will consist of a variety of measures
      designed to measure executive functioning, problem solving skills, and quality of life. All
      assessments will be completed online, using a web-based data collection. Attendance and
      treatment compliance will be tracked, and outcomes will be monitored using online data
      collection methods. Treatment satisfaction and participant subjective experience (including
      technical difficulties that make access to web-delivered treatment impossible) will also be
      assessed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Difficulties in Emotion Regulation Scale(DERS)
time frame: up to 28 weeks
description: 36-item self-report questionnaire that focuses on emotional awareness, acceptance, ability to control impulsivity, and flexible use of strategies
measure: The Brain Injury Rehabilitation Trust Regulation of Emotions Questionnaire (BREQ)
time frame: up to 28 weeks
description: 32 item self-report questionnaire assessing deficits in emotion regulation, developed specifically to assess emotional dysregulation related to TBI
measure: Problem Solving Inventory
time frame: up to 28 weeks
description: 35-item self-report questionnaire assessing problem solving capability
measure: Social Problem Solving Inventory-Revised: Short Form
time frame: up to 28 weeks
description: 25-item self-report questionnaire assessing problem solving in everyday living
measure: Positive Affect Negative Affect Scale
time frame: up to 28 weeks
description: 20-item self-report measure of positive and negative affect within a specified time frame
measure: Satisfaction with Life Scale
time frame: T1 (baseline)
description: 5- item measure of global satisfaction with life
measure: Satisfaction with Life Scale
time frame: T2 (week 4)
description: 5- item measure of global satisfaction with life
measure: Satisfaction with Life Scale
time frame: T3 (week 16)
description: 5- item measure of global satisfaction with life
measure: Satisfaction with Life Scale
time frame: T4 (week 28)
description: 5- item measure of global satisfaction with life
measure: Satisfaction with Therapy and Therapist Scale
time frame: T3 (week 16)
description: 12-item scale that assesses satisfaction with treatment and therapist
measure: Satisfaction with Therapy and Therapist Scale
time frame: T4 (week 28)
description: 12-item scale that assesses satisfaction with treatment and therapist
measure: Treatment Compliance
time frame: up to 28 weeks
description: therapist's ratings of participant on each of the following areas at each session: attendance, participation, homework completion, skill acquisition, skill generalization, ease of use of technology, and interpersonal behavior
arm group label: Online Emotional Regulation Treatment
arm group type: Experimental
description: Participants will receive 24 treatment sessions, with baseline, post-treatment screening and follow-up screening, and bi-weekly assessments
intervention type: Behavioral
intervention name: Online Emotional Regulation Treatment
description: Emotional Regulation Training (EmReg) is a cognitive-behavioral approach which aims to increase awareness, and self-monitoring of affective states to improve self-regulation. EmReg combines didactic and experiential training, and emphasizes skill acquisition and generalization through examination of incidents of emotional dysregulation in one's life and completion of homework assignments. The treatment is divided into two phases: knowledge provision and practice facilitation. During the knowledge provision phase participants are introduced to the objectives and the main concepts of the treatment, to increase their familiarity with the terminology, and to the emotional regulation skills they acquire during the practice facilitation phase. During the practice facilitation phase participants receive training in emotional regulation skills, which they practice in-session with the guidance of the therapist and feedback from the group, as well as out-of-session as homework assignments.
arm group label: Online Emotional Regulation Treatment
other name: Emotional Regulation Training (EmReg)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wayne Gordon, PhD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic