<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/NCT03299803</url>
  </required_header>
  <id_info>
    <org_study_id>R15NR016362</org_study_id>
    <nct_id>NCT03299803</nct_id>
  </id_info>
  <brief_title>Depression in Men With Physical Disabilities</brief_title>
  <official_title>Partnership to Develop and Pilot-Test a Peer Program to Reduce Depressive Symptoms in Men With Physical Disabilities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>Yes</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 project is intended to develop an evidence-based peer group counseling program that&#xD;
      addresses depressive symptoms in men with physical disabilities. Expanding treatment options&#xD;
      for depressive symptoms in men with physical disabilities will improve their access to care.&#xD;
      The benefits of men with physical disabilities receiving effective treatment for depressive&#xD;
      symptoms include better health, independent living, and longer life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previously the investigators developed, tested and disseminated a highly effective peer&#xD;
      counseling program to reduce depressive symptoms in women with physical disabilities (WPDs)&#xD;
      in partnership with Oregon Centers for Independent Living (CILs). WPDs with baseline Center&#xD;
      for Epidemiologic Depression (CES-D) scores &gt;16 demonstrated significant improvement in&#xD;
      depressive symptoms that were sustained over a three month follow-up period (ES partial&#xD;
      eta2=.10). The program is offered by two peers in 14 weekly 2.5 hour group sessions. Our&#xD;
      academic-disability community partnership created Healing Pathways using community-based&#xD;
      participatory research (CBPR) methods and the investigators have sustained our partnership&#xD;
      over 9 years. Healing Pathways is currently publicly funded and offered by four of the seven&#xD;
      CILs in Oregon. The success of Healing Pathways is a direct result of community investment in&#xD;
      and ownership of the program. This project intends to replicate this model to address&#xD;
      depression in men with physical disabilities (MPDs).&#xD;
&#xD;
      Depression is a common secondary condition in MPDs, occurring at rates between 37-64%.This is&#xD;
      2-6 times the rate of depression found in non-disabled men. MPDs who work in CILs or other&#xD;
      consumer-controlled non-profit agencies are uniquely situated to address depression in their&#xD;
      peer group. The Rehabilitation Act of 1973 mandated the formation of CILs to maximize the&#xD;
      leadership, empowerment, independence, and productivity of people with disabilities and to&#xD;
      integrate them into mainstream society by providing four core independent living services.&#xD;
      The core services are: information and referral, independent living skills training, peer&#xD;
      counseling, and individual and systems advocacy. CILs are grounded in Independent Living (IL)&#xD;
      philosophy, promulgating inclusion across disability-types, de-medicalization and&#xD;
      de-institutionalization, and the belief that people with disabilities are the best experts on&#xD;
      their own health. There are 403 CILs across the nation, a largely untapped infrastructure&#xD;
      with great potential to augment health services for people with disabilities using a&#xD;
      peer-to-peer model. The sweeping nature of mental health reforms occurring in the span of a&#xD;
      lifetime has given rise to consumer-run peer programs and there is mounting evidence,&#xD;
      including randomized controlled trials, that they are efficacious in improving well-being and&#xD;
      psychiatric symptoms. Many persons with chronic mental illness prefer peer programs, finding&#xD;
      them more relatable and empowering than traditional services. Although many MPDs may also&#xD;
      prefer the option of peer counseling compared to traditional psychotherapy, to our knowledge&#xD;
      there are no peer programs that address the co-occurrence of physical disability and&#xD;
      depression in men. The long-term goal of this program of research is to improve mental health&#xD;
      outcomes in people with physical disabilities by partnering with members of this community.&#xD;
      This approach recognizes disability communities as cultural entities, respects the values of&#xD;
      IL philosophy, and emphasizes the interconnection between mental and physical health. The&#xD;
      objective here, the investigators' next step in pursuit of that goal, is to develop and&#xD;
      pilot-test a peer program for MPDs with depression. Using a community-engaged, exploratory&#xD;
      sequential, mixed methods design, this study intends to achieve the following three specific&#xD;
      aims:&#xD;
&#xD;
        1. Adapt the Healing Pathways program to meet the needs of MPDs with depressive symptoms.&#xD;
&#xD;
        2. Conduct a pilot study to assess the feasibility and acceptability of the peer program.&#xD;
&#xD;
        3. Estimate the effect size of the peer program for depressive symptoms. The outcomes of&#xD;
           this study will collectively inform the development of a future randomized controlled&#xD;
           trial of a program designed to treat depressive symptoms in MPDs. Further, the proposed&#xD;
           study addresses several public health goals including Healthy People 2020 goal DH18 to&#xD;
           reduce the proportion of people with disabilities who report serious emotional&#xD;
           distress,24 and the President's New Freedom Commission on Mental Health goals 1-3, to&#xD;
           understand that mental health is essential to overall health, promote mental health&#xD;
           treatments that are consumer-driven, and eliminate disparities in mental health care.&#xD;
           Because bias against people with disabilities is common among health care providers,&#xD;
           education of future health researchers is also necessary to help meet these goals. As&#xD;
           part of the proposed project, nursing students will received a mentored experience to&#xD;
           support culturally appropriate research with members of the disability community.&#xD;
           Experiences will include didactic instruction, community immersion, and research&#xD;
           training. Development of a cadre of future researchers who have the knowledge,&#xD;
           abilities, and skills to advance the health of people with disabilities through&#xD;
           community partnerships is a goal of the project.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Center for Epidemiologic Studies Depression Measure</measure>
    <time_frame>3 months</time_frame>
    <description>20-item self-report measure of depressive symptoms over the past week</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Men's Healing Pathways</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Men with physical disabilities will receive a 15 session weekly peer implemented program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Telephone contact only</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Men's Healing Pathways</intervention_name>
    <description>Peer implemented group self management program to reduce depressive symptoms in men with physical disabilities</description>
    <arm_group_label>Men's Healing Pathways</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-identifies as having a physical disability&#xD;
&#xD;
          -  Diagnosis of Depression&#xD;
&#xD;
          -  Must be able to participate and attend all intervention sessions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently suicidal with intent and plan&#xD;
&#xD;
          -  Diagnosis of schizophrenia or schizoaffective disorder&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>male</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dena Hassouneh</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97086</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>December 9, 2019</last_update_submitted>
  <last_update_submitted_qc>December 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Dena Hassouneh</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No information will be shared</ipd_description>
  </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/NCT03299803
org study id: R15NR016362
nct id: NCT03299803
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This project is intended to develop an evidence-based peer group counseling program that
      addresses depressive symptoms in men with physical disabilities. Expanding treatment options
      for depressive symptoms in men with physical disabilities will improve their access to care.
      The benefits of men with physical disabilities receiving effective treatment for depressive
      symptoms include better health, independent living, and longer life.
Previously the investigators developed, tested and disseminated a highly effective peer
      counseling program to reduce depressive symptoms in women with physical disabilities (WPDs)
      in partnership with Oregon Centers for Independent Living (CILs). WPDs with baseline Center
      for Epidemiologic Depression (CES-D) scores >16 demonstrated significant improvement in
      depressive symptoms that were sustained over a three month follow-up period (ES partial
      eta2=.10). The program is offered by two peers in 14 weekly 2.5 hour group sessions. Our
      academic-disability community partnership created Healing Pathways using community-based
      participatory research (CBPR) methods and the investigators have sustained our partnership
      over 9 years. Healing Pathways is currently publicly funded and offered by four of the seven
      CILs in Oregon. The success of Healing Pathways is a direct result of community investment in
      and ownership of the program. This project intends to replicate this model to address
      depression in men with physical disabilities (MPDs).

      Depression is a common secondary condition in MPDs, occurring at rates between 37-64%.This is
      2-6 times the rate of depression found in non-disabled men. MPDs who work in CILs or other
      consumer-controlled non-profit agencies are uniquely situated to address depression in their
      peer group. The Rehabilitation Act of 1973 mandated the formation of CILs to maximize the
      leadership, empowerment, independence, and productivity of people with disabilities and to
      integrate them into mainstream society by providing four core independent living services.
      The core services are: information and referral, independent living skills training, peer
      counseling, and individual and systems advocacy. CILs are grounded in Independent Living (IL)
      philosophy, promulgating inclusion across disability-types, de-medicalization and
      de-institutionalization, and the belief that people with disabilities are the best experts on
      their own health. There are 403 CILs across the nation, a largely untapped infrastructure
      with great potential to augment health services for people with disabilities using a
      peer-to-peer model. The sweeping nature of mental health reforms occurring in the span of a
      lifetime has given rise to consumer-run peer programs and there is mounting evidence,
      including randomized controlled trials, that they are efficacious in improving well-being and
      psychiatric symptoms. Many persons with chronic mental illness prefer peer programs, finding
      them more relatable and empowering than traditional services. Although many MPDs may also
      prefer the option of peer counseling compared to traditional psychotherapy, to our knowledge
      there are no peer programs that address the co-occurrence of physical disability and
      depression in men. The long-term goal of this program of research is to improve mental health
      outcomes in people with physical disabilities by partnering with members of this community.
      This approach recognizes disability communities as cultural entities, respects the values of
      IL philosophy, and emphasizes the interconnection between mental and physical health. The
      objective here, the investigators' next step in pursuit of that goal, is to develop and
      pilot-test a peer program for MPDs with depression. Using a community-engaged, exploratory
      sequential, mixed methods design, this study intends to achieve the following three specific
      aims:

        1. Adapt the Healing Pathways program to meet the needs of MPDs with depressive symptoms.

        2. Conduct a pilot study to assess the feasibility and acceptability of the peer program.

        3. Estimate the effect size of the peer program for depressive symptoms. The outcomes of
           this study will collectively inform the development of a future randomized controlled
           trial of a program designed to treat depressive symptoms in MPDs. Further, the proposed
           study addresses several public health goals including Healthy People 2020 goal DH18 to
           reduce the proportion of people with disabilities who report serious emotional
           distress,24 and the President's New Freedom Commission on Mental Health goals 1-3, to
           understand that mental health is essential to overall health, promote mental health
           treatments that are consumer-driven, and eliminate disparities in mental health care.
           Because bias against people with disabilities is common among health care providers,
           education of future health researchers is also necessary to help meet these goals. As
           part of the proposed project, nursing students will received a mentored experience to
           support culturally appropriate research with members of the disability community.
           Experiences will include didactic instruction, community immersion, and research
           training. Development of a cadre of future researchers who have the knowledge,
           abilities, and skills to advance the health of people with disabilities through
           community partnerships is a goal of the project.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Center for Epidemiologic Studies Depression Measure
time frame: 3 months
description: 20-item self-report measure of depressive symptoms over the past week
arm group label: Men's Healing Pathways
arm group type: Experimental
description: Men with physical disabilities will receive a 15 session weekly peer implemented program
arm group label: Control group
arm group type: No Intervention
description: Telephone contact only
intervention type: Behavioral
intervention name: Men's Healing Pathways
description: Peer implemented group self management program to reduce depressive symptoms in men with physical disabilities
arm group label: Men's Healing Pathways
criteria: 
gender: Male
gender based: Yes
gender description: male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Dena Hassouneh
investigator title: Professor
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No
ipd description: No information will be shared