<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/NCT03266614</url>
  </required_header>
  <id_info>
    <org_study_id>4458</org_study_id>
    <nct_id>NCT03266614</nct_id>
  </id_info>
  <brief_title>&quot;Recovery 4 US&quot; - A Photovoice-based Social Media Program</brief_title>
  <acronym>R4US</acronym>
  <official_title>&quot;Recovery 4 US&quot; - A Photovoice-based Social Media Program to Enhance the Recovery and Community Participation of Individuals With Psychiatric Disabilities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University Charles River Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston University Charles River Campus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized trial evaluating &quot;Recovery 4 US&quot;, a social media program aimed at&#xD;
      the enhancement of community participation and overall recovery of individuals with&#xD;
      psychiatric disabilities.This innovative e-mental health program integrates Internet and&#xD;
      mobile technologies and is designed to be a self-sustaining recovery-oriented virtual&#xD;
      community for individuals living with a disabling mental illness based on the principles of&#xD;
      Photovoice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized trial evaluating &quot;Recovery 4 US&quot;, a social media program aimed at&#xD;
      the enhancement of community participation and overall recovery of individuals with&#xD;
      psychiatric disabilities.This innovative e-mental health program integrates Internet and&#xD;
      mobile technologies and is designed to be a self-sustaining recovery-oriented virtual&#xD;
      community for individuals living with a disabling mental illness based on the principles of&#xD;
      Photovoice.&#xD;
&#xD;
      The &quot;Recovery 4 US&quot; program which includes a mobile phone application and a password&#xD;
      protected website, has three main components: 1) receipt of daily hope-inspiring message,&#xD;
      paired with a corresponding visual image; 2) creation and viewing of recovery-oriented&#xD;
      Photovoice works; and 3) opportunity to attend community events initiated by members of the&#xD;
      &quot;Recovery 4 US&quot; community.&#xD;
&#xD;
      The benefits of the &quot;Recovery 4 US&quot; program will be evaluated through a randomized trial with&#xD;
      n=60 participants. The study will take place at the Boston University Center for Psychiatric&#xD;
      Rehabilitation. Participants will be randomized to the experimental group (provided with a&#xD;
      smartphone and access to &quot;Recovery 4 US&quot; application and website) or the control group&#xD;
      (provided with a smartphone but without access to the &quot;Recovery 4 US&quot; app or website). We&#xD;
      anticipate participation in the program will be associated with reduced loneliness, increased&#xD;
      hopefulness, community participation, and overall recovery.&#xD;
&#xD;
      The recruitment goal for this study was amended to n=70.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 7, 2017</start_date>
  <completion_date type="Actual">July 1, 2018</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>UCLA Loneliness Scale</measure>
    <time_frame>Change from Baseline to 3 months to 6 months</time_frame>
    <description>A 20-item 4-point Likert-type scale, widely used measure of loneliness and social isolation with Cronbach's alpha coefficients ranging from .89 to .94</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Herth Hope Index</measure>
    <time_frame>Change from Baseline to 3 months to 6 months</time_frame>
    <description>12 item 4-point Likert type scale measuring the level of generalized hopefulness of the individual; the reported Cronbach's alpha coefficient of internal consistency of the scale is .97</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale</measure>
    <time_frame>Change from Baseline to 3 months to 6 months</time_frame>
    <description>10-item 5-point Likert-type scale self-report measure of the level of stress experienced at a given point of time. It was designed to capture how unpredictable, uncontrollable and overloaded respondents find their lives based on their capacity to cope with stress. Reported internal consistency coefficients for the scale ranged between 0.90 and 0.92</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multi-Dimensional Assessment of Community Participation</measure>
    <time_frame>Change from Baseline to 3 months to 6 months</time_frame>
    <description>Consists of objective and subjective measures of community belonging, inclusion and participation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery Assessment Scale</measure>
    <time_frame>Change from Baseline to 3 months to 6 months</time_frame>
    <description>24-item 5-point Likert rating scale assessing the level of overall recovery among people with psychiatric disabilities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BASIS-R</measure>
    <time_frame>Change from Baseline to 3 months to 6 months</time_frame>
    <description>measures: mood disturbances, anxiety, interpersonal and role functioning, daily living skills, psychotic symptoms, impulsivity and substance use on a scale from no difficulty to extreme difficulty.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Mental Illness</condition>
  <condition>Social Isolation</condition>
  <condition>Loneliness</condition>
  <arm_group>
    <arm_group_label>Recovery 4 US</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group receives a smartphone with the Recovery 4 US application and access to the application website.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Services as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group receives a smartphone but no access to the Recovery 4 US application.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Recovery 4 Us</intervention_name>
    <description>R4US is a social media program aimed at the enhancement of community participation and overall recovery of individuals with psychiatric disabilities.</description>
    <arm_group_label>Recovery 4 US</arm_group_label>
    <other_name>R4US</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  are 18 or older&#xD;
&#xD;
          -  have been recipients of services at the BU CPR Recovery Center due to having a DSM-V&#xD;
             diagnosis of mental illness, including dual diagnosis (dual diagnosis refers to&#xD;
             co-occurring mental illness and alcohol/ substance use disorder) as indicated in their&#xD;
             records&#xD;
&#xD;
          -  are interested in participating in a social media program&#xD;
&#xD;
          -  are fluent in English&#xD;
&#xD;
          -  have a basic ability to use a mobile phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give full and knowing consent&#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>Zlatka Russinova, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston University Center for Psychiatric Rehabilitation</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston University Charles River Campus</investigator_affiliation>
    <investigator_full_name>Zlatka Russinova</investigator_full_name>
    <investigator_title>Research Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Mental Illness</keyword>
  <keyword>Loneliness</keyword>
  <keyword>Hope</keyword>
  <keyword>Community</keyword>
  <keyword>Social Media</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</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/NCT03266614
org study id: 4458
nct id: NCT03266614
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a randomized trial evaluating "Recovery 4 US", a social media program aimed at
      the enhancement of community participation and overall recovery of individuals with
      psychiatric disabilities.This innovative e-mental health program integrates Internet and
      mobile technologies and is designed to be a self-sustaining recovery-oriented virtual
      community for individuals living with a disabling mental illness based on the principles of
      Photovoice.
This study is a randomized trial evaluating "Recovery 4 US", a social media program aimed at
      the enhancement of community participation and overall recovery of individuals with
      psychiatric disabilities.This innovative e-mental health program integrates Internet and
      mobile technologies and is designed to be a self-sustaining recovery-oriented virtual
      community for individuals living with a disabling mental illness based on the principles of
      Photovoice.

      The "Recovery 4 US" program which includes a mobile phone application and a password
      protected website, has three main components: 1) receipt of daily hope-inspiring message,
      paired with a corresponding visual image; 2) creation and viewing of recovery-oriented
      Photovoice works; and 3) opportunity to attend community events initiated by members of the
      "Recovery 4 US" community.

      The benefits of the "Recovery 4 US" program will be evaluated through a randomized trial with
      n=60 participants. The study will take place at the Boston University Center for Psychiatric
      Rehabilitation. Participants will be randomized to the experimental group (provided with a
      smartphone and access to "Recovery 4 US" application and website) or the control group
      (provided with a smartphone but without access to the "Recovery 4 US" app or website). We
      anticipate participation in the program will be associated with reduced loneliness, increased
      hopefulness, community participation, and overall recovery.

      The recruitment goal for this study was amended to n=70.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: UCLA Loneliness Scale
time frame: Change from Baseline to 3 months to 6 months
description: A 20-item 4-point Likert-type scale, widely used measure of loneliness and social isolation with Cronbach's alpha coefficients ranging from .89 to .94
measure: Herth Hope Index
time frame: Change from Baseline to 3 months to 6 months
description: 12 item 4-point Likert type scale measuring the level of generalized hopefulness of the individual; the reported Cronbach's alpha coefficient of internal consistency of the scale is .97
measure: Perceived Stress Scale
time frame: Change from Baseline to 3 months to 6 months
description: 10-item 5-point Likert-type scale self-report measure of the level of stress experienced at a given point of time. It was designed to capture how unpredictable, uncontrollable and overloaded respondents find their lives based on their capacity to cope with stress. Reported internal consistency coefficients for the scale ranged between 0.90 and 0.92
measure: Multi-Dimensional Assessment of Community Participation
time frame: Change from Baseline to 3 months to 6 months
description: Consists of objective and subjective measures of community belonging, inclusion and participation
measure: Recovery Assessment Scale
time frame: Change from Baseline to 3 months to 6 months
description: 24-item 5-point Likert rating scale assessing the level of overall recovery among people with psychiatric disabilities.
measure: BASIS-R
time frame: Change from Baseline to 3 months to 6 months
description: measures: mood disturbances, anxiety, interpersonal and role functioning, daily living skills, psychotic symptoms, impulsivity and substance use on a scale from no difficulty to extreme difficulty.
arm group label: Recovery 4 US
arm group type: Experimental
description: This group receives a smartphone with the Recovery 4 US application and access to the application website.
arm group label: Services as usual
arm group type: No Intervention
description: This group receives a smartphone but no access to the Recovery 4 US application.
intervention type: Behavioral
intervention name: Recovery 4 Us
description: R4US is a social media program aimed at the enhancement of community participation and overall recovery of individuals with psychiatric disabilities.
arm group label: Recovery 4 US
other name: R4US
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zlatka Russinova, PhD
role: Principal Investigator
affiliation: Boston University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston University Charles River Campus
investigator full name: Zlatka Russinova
investigator title: Research Associate Professor
mesh term: Mental Disorders