<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/NCT03293797</url>
  </required_header>
  <id_info>
    <org_study_id>387-2015</org_study_id>
    <nct_id>NCT03293797</nct_id>
  </id_info>
  <brief_title>Ultra-Brief Intervention to Reduce Depressive and Anxious Symptoms</brief_title>
  <official_title>Improving Access to Quality Mental Healthcare Through Innovations in Psychotherapy: A Pilot Study of a Novel, Ultra-Brief Intervention to Reduce Depressive and Anxious Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</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>
      Symptoms of depression and anxiety are extremely prevalent in the population. Unfortunately,&#xD;
      patients often face barriers to accessing mental health care, particularly psychotherapeutic&#xD;
      interventions, including long wait-times and demanding therapeutic protocols. For instance,&#xD;
      Mindfulness-Based Therapy (MBT) has demonstrated effectiveness at decreasing symptoms of&#xD;
      depression and anxiety, and improving wellbeing; however, 'traditional' MBT can demand over&#xD;
      30 hours of clinical time, and 50-60 hours of homework, all of which can be barriers to care.&#xD;
      A pilot, uncontrolled study conducted at Sunnybrook illustrated the potential feasibility /&#xD;
      efficaciousness of a novel abbreviated MBT in improving hospital staff wellbeing. The goal of&#xD;
      this controlled study is to further test feasibility and acceptability of this intervention&#xD;
      to reduce depressive / anxious symptoms, reduce stress and improve wellbeing in outpatient&#xD;
      mood/anxiety patients. If efficacious, this Abbreviated MBT could reduce barriers to&#xD;
      accessing mental health care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND: ABBREVIATED-MINDFULNESS BASED THERAPY (A-MBT)&#xD;
&#xD;
      By the age of 40, 1 in 2 Canadians have been or are presently experiencing mental health&#xD;
      issues. In particular, anxiety and mood disorders are the most prevalent lifetime mental&#xD;
      health illnesses, affecting 11.6% of the population. Mindfulness based treatments (MBTs) have&#xD;
      strong evidence for improving patient wellness through reduction of anxiety and mood symptoms&#xD;
      in clinical populations. Although efficacious, 'traditional' MBTs are very demanding in terms&#xD;
      of time and homework a relevant factor when considering the recent calls for waittime&#xD;
      reductions in psychotherapeutic mental health services. These programs take 30+ hours&#xD;
      (including 2-3 hr. weekly sessions across 8 weeks, plus a 1-day retreat) and expect 45-60&#xD;
      min./day of meditation homework. The goal of this project is to test the effectiveness of an&#xD;
      abbreviated MBI in reducing anxiety and/or mood disturbances and improving patient&#xD;
      well-being.&#xD;
&#xD;
      MBTs use a non-stigmatizing approach, combining secularized eastern meditative practices with&#xD;
      western psychological advances to improve stress-management and self-care. Participants learn&#xD;
      to generate less distress, engage more positively and fully in their lives and experiences,&#xD;
      and respond more adaptively to challenges instead of reacting in automatic and unhelpful&#xD;
      ways. Participants in MBI often describe the intervention as transformative. Professional&#xD;
      experience and new insights into MBTs suggest that these 'tradition' treatment programs can&#xD;
      be further abbreviated to develop a effective and accessible clinical intervention. This&#xD;
      abbreviated MBT has been developed, which if effective will curtail wait-times and increase&#xD;
      patient treatment annually.&#xD;
&#xD;
      RATIONAL &amp; HYPOTHESIS/RESEARCH QUESTION Rational&#xD;
&#xD;
      Patients face barriers to accessing psychotherapy, including long wait-times and/or protocols&#xD;
      that are too demanding for many patients. Traditional Mindfulness-Based Therapies (MBTs) are&#xD;
      highly studied and well-recognized treatment options to reduce anxiety and mood symptoms -&#xD;
      demonstrating repeated efficacy in clinical populations. However, the high demands of&#xD;
      clinical time and homework are a barrier to many patients. Further, longer clinical&#xD;
      interventions mean fewer patients being treated per hour of clinician's time, and therefore&#xD;
      longer wait-times. Clinical experience and new insights into MBTs suggest that these&#xD;
      'tradition' treatment programs can be further abbreviated to develop an effective and more&#xD;
      accessible therapy. If this Abbreviated MBT is demonstrated to be clinically effective, it&#xD;
      can reduce barriers to mental health care by reaching more patients in a more timely fashion.&#xD;
&#xD;
      The specific objective of this study will be to evaluate a novel and potentially highly&#xD;
      effective strategy to reduce depressive / anxious symptoms and stress, while improve quality&#xD;
      of life and mental wellbeing among mood and anxiety outpatients referred to the&#xD;
      Mindfulness-Based Therapy Clinic at Sunnybrook Health Sciences Centre.&#xD;
&#xD;
      Hypothesis/Research Question The study hypothesis is that an abbreviated MBT for mood /&#xD;
      anxiety outpatient populations will show improvement in self-reported measures of clinical&#xD;
      primary (Depression, Anxiety) and secondary (well-being, stress, self-compassion) outcomes&#xD;
      and will be feasible for the population. Feasibility will be determined by patient program&#xD;
      adherence (70% of participants attend ≥75% of sessions) and effect size (moderate magnitude&#xD;
      of change in PHQ-9 / GAD-7), Cohen's d = ≥0.5). The effect size will provide a measure of how&#xD;
      practically and clinically significant the treatment effect is, by measuring change in&#xD;
      baseline, pre-treatment, post-treatment, 1/3/6 month and 1 year follow-up mean scores for the&#xD;
      outcome measures.&#xD;
&#xD;
      Study Significance&#xD;
&#xD;
      The current pilot study will explore the effects of an Abbreviated-MBT on symptoms of&#xD;
      depression and anxiety in an outpatient clinical sample; if effective: a) this would be the&#xD;
      first known pilot study to consider and demonstrate efficacy of an Abbreviated-MBT in a&#xD;
      clinical outpatient population; b) this treatment could increase the volume of patients&#xD;
      treated by up to 3x, reduce wait-times by 2-3 fold, and reach a broader group of patients,&#xD;
      including those for whom the investment of time of traditional MBT is too prohibitive&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</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>Change from Baseline Depressive Symptoms at 5 Week</measure>
    <time_frame>Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)</time_frame>
    <description>Scale used to measure Depressive Symptoms: Patient Health Questionnaire 9-item (PHQ-9)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Anxiety Symptoms at 5 Week</measure>
    <time_frame>Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)</time_frame>
    <description>Scale used to measure Anxiety Symptoms: Generalized Anxiety Disorder 7-item (GAD-7)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Mental Wellbeing at 5 Week</measure>
    <time_frame>Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)</time_frame>
    <description>Scale used to measure Mental Wellbeing: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Self-Compassion at 5 Week</measure>
    <time_frame>Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)]</time_frame>
    <description>Scale used to measure Self-Compassion: Self-Compassion Scale Short-Form (SCS-SF)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <condition>Mood</condition>
  <arm_group>
    <arm_group_label>Abbreviated Mindfulness-based Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 week, abbreviated group MBT treatment for depression and anxiety</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Abbreviated-Mindfulness-based Therapy</intervention_name>
    <description>A-MBT will be delivered in group format, 120 minutes per week, for 5 consecutive weeks with 10-20 participants per group.</description>
    <arm_group_label>Abbreviated Mindfulness-based Therapy</arm_group_label>
    <other_name>A-MBT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consenting mood and anxiety outpatients referred to Dr. Selchen in the Sunnybrook&#xD;
             Mindfulness-Based Therapy Clinic&#xD;
&#xD;
          -  Due to the nature of the assessment procedures, which include English-language self-&#xD;
             report questionnaires and scales, ability to communicate in written and spoken English&#xD;
             is an inclusion criterion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have active or recent (within 3 months) substance abuse/dependence, a&#xD;
             history of dementia, untreated posttraumatic stress symptoms, active psychotic or&#xD;
             manic symptoms, recent suicide attempt/active suicidality, or current self-injurious&#xD;
             behaviour&#xD;
&#xD;
          -  Previously completed a course (≥ 8 weeks) of a Mindfulness-Based Therapy within the&#xD;
             last 3 years&#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>Steven Selchen, MD MSt FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Healthy Sciences Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Benjamin Diplock, BSc MAc</last_name>
    <phone>416-480-6100</phone>
    <phone_ext>81233</phone_ext>
    <email>ben.diplock@sunnybrook.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Steven Selchen, MD MSt FRCPC</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin Diplock, BSc</last_name>
      <phone>416-480-6100</phone>
      <phone_ext>81233</phone_ext>
      <email>ben.diplock@sunnybrook.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>December 12, 2018</last_update_submitted>
  <last_update_submitted_qc>December 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mindfulness-based Therapy</keyword>
  <keyword>Wellbeing</keyword>
  <keyword>Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03293797
org study id: 387-2015
nct id: NCT03293797
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Symptoms of depression and anxiety are extremely prevalent in the population. Unfortunately,
      patients often face barriers to accessing mental health care, particularly psychotherapeutic
      interventions, including long wait-times and demanding therapeutic protocols. For instance,
      Mindfulness-Based Therapy (MBT) has demonstrated effectiveness at decreasing symptoms of
      depression and anxiety, and improving wellbeing; however, 'traditional' MBT can demand over
      30 hours of clinical time, and 50-60 hours of homework, all of which can be barriers to care.
      A pilot, uncontrolled study conducted at Sunnybrook illustrated the potential feasibility /
      efficaciousness of a novel abbreviated MBT in improving hospital staff wellbeing. The goal of
      this controlled study is to further test feasibility and acceptability of this intervention
      to reduce depressive / anxious symptoms, reduce stress and improve wellbeing in outpatient
      mood/anxiety patients. If efficacious, this Abbreviated MBT could reduce barriers to
      accessing mental health care.
BACKGROUND: ABBREVIATED-MINDFULNESS BASED THERAPY (A-MBT)

      By the age of 40, 1 in 2 Canadians have been or are presently experiencing mental health
      issues. In particular, anxiety and mood disorders are the most prevalent lifetime mental
      health illnesses, affecting 11.6% of the population. Mindfulness based treatments (MBTs) have
      strong evidence for improving patient wellness through reduction of anxiety and mood symptoms
      in clinical populations. Although efficacious, 'traditional' MBTs are very demanding in terms
      of time and homework a relevant factor when considering the recent calls for waittime
      reductions in psychotherapeutic mental health services. These programs take 30+ hours
      (including 2-3 hr. weekly sessions across 8 weeks, plus a 1-day retreat) and expect 45-60
      min./day of meditation homework. The goal of this project is to test the effectiveness of an
      abbreviated MBI in reducing anxiety and/or mood disturbances and improving patient
      well-being.

      MBTs use a non-stigmatizing approach, combining secularized eastern meditative practices with
      western psychological advances to improve stress-management and self-care. Participants learn
      to generate less distress, engage more positively and fully in their lives and experiences,
      and respond more adaptively to challenges instead of reacting in automatic and unhelpful
      ways. Participants in MBI often describe the intervention as transformative. Professional
      experience and new insights into MBTs suggest that these 'tradition' treatment programs can
      be further abbreviated to develop a effective and accessible clinical intervention. This
      abbreviated MBT has been developed, which if effective will curtail wait-times and increase
      patient treatment annually.

      RATIONAL & HYPOTHESIS/RESEARCH QUESTION Rational

      Patients face barriers to accessing psychotherapy, including long wait-times and/or protocols
      that are too demanding for many patients. Traditional Mindfulness-Based Therapies (MBTs) are
      highly studied and well-recognized treatment options to reduce anxiety and mood symptoms -
      demonstrating repeated efficacy in clinical populations. However, the high demands of
      clinical time and homework are a barrier to many patients. Further, longer clinical
      interventions mean fewer patients being treated per hour of clinician's time, and therefore
      longer wait-times. Clinical experience and new insights into MBTs suggest that these
      'tradition' treatment programs can be further abbreviated to develop an effective and more
      accessible therapy. If this Abbreviated MBT is demonstrated to be clinically effective, it
      can reduce barriers to mental health care by reaching more patients in a more timely fashion.

      The specific objective of this study will be to evaluate a novel and potentially highly
      effective strategy to reduce depressive / anxious symptoms and stress, while improve quality
      of life and mental wellbeing among mood and anxiety outpatients referred to the
      Mindfulness-Based Therapy Clinic at Sunnybrook Health Sciences Centre.

      Hypothesis/Research Question The study hypothesis is that an abbreviated MBT for mood /
      anxiety outpatient populations will show improvement in self-reported measures of clinical
      primary (Depression, Anxiety) and secondary (well-being, stress, self-compassion) outcomes
      and will be feasible for the population. Feasibility will be determined by patient program
      adherence (70% of participants attend ≥75% of sessions) and effect size (moderate magnitude
      of change in PHQ-9 / GAD-7), Cohen's d = ≥0.5). The effect size will provide a measure of how
      practically and clinically significant the treatment effect is, by measuring change in
      baseline, pre-treatment, post-treatment, 1/3/6 month and 1 year follow-up mean scores for the
      outcome measures.

      Study Significance

      The current pilot study will explore the effects of an Abbreviated-MBT on symptoms of
      depression and anxiety in an outpatient clinical sample; if effective: a) this would be the
      first known pilot study to consider and demonstrate efficacy of an Abbreviated-MBT in a
      clinical outpatient population; b) this treatment could increase the volume of patients
      treated by up to 3x, reduce wait-times by 2-3 fold, and reach a broader group of patients,
      including those for whom the investment of time of traditional MBT is too prohibitive
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline Depressive Symptoms at 5 Week
time frame: Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)
description: Scale used to measure Depressive Symptoms: Patient Health Questionnaire 9-item (PHQ-9)
measure: Change from Baseline Anxiety Symptoms at 5 Week
time frame: Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)
description: Scale used to measure Anxiety Symptoms: Generalized Anxiety Disorder 7-item (GAD-7)
measure: Change from Baseline Mental Wellbeing at 5 Week
time frame: Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)
description: Scale used to measure Mental Wellbeing: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
measure: Change from Baseline Self-Compassion at 5 Week
time frame: Baseline (Week 0), Pre- (Week 1) and Post-Treatment Assessment (Week 5)]
description: Scale used to measure Self-Compassion: Self-Compassion Scale Short-Form (SCS-SF)
arm group label: Abbreviated Mindfulness-based Therapy
arm group type: Experimental
description: 5 week, abbreviated group MBT treatment for depression and anxiety
intervention type: Behavioral
intervention name: Abbreviated-Mindfulness-based Therapy
description: A-MBT will be delivered in group format, 120 minutes per week, for 5 consecutive weeks with 10-20 participants per group.
arm group label: Abbreviated Mindfulness-based Therapy
other name: A-MBT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steven Selchen, MD MSt FRCPC
role: Principal Investigator
affiliation: Sunnybrook Healthy Sciences Centre
last name: Benjamin Diplock, BSc MAc
phone: 416-480-6100
phone ext: 81233
email: ben.diplock@sunnybrook.ca
last name: Steven Selchen, MD MSt FRCPC
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor
mesh term: Depression
sharing ipd: Undecided