<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/NCT03255954</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00119669</org_study_id>
    <nct_id>NCT03255954</nct_id>
  </id_info>
  <brief_title>IPC for University Counseling Centers</brief_title>
  <official_title>Interpersonal Counseling (IPC) for University Counseling Centers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amherst College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</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>
      Interpersonal Counseling (IPC) is brief, structured modification of Interpersonal&#xD;
      Psychotherapy (IPT). IPC was developed as a brief triage manual to treat depression in&#xD;
      primary care, family practice and non-mental health programs, and work and educational&#xD;
      settings. College and university students are at the age where first episodes of depression,&#xD;
      bipolar disorder, or psychosis may occur. IPC is relevant for this population as many&#xD;
      university students' distress are related to profound life changes, role transitions,&#xD;
      loneliness and social/cultural isolation, which are focuses of treatment in IPC. While there&#xD;
      is considerable evidence for the efficacy of IPT and IPC, this adaptation for university&#xD;
      students has not yet been studied. The investigators propose to administer IPC to across&#xD;
      several college campuses, and to recruit 20 participants at each counseling center.&#xD;
      Participants will receive 3-6 one-hour therapy sessions, and will complete self-report&#xD;
      measures of depression, psychosocial functioning, college adjustment, and treatment&#xD;
      satisfaction. IPC has the potential to reduce depressive symptoms and prevent presenting&#xD;
      symptoms from worsening. For these reasons, developing and testing a brief, yet comprehensive&#xD;
      psychosocial intervention for distressed college students has tremendous importance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interpersonal Psychotherapy (IPT) is a short term, evidence-based treatment approach that has&#xD;
      shown benefits in treating major depressive disorder as well as other psychiatric conditions.&#xD;
      IPT focuses on the patient's current life events, including social and interpersonal&#xD;
      functioning, as a means of understanding and treating maladaptive symptoms. Interpersonal&#xD;
      Counseling (IPC) is a modification of the Interpersonal Psychotherapy (IPT) protocol.&#xD;
      Subsequently, IPC was developed as a brief intervention for depression to be used in primary&#xD;
      care, family practice and non-mental health programs, educational and work settings. IPC is a&#xD;
      treatment approach ready for dissemination and implementation by non-mental health workers&#xD;
      who have direct contact with individuals at risk for depression and other pathologies. IPC&#xD;
      has been used for efficient training, for preventative and screening purposes in doctor's&#xD;
      offices, schools, community based centers and organizations.&#xD;
&#xD;
      IPC synthesizes the fundamental principles of IPT into 3-6 sessions. Individuals receiving&#xD;
      IPC are initially assessed for symptoms of pathology, and then encouraged to identify&#xD;
      interpersonal problem areas which may be contributing to their presenting symptoms. The key&#xD;
      principles and techniques standard to IPT are also applied in IPC, so that the protocol can&#xD;
      act not only as an assessment tool, but also as a brief intervention. After identifying an&#xD;
      interpersonal problem area, the IPC clinician works with the client to mobilize social&#xD;
      support and rehearse more effective communication strategies. Once the IPC protocol is&#xD;
      completed, clinical decisions can be made regarding clients' need for follow-up psychotherapy&#xD;
      or alternative referrals.&#xD;
&#xD;
      Over the last decade, college and university counseling centers are reporting that students&#xD;
      are seeking psychiatric services under more distress and with more severe disorders.&#xD;
      College-age students are generally at increased risk for experiencing psychopathology; they&#xD;
      are at the age where first episodes of depression, bipolar disorder, or psychosis often&#xD;
      occur. Secondly, college students are often away from their social and family networks for&#xD;
      the first time, and may experience less instrumental social support when experiencing periods&#xD;
      of psychological distress. To date, most college counseling centers conduct psychological&#xD;
      assessments of students presenting for services and provide supportive counseling, often for&#xD;
      a finite number of sessions due to the heavy volume of student referrals. For these reasons,&#xD;
      it is important to have a brief, yet comprehensive protocol for screening and intervening&#xD;
      with distressed college students. Such protocols should be structured and accessible to&#xD;
      implementation by a range of professionals: clinical social workers or psychologists,&#xD;
      practicum students and interns training in these fields. IPC, a systematic, brief evaluation,&#xD;
      support and triage approach may help university counseling centers in both their treatment&#xD;
      and intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2017</start_date>
  <completion_date type="Actual">August 30, 2023</completion_date>
  <primary_completion_date type="Actual">August 30, 2023</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retention rate</measure>
    <time_frame>One year</time_frame>
    <description>Retention rate will be assessed by calculating the number of participants who completed the study compared to the number of participants who enrolled in the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction questionnaire</measure>
    <time_frame>Participants complete a satisfaction questionnaire when they have completed the study (maximum of 3 months)</time_frame>
    <description>Assess satisfaction of IPC-C via a 9 question, 7 point likert satisfaction scale questionnaire. High satisfaction with IPC will be evidenced by average scores of 6 on a 7 point satisfaction scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Interpersonal Counseling-C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Interpersonal Counseling for University Counseling Centers is a psychotherapeutic intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interpersonal Counseling for University Counseling Centers</intervention_name>
    <description>Interpersonal Counseling (IPC) is a brief version of Interpersonal Psychotherapy (IPT). IPC synthesizes the fundamental IPT principles into 3-6 sessions. Individuals receiving IPC are initially assessed for symptoms of depression, and then encouraged to identify interpersonal problem areas which may be contributing to their presenting symptoms.</description>
    <arm_group_label>Interpersonal Counseling-C</arm_group_label>
    <other_name>IPC-C</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-40 years old&#xD;
&#xD;
          -  Currently receiving counseling at one of the study locations&#xD;
&#xD;
          -  Adjustment disorder with depressed mood or mild to moderate depression which&#xD;
             correlates with a Patient Health Questionnaire-9 (PHQ-9) score of 5-14.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Poses a significant risk for dangerousness to self or others, or suffers from a&#xD;
             concomitant medical or psychiatric comorbidity that makes the study protocol&#xD;
             inadvisable (i.e., post-traumatic stress disorder, autism, psychotic disorder, bipolar&#xD;
             I or II disorder, eating disorder, alcohol or substance abuse or current use)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leslie Miller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Homewood Counseling Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amherst College Counseling Center</name>
      <address>
        <city>Amherst</city>
        <state>Massachusetts</state>
        <zip>01002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Toronto</name>
      <address>
        <city>Toronto</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>May 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Interpersonal Counseling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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/NCT03255954
org study id: IRB00119669
nct id: NCT03255954
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Interpersonal Counseling (IPC) is brief, structured modification of Interpersonal
      Psychotherapy (IPT). IPC was developed as a brief triage manual to treat depression in
      primary care, family practice and non-mental health programs, and work and educational
      settings. College and university students are at the age where first episodes of depression,
      bipolar disorder, or psychosis may occur. IPC is relevant for this population as many
      university students' distress are related to profound life changes, role transitions,
      loneliness and social/cultural isolation, which are focuses of treatment in IPC. While there
      is considerable evidence for the efficacy of IPT and IPC, this adaptation for university
      students has not yet been studied. The investigators propose to administer IPC to across
      several college campuses, and to recruit 20 participants at each counseling center.
      Participants will receive 3-6 one-hour therapy sessions, and will complete self-report
      measures of depression, psychosocial functioning, college adjustment, and treatment
      satisfaction. IPC has the potential to reduce depressive symptoms and prevent presenting
      symptoms from worsening. For these reasons, developing and testing a brief, yet comprehensive
      psychosocial intervention for distressed college students has tremendous importance.
Interpersonal Psychotherapy (IPT) is a short term, evidence-based treatment approach that has
      shown benefits in treating major depressive disorder as well as other psychiatric conditions.
      IPT focuses on the patient's current life events, including social and interpersonal
      functioning, as a means of understanding and treating maladaptive symptoms. Interpersonal
      Counseling (IPC) is a modification of the Interpersonal Psychotherapy (IPT) protocol.
      Subsequently, IPC was developed as a brief intervention for depression to be used in primary
      care, family practice and non-mental health programs, educational and work settings. IPC is a
      treatment approach ready for dissemination and implementation by non-mental health workers
      who have direct contact with individuals at risk for depression and other pathologies. IPC
      has been used for efficient training, for preventative and screening purposes in doctor's
      offices, schools, community based centers and organizations.

      IPC synthesizes the fundamental principles of IPT into 3-6 sessions. Individuals receiving
      IPC are initially assessed for symptoms of pathology, and then encouraged to identify
      interpersonal problem areas which may be contributing to their presenting symptoms. The key
      principles and techniques standard to IPT are also applied in IPC, so that the protocol can
      act not only as an assessment tool, but also as a brief intervention. After identifying an
      interpersonal problem area, the IPC clinician works with the client to mobilize social
      support and rehearse more effective communication strategies. Once the IPC protocol is
      completed, clinical decisions can be made regarding clients' need for follow-up psychotherapy
      or alternative referrals.

      Over the last decade, college and university counseling centers are reporting that students
      are seeking psychiatric services under more distress and with more severe disorders.
      College-age students are generally at increased risk for experiencing psychopathology; they
      are at the age where first episodes of depression, bipolar disorder, or psychosis often
      occur. Secondly, college students are often away from their social and family networks for
      the first time, and may experience less instrumental social support when experiencing periods
      of psychological distress. To date, most college counseling centers conduct psychological
      assessments of students presenting for services and provide supportive counseling, often for
      a finite number of sessions due to the heavy volume of student referrals. For these reasons,
      it is important to have a brief, yet comprehensive protocol for screening and intervening
      with distressed college students. Such protocols should be structured and accessible to
      implementation by a range of professionals: clinical social workers or psychologists,
      practicum students and interns training in these fields. IPC, a systematic, brief evaluation,
      support and triage approach may help university counseling centers in both their treatment
      and intervention.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Retention rate
time frame: One year
description: Retention rate will be assessed by calculating the number of participants who completed the study compared to the number of participants who enrolled in the study
measure: Satisfaction questionnaire
time frame: Participants complete a satisfaction questionnaire when they have completed the study (maximum of 3 months)
description: Assess satisfaction of IPC-C via a 9 question, 7 point likert satisfaction scale questionnaire. High satisfaction with IPC will be evidenced by average scores of 6 on a 7 point satisfaction scale
arm group label: Interpersonal Counseling-C
arm group type: Experimental
description: Interpersonal Counseling for University Counseling Centers is a psychotherapeutic intervention
intervention type: Other
intervention name: Interpersonal Counseling for University Counseling Centers
description: Interpersonal Counseling (IPC) is a brief version of Interpersonal Psychotherapy (IPT). IPC synthesizes the fundamental IPT principles into 3-6 sessions. Individuals receiving IPC are initially assessed for symptoms of depression, and then encouraged to identify interpersonal problem areas which may be contributing to their presenting symptoms.
arm group label: Interpersonal Counseling-C
other name: IPC-C
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Leslie Miller, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Depression
sharing ipd: No