<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/NCT03825640</url>
  </required_header>
  <id_info>
    <org_study_id>1806002090</org_study_id>
    <secondary_id>R34MH117198</secondary_id>
    <nct_id>NCT03825640</nct_id>
  </id_info>
  <brief_title>Project CARE: An Integrated Treatment Adherence Program for Bipolar Disorder at the Time of Prison Release - Open Trial</brief_title>
  <official_title>Project CARE (Community Treatment Adherence at Re-Entry): An Integrated Treatment Adherence Program for Bipolar Disorder at the Time of Prison Release - Open Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Brown 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>
      The aim of this program of research is to develop and pilot the CARE (Community treatment&#xD;
      Adherence at Re-Entry) program, an adjunctive intervention for incarcerated individuals with&#xD;
      bipolar disorder (BD) transitioning from prison to the community.&#xD;
&#xD;
      The purpose of this proposed project is to establish the feasibility, acceptability, and&#xD;
      preliminary effects of this newly developed intervention on symptom outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bipolar disorder (BD) is a serious, disabling, and highly recurrent illness that is&#xD;
      disproportionately represented in the criminal justice system. BD increases risk for several&#xD;
      adverse outcomes for prisoners, including mood instability, suicide attempts, substance use&#xD;
      relapse, and high rates of repeat incarceration. Despite these serious negative consequences,&#xD;
      up to 70% of prisoners with BD do not receive mental health treatment upon prison release.&#xD;
      Lack of engagement in ongoing mental health treatment for BD upon community re-entry&#xD;
      represents one potent factor that perpetuates risk for adverse outcomes, and consequences of&#xD;
      untreated BD (e.g., impulsivity, substance use) may greatly exacerbate difficulties in&#xD;
      establishing stable living conditions (e.g., adequate housing, legal employment) at community&#xD;
      re-entry. Thus, there is a critical need for interventions to facilitate engagement with&#xD;
      treatment for BD during this vulnerable transition.&#xD;
&#xD;
      To that end, the primary aim of this study is to develop and establish the feasibility and&#xD;
      acceptability of the Community treatment Adherence at Re-Entry (CARE) program. CARE is an&#xD;
      innovative intervention that will combine evidence-based cognitive-behavioral, family, and&#xD;
      telephone outreach strategies to promote treatment engagement and improve clinical outcomes&#xD;
      for prisoners with BD during the period of community re-entry. CARE will include 3 individual&#xD;
      and 1 family session, followed by 11 brief telephone contacts for up to 6 months&#xD;
      post-release. Given its moderate intensity, adjunctive nature, use of community mental health&#xD;
      counselors, and use of telephone administration for post-release follow-up, CARE has been&#xD;
      designed with an eye toward community implementation. Its proposed mechanisms of action&#xD;
      (i.e., increasing values-action consistency, enhancing social supports, and linkage to&#xD;
      community treatment services) are further well matched to the practical and clinical needs of&#xD;
      re-entering individuals.&#xD;
&#xD;
      The aim of this research is to conduct a small open trial (n=12) of the CARE intervention.&#xD;
      Assessments will occur at baseline, immediately pre-release, 4 weeks post-release, and 24&#xD;
      weeks post-release (post-treatment). This study will examine the feasibility and&#xD;
      acceptability of CARE (e.g., uptake, adherence to, and completion of the CARE intervention,&#xD;
      satisfaction with the intervention, understanding of intervention principles) and of this&#xD;
      research design. This study will also examine treatment effects (within relevant confidence&#xD;
      intervals) on outcomes (e.g., mood symptoms). Change in potential mechanisms (i.e.,&#xD;
      values-action consistency derived from intervention principles) will be examined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">January 15, 2020</completion_date>
  <primary_completion_date type="Actual">January 15, 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Client Satisfaction Questionnaire-8 (CSQ-8)</measure>
    <time_frame>24 weeks post-release</time_frame>
    <description>Intervention feasibility and acceptability; Total satisfaction scores range from 8 (low) to 32 (high)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)</measure>
    <time_frame>24 weeks post-release</time_frame>
    <description>depressive symptom severity; Total depressive symptom severity scores range from 0 (none) to 27 (very severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Altman Self-Rating Scale for Mania (ASRM)</measure>
    <time_frame>24 weeks post-release</time_frame>
    <description>manic symptom severity; Total manic symptom severity scores range from 0 (none) to 20 (severe)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>Community treatment Adherence at Re-Entry (CARE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CARE will begin within the 2 months before prison release, and will continue for 6 months after re-entry. CARE will be comprised of: a) 3 individual sessions with the CARE counselor; b) 1 optional family/significant other (SO) session; and c) 11 brief (15-20 min) follow-up telephone contacts with prisoners and their SO over the first 6 months post-release.&#xD;
The CARE intervention will incorporate motivational strategies from existing interventions (e.g., Acceptance and Commitment Therapy) in order to clarify values and goals to enhance motivation for community treatment engagement and behavior change. CARE will also integrate bipolar disorder psychoeducation and strategies from existing family models of intervention for BD (e.g., McMaster Model of Family Functioning) that are designed to improve family communication, social support, and problem-solving around BD illness management over this vulnerable transition period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CARE</intervention_name>
    <description>Hybrid in-person and telephone-based adjunctive intervention for bipolar disorder across the transition from prison to the community.</description>
    <arm_group_label>Community treatment Adherence at Re-Entry (CARE)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DSM-5 diagnosis of bipolar I, bipolar II, or bipolar disorder not elsewhere classified&#xD;
&#xD;
          -  Anticipated prison release within 4-10 weeks&#xD;
&#xD;
          -  Expected release to locations anywhere within RI or to locations in other states&#xD;
             within a 30 mile radius of Providence&#xD;
&#xD;
          -  Aged 18 or older&#xD;
&#xD;
          -  Willingness to sign an informed consent document that describes study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of current psychiatric symptoms severe enough to warrant separation from the&#xD;
             general prison population&#xD;
&#xD;
          -  Cognitive impairment sufficient to prevent successful completion of the baseline&#xD;
             interview.&#xD;
&#xD;
          -  Inability to understand sufficiently well to understand the consent form or assessment&#xD;
             instruments when they are read aloud.&#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>Lauren Weinstock, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rhode Island Department of Corrections</name>
      <address>
        <city>Cranston</city>
        <state>Rhode Island</state>
        <zip>02920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brown University</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>February 12, 2020</last_update_submitted>
  <last_update_submitted_qc>February 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2020</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>Bipolar Disorder</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/NCT03825640
org study id: 1806002090
secondary id: R34MH117198
nct id: NCT03825640
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this program of research is to develop and pilot the CARE (Community treatment
      Adherence at Re-Entry) program, an adjunctive intervention for incarcerated individuals with
      bipolar disorder (BD) transitioning from prison to the community.

      The purpose of this proposed project is to establish the feasibility, acceptability, and
      preliminary effects of this newly developed intervention on symptom outcomes.
Bipolar disorder (BD) is a serious, disabling, and highly recurrent illness that is
      disproportionately represented in the criminal justice system. BD increases risk for several
      adverse outcomes for prisoners, including mood instability, suicide attempts, substance use
      relapse, and high rates of repeat incarceration. Despite these serious negative consequences,
      up to 70% of prisoners with BD do not receive mental health treatment upon prison release.
      Lack of engagement in ongoing mental health treatment for BD upon community re-entry
      represents one potent factor that perpetuates risk for adverse outcomes, and consequences of
      untreated BD (e.g., impulsivity, substance use) may greatly exacerbate difficulties in
      establishing stable living conditions (e.g., adequate housing, legal employment) at community
      re-entry. Thus, there is a critical need for interventions to facilitate engagement with
      treatment for BD during this vulnerable transition.

      To that end, the primary aim of this study is to develop and establish the feasibility and
      acceptability of the Community treatment Adherence at Re-Entry (CARE) program. CARE is an
      innovative intervention that will combine evidence-based cognitive-behavioral, family, and
      telephone outreach strategies to promote treatment engagement and improve clinical outcomes
      for prisoners with BD during the period of community re-entry. CARE will include 3 individual
      and 1 family session, followed by 11 brief telephone contacts for up to 6 months
      post-release. Given its moderate intensity, adjunctive nature, use of community mental health
      counselors, and use of telephone administration for post-release follow-up, CARE has been
      designed with an eye toward community implementation. Its proposed mechanisms of action
      (i.e., increasing values-action consistency, enhancing social supports, and linkage to
      community treatment services) are further well matched to the practical and clinical needs of
      re-entering individuals.

      The aim of this research is to conduct a small open trial (n=12) of the CARE intervention.
      Assessments will occur at baseline, immediately pre-release, 4 weeks post-release, and 24
      weeks post-release (post-treatment). This study will examine the feasibility and
      acceptability of CARE (e.g., uptake, adherence to, and completion of the CARE intervention,
      satisfaction with the intervention, understanding of intervention principles) and of this
      research design. This study will also examine treatment effects (within relevant confidence
      intervals) on outcomes (e.g., mood symptoms). Change in potential mechanisms (i.e.,
      values-action consistency derived from intervention principles) will be examined.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
time frame: 24 weeks post-release
description: Intervention feasibility and acceptability; Total satisfaction scores range from 8 (low) to 32 (high)
measure: Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
time frame: 24 weeks post-release
description: depressive symptom severity; Total depressive symptom severity scores range from 0 (none) to 27 (very severe)
measure: Altman Self-Rating Scale for Mania (ASRM)
time frame: 24 weeks post-release
description: manic symptom severity; Total manic symptom severity scores range from 0 (none) to 20 (severe)
arm group label: Community treatment Adherence at Re-Entry (CARE)
arm group type: Experimental
description: CARE will begin within the 2 months before prison release, and will continue for 6 months after re-entry. CARE will be comprised of: a) 3 individual sessions with the CARE counselor; b) 1 optional family/significant other (SO) session; and c) 11 brief (15-20 min) follow-up telephone contacts with prisoners and their SO over the first 6 months post-release.
The CARE intervention will incorporate motivational strategies from existing interventions (e.g., Acceptance and Commitment Therapy) in order to clarify values and goals to enhance motivation for community treatment engagement and behavior change. CARE will also integrate bipolar disorder psychoeducation and strategies from existing family models of intervention for BD (e.g., McMaster Model of Family Functioning) that are designed to improve family communication, social support, and problem-solving around BD illness management over this vulnerable transition period.
intervention type: Behavioral
intervention name: CARE
description: Hybrid in-person and telephone-based adjunctive intervention for bipolar disorder across the transition from prison to the community.
arm group label: Community treatment Adherence at Re-Entry (CARE)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lauren Weinstock, PhD
role: Principal Investigator
affiliation: Brown University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bipolar Disorder