<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/NCT02190968</url>
  </required_header>
  <id_info>
    <org_study_id>R01MH102229-01A1</org_study_id>
    <nct_id>NCT02190968</nct_id>
  </id_info>
  <brief_title>Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance</brief_title>
  <official_title>Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Colorado, Boulder</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Toronto</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>
      Many patients report residual depressive symptoms despite seemingly successful treatment.&#xD;
      With the investigators' previous funding, we developed - Mindful Mood Balance - an online&#xD;
      treatment that targets RDS by teaching specific emotion regulation and depression&#xD;
      self-management skills that are entirely compatible with antidepressant treatment. The&#xD;
      investigators now propose a controlled study to determine whether MMB is more effective than&#xD;
      usual care at reducing RDS and other key outcomes. If successful, MMB's online delivery&#xD;
      format would provide high fidelity and low-cost empirically supported management of residual&#xD;
      symptoms, leading to more robust remission, improved functioning and sustained recovery from&#xD;
      MDD over time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Residual depressive symptoms (RDS) following remission of major depressive disorder (MDD) are&#xD;
      reported by 80-90% of adults receiving first-line antidepressant pharmacotherapy and carry an&#xD;
      elevated risk for a chronic course of illness, rapid relapse and functional impairment.&#xD;
      Strategies for managing residual symptoms, however, have met with mixed success. Mindful Mood&#xD;
      Balance (MMB; R34 MH0877223) is an individually tailored, web-based treatment designed to&#xD;
      train remitted depressed patients to disengage from dysphoria-activated depressogenic&#xD;
      thinking that perpetuates RDS and increases risk for relapse/recurrence. MMB was developed to&#xD;
      increase access to Mindfulness-Based Cognitive Therapy (MBCT; R01 MH066992), an empirically&#xD;
      supported prophylactic group treatment that can be easily sequenced with acute phase&#xD;
      antidepressant pharmacotherapy. Results from our open trial of MMB (N=100) showed an effect&#xD;
      size of d=1.09 for pre to post treatment reductions in depression scores among patients with&#xD;
      RDS and d=1.54 in a quasi-experimental comparison to patients receiving usual care, with an&#xD;
      on average reduction of 1.98 points on the PHQ-9 for MMB patients. The investigators now&#xD;
      propose a pragmatic randomized clinical trial of MMB to evaluate its effectiveness in&#xD;
      reducing RDS in recurrently depressed patients. Patients will be members of Kaiser-Permanente&#xD;
      Colorado (N = 460), aged 18 to 75, who score &gt;5 and &lt;9 on the PHQ-9, in remission from MDD&#xD;
      and will be randomized 1:1 to either the usual depression care pathway (DepCare) or Mindful&#xD;
      Mood Balance (MMB)+DepCare.&#xD;
&#xD;
      The investigators plan to test whether patients receiving MMB+DepCare will show greater&#xD;
      reductions in RDS at both 8 week and 12 months follow up, than those receiving DepCare alone.&#xD;
      The investigators are also interested in examining whether fewer patients in MMB+DepCare will&#xD;
      relapse over the follow up and will have higher end state functioning and quality of life. In&#xD;
      order to examine the costs associated with adding this online treatment to the Depression&#xD;
      Care Pathways at KPCO, the investigators will calculate the marginal costs per additional&#xD;
      number of depression free days (DFDs) for patients. Resolution of RDS can reduce the enormous&#xD;
      personal and social costs experienced by Americans with this persistent symptom burden.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2015</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">November 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>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Health Questionnaire-9</measure>
    <time_frame>Change from Baseline to 12 weeks and 15 months</time_frame>
    <description>Changes in self reported depressive symptom severity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Health Questionnaire-9</measure>
    <time_frame>Between 12 weeks and 15 months</time_frame>
    <description>Rates of depressive relapse, defined as patients who score 15 or greater on the PHQ-9</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Health Questionnaire-9</measure>
    <time_frame>Between baseline to 12 weeks.</time_frame>
    <description>Conversion from moderate/high risk to low risk symptom categories, defined as a patient whose PHQ-9 score drops from a baseline PHQ-9 score between 5 and 9 to a mean score of 4 or less</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ruminative Responses Scale</measure>
    <time_frame>Change from Baseline to 6 weeks, 12 weeks and 15 months</time_frame>
    <description>A self-report measure of rumination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Five Facet Mindfulness Questionnaire</measure>
    <time_frame>Change from Baseline to 6 weeks, 12 weeks and 15 months</time_frame>
    <description>Self report measure of mindful awareness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Five Facet Mindfulness Scale</measure>
    <time_frame>Change from Baseline to 6 weeks, 12 weeks and 15 months</time_frame>
    <description>Self report measure of mindful awareness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experiences Questionnaire</measure>
    <time_frame>Change from Baseline to 6 weeks, 12 weeks and 15 months</time_frame>
    <description>Self report measure of decentering/wider awareness</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Depression Free Days</measure>
    <time_frame>Change from Baseline to 12 weeks and 15 months</time_frame>
    <description>Self report of days free of depression</description>
  </other_outcome>
  <other_outcome>
    <measure>Generalized Anxiety Disorder Assessment - 7</measure>
    <time_frame>Change from Baseline to 12 weeks and 15 months</time_frame>
    <description>Self report measure of generalized anxiety</description>
  </other_outcome>
  <other_outcome>
    <measure>Short Form Health Survey - 12</measure>
    <time_frame>Change from Baseline to 12 weeks and 15 months</time_frame>
    <description>Self report measure of physical and mental health</description>
  </other_outcome>
  <other_outcome>
    <measure>Emotion Dot Probe Task</measure>
    <time_frame>Change from Baseline to 12 weeks and 15 months</time_frame>
    <description>A behavioural measure of attentional bias</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">460</enrollment>
  <condition>Major Depressive Disorder, Recurrent, in Remission</condition>
  <condition>Depressive Symptoms</condition>
  <arm_group>
    <arm_group_label>Mindful Mood Balance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An 8 session internet intervention targeting residual depressive symptoms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Depression Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual Depression Care through Kaiser Permanente Colorado</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Depression Care</intervention_name>
    <description>Usual Depression Care will be based on the Kaiser Permanente Adult Depression National Guidelines - an adaptation of STAR*D (Rush et al., 2006) for antidepressant management and the IMPACT (Unitzer et al., 2002; 2008) model for therapy.</description>
    <arm_group_label>Mindful Mood Balance</arm_group_label>
    <arm_group_label>Usual Depression Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindful Mood Balance</intervention_name>
    <description>Mindful Mood Balance is an individually tailored, web-based version of Mindfulness-Based Cognitive Therapy, a manualized, group skills training program (Segal et al., 2002) that is based on an integration of aspects of cognitive therapy for depression (Beck, 1979) with components of the mindfulness-based stress reduction program (Kabat-Zinn, 1990). Patients participated in 8 internet sessions, each of which incorporates didactic and experiential learning, along with home practice of skills taught in the program.</description>
    <arm_group_label>Mindful Mood Balance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a PHQ-9 score between 5 and 9&#xD;
&#xD;
          -  At least one prior episode of MDD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of schizophrenia or current psychosis, organic mental disorder or pervasive&#xD;
             developmental delay&#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>Zindel V Segal, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaiser Permanente Institute for Health Research</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80237-8066</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://mbct.com/</url>
    <description>Mindfulness Based Cognitive Therapy Website</description>
  </link>
  <reference>
    <citation>Boggs JM, Beck A, Felder JN, Dimidjian S, Metcalf CA, Segal ZV. Web-based intervention in mindfulness meditation for reducing residual depressive symptoms and relapse prophylaxis: a qualitative study. J Med Internet Res. 2014 Mar 24;16(3):e87. doi: 10.2196/jmir.3129.</citation>
    <PMID>24662625</PMID>
  </reference>
  <reference>
    <citation>Segal ZV, Bieling P, Young T, MacQueen G, Cooke R, Martin L, Bloch R, Levitan RD. Antidepressant monotherapy vs sequential pharmacotherapy and mindfulness-based cognitive therapy, or placebo, for relapse prophylaxis in recurrent depression. Arch Gen Psychiatry. 2010 Dec;67(12):1256-64. doi: 10.1001/archgenpsychiatry.2010.168.</citation>
    <PMID>21135325</PMID>
  </reference>
  <reference>
    <citation>Dimidjian S, Beck A, Felder JN, Boggs JM, Gallop R, Segal ZV. Web-based Mindfulness-based Cognitive Therapy for reducing residual depressive symptoms: An open trial and quasi-experimental comparison to propensity score matched controls. Behav Res Ther. 2014 Dec;63:83-9. doi: 10.1016/j.brat.2014.09.004. Epub 2014 Sep 18.</citation>
    <PMID>25461782</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Toronto</investigator_affiliation>
    <investigator_full_name>Zindel Segal</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Mindfulness Based Cognitive Therapy</keyword>
  <keyword>Internet interventions</keyword>
  <keyword>Residual depressive symptoms</keyword>
  <keyword>Depressive relapse prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</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/NCT02190968
org study id: R01MH102229-01A1
nct id: NCT02190968
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Many patients report residual depressive symptoms despite seemingly successful treatment.
      With the investigators' previous funding, we developed - Mindful Mood Balance - an online
      treatment that targets RDS by teaching specific emotion regulation and depression
      self-management skills that are entirely compatible with antidepressant treatment. The
      investigators now propose a controlled study to determine whether MMB is more effective than
      usual care at reducing RDS and other key outcomes. If successful, MMB's online delivery
      format would provide high fidelity and low-cost empirically supported management of residual
      symptoms, leading to more robust remission, improved functioning and sustained recovery from
      MDD over time.
Residual depressive symptoms (RDS) following remission of major depressive disorder (MDD) are
      reported by 80-90% of adults receiving first-line antidepressant pharmacotherapy and carry an
      elevated risk for a chronic course of illness, rapid relapse and functional impairment.
      Strategies for managing residual symptoms, however, have met with mixed success. Mindful Mood
      Balance (MMB; R34 MH0877223) is an individually tailored, web-based treatment designed to
      train remitted depressed patients to disengage from dysphoria-activated depressogenic
      thinking that perpetuates RDS and increases risk for relapse/recurrence. MMB was developed to
      increase access to Mindfulness-Based Cognitive Therapy (MBCT; R01 MH066992), an empirically
      supported prophylactic group treatment that can be easily sequenced with acute phase
      antidepressant pharmacotherapy. Results from our open trial of MMB (N=100) showed an effect
      size of d=1.09 for pre to post treatment reductions in depression scores among patients with
      RDS and d=1.54 in a quasi-experimental comparison to patients receiving usual care, with an
      on average reduction of 1.98 points on the PHQ-9 for MMB patients. The investigators now
      propose a pragmatic randomized clinical trial of MMB to evaluate its effectiveness in
      reducing RDS in recurrently depressed patients. Patients will be members of Kaiser-Permanente
      Colorado (N = 460), aged 18 to 75, who score >5 and <9 on the PHQ-9, in remission from MDD
      and will be randomized 1:1 to either the usual depression care pathway (DepCare) or Mindful
      Mood Balance (MMB)+DepCare.

      The investigators plan to test whether patients receiving MMB+DepCare will show greater
      reductions in RDS at both 8 week and 12 months follow up, than those receiving DepCare alone.
      The investigators are also interested in examining whether fewer patients in MMB+DepCare will
      relapse over the follow up and will have higher end state functioning and quality of life. In
      order to examine the costs associated with adding this online treatment to the Depression
      Care Pathways at KPCO, the investigators will calculate the marginal costs per additional
      number of depression free days (DFDs) for patients. Resolution of RDS can reduce the enormous
      personal and social costs experienced by Americans with this persistent symptom burden.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Patient Health Questionnaire-9
time frame: Change from Baseline to 12 weeks and 15 months
description: Changes in self reported depressive symptom severity
measure: Patient Health Questionnaire-9
time frame: Between 12 weeks and 15 months
description: Rates of depressive relapse, defined as patients who score 15 or greater on the PHQ-9
measure: Patient Health Questionnaire-9
time frame: Between baseline to 12 weeks.
description: Conversion from moderate/high risk to low risk symptom categories, defined as a patient whose PHQ-9 score drops from a baseline PHQ-9 score between 5 and 9 to a mean score of 4 or less
measure: Ruminative Responses Scale
time frame: Change from Baseline to 6 weeks, 12 weeks and 15 months
description: A self-report measure of rumination
measure: Five Facet Mindfulness Questionnaire
time frame: Change from Baseline to 6 weeks, 12 weeks and 15 months
description: Self report measure of mindful awareness
measure: Five Facet Mindfulness Scale
time frame: Change from Baseline to 6 weeks, 12 weeks and 15 months
description: Self report measure of mindful awareness
measure: Experiences Questionnaire
time frame: Change from Baseline to 6 weeks, 12 weeks and 15 months
description: Self report measure of decentering/wider awareness
measure: Depression Free Days
time frame: Change from Baseline to 12 weeks and 15 months
description: Self report of days free of depression
measure: Generalized Anxiety Disorder Assessment - 7
time frame: Change from Baseline to 12 weeks and 15 months
description: Self report measure of generalized anxiety
measure: Short Form Health Survey - 12
time frame: Change from Baseline to 12 weeks and 15 months
description: Self report measure of physical and mental health
measure: Emotion Dot Probe Task
time frame: Change from Baseline to 12 weeks and 15 months
description: A behavioural measure of attentional bias
arm group label: Mindful Mood Balance
arm group type: Experimental
description: An 8 session internet intervention targeting residual depressive symptoms.
arm group label: Usual Depression Care
arm group type: Active Comparator
description: Usual Depression Care through Kaiser Permanente Colorado
intervention type: Behavioral
intervention name: Usual Depression Care
description: Usual Depression Care will be based on the Kaiser Permanente Adult Depression National Guidelines - an adaptation of STAR*D (Rush et al., 2006) for antidepressant management and the IMPACT (Unitzer et al., 2002; 2008) model for therapy.
arm group label: Mindful Mood Balance
arm group label: Usual Depression Care
intervention type: Behavioral
intervention name: Mindful Mood Balance
description: Mindful Mood Balance is an individually tailored, web-based version of Mindfulness-Based Cognitive Therapy, a manualized, group skills training program (Segal et al., 2002) that is based on an integration of aspects of cognitive therapy for depression (Beck, 1979) with components of the mindfulness-based stress reduction program (Kabat-Zinn, 1990). Patients participated in 8 internet sessions, each of which incorporates didactic and experiential learning, along with home practice of skills taught in the program.
arm group label: Mindful Mood Balance
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zindel V Segal, PhD
role: Principal Investigator
affiliation: University of Toronto
facility: 
country: United States
url: http://mbct.com/
description: Mindfulness Based Cognitive Therapy Website
citation: Boggs JM, Beck A, Felder JN, Dimidjian S, Metcalf CA, Segal ZV. Web-based intervention in mindfulness meditation for reducing residual depressive symptoms and relapse prophylaxis: a qualitative study. J Med Internet Res. 2014 Mar 24;16(3):e87. doi: 10.2196/jmir.3129.
PMID: 24662625
citation: Segal ZV, Bieling P, Young T, MacQueen G, Cooke R, Martin L, Bloch R, Levitan RD. Antidepressant monotherapy vs sequential pharmacotherapy and mindfulness-based cognitive therapy, or placebo, for relapse prophylaxis in recurrent depression. Arch Gen Psychiatry. 2010 Dec;67(12):1256-64. doi: 10.1001/archgenpsychiatry.2010.168.
PMID: 21135325
citation: Dimidjian S, Beck A, Felder JN, Boggs JM, Gallop R, Segal ZV. Web-based Mindfulness-based Cognitive Therapy for reducing residual depressive symptoms: An open trial and quasi-experimental comparison to propensity score matched controls. Behav Res Ther. 2014 Dec;63:83-9. doi: 10.1016/j.brat.2014.09.004. Epub 2014 Sep 18.
PMID: 25461782
responsible party type: Principal Investigator
investigator affiliation: University of Toronto
investigator full name: Zindel Segal
investigator title: Professor
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major