<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/NCT02261818</url>
  </required_header>
  <id_info>
    <org_study_id>K23MH100705</org_study_id>
    <nct_id>NCT02261818</nct_id>
  </id_info>
  <brief_title>Using Peer Mentors to Deliver Depression Care</brief_title>
  <official_title>Phase 1 Study of Using Peers to Deliver Depression Care to Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Can peer mentors be integrated into depression care to older adults with mental health&#xD;
      professional supervision? We will assess whether peer mentors who are lay persons who are in&#xD;
      recovery from depression can provide depression care services to older adults with&#xD;
      depression. Older adults who are 50 and older will be screened for depression in the clinic&#xD;
      and community. Those who meet criteria will be paired with a peer mentor for 8 meetings. Peer&#xD;
      mentors will audiorecord their meetings with the patient and the recordings will be analyzed&#xD;
      to assess what kinds of communication and behaviors the peer mentors engage in and what among&#xD;
      those communications may be associated with relieving depression. The peer mentor will be&#xD;
      trained and supervised by a psychiatrist and they will form a team to provide the depression&#xD;
      care to the older adult. The study aims to relieve depressive symptoms and engage older&#xD;
      adults in care. Both older adults and peer mentors wil be interviewed after the study to&#xD;
      assess the strengths and weaknesses of peer mentor delivery of depression care. A manual will&#xD;
      be developed describing the process and procedures of the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recruitment of peer mentors. We will recruit peer mentors from a community organization who&#xD;
      are in recovery and are recommended by the organization and have had basic training in&#xD;
      supportive listening and experience working with persons in the community in need of mental&#xD;
      health support. We will recruit 10 peer mentors, striving for a balance of men and women, and&#xD;
      accounting for attrition, so that at least 5 peer mentors will participate in the project.&#xD;
      The study doctor will meet and interview interested peers to screen for eligibility criteria,&#xD;
      motivation and aptitude. Persons who do not meet criteria for continued participation in the&#xD;
      study will be referred to other volunteer opportunities when appropriate.&#xD;
&#xD;
      Recruitment of patients. Twenty patient participants will be recruited through the internal&#xD;
      medicine and psychiatry clinics at Johns Hopkins Bayview Medical Center as well as the&#xD;
      community. A research assistant will screen patients for depressive symptoms with the Patient&#xD;
      Health Questionnaire-9 (PHQ-9). Patients meeting eligibility criteria will give written&#xD;
      informed consent. Eligible patients will be scheduled for another appointment to meet with&#xD;
      the study doctor in a private room at offices in the clinical campus.&#xD;
&#xD;
      Training of peer mentors. The PI and research assistant will conduct 5 sessions totaling 20&#xD;
      hours of training for the peer mentors. Training will refine the peer mentor's social support&#xD;
      behaviors, which include the use of effective communication skills, rapport building, active&#xD;
      listening, and sharing of experiential knowledge, and expression of empathy. Issues of&#xD;
      cultural interviewing, cultural competence, patient confidentiality, DSM-IV diagnosis,&#xD;
      differentiation of peer and professional roles and patient safety will be addressed.&#xD;
      Knowledge regarding how mental health and illness presents itself in old age and the specific&#xD;
      developmental problems older adults face will be provided. Training will include review of&#xD;
      written materials, lectures, discussion of case studies and role play. Upon completion of the&#xD;
      training, peer mentors will be assessed for mental health knowledge and interpersonal skills&#xD;
      and those who pass muster will be matched with patients.&#xD;
&#xD;
      The peer mentor role: Activities of the peer mentor with the patient will be structured by&#xD;
      the following principles which are derived from important elements of both peer support and&#xD;
      psychotherapy and our preliminary work:&#xD;
&#xD;
      Principles to structure peer mentor interactions with patients&#xD;
&#xD;
        1. Establish a working relationship&#xD;
&#xD;
        2. Establish goals of meetings with patient&#xD;
&#xD;
        3. Provide active listening, empathy, reciprocity, mutual respect, provision of emotional&#xD;
           support Provide support and encourage work toward patient-identified goals to relieve&#xD;
           depression&#xD;
&#xD;
        4. Work on patient-identified goals by engaging multiple techniques as appropriate: sharing&#xD;
           appropriate coping strategies eg. positive thinking, experiential knowledge, problem&#xD;
           solving, consideration of different perspectives.&#xD;
&#xD;
        5. Provide psychoeducation. Discuss the kinds of depression services available,&#xD;
           medications, psychotherapy Acknowledge socioeconomic contributors to depression&#xD;
&#xD;
        6. Provide information on community resources&#xD;
&#xD;
        7. Connect to professional clinical services if appropriate The psychiatrist role: Peer&#xD;
           mentors will meet with the candidate who is a psychiatrist on a weekly basis. The&#xD;
           psychiatrist will provide: (1) clinical leadership and structure by reinforcing the&#xD;
           principles of the peer-patient meetings; and (2) supervision and coaching which will&#xD;
           involve encouragement, continuing education, training and skill enhancement for the peer&#xD;
           mentor. The psychiatrist will guide the peer mentor to ensure that a positive social&#xD;
           experience is being provided and to manage the patient in a way that ensures the&#xD;
           realization of the patient's goal. The peer mentor will share impressions of patient&#xD;
           progress and receive any guidance needed from the psychiatrist.&#xD;
&#xD;
      Study procedures. After patient consent is obtained, the psychiatrist will meet with the&#xD;
      patient for a clinical interview so that the psychiatrist can form an impression of the&#xD;
      patient and provide relevant guidance to the peer mentor. The patient will then be matched&#xD;
      with a peer mentor. The peer mentor will contact the patient by telephone to schedule a&#xD;
      meeting and meet with the peer mentor at his home or in the clinic. The peer mentor will meet&#xD;
      the patient weekly for 8 one-hour sessions. The peer mentors will meet individually on a&#xD;
      weekly basis with the psychiatrist during the study period in a collaborative and supervisory&#xD;
      effort regarding the care of the patient Data Analysis. Analysis will involve both&#xD;
      quantitative and qualitative methods. We will identify measured factors related to engagement&#xD;
      and depression response and remission so that we can understand how the delivery model may&#xD;
      need to be tailored or modified. This analysis will consider depression response and&#xD;
      remission and engagement as dependent variables, with other variables as predictors or effect&#xD;
      modifiers. We will also carry out debriefing interviews with peers and patients in order to&#xD;
      look for themes that will call attention to factors that are most salient to patients and&#xD;
      peers.&#xD;
&#xD;
      Quantitative analysis. Influential variables will be identified in the statistical models&#xD;
      according to association with the dependent variables, namely 1) engagement in depression&#xD;
      care defined as two or more sessions attended with the peer mentor, and 2) decrease in&#xD;
      depressive symptoms which will be treated as a continuous variable.&#xD;
&#xD;
      Qualitative analysis. We will collect qualitative data to obtain the perspective of peer&#xD;
      mentors and patients themselves regarding study processes and mediators from their point of&#xD;
      view. Two semi-structured interviews with patients and peer mentors will be conducted by the&#xD;
      PI at 4 weeks and upon completion of the study. The purpose will be to obtain feedback&#xD;
      regarding positive and negative aspects of the peer delivery model which will provide&#xD;
      perspectives different from the expert and valuable for that reason.&#xD;
&#xD;
      ANALYSIS OF PROCESS We will analyze the process of the peer mentor-patient interactions by 1)&#xD;
      conducting an interaction analysis which will provide quantitative associations between&#xD;
      communication elements and outcomes to determine which elements are salient to the&#xD;
      effectiveness of the peer delivery model, and 2) conducting a qualitative analysis of the&#xD;
      voice recordings to assess how the peer mentors implement the critical elements and how&#xD;
      patients respond to them. The analyses of process will serve to determine the content of the&#xD;
      training for peer mentors, the activities peers will perform with patients and manual&#xD;
      development.&#xD;
&#xD;
      The Roter Interaction Analysis System (RIAS) is a widely used system for interaction&#xD;
      assessment in medical contexts. The RIAS has demonstrated predictive validity to patient&#xD;
      satisfaction, patient recall, and improvements in levels of emotional distress. Combined with&#xD;
      quantitative process and outcome measures of care, statistical analysis can establish&#xD;
      associations between specific communicative thematic categories and patient outcomes.&#xD;
&#xD;
      Data Analysis. We will evaluate the specific interactions between peer and patient employing&#xD;
      the RIAS to investigate the specific interactions that are associated with engagement and&#xD;
      depression response and remission so that we can refine the training required for peers and&#xD;
      develop measures tapping effective interaction strategies. We will also carry out open-ended&#xD;
      interviews with patients that complement the RIAS analysis to assess how the peer mentors&#xD;
      implement the critical elements and how patients respond.&#xD;
&#xD;
      Quantitative analysis. The voice recordings to be analyzed with the RIAS in Phase 2 are&#xD;
      obtained from two sources: (1) 28 voice recordings of peer mentor-patient interactions were&#xD;
      obtained in our preliminary work and (2) 160 voice recordings of peer mentor-patient&#xD;
      interactions will be obtained in the pilot study proposed in this application. The PI will&#xD;
      work with Dr. Roter's laboratory for consultation where coding, reliability testing, and data&#xD;
      entry into an SPSS file will occur. We will draw upon our conceptual model as well as&#xD;
      incorporate the results of the quantitative and qualitative analysis regarding mediators to&#xD;
      construct peer mentor and patient communication profiles which will then be linked to&#xD;
      outcomes. Those elements which are associated with outcomes should be the focus of peer&#xD;
      mentor training and be integrated into the manual. We will use linear regression to assess&#xD;
      the presence, strength, and statistical associations between RIAS categories and outcomes.&#xD;
&#xD;
      Qualitative analysis. The goal of qualitative analysis of the voice recordings will be to&#xD;
      enrich the inferences we make using RIAS data to capture the nuances of what is occurring in&#xD;
      the peer mentor-patient relationship. The PI and the research assistant will listen to the&#xD;
      voice recordings of peer mentor-patient interactions at weeks 1, 4, and 8. They will mark and&#xD;
      transcribe sections in the voice recordings that show how interaction elements such as&#xD;
      affective exchange take place between the peer mentor and patient, and those sections that&#xD;
      provide examples of variations in the methods the peer mentors use and the responses of the&#xD;
      patients. The transcriptions will be coded and analyzed for themes. This analysis will&#xD;
      contextualize the results of the RIAS analysis and provide knowledge about peer mentor&#xD;
      communication and behavior.&#xD;
&#xD;
      Manual development: Knowledge obtained from the study will be developed into a manual which&#xD;
      will form the basis for a larger peer mentor study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depression With PHQ-9</measure>
    <time_frame>at 8 weeks</time_frame>
    <description>PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Meetings with peer mentors</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Peer mentors who have experience of depression are trained and supervised to provide social support to older adults to relieve depression. They will provide active listening, empathy, work on a patient-derived goal, psychoeducation and connection to both clinical and community resources.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Meetings with peer mentors</intervention_name>
    <description>Peer mentors provide social support to address depressive symptoms</description>
    <arm_group_label>Meetings with peer mentors</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Peer mentors: Inclusion criteria:&#xD;
&#xD;
          1. 50 years and older,&#xD;
&#xD;
          2. able to give informed consent;&#xD;
&#xD;
          3. received basic training in behavioral health,&#xD;
&#xD;
          4. history of depression.-&#xD;
&#xD;
        Patients:&#xD;
&#xD;
          1. 50 years and older;&#xD;
&#xD;
          2. clinically significant depression (defined above);&#xD;
&#xD;
          3. able to communicate in English;&#xD;
&#xD;
          4. willing to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Peer mentors: Exclusion criteria:&#xD;
&#xD;
          1. meet current diagnostic criteria for Minor or Major Depressive Disorder;&#xD;
&#xD;
          2. meet current diagnostic criteria for a psychotic disorder;&#xD;
&#xD;
          3. meet current diagnostic criteria for substance abuse or dependence.&#xD;
&#xD;
        Patients:&#xD;
&#xD;
          1. meet diagnostic criteria for mania or hypomania;&#xD;
&#xD;
          2. meet diagnostic criteria for psychotic syndrome;&#xD;
&#xD;
          3. meet diagnostic criteria for alcohol abuse or dependence;&#xD;
&#xD;
          4. acutely suicidal or psychotic; and,&#xD;
&#xD;
          5. a score on the Mini-Mental State Examination (MMSE) &lt;24.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin Hui Joo, MA MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Bayview Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <results_first_submitted>March 7, 2017</results_first_submitted>
  <results_first_submitted_qc>August 24, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 2, 2017</results_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johns Hopkins University</investigator_affiliation>
    <investigator_full_name>Jin Hui Joo</investigator_full_name>
    <investigator_title>Primary Investigator</investigator_title>
  </responsible_party>
  <keyword>depression</keyword>
  <keyword>aging</keyword>
  <keyword>health services</keyword>
  <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>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>No pre-study details.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Meetings With Peer Mentors</title>
          <description>Peer mentors who have experience of depression are trained and supervised to provide social support to older adults to relieve depression. They will provide active listening, empathy, work on a patient-derived goal, psychoeducation and connection to both clinical and community resources.&#xD;
Meetings with peer mentors: Peer mentors provide peer support to address depressive symptoms</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>30 participants</population>
      <group_list>
        <group group_id="B1">
          <title>Meetings With Peer Mentors</title>
          <description>Peer mentors who have experience of depression are trained and supervised to provide social support to older adults to relieve depression. They will provide active listening, empathy, work on a patient-derived goal, psychoeducation and connection to both clinical and community resources.&#xD;
Meetings with peer mentors: Peer mentors provide social support to address depressive symptoms</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.9" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Depression With PHQ-9</title>
        <description>PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.</description>
        <time_frame>at 8 weeks</time_frame>
        <population>Patient participants</population>
        <group_list>
          <group group_id="O1">
            <title>Meetings With Peer Mentors</title>
            <description>Peer mentors who have experience of depression are trained and supervised to provide social support to older adults to relieve depression. They will provide active listening, empathy, work on a patient-derived goal, psychoeducation and connection to both clinical and community resources.&#xD;
Meetings with peer mentors: Peer mentors provide social support to address depressive symptoms</description>
          </group>
        </group_list>
        <measure>
          <title>Depression With PHQ-9</title>
          <description>PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.</description>
          <population>Patient participants</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" spread="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Over 8 weeks</time_frame>
      <desc>No adverse events</desc>
      <group_list>
        <group group_id="E1">
          <title>Meetings With Peer Mentors</title>
          <description>Peer mentors who have experience of depression are trained and supervised to provide social support to older adults to relieve depression. They will provide active listening, empathy, work on a patient-derived goal, psychoeducation and connection to both clinical and community resources.&#xD;
Meetings with peer mentors: Peer mentors provide social support to address depressive symptoms</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Jin Hui Joo</name_or_title>
      <organization>Johns Hopkins University</organization>
      <phone>4105502282 ext 410</phone>
      <email>jjoo1@jhmi.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02261818
org study id: K23MH100705
nct id: NCT02261818
lead sponsor: 
has dmc: No
Can peer mentors be integrated into depression care to older adults with mental health
      professional supervision? We will assess whether peer mentors who are lay persons who are in
      recovery from depression can provide depression care services to older adults with
      depression. Older adults who are 50 and older will be screened for depression in the clinic
      and community. Those who meet criteria will be paired with a peer mentor for 8 meetings. Peer
      mentors will audiorecord their meetings with the patient and the recordings will be analyzed
      to assess what kinds of communication and behaviors the peer mentors engage in and what among
      those communications may be associated with relieving depression. The peer mentor will be
      trained and supervised by a psychiatrist and they will form a team to provide the depression
      care to the older adult. The study aims to relieve depressive symptoms and engage older
      adults in care. Both older adults and peer mentors wil be interviewed after the study to
      assess the strengths and weaknesses of peer mentor delivery of depression care. A manual will
      be developed describing the process and procedures of the study.
Recruitment of peer mentors. We will recruit peer mentors from a community organization who
      are in recovery and are recommended by the organization and have had basic training in
      supportive listening and experience working with persons in the community in need of mental
      health support. We will recruit 10 peer mentors, striving for a balance of men and women, and
      accounting for attrition, so that at least 5 peer mentors will participate in the project.
      The study doctor will meet and interview interested peers to screen for eligibility criteria,
      motivation and aptitude. Persons who do not meet criteria for continued participation in the
      study will be referred to other volunteer opportunities when appropriate.

      Recruitment of patients. Twenty patient participants will be recruited through the internal
      medicine and psychiatry clinics at Johns Hopkins Bayview Medical Center as well as the
      community. A research assistant will screen patients for depressive symptoms with the Patient
      Health Questionnaire-9 (PHQ-9). Patients meeting eligibility criteria will give written
      informed consent. Eligible patients will be scheduled for another appointment to meet with
      the study doctor in a private room at offices in the clinical campus.

      Training of peer mentors. The PI and research assistant will conduct 5 sessions totaling 20
      hours of training for the peer mentors. Training will refine the peer mentor's social support
      behaviors, which include the use of effective communication skills, rapport building, active
      listening, and sharing of experiential knowledge, and expression of empathy. Issues of
      cultural interviewing, cultural competence, patient confidentiality, DSM-IV diagnosis,
      differentiation of peer and professional roles and patient safety will be addressed.
      Knowledge regarding how mental health and illness presents itself in old age and the specific
      developmental problems older adults face will be provided. Training will include review of
      written materials, lectures, discussion of case studies and role play. Upon completion of the
      training, peer mentors will be assessed for mental health knowledge and interpersonal skills
      and those who pass muster will be matched with patients.

      The peer mentor role: Activities of the peer mentor with the patient will be structured by
      the following principles which are derived from important elements of both peer support and
      psychotherapy and our preliminary work:

      Principles to structure peer mentor interactions with patients

        1. Establish a working relationship

        2. Establish goals of meetings with patient

        3. Provide active listening, empathy, reciprocity, mutual respect, provision of emotional
           support Provide support and encourage work toward patient-identified goals to relieve
           depression

        4. Work on patient-identified goals by engaging multiple techniques as appropriate: sharing
           appropriate coping strategies eg. positive thinking, experiential knowledge, problem
           solving, consideration of different perspectives.

        5. Provide psychoeducation. Discuss the kinds of depression services available,
           medications, psychotherapy Acknowledge socioeconomic contributors to depression

        6. Provide information on community resources

        7. Connect to professional clinical services if appropriate The psychiatrist role: Peer
           mentors will meet with the candidate who is a psychiatrist on a weekly basis. The
           psychiatrist will provide: (1) clinical leadership and structure by reinforcing the
           principles of the peer-patient meetings; and (2) supervision and coaching which will
           involve encouragement, continuing education, training and skill enhancement for the peer
           mentor. The psychiatrist will guide the peer mentor to ensure that a positive social
           experience is being provided and to manage the patient in a way that ensures the
           realization of the patient's goal. The peer mentor will share impressions of patient
           progress and receive any guidance needed from the psychiatrist.

      Study procedures. After patient consent is obtained, the psychiatrist will meet with the
      patient for a clinical interview so that the psychiatrist can form an impression of the
      patient and provide relevant guidance to the peer mentor. The patient will then be matched
      with a peer mentor. The peer mentor will contact the patient by telephone to schedule a
      meeting and meet with the peer mentor at his home or in the clinic. The peer mentor will meet
      the patient weekly for 8 one-hour sessions. The peer mentors will meet individually on a
      weekly basis with the psychiatrist during the study period in a collaborative and supervisory
      effort regarding the care of the patient Data Analysis. Analysis will involve both
      quantitative and qualitative methods. We will identify measured factors related to engagement
      and depression response and remission so that we can understand how the delivery model may
      need to be tailored or modified. This analysis will consider depression response and
      remission and engagement as dependent variables, with other variables as predictors or effect
      modifiers. We will also carry out debriefing interviews with peers and patients in order to
      look for themes that will call attention to factors that are most salient to patients and
      peers.

      Quantitative analysis. Influential variables will be identified in the statistical models
      according to association with the dependent variables, namely 1) engagement in depression
      care defined as two or more sessions attended with the peer mentor, and 2) decrease in
      depressive symptoms which will be treated as a continuous variable.

      Qualitative analysis. We will collect qualitative data to obtain the perspective of peer
      mentors and patients themselves regarding study processes and mediators from their point of
      view. Two semi-structured interviews with patients and peer mentors will be conducted by the
      PI at 4 weeks and upon completion of the study. The purpose will be to obtain feedback
      regarding positive and negative aspects of the peer delivery model which will provide
      perspectives different from the expert and valuable for that reason.

      ANALYSIS OF PROCESS We will analyze the process of the peer mentor-patient interactions by 1)
      conducting an interaction analysis which will provide quantitative associations between
      communication elements and outcomes to determine which elements are salient to the
      effectiveness of the peer delivery model, and 2) conducting a qualitative analysis of the
      voice recordings to assess how the peer mentors implement the critical elements and how
      patients respond to them. The analyses of process will serve to determine the content of the
      training for peer mentors, the activities peers will perform with patients and manual
      development.

      The Roter Interaction Analysis System (RIAS) is a widely used system for interaction
      assessment in medical contexts. The RIAS has demonstrated predictive validity to patient
      satisfaction, patient recall, and improvements in levels of emotional distress. Combined with
      quantitative process and outcome measures of care, statistical analysis can establish
      associations between specific communicative thematic categories and patient outcomes.

      Data Analysis. We will evaluate the specific interactions between peer and patient employing
      the RIAS to investigate the specific interactions that are associated with engagement and
      depression response and remission so that we can refine the training required for peers and
      develop measures tapping effective interaction strategies. We will also carry out open-ended
      interviews with patients that complement the RIAS analysis to assess how the peer mentors
      implement the critical elements and how patients respond.

      Quantitative analysis. The voice recordings to be analyzed with the RIAS in Phase 2 are
      obtained from two sources: (1) 28 voice recordings of peer mentor-patient interactions were
      obtained in our preliminary work and (2) 160 voice recordings of peer mentor-patient
      interactions will be obtained in the pilot study proposed in this application. The PI will
      work with Dr. Roter's laboratory for consultation where coding, reliability testing, and data
      entry into an SPSS file will occur. We will draw upon our conceptual model as well as
      incorporate the results of the quantitative and qualitative analysis regarding mediators to
      construct peer mentor and patient communication profiles which will then be linked to
      outcomes. Those elements which are associated with outcomes should be the focus of peer
      mentor training and be integrated into the manual. We will use linear regression to assess
      the presence, strength, and statistical associations between RIAS categories and outcomes.

      Qualitative analysis. The goal of qualitative analysis of the voice recordings will be to
      enrich the inferences we make using RIAS data to capture the nuances of what is occurring in
      the peer mentor-patient relationship. The PI and the research assistant will listen to the
      voice recordings of peer mentor-patient interactions at weeks 1, 4, and 8. They will mark and
      transcribe sections in the voice recordings that show how interaction elements such as
      affective exchange take place between the peer mentor and patient, and those sections that
      provide examples of variations in the methods the peer mentors use and the responses of the
      patients. The transcriptions will be coded and analyzed for themes. This analysis will
      contextualize the results of the RIAS analysis and provide knowledge about peer mentor
      communication and behavior.

      Manual development: Knowledge obtained from the study will be developed into a manual which
      will form the basis for a larger peer mentor study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Depression With PHQ-9
time frame: at 8 weeks
description: PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
arm group label: Meetings with peer mentors
arm group type: Other
description: Peer mentors who have experience of depression are trained and supervised to provide social support to older adults to relieve depression. They will provide active listening, empathy, work on a patient-derived goal, psychoeducation and connection to both clinical and community resources.
intervention type: Behavioral
intervention name: Meetings with peer mentors
description: Peer mentors provide social support to address depressive symptoms
arm group label: Meetings with peer mentors
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Jin Hui Joo, MA MA
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Johns Hopkins University
investigator full name: Jin Hui Joo
investigator title: Primary Investigator
mesh term: Depression
mesh term: Depressive Disorder
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 