<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/NCT01670123</url>
  </required_header>
  <id_info>
    <org_study_id>MH091260</org_study_id>
    <nct_id>NCT01670123</nct_id>
  </id_info>
  <brief_title>Development of a Personalized Real-time Intervention for Bipolar Disorder</brief_title>
  <acronym>PRISM</acronym>
  <official_title>Development of a Personalized Real-time Intervention for Bipolar Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This three-year intervention development proposal is submitted to the NIMH DATR Mood&#xD;
      Disorders/Sleep Disorders Program A2-AID and is led by a New Investigator. The goal of this&#xD;
      study is to further develop and then evaluate the clinical utility of a new personalized&#xD;
      smart-phone intervention to enhance illness self-management in people with bipolar disorder.&#xD;
      Bipolar disorder is a heterogeneous fluctuating condition and a leading source of disability.&#xD;
      Consistent with NIMH Strategic Aim 3.2, self-monitoring tools are vital to clinical&#xD;
      management and evidence-based psychosocial interventions for bipolar disorder. Practice&#xD;
      guidelines state that all patients should receive education in self-monitoring and&#xD;
      identifying adaptive responses to early warning signs and symptoms. Advances in technology&#xD;
      have enabled electronic monitoring of patient-reported outcomes using mobile devices - an&#xD;
      assessment strategy called Ecological Momentary Assessment (EMA). Using freely available&#xD;
      software, we have developed a preliminary version of a novel smart-phone intervention that&#xD;
      integrates EMA with brief psychosocial intervention designed for people with bipolar&#xD;
      disorder. Mobile real-time interventions have been successfully applied in other chronic&#xD;
      illnesses and have theoretical advantages over clinic-based interventions in motivating and&#xD;
      cuing health-protective behavior. Our new intervention is called Personalized Real-Time&#xD;
      Intervention for Stabilizing Mood (PRISM), and it delivers tailored intervention content&#xD;
      naturalistically at the moment that symptoms occur. We recently conducted a small&#xD;
      proof-of-concept study of PRISM in outpatient adults with bipolar disorder that suggests the&#xD;
      intervention is feasible, presents no technological or operational barriers, yields data that&#xD;
      corresponds with clinical ratings, and is perceived as useful by participants. Building from&#xD;
      our preliminary work, we propose to further develop the intervention based on participant&#xD;
      feedback and theoretically-driven enhancements. We will then conduct a randomized trial to&#xD;
      assess the clinical utility of this new intervention over 12 weeks. Specifically, we will&#xD;
      randomize a sample of 90 adults aged 18 and older with Bipolar Disorder I or II to one of two&#xD;
      experimental conditions. Participants in both conditions will participate in two in-person&#xD;
      sessions adapted from an evidence-based psychosocial intervention for bipolar disorder, aimed&#xD;
      at identifying early warning signs and adaptive responses to symptom fluctuations. The&#xD;
      Control condition will participate in the in-person sessions, and the PRISM condition will&#xD;
      also utilize the smart phone device for 12 weeks. In this pilot trial, we will compare&#xD;
      outcomes between the two conditions on standard clinical ratings of depressive and manic&#xD;
      symptoms, along with psychosocial functioning. We will assess predictors of compliance and&#xD;
      changes in outcomes in the PRISM condition to inform a larger effectiveness trial. We will&#xD;
      use exploratory analyses to further refine the intervention, including capitalizing on the&#xD;
      rich repeated measures obtained by the device. This study will provide a strong basis for a&#xD;
      larger effectiveness trial, along with a potentially useful tool to enhance self-management&#xD;
      in bipolar disorder. PUBLIC HEALTH RELEVANCE: Bipolar disorder is a leading cause of&#xD;
      disability, and many people do not have access to evidence-based psychosocial interventions.&#xD;
      Mobile devices may prove more effective than clinic-based interventions, because they deliver&#xD;
      self-management strategies at the moment that symptoms occur. To lead to a larger&#xD;
      effectiveness study, we propose to further develop our novel intervention uses mobile&#xD;
      technology to monitor and intervene with symptoms in real-time, and then conduct a 12-week&#xD;
      randomized trial in 90 patients to evaluate the acceptability and short-term efficacy of our&#xD;
      smart-phone based intervention for bipolar disorder.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2010</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Montgomery Asberg Depression Rating Scale</measure>
    <time_frame>3 month</time_frame>
    <description>Depression severity measure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Young Mania Rating Scale</measure>
    <time_frame>3 Month</time_frame>
    <description>Mania symptom severity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>Mobile Phone Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will involve daily self-monitoring with an electronic mobile device with responses to survey questions about mood status. Mood status reports are linked with personalized coping strategies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paper-and-pencil condition</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This arm will complete a paper-and-pencil mood chart on a daily basis</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Personalized Real-Time Intervention for Stabilizing Mood</intervention_name>
    <description>Interactive mobile web-based behavioral intervention targeting symptoms of bipolar disorder</description>
    <arm_group_label>Mobile Phone Condition</arm_group_label>
    <arm_group_label>Paper-and-pencil condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DSM-IV diagnosis of bipolar disorder&#xD;
&#xD;
          -  Currently an outpatient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric hospitalization in the past month&#xD;
&#xD;
          -  Substance abuse diagnosis in the past 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>October 9, 2018</last_update_submitted>
  <last_update_submitted_qc>October 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Colin Depp</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Mobile phone</keyword>
  <keyword>electronic intervention</keyword>
  <keyword>behavioral intervention</keyword>
  <keyword>telehealth</keyword>
  <keyword>bipolar disorder</keyword>
  <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/NCT01670123
org study id: MH091260
nct id: NCT01670123
lead sponsor: 
has dmc: No
This three-year intervention development proposal is submitted to the NIMH DATR Mood
      Disorders/Sleep Disorders Program A2-AID and is led by a New Investigator. The goal of this
      study is to further develop and then evaluate the clinical utility of a new personalized
      smart-phone intervention to enhance illness self-management in people with bipolar disorder.
      Bipolar disorder is a heterogeneous fluctuating condition and a leading source of disability.
      Consistent with NIMH Strategic Aim 3.2, self-monitoring tools are vital to clinical
      management and evidence-based psychosocial interventions for bipolar disorder. Practice
      guidelines state that all patients should receive education in self-monitoring and
      identifying adaptive responses to early warning signs and symptoms. Advances in technology
      have enabled electronic monitoring of patient-reported outcomes using mobile devices - an
      assessment strategy called Ecological Momentary Assessment (EMA). Using freely available
      software, we have developed a preliminary version of a novel smart-phone intervention that
      integrates EMA with brief psychosocial intervention designed for people with bipolar
      disorder. Mobile real-time interventions have been successfully applied in other chronic
      illnesses and have theoretical advantages over clinic-based interventions in motivating and
      cuing health-protective behavior. Our new intervention is called Personalized Real-Time
      Intervention for Stabilizing Mood (PRISM), and it delivers tailored intervention content
      naturalistically at the moment that symptoms occur. We recently conducted a small
      proof-of-concept study of PRISM in outpatient adults with bipolar disorder that suggests the
      intervention is feasible, presents no technological or operational barriers, yields data that
      corresponds with clinical ratings, and is perceived as useful by participants. Building from
      our preliminary work, we propose to further develop the intervention based on participant
      feedback and theoretically-driven enhancements. We will then conduct a randomized trial to
      assess the clinical utility of this new intervention over 12 weeks. Specifically, we will
      randomize a sample of 90 adults aged 18 and older with Bipolar Disorder I or II to one of two
      experimental conditions. Participants in both conditions will participate in two in-person
      sessions adapted from an evidence-based psychosocial intervention for bipolar disorder, aimed
      at identifying early warning signs and adaptive responses to symptom fluctuations. The
      Control condition will participate in the in-person sessions, and the PRISM condition will
      also utilize the smart phone device for 12 weeks. In this pilot trial, we will compare
      outcomes between the two conditions on standard clinical ratings of depressive and manic
      symptoms, along with psychosocial functioning. We will assess predictors of compliance and
      changes in outcomes in the PRISM condition to inform a larger effectiveness trial. We will
      use exploratory analyses to further refine the intervention, including capitalizing on the
      rich repeated measures obtained by the device. This study will provide a strong basis for a
      larger effectiveness trial, along with a potentially useful tool to enhance self-management
      in bipolar disorder. PUBLIC HEALTH RELEVANCE: Bipolar disorder is a leading cause of
      disability, and many people do not have access to evidence-based psychosocial interventions.
      Mobile devices may prove more effective than clinic-based interventions, because they deliver
      self-management strategies at the moment that symptoms occur. To lead to a larger
      effectiveness study, we propose to further develop our novel intervention uses mobile
      technology to monitor and intervene with symptoms in real-time, and then conduct a 12-week
      randomized trial in 90 patients to evaluate the acceptability and short-term efficacy of our
      smart-phone based intervention for bipolar disorder.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Montgomery Asberg Depression Rating Scale
time frame: 3 month
description: Depression severity measure
measure: Young Mania Rating Scale
time frame: 3 Month
description: Mania symptom severity
arm group label: Mobile Phone Condition
arm group type: Experimental
description: This arm will involve daily self-monitoring with an electronic mobile device with responses to survey questions about mood status. Mood status reports are linked with personalized coping strategies.
arm group label: Paper-and-pencil condition
arm group type: Placebo Comparator
description: This arm will complete a paper-and-pencil mood chart on a daily basis
intervention type: Behavioral
intervention name: Personalized Real-Time Intervention for Stabilizing Mood
description: Interactive mobile web-based behavioral intervention targeting symptoms of bipolar disorder
arm group label: Mobile Phone Condition
arm group label: Paper-and-pencil condition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Colin Depp
investigator title: Associate Professor
mesh term: Bipolar Disorder