<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/NCT04458181</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00004619-2</org_study_id>
    <nct_id>NCT04458181</nct_id>
  </id_info>
  <brief_title>Journaling and Addiction Recovery: Piloting &quot;Positive Peer Journaling&quot;</brief_title>
  <acronym>PPJ</acronym>
  <official_title>Journaling and Addiction Recovery: Piloting &quot;Positive Peer Journaling&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</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>
      The main objective of this study is to pilot test the Positive Peer Journaling (PPJ)&#xD;
      intervention and its feasibility and acceptability. A second objective is to compare&#xD;
      individuals assigned to PPJ to individuals in a treatment as usual control group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Actual">November 1, 2021</completion_date>
  <primary_completion_date type="Actual">November 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>Satisfaction with Life</measure>
    <time_frame>9 weeks</time_frame>
    <description>Score on the &quot;Satisfaction with Life&quot; scale. This scale has 5 items assessed on a 7 point Likert-type response format. Scores range from 5 to 35 with higher scores representing higher satisfaction with life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Happiness with recovery</measure>
    <time_frame>9 weeks</time_frame>
    <description>Score on a single item, &quot;In general, I am happy with my recovery.&quot; This item uses an 11 point scale ranging from 0 to 11. Higher scores represent higher happiness with recovery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Commitment to sobriety</measure>
    <time_frame>9 weeks</time_frame>
    <description>Score on a single item, &quot;I will do whatever it takes to recover from my addiction.&quot; This item uses an 11 point scale ranging from 0-11. Higher scores represent greater commitment to sobriety.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Addiction</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will complete the intervention, Positive Peer Journaling (PPJ), while also continuing to attend intensive outpatient treatment for addiction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>There will be no intervention for those randomized to the control group. However, they will complete assessment instruments throughout the study period while also continuing to attend intensive outpatient treatment for addiction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Positive Peer Journaling (PPJ)</intervention_name>
    <description>PPJ is a journaling practice to support addiction recovery. PPJ encourages past 24 hour review and upcoming 24 hour planning to improve subjective wellbeing in recovery and reduce relapse. PPJ uses journals with column headings under which individuals make bullet-pointed lists. On the left hand page, past 24 hours is recalled, itemizing &quot;good&quot; and &quot;bad&quot; things that happened and things for which one is grateful. Good wishes for others are also expressed on this page. On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as &quot;recovery,&quot; &quot;work/school,&quot; &quot;spirituality,&quot; &quot;home and household,&quot; and &quot;health.&quot;</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  meet DSM-V criteria for past-year Substance Use Disorder as primary or secondary&#xD;
             diagnosis,&#xD;
&#xD;
          -  English literacy sufficient to make short written lists needed to complete PPJ and&#xD;
             homework assessments,&#xD;
&#xD;
          -  minimum 2 weeks sustained abstinence,&#xD;
&#xD;
          -  completed first 2 weeks of treatment at Nuway (approximately 2 weeks), an intensive&#xD;
             outpatient substance use disorder treatment program and the recruitment site,&#xD;
&#xD;
          -  agree to be audio recorded or transcription recorded in group meetings and in&#xD;
             individual meetings with research staff,&#xD;
&#xD;
          -  currently are clients in the Nuway outpatient program,&#xD;
&#xD;
          -  participants must be English speaking and literacy must be strong enough to write&#xD;
             short lists and to understand the questions asked in the questionnaires,&#xD;
&#xD;
          -  participants must have an electronic device that connects to the internet and internet&#xD;
             connection for online delivery of intervention during COVID-19.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of a psychotic disorder, psychiatric condition (e.g., suicidal ideation), or&#xD;
             cognitive impairment (e.g., severe dementia, traumatic brain injury) limiting ability&#xD;
             to give consent and/or participate in the study;&#xD;
&#xD;
          -  severe psychiatric illness (current schizophrenia, major depression with suicidal&#xD;
             ideation);&#xD;
&#xD;
          -  personality disorders that would interfere with satisfactory participation in or&#xD;
             completion of the study protocol,&#xD;
&#xD;
          -  inability to give informed, voluntary consent to participate,&#xD;
&#xD;
          -  lack of sufficient English literacy to participate, defined as inability to make a&#xD;
             list of 5 things they did yesterday and inability to understand questionnaire items,&#xD;
&#xD;
          -  any impairment, activity, or situation that in the judgement of the research staff&#xD;
             would prevent satisfactory participation in or completion of the study protocol.&#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>Amy Krentzman, MSW, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minenesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NUWAY</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55413</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>December 14, 2021</last_update_submitted>
  <last_update_submitted_qc>December 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Behavior, Addictive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>December 21, 2022</submitted>
  </pending_results>
  <!-- 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/NCT04458181
org study id: STUDY00004619-2
nct id: NCT04458181
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of this study is to pilot test the Positive Peer Journaling (PPJ)
      intervention and its feasibility and acceptability. A second objective is to compare
      individuals assigned to PPJ to individuals in a treatment as usual control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Satisfaction with Life
time frame: 9 weeks
description: Score on the "Satisfaction with Life" scale. This scale has 5 items assessed on a 7 point Likert-type response format. Scores range from 5 to 35 with higher scores representing higher satisfaction with life.
measure: Happiness with recovery
time frame: 9 weeks
description: Score on a single item, "In general, I am happy with my recovery." This item uses an 11 point scale ranging from 0 to 11. Higher scores represent higher happiness with recovery.
measure: Commitment to sobriety
time frame: 9 weeks
description: Score on a single item, "I will do whatever it takes to recover from my addiction." This item uses an 11 point scale ranging from 0-11. Higher scores represent greater commitment to sobriety.
arm group label: Treatment Group
arm group type: Experimental
description: Participants in this group will complete the intervention, Positive Peer Journaling (PPJ), while also continuing to attend intensive outpatient treatment for addiction.
arm group label: Control Group
arm group type: No Intervention
description: There will be no intervention for those randomized to the control group. However, they will complete assessment instruments throughout the study period while also continuing to attend intensive outpatient treatment for addiction.
intervention type: Behavioral
intervention name: Positive Peer Journaling (PPJ)
description: PPJ is a journaling practice to support addiction recovery. PPJ encourages past 24 hour review and upcoming 24 hour planning to improve subjective wellbeing in recovery and reduce relapse. PPJ uses journals with column headings under which individuals make bullet-pointed lists. On the left hand page, past 24 hours is recalled, itemizing "good" and "bad" things that happened and things for which one is grateful. Good wishes for others are also expressed on this page. On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as "recovery," "work/school," "spirituality," "home and household," and "health."
arm group label: Treatment Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amy Krentzman, MSW, PhD
role: Principal Investigator
affiliation: University of Minenesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Behavior, Addictive
sharing ipd: Undecided
submitted: December 21, 2022