<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/NCT03836456</url>
  </required_header>
  <id_info>
    <org_study_id>DalhousieU</org_study_id>
    <nct_id>NCT03836456</nct_id>
  </id_info>
  <brief_title>Approaches That Support Mental Health in Post-secondary Students With Adverse Childhood Experiences</brief_title>
  <acronym>ACE</acronym>
  <official_title>Defining Approaches That Support the Mental Health of Post-secondary Students Who Experienced More Than Three Adverse Childhood Experiences</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dalhousie University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dalhousie 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 objective of this study is to understand the prevalence of adverse childhood experiences&#xD;
      (ACE) in students and to determine whether Mindfulness based stress resilience training&#xD;
      (MBSR) is effective for promoting mental health in students with high ACE scores (&gt;3). A&#xD;
      double-blind randomized control study will examine the efficacy of MBSR in promoting positive&#xD;
      change in measures of hope, rumination, forgiveness and stress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Adverse Childhood Experiences Study examined the physical health and psychosocial&#xD;
      consequences of ACE across the lifespan. This study demonstrated adverse childhood&#xD;
      experiences (ACE) prevalence to be high and a direct correlation between ACE scores (a tally&#xD;
      of different types of abuse, neglect, and household dysfunction experienced under the age of&#xD;
      18) and prevalence of physical health and psychosocial problems in adulthood. Adults with &gt;3&#xD;
      ACE are more likely to experience social underachievement (e.g. lower educational achievement&#xD;
      and economic productivity), physical and mental health problems (e.g. depression, heart&#xD;
      disease, suicide attempts, substance abuse) and unhealthy lifestyle behaviours (e.g. smoking,&#xD;
      physical inactivity). Worldwide, ACE have been shown to be prevalent, independent of social&#xD;
      and economic factors, and highly interrelated. 12.5% of subjects reported &gt;4 ACE. Among&#xD;
      post-secondary students, studies determined high ACE scores to be associated with higher&#xD;
      prevalence of risk behaviours and physical health and psychosocial problems. Failure to&#xD;
      support the physical and mental health of students can lead to increased attrition,&#xD;
      deterioration of well-being, and intentional self-harm.&#xD;
&#xD;
      Recognition of ACE prevalence and its consequences has been paralleled by the development of&#xD;
      interventions for mitigating the lifetime health and social consequences of ACE. A 2016 study&#xD;
      examining interventions believed to improve the mental health of adults with significant ACE&#xD;
      (&gt;3) identified mindfulness-based therapies (MBT) as being effective. Mindfulness is a form&#xD;
      of cognitive training that cultivates self-regulative ability and enhances resilience.&#xD;
&#xD;
      As no Canadian post-secondary institution has comprehensively investigated the prevalence of&#xD;
      student ACE, the objective of this study is to understand the prevalence of ACE in students&#xD;
      and to determine whether MBT is effective for promoting mental health in students with high&#xD;
      ACE scores (&gt;3).&#xD;
&#xD;
      A double-blind randomized control study will examine the efficacy of MBT, specifically&#xD;
      Mindfulness-based Stress Resilience Training (MBSR), in promoting positive change in measures&#xD;
      of hope, rumination, forgiveness and distress. Interventions that positively effect these&#xD;
      measures are known to enhance quality of life. First year students enrolled at Dalhousie&#xD;
      University will be recruited. Subjects will complete an ACE questionnaire and those with &gt;3&#xD;
      ACE prior to age 18 will be invited to participate in this study. Students with prior MBT&#xD;
      training will be excluded. Subjects will be randomized to one of two groups: MBSR or an&#xD;
      established active control (Health Enhancement Program (HEP)). We selected MBSR because it is&#xD;
      secular, codified, and the most scientifically studied mindfulness-based intervention to&#xD;
      date. Power analyses determined 25 subjects per group is sufficient to detect a significant&#xD;
      difference in outcomes across the groups. Interventionists and subjects will be blinded.&#xD;
      Students will be led in group based MBSR or HEP for 4 weeks. Prior to and after the 4-week&#xD;
      intervention subjects' outcomes will be determined using the: Perceived Stress Scale;&#xD;
      Rumination and Reflection Questionnaire; Heartland Forgiveness Scale and; Adult Dispositional&#xD;
      Hope Scale.&#xD;
&#xD;
      Development of evidence-based programs that support the identification of ACE in students and&#xD;
      identification of interventions that mitigate negative lifetime consequences of ACE outcomes&#xD;
      is needed. This pilot study will increase understanding of Canadian student ACE and assess&#xD;
      the effectiveness of MBSR as a tool for supporting the mental health of students who have&#xD;
      experienced significant ACE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2019</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>
    <intervention_model_description>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Data collected will be coded and codes will not be revealed to the investigators or outcome assessors until after data analysis is complete. The study participants will be told they are participating in an intervention to promote mental health but not told which of the 2 interventions is the active control.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Stress</measure>
    <time_frame>Pre and Post intervention (1 week)</time_frame>
    <description>Measure of current stress using the Perceived Stress Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rumination and Reflection</measure>
    <time_frame>Pre and post intervention (1 week)</time_frame>
    <description>Measured using the Rumination and Reflection Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forgiveness</measure>
    <time_frame>Pre and post intervention (1 week)</time_frame>
    <description>Measures using the Heartland Forgiveness Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hope</measure>
    <time_frame>Pre and post intervention (1 week)</time_frame>
    <description>Measured using the Adult Dispositional Hope Scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Adverse Childhood Experiences</condition>
  <condition>Mindfulness</condition>
  <condition>Students</condition>
  <arm_group>
    <arm_group_label>Experimental Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mindfulness Based Stress Resilience Training: This approach will be conducted with study participants for 4 weeks. One evening per week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Control Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Health Enhancement Program: This is a validated active comparator used in Mindfulness-based training studies. It will be conducted with the participants one evening per week for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness-based Stress Resilience Training</intervention_name>
    <description>Mindfulness is a form of cognitive training that cultivates self-regulative ability and enhances resilience</description>
    <arm_group_label>Experimental Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Enhancement Program</intervention_name>
    <description>This is a validated active control developed to serve as a control for mindfulness-based studies.</description>
    <arm_group_label>Active Control Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Post-secondary education students who are over the age of 18 and who had experienced&#xD;
             more than 3 Adverse Childhood Experiences&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons who had received prior training in mindfulness based approaches.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nancy Ross, PhD</last_name>
    <role>Study Director</role>
    <affiliation>School of Social Work, Faculty of Health,Dalhousie University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Robert Gilbert, PhD</last_name>
    <phone>9024713336</phone>
    <email>rob.gilbert@dal.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amy Munroe, BSc</last_name>
    <phone>9024944129</phone>
    <email>amy.munroe@dal.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dalhousie University</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Robert Gilbert, PhD</last_name>
      <phone>9024732791</phone>
      <email>rob.gilbert@dal.ca</email>
    </contact>
    <contact_backup>
      <last_name>Amy Munroe, BSc</last_name>
      <phone>9024944129</phone>
      <email>amy.munroe@dal.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dalhousie University</investigator_affiliation>
    <investigator_full_name>Rob Gilbert</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <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/NCT03836456
org study id: DalhousieU
nct id: NCT03836456
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to understand the prevalence of adverse childhood experiences
      (ACE) in students and to determine whether Mindfulness based stress resilience training
      (MBSR) is effective for promoting mental health in students with high ACE scores (>3). A
      double-blind randomized control study will examine the efficacy of MBSR in promoting positive
      change in measures of hope, rumination, forgiveness and stress.
The Adverse Childhood Experiences Study examined the physical health and psychosocial
      consequences of ACE across the lifespan. This study demonstrated adverse childhood
      experiences (ACE) prevalence to be high and a direct correlation between ACE scores (a tally
      of different types of abuse, neglect, and household dysfunction experienced under the age of
      18) and prevalence of physical health and psychosocial problems in adulthood. Adults with >3
      ACE are more likely to experience social underachievement (e.g. lower educational achievement
      and economic productivity), physical and mental health problems (e.g. depression, heart
      disease, suicide attempts, substance abuse) and unhealthy lifestyle behaviours (e.g. smoking,
      physical inactivity). Worldwide, ACE have been shown to be prevalent, independent of social
      and economic factors, and highly interrelated. 12.5% of subjects reported >4 ACE. Among
      post-secondary students, studies determined high ACE scores to be associated with higher
      prevalence of risk behaviours and physical health and psychosocial problems. Failure to
      support the physical and mental health of students can lead to increased attrition,
      deterioration of well-being, and intentional self-harm.

      Recognition of ACE prevalence and its consequences has been paralleled by the development of
      interventions for mitigating the lifetime health and social consequences of ACE. A 2016 study
      examining interventions believed to improve the mental health of adults with significant ACE
      (>3) identified mindfulness-based therapies (MBT) as being effective. Mindfulness is a form
      of cognitive training that cultivates self-regulative ability and enhances resilience.

      As no Canadian post-secondary institution has comprehensively investigated the prevalence of
      student ACE, the objective of this study is to understand the prevalence of ACE in students
      and to determine whether MBT is effective for promoting mental health in students with high
      ACE scores (>3).

      A double-blind randomized control study will examine the efficacy of MBT, specifically
      Mindfulness-based Stress Resilience Training (MBSR), in promoting positive change in measures
      of hope, rumination, forgiveness and distress. Interventions that positively effect these
      measures are known to enhance quality of life. First year students enrolled at Dalhousie
      University will be recruited. Subjects will complete an ACE questionnaire and those with >3
      ACE prior to age 18 will be invited to participate in this study. Students with prior MBT
      training will be excluded. Subjects will be randomized to one of two groups: MBSR or an
      established active control (Health Enhancement Program (HEP)). We selected MBSR because it is
      secular, codified, and the most scientifically studied mindfulness-based intervention to
      date. Power analyses determined 25 subjects per group is sufficient to detect a significant
      difference in outcomes across the groups. Interventionists and subjects will be blinded.
      Students will be led in group based MBSR or HEP for 4 weeks. Prior to and after the 4-week
      intervention subjects' outcomes will be determined using the: Perceived Stress Scale;
      Rumination and Reflection Questionnaire; Heartland Forgiveness Scale and; Adult Dispositional
      Hope Scale.

      Development of evidence-based programs that support the identification of ACE in students and
      identification of interventions that mitigate negative lifetime consequences of ACE outcomes
      is needed. This pilot study will increase understanding of Canadian student ACE and assess
      the effectiveness of MBSR as a tool for supporting the mental health of students who have
      experienced significant ACE.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Data collected will be coded and codes will not be revealed to the investigators or outcome assessors until after data analysis is complete. The study participants will be told they are participating in an intervention to promote mental health but not told which of the 2 interventions is the active control.
measure: Stress
time frame: Pre and Post intervention (1 week)
description: Measure of current stress using the Perceived Stress Scale
measure: Rumination and Reflection
time frame: Pre and post intervention (1 week)
description: Measured using the Rumination and Reflection Questionnaire
measure: Forgiveness
time frame: Pre and post intervention (1 week)
description: Measures using the Heartland Forgiveness Scale
measure: Hope
time frame: Pre and post intervention (1 week)
description: Measured using the Adult Dispositional Hope Scale
arm group label: Experimental Intervention
arm group type: Experimental
description: Mindfulness Based Stress Resilience Training: This approach will be conducted with study participants for 4 weeks. One evening per week.
arm group label: Active Control Intervention
arm group type: Active Comparator
description: Health Enhancement Program: This is a validated active comparator used in Mindfulness-based training studies. It will be conducted with the participants one evening per week for 4 weeks.
intervention type: Behavioral
intervention name: Mindfulness-based Stress Resilience Training
description: Mindfulness is a form of cognitive training that cultivates self-regulative ability and enhances resilience
arm group label: Experimental Intervention
intervention type: Behavioral
intervention name: Health Enhancement Program
description: This is a validated active control developed to serve as a control for mindfulness-based studies.
arm group label: Active Control Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nancy Ross, PhD
role: Study Director
affiliation: School of Social Work, Faculty of Health,Dalhousie University
last name: Robert Gilbert, PhD
phone: 9024713336
email: rob.gilbert@dal.ca
last name: Amy Munroe, BSc
phone: 9024944129
email: amy.munroe@dal.ca
facility: 
contact: 
contact backup: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Dalhousie University
investigator full name: Rob Gilbert
investigator title: Associate Professor
sharing ipd: No