<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/NCT02987426</url>
  </required_header>
  <id_info>
    <org_study_id>16230</org_study_id>
    <nct_id>NCT02987426</nct_id>
  </id_info>
  <brief_title>Can Brief-mindfulness Interventions Improve Psychiatric Symptoms?</brief_title>
  <official_title>Can Brief Mindfulness-oriented Interventions Improve Psychiatric Symptoms and Shorten Psychiatric Hospitalizations? A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lady Davis Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lady Davis Institute</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>
      Mindfulness-based interventions have gained increasing popularity in recent years as&#xD;
      effective treatment for mental illness. Mindfulness is defined as paying attention in a&#xD;
      particular way: on purpose, in the present moment, and non-judgmentally: &quot;Being&quot;, rather than&#xD;
      &quot;Doing&quot;. Such mental states can improve emotional regulation through frontal cortex&#xD;
      inhibition of otherwise dysregulated subcortical emotion-related circuits. Formal mindfulness&#xD;
      approaches such as mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress&#xD;
      reduction, have been highly effective in a broad range of psychiatric disorders.&#xD;
&#xD;
      Mindfulness-oriented interventions, are potentially useful in acute psychiatric&#xD;
      hospitalizations, since they can be delivered as group therapies and are be both&#xD;
      cost-effective and scalable. However, such interventions have rarely been provided to&#xD;
      patients during psychiatric hospitalizations, where patients are treated for a variety of&#xD;
      psychiatric diagnoses, and may have unpredictable lengths of stay. Additionally, there had&#xD;
      been concerns that longer traditional mindfulness based interventions (e.g. 30 minute silent&#xD;
      meditation) may exacerbate acute psychosis. However, strong evidence suggests that patients&#xD;
      with psychotic symptoms appear to be largely unaffected by shorter interventions. Similarly,&#xD;
      MBCT have been helpful to treat other major reasons for hospitalization such as: bipolar&#xD;
      disorder, severe anxiety, substance use disorders, and major depressive disorder.&#xD;
&#xD;
      Few studies have examined mindfulness-oriented treatments in inpatient settings, including&#xD;
      two small studies involving mindfulness groups on an acute psychiatric inpatient ward (n&lt;10)&#xD;
      . Another study (n=23) offered inpatients with a diagnosis of major depressive disorder&#xD;
      mindfulness-based activities. All studies concluded that mindfulness-oriented approaches in&#xD;
      inpatient settings were feasible, although these needed to be brief interventions, given the&#xD;
      risks and lack of efficacy of longer MBI (e.g. 40-minute silent meditation) in severe mental&#xD;
      illness.&#xD;
&#xD;
      A cross-sectional study conducted by our team (n=40) demonstrated that brief group&#xD;
      mindfulness-oriented lasting 10 minutes were very well tolerated by 92.5% of psychiatric&#xD;
      inpatients. The remaining 7.5% of patients left the session before 10-minutes, but had no&#xD;
      symptomatic exacerbations or adverse effects. Moreover, the 50% of patients self- reported&#xD;
      improvements in general well-being and mood after a single 10-minute session. Having been&#xD;
      recently admitted to the psychiatric inpatient or having a diagnosis of acute psychosis (75%&#xD;
      of inpatients) did not affect patients' capacity to tolerate and benefit from the&#xD;
      intervention. In this inpatient psychiatric population, we found that mindfulness-oriented&#xD;
      interventions that were brief and involved physical movement (e.g. seated Tai Chi) were&#xD;
      better enjoyed compared to other interventions.&#xD;
&#xD;
      Despite the growing literature in this field, data is needed on the effectiveness and health&#xD;
      service implications of brief group mindfulness-oriented interventions in inpatient&#xD;
      psychiatry settings. Outcome studies conducted so far cannot be interpreted reliably due to&#xD;
      methodological flaws, including inadequate control groups, very small sample sizes (often&#xD;
      n&lt;10), and lack of randomization. In Canada, the direct cost of treatment for mental illness&#xD;
      is estimated as 42.3 billion. Much of these costs are driven by psychiatric admissions. Thus,&#xD;
      if brief mindfulness-oriented interventions are effective at lowering psychiatric symptom&#xD;
      severity and shortening psychiatric hospitalizations, this could lead to significant&#xD;
      cost-savings.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 19, 2017</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</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>
    <intervention_model_description>Mindfulness Intervention</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Brief Psychiatric Rating Scale score</measure>
    <time_frame>1-week follow-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inpatient Psychiatric length of stay (days)</measure>
    <time_frame>Within 12 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Insomnia with Athens scale</measure>
    <time_frame>At admission to the psychiatry unit and at 1-week follow-up</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life assessed with Euro-QOL scale</measure>
    <time_frame>At admission to the psychiatry unit and at 1-week follow-up</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Psychotropic medication and &quot;as needed&quot; PRN medication use</measure>
    <time_frame>At admission to the psychiatry unit and at 1-week follow-up</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Likert Scale</measure>
    <time_frame>At 1-week follow-up</time_frame>
    <description>The patient's satisfaction will be assessed with a 10 point Likerts scale</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Psychiatric Disorders</condition>
  <arm_group>
    <arm_group_label>Mindfulness-oriented intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will get a mindfulness-oriented intervention daily for 10 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will continue receiving their normal inpatient psychiatric care and receive information (paper brochures) about health promotion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness-oriented intervention</intervention_name>
    <description>The 10 minutes daily sessions every weekday, will take place at the inpatient unit in groups of 10 people. The intervention will be alternating between three forms of &quot;moving&quot; mindfulness-oriented interventions as detailed below:&#xD;
Seated Tai Chi: patients will slowly move their arms in soft movements coordinated with slow breaths Gentle stretching: patients will slowly stretch their bodies coordinated with the breath and with awareness of physical sensations throughout the body4 Walking meditation: patients will walk slowly in no particular direction, focusing close attention on the act of walking</description>
    <arm_group_label>Mindfulness-oriented intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 years and above&#xD;
&#xD;
          2. Admitted to the Open Unit of Jewish General Hospital Psychiatric Inpatient Unit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute high risk to self and others - defined by being hospitalized in the confined&#xD;
             (locked) unit (High Care or UTT at JGH).&#xD;
&#xD;
          2. Have been diagnosed by their psychiatrist with a diagnosis of moderate-to-severe&#xD;
             dementia that would interfere with their ability to complete self-reported&#xD;
             questionnaires.&#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>Jewish General Hospital</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>April 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>September 11, 2020</last_update_submitted>
  <last_update_submitted_qc>September 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lady Davis Institute</investigator_affiliation>
    <investigator_full_name>Dr. Karl Looper</investigator_full_name>
    <investigator_title>Psychiatrist-in-Chief, Jewish General Hospital Associate Professor, Department of Psychiatry, McGill University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02987426
org study id: 16230
nct id: NCT02987426
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Mindfulness-based interventions have gained increasing popularity in recent years as
      effective treatment for mental illness. Mindfulness is defined as paying attention in a
      particular way: on purpose, in the present moment, and non-judgmentally: "Being", rather than
      "Doing". Such mental states can improve emotional regulation through frontal cortex
      inhibition of otherwise dysregulated subcortical emotion-related circuits. Formal mindfulness
      approaches such as mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress
      reduction, have been highly effective in a broad range of psychiatric disorders.

      Mindfulness-oriented interventions, are potentially useful in acute psychiatric
      hospitalizations, since they can be delivered as group therapies and are be both
      cost-effective and scalable. However, such interventions have rarely been provided to
      patients during psychiatric hospitalizations, where patients are treated for a variety of
      psychiatric diagnoses, and may have unpredictable lengths of stay. Additionally, there had
      been concerns that longer traditional mindfulness based interventions (e.g. 30 minute silent
      meditation) may exacerbate acute psychosis. However, strong evidence suggests that patients
      with psychotic symptoms appear to be largely unaffected by shorter interventions. Similarly,
      MBCT have been helpful to treat other major reasons for hospitalization such as: bipolar
      disorder, severe anxiety, substance use disorders, and major depressive disorder.

      Few studies have examined mindfulness-oriented treatments in inpatient settings, including
      two small studies involving mindfulness groups on an acute psychiatric inpatient ward (n<10)
      . Another study (n=23) offered inpatients with a diagnosis of major depressive disorder
      mindfulness-based activities. All studies concluded that mindfulness-oriented approaches in
      inpatient settings were feasible, although these needed to be brief interventions, given the
      risks and lack of efficacy of longer MBI (e.g. 40-minute silent meditation) in severe mental
      illness.

      A cross-sectional study conducted by our team (n=40) demonstrated that brief group
      mindfulness-oriented lasting 10 minutes were very well tolerated by 92.5% of psychiatric
      inpatients. The remaining 7.5% of patients left the session before 10-minutes, but had no
      symptomatic exacerbations or adverse effects. Moreover, the 50% of patients self- reported
      improvements in general well-being and mood after a single 10-minute session. Having been
      recently admitted to the psychiatric inpatient or having a diagnosis of acute psychosis (75%
      of inpatients) did not affect patients' capacity to tolerate and benefit from the
      intervention. In this inpatient psychiatric population, we found that mindfulness-oriented
      interventions that were brief and involved physical movement (e.g. seated Tai Chi) were
      better enjoyed compared to other interventions.

      Despite the growing literature in this field, data is needed on the effectiveness and health
      service implications of brief group mindfulness-oriented interventions in inpatient
      psychiatry settings. Outcome studies conducted so far cannot be interpreted reliably due to
      methodological flaws, including inadequate control groups, very small sample sizes (often
      n<10), and lack of randomization. In Canada, the direct cost of treatment for mental illness
      is estimated as 42.3 billion. Much of these costs are driven by psychiatric admissions. Thus,
      if brief mindfulness-oriented interventions are effective at lowering psychiatric symptom
      severity and shortening psychiatric hospitalizations, this could lead to significant
      cost-savings.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Mindfulness Intervention
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Change in Brief Psychiatric Rating Scale score
time frame: 1-week follow-up
measure: Inpatient Psychiatric length of stay (days)
time frame: Within 12 months
measure: Insomnia with Athens scale
time frame: At admission to the psychiatry unit and at 1-week follow-up
measure: Quality of life assessed with Euro-QOL scale
time frame: At admission to the psychiatry unit and at 1-week follow-up
measure: Psychotropic medication and "as needed" PRN medication use
time frame: At admission to the psychiatry unit and at 1-week follow-up
measure: Likert Scale
time frame: At 1-week follow-up
description: The patient's satisfaction will be assessed with a 10 point Likerts scale
arm group label: Mindfulness-oriented intervention
arm group type: Experimental
description: Patients will get a mindfulness-oriented intervention daily for 10 minutes.
arm group label: Treatment as Usual
arm group type: No Intervention
description: This group will continue receiving their normal inpatient psychiatric care and receive information (paper brochures) about health promotion.
intervention type: Behavioral
intervention name: Mindfulness-oriented intervention
description: The 10 minutes daily sessions every weekday, will take place at the inpatient unit in groups of 10 people. The intervention will be alternating between three forms of "moving" mindfulness-oriented interventions as detailed below:
Seated Tai Chi: patients will slowly move their arms in soft movements coordinated with slow breaths Gentle stretching: patients will slowly stretch their bodies coordinated with the breath and with awareness of physical sensations throughout the body4 Walking meditation: patients will walk slowly in no particular direction, focusing close attention on the act of walking
arm group label: Mindfulness-oriented intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Lady Davis Institute
investigator full name: Dr. Karl Looper
investigator title: Psychiatrist-in-Chief, Jewish General Hospital Associate Professor, Department of Psychiatry, McGill University
mesh term: Mental Disorders
mesh term: Problem Behavior
sharing ipd: No