<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/NCT03308344</url>
  </required_header>
  <id_info>
    <org_study_id>20120295</org_study_id>
    <nct_id>NCT03308344</nct_id>
  </id_info>
  <brief_title>Mindfulness Training in Military Spouses</brief_title>
  <official_title>Promoting Wellbeing in Military Spouses With Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</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>
      This project aims to contextualize the delivery of mindfulness training for military spouses&#xD;
      and evaluate its effectiveness on measures of executive functions and psychological&#xD;
      well-being.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In addition to psychological and physical health challenges that military service members&#xD;
      face, military deployment is known to have deleterious effects on the entire family unit. The&#xD;
      January 2010 issue of the New England Journal of Medicine reported medical data from over&#xD;
      250,000 wives of deployed soldiers. These women suffered from clinically significant levels&#xD;
      of anxiety, depression, sleep disturbances, and adjustment disorders. Thus, the psychological&#xD;
      profile of military spouses sadly parallels that of the military servicemembers.&#xD;
      Unfortunately, the effect of deployment on the psychological health in military spouses is&#xD;
      largely unstudied, and very few resilience-building programs are available for military&#xD;
      families.&#xD;
&#xD;
      Prior research showed that mindfulness training (MT), as a resilience-building program in&#xD;
      civilian and military servicemembers, can effectively protect against degradation in of&#xD;
      executive functions (i.e., attention, working memory) and benefit psychological well-being&#xD;
      over high-demand intervals. While research evidence mounts that MT is beneficial for service&#xD;
      members, there is almost no research examining the impact of MT on military spouses'&#xD;
      cognitive functioning and psychological well-being.&#xD;
&#xD;
      The present study aims to investigate if MT may successfully benefit cognitive functioning&#xD;
      and psychological well-being in military spouses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants will be assigned into three groups: (i) a mindfulness training with spouse trainers (MT-ST, n = 60) that will receive the training from peers who underwent an extensive training practicum; (ii) a mindfulness training with mindfulness expert trainer group (MT-ME, n = 30) that will receive the training from a mindfulness expert trainer; and (ii) a wait-list control group (WLC, n = 30) that will be tested before and after a no-training interval and may receive MT at a later time after their second testing if they are interested.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Sustained Attention to Response Task (SART)</measure>
    <time_frame>Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.</time_frame>
    <description>SART is used to assess attentional performance and mind wandering. The task uses a continuous performance paradigm involving button presses to frequently presented non-targets (numbers 1, 2, 4, 5, 6, 7, 8, and 9) but requires the participants to withhold their motor response to the infrequent target (number 3). The subjective experience of mind wandering during SART is assessed through experience sampling probes randomly presented throughout the task.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Working Memory task (WM)</measure>
    <time_frame>Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.</time_frame>
    <description>WMMW is used to assess working memory performance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Positive and Negative Affect Scale (PANAS)</measure>
    <time_frame>Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.</time_frame>
    <description>PANAS assesses positive and negative affect. It consists of a list of descriptors of positive (e.g., 'interested', 'enthusiastic') and negative (e.g., 'irritable', 'upset') affects. Items are rated on a 5-point scale (1 = very slightly or not at all, 5 = extremely), according to how participants feel. The Positive Affect scale reflects the extent to which a person feels enthusiastic, active, and alert; the Negative Affect scale reflects unpleasant mood states, such as anger, disgust, and fear.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Perceived Stress Scale (PSS)</measure>
    <time_frame>Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.</time_frame>
    <description>PSS assesses the degree to which situations in one's life are viewed as stressful within the past month. Individual items assess feelings of stress, nervousness, irritation at life's hassles, and perceptions of one's own coping and control over a situation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-Compassion Scale (SCQ)</measure>
    <time_frame>Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.</time_frame>
    <description>SCQ assesses self-compassion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Center for Epidemiological Studies Depression Scale (CES-D)</measure>
    <time_frame>Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.</time_frame>
    <description>This 20-item scale measures the major components of depressive symptomatology in the general population (i.e., nonpsychiatric persons older than 18).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Anxiety Sensitivity Index (ASI)</measure>
    <time_frame>Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.</time_frame>
    <description>ASI assesses the construct of anxiety sensitivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Perseverative Thoughts Questionnaire (PTQ)</measure>
    <time_frame>Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.</time_frame>
    <description>PTQ assesses stress due to reoccurring thoughts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Marital Satisfaction</measure>
    <time_frame>Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.</time_frame>
    <description>Marital Satisfaction questionnaire assesses the level of marital satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Practice Logs</measure>
    <time_frame>Participants will complete paper practice logs tracking their daily practice (i.e., minutes) from the beginning through the study completion, which is an average of 5 weeks after the beginning of the intervention.</time_frame>
    <description>Practice logs will be used to keep track of participants' daily mindfulness practice.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic Questions</measure>
    <time_frame>Demographic questions will only be asked at the pre-intervention baseline (testing 1).</time_frame>
    <description>General demographic questions will be asked to gather information about the participants, i.e. gender, age, partner ranking, partner deployment status etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cognitive Failures Questionnaire (CFQ)</measure>
    <time_frame>Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.</time_frame>
    <description>CFQ assesses one's attention and awareness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feedback regarding the training</measure>
    <time_frame>Feedback questions will be asked only at the second testing session (testing 2), which is an average of 5 weeks from the baseline.</time_frame>
    <description>If participants were part of any of the training groups, they will be asked to provide feedback of the training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feedback regarding the testing</measure>
    <time_frame>Feedback questions will be asked only at the second testing session (testing 2), which is an average of 5 weeks from the baseline.</time_frame>
    <description>A 10-item questionnaire for participants to express their views and motivations about the tasks completed during the testing session.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General questions regarding life tendencies</measure>
    <time_frame>Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.</time_frame>
    <description>General questions regarding life tendencies in a variety of situations during the past two weeks.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Psychological Stress</condition>
  <arm_group>
    <arm_group_label>Spouse Trainers (MT-ST)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will engage in a short-form mindfulness training delivered by their peers who underwent an extensive training practicum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will be tested before and after a no-training interval and may receive training at a later time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mindfulness Expert (MT-ME)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will engage in a short-form mindfulness training delivered by an expert mindfulness trainer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness training</intervention_name>
    <description>The present MT program includes topics related to mindfulness, emotion regulation, and connection. It will be delivered in short, weekly sessions.</description>
    <arm_group_label>Mindfulness Expert (MT-ME)</arm_group_label>
    <arm_group_label>Spouse Trainers (MT-ST)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Being in a relationship or married to U.S. Army active-duty member or veteran.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A non-controlled severe medical disease that might interfere with the performance in&#xD;
             the study.&#xD;
&#xD;
          -  Any other condition that the investigator might deem problematic for the inclusion of&#xD;
             the volunteer in a training study of this nature.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amishi Jha, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Jha AP, Morrison AB, Dainer-Best J, Parker S, Rostrup N, Stanley EA. Minds &quot;at attention&quot;: mindfulness training curbs attentional lapses in military cohorts. PLoS One. 2015 Feb 11;10(2):e0116889. doi: 10.1371/journal.pone.0116889. eCollection 2015.</citation>
    <PMID>25671579</PMID>
  </reference>
  <reference>
    <citation>Jha AP, Stanley EA, Kiyonaga A, Wong L, Gelfand L. Examining the protective effects of mindfulness training on working memory capacity and affective experience. Emotion. 2010 Feb;10(1):54-64. doi: 10.1037/a0018438.</citation>
    <PMID>20141302</PMID>
  </reference>
  <reference>
    <citation>Mansfield AJ, Kaufman JS, Marshall SW, Gaynes BN, Morrissey JP, Engel CC. Deployment and the use of mental health services among U.S. Army wives. N Engl J Med. 2010 Jan 14;362(2):101-9. doi: 10.1056/NEJMoa0900177.</citation>
    <PMID>20071699</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>October 6, 2017</study_first_submitted>
  <study_first_submitted_qc>October 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>August 2, 2019</last_update_submitted>
  <last_update_submitted_qc>August 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Amishi Jha</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</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/NCT03308344
org study id: 20120295
nct id: NCT03308344
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project aims to contextualize the delivery of mindfulness training for military spouses
      and evaluate its effectiveness on measures of executive functions and psychological
      well-being.
In addition to psychological and physical health challenges that military service members
      face, military deployment is known to have deleterious effects on the entire family unit. The
      January 2010 issue of the New England Journal of Medicine reported medical data from over
      250,000 wives of deployed soldiers. These women suffered from clinically significant levels
      of anxiety, depression, sleep disturbances, and adjustment disorders. Thus, the psychological
      profile of military spouses sadly parallels that of the military servicemembers.
      Unfortunately, the effect of deployment on the psychological health in military spouses is
      largely unstudied, and very few resilience-building programs are available for military
      families.

      Prior research showed that mindfulness training (MT), as a resilience-building program in
      civilian and military servicemembers, can effectively protect against degradation in of
      executive functions (i.e., attention, working memory) and benefit psychological well-being
      over high-demand intervals. While research evidence mounts that MT is beneficial for service
      members, there is almost no research examining the impact of MT on military spouses'
      cognitive functioning and psychological well-being.

      The present study aims to investigate if MT may successfully benefit cognitive functioning
      and psychological well-being in military spouses.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be assigned into three groups: (i) a mindfulness training with spouse trainers (MT-ST, n = 60) that will receive the training from peers who underwent an extensive training practicum; (ii) a mindfulness training with mindfulness expert trainer group (MT-ME, n = 30) that will receive the training from a mindfulness expert trainer; and (ii) a wait-list control group (WLC, n = 30) that will be tested before and after a no-training interval and may receive MT at a later time after their second testing if they are interested.
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in Sustained Attention to Response Task (SART)
time frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
description: SART is used to assess attentional performance and mind wandering. The task uses a continuous performance paradigm involving button presses to frequently presented non-targets (numbers 1, 2, 4, 5, 6, 7, 8, and 9) but requires the participants to withhold their motor response to the infrequent target (number 3). The subjective experience of mind wandering during SART is assessed through experience sampling probes randomly presented throughout the task.
measure: Change in Working Memory task (WM)
time frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
description: WMMW is used to assess working memory performance
measure: Change in Positive and Negative Affect Scale (PANAS)
time frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
description: PANAS assesses positive and negative affect. It consists of a list of descriptors of positive (e.g., 'interested', 'enthusiastic') and negative (e.g., 'irritable', 'upset') affects. Items are rated on a 5-point scale (1 = very slightly or not at all, 5 = extremely), according to how participants feel. The Positive Affect scale reflects the extent to which a person feels enthusiastic, active, and alert; the Negative Affect scale reflects unpleasant mood states, such as anger, disgust, and fear.
measure: Change in Perceived Stress Scale (PSS)
time frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
description: PSS assesses the degree to which situations in one's life are viewed as stressful within the past month. Individual items assess feelings of stress, nervousness, irritation at life's hassles, and perceptions of one's own coping and control over a situation.
measure: Change in Self-Compassion Scale (SCQ)
time frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
description: SCQ assesses self-compassion.
measure: Change in Center for Epidemiological Studies Depression Scale (CES-D)
time frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
description: This 20-item scale measures the major components of depressive symptomatology in the general population (i.e., nonpsychiatric persons older than 18).
measure: Change in Anxiety Sensitivity Index (ASI)
time frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
description: ASI assesses the construct of anxiety sensitivity.
measure: Change in Perseverative Thoughts Questionnaire (PTQ)
time frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
description: PTQ assesses stress due to reoccurring thoughts
measure: Change in Marital Satisfaction
time frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
description: Marital Satisfaction questionnaire assesses the level of marital satisfaction.
measure: Practice Logs
time frame: Participants will complete paper practice logs tracking their daily practice (i.e., minutes) from the beginning through the study completion, which is an average of 5 weeks after the beginning of the intervention.
description: Practice logs will be used to keep track of participants' daily mindfulness practice.
measure: Demographic Questions
time frame: Demographic questions will only be asked at the pre-intervention baseline (testing 1).
description: General demographic questions will be asked to gather information about the participants, i.e. gender, age, partner ranking, partner deployment status etc.
measure: Change in Cognitive Failures Questionnaire (CFQ)
time frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
description: CFQ assesses one's attention and awareness.
measure: Feedback regarding the training
time frame: Feedback questions will be asked only at the second testing session (testing 2), which is an average of 5 weeks from the baseline.
description: If participants were part of any of the training groups, they will be asked to provide feedback of the training.
measure: Feedback regarding the testing
time frame: Feedback questions will be asked only at the second testing session (testing 2), which is an average of 5 weeks from the baseline.
description: A 10-item questionnaire for participants to express their views and motivations about the tasks completed during the testing session.
measure: General questions regarding life tendencies
time frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
description: General questions regarding life tendencies in a variety of situations during the past two weeks.
arm group label: Spouse Trainers (MT-ST)
arm group type: Experimental
description: Participants will engage in a short-form mindfulness training delivered by their peers who underwent an extensive training practicum.
arm group label: Wait-list control
arm group type: No Intervention
description: Participants will be tested before and after a no-training interval and may receive training at a later time.
arm group label: Mindfulness Expert (MT-ME)
arm group type: Experimental
description: Participants will engage in a short-form mindfulness training delivered by an expert mindfulness trainer.
intervention type: Behavioral
intervention name: Mindfulness training
description: The present MT program includes topics related to mindfulness, emotion regulation, and connection. It will be delivered in short, weekly sessions.
arm group label: Mindfulness Expert (MT-ME)
arm group label: Spouse Trainers (MT-ST)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amishi Jha, Ph.D.
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
citation: Jha AP, Morrison AB, Dainer-Best J, Parker S, Rostrup N, Stanley EA. Minds "at attention": mindfulness training curbs attentional lapses in military cohorts. PLoS One. 2015 Feb 11;10(2):e0116889. doi: 10.1371/journal.pone.0116889. eCollection 2015.
PMID: 25671579
citation: Jha AP, Stanley EA, Kiyonaga A, Wong L, Gelfand L. Examining the protective effects of mindfulness training on working memory capacity and affective experience. Emotion. 2010 Feb;10(1):54-64. doi: 10.1037/a0018438.
PMID: 20141302
citation: Mansfield AJ, Kaufman JS, Marshall SW, Gaynes BN, Morrissey JP, Engel CC. Deployment and the use of mental health services among U.S. Army wives. N Engl J Med. 2010 Jan 14;362(2):101-9. doi: 10.1056/NEJMoa0900177.
PMID: 20071699
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Amishi Jha
investigator title: Associate Professor
mesh term: Stress, Psychological
sharing ipd: No