<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/NCT01680419</url>
  </required_header>
  <id_info>
    <org_study_id>R44MH088063-02</org_study_id>
    <nct_id>NCT01680419</nct_id>
  </id_info>
  <brief_title>Mission Reconnect: Promoting Resilience and Reintegration of Post-Deployment Veterans and Their Families</brief_title>
  <official_title>Mission Reconnect: Promoting Resilience and Reintegration of Post-Deployment Veterans and Their Families</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Collinge and Associates, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Collinge and Associates, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An urgent and growing need exists for interventions that support the long-term adjustment and&#xD;
      mental health needs of OIF/OEF veterans and their relationship partners after the return from&#xD;
      deployment. This project will complete production of a multimedia intervention program for&#xD;
      autonomous use, delivered by Internet and mobile app technology, that teaches couples&#xD;
      selected mind/body interventions and massage techniques to promote stress reduction,&#xD;
      compassion, resiliency and relationship re-integration. A four-armed randomized trial will&#xD;
      evaluate mental health outcomes as a free-standing program and as complementary to a current&#xD;
      standard of care structured group program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is an urgent and growing need for mental health interventions supporting both short-&#xD;
      and long-term reintegration of veterans of OIF and OEF into their communities and significant&#xD;
      relationships. Innovative approaches are needed to support the well-being of veterans who may&#xD;
      not access or be reached by formal services.&#xD;
&#xD;
      OBJECTIVES. This Phase II project will complete development and evaluation of a&#xD;
      self-directed, home-based intervention to be used by OIF/OEF veterans and their loved ones to&#xD;
      aid in the readjustment process. &quot;Mission Reconnect&quot; is an integrated program of (1) guided&#xD;
      mind/body stress reduction and relaxation practices, (2) contemplative practices to engender&#xD;
      and support appreciation, empathy and forgiveness for oneself and one's loved ones, and (3)&#xD;
      video instruction in use of simple massage techniques with a partner for connection and&#xD;
      stress reduction. Feasibility was established in Phase I with high user satisfaction and&#xD;
      significant impact on measures of stress, depression, PTSD, and self-compassion, as well as&#xD;
      qualitative data. In Phase II We will complete and evaluate the full program in a four-arm&#xD;
      randomized controlled trial.&#xD;
&#xD;
      SPECIFIC AIMS. 1. Revise program content based on Phase I quantitative and qualitative data.&#xD;
      2. Film a diverse group of ten 10 veteran/partner dyads receiving and using revised material;&#xD;
      use video footage for the final program. 3. Produce high quality audio and video components&#xD;
      of the revised program. 4. Produce a multi-modal system for delivery of instructional&#xD;
      components that leverages innovations in web-based and mobile device technologies to maximize&#xD;
      access, utilization, and data collection. 5. Conduct an RCT with 160 dyads of OIF/OEF&#xD;
      veterans and their chosen partners. 6. Evaluate impact of intervention on measures of stress,&#xD;
      depression, PTSD symptoms, sleep quality, self-compassion, social support and relationship&#xD;
      satisfaction. 7. Evaluate program utilization and satisfaction, massage effects,&#xD;
      self-efficacy and satisfaction in users of the revised program.&#xD;
&#xD;
      IMPACT ON THE FIELD. Mission Reconnect offers a convenient, low cost resource helping users&#xD;
      develop wellness skills to reduce current and future distress, enhance empathy and improve&#xD;
      quality of life. The intervention can complement formal mental health services, or be used&#xD;
      alone. This is a potential aid to the two million OIF/OEF veterans, their partners and&#xD;
      families, as well as the 20 million living veterans of other eras, whose wounds of war can&#xD;
      last for decades if unaddressed.&#xD;
&#xD;
      INNOVATION. The project leverages the dyadic relationship as a context for reciprocal and&#xD;
      mutual use of complementary therapies for health promotion in both the veteran and partner.&#xD;
      Project technology utilizes state of the art mobile app design, seamless integration across&#xD;
      multiple devices, automated background data collection, and device-specific reminder alerts.&#xD;
&#xD;
      COMMERCIAL APPLICATION. The product will be marketed to family support programs of all&#xD;
      branches of the military, VA system, and the private sector, including non-profit veterans'&#xD;
      associations.&#xD;
&#xD;
      PRODUCT. Mission Reconnect is an integrated multimedia program deliverable over the Internet&#xD;
      and mobile devices, and hard copy (DVD, CD, manual).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Phase 2</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Perceived Stress Scale (PSS-10)</measure>
    <time_frame>Baseline, 2 months, 4 months</time_frame>
    <description>Change from baseline to 2 months and 4 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Beck Depression Inventory (BDI)</measure>
    <time_frame>Baseline, 2 months, 4 months</time_frame>
    <description>Change from baseline to 2 months and 4 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Posttraumatic Checklist-Civilian (PCL-C)</measure>
    <time_frame>Baseline, 2 months, 4 months</time_frame>
    <description>Change from baseline to 2 months and 4 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in The Self-Compassion Scale</measure>
    <time_frame>Baseline, 2 months, 4 months</time_frame>
    <description>Change from baseline to 2 months and 4 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Responses to Stressful Experiences Scale (RSES)</measure>
    <time_frame>Baseline, 2 months, 4 months</time_frame>
    <description>Change from baseline to 2 months and 4 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Multidimensional Perceived Social Support Scale (MPSSS)</measure>
    <time_frame>Baseline, 2 months, 4 months</time_frame>
    <description>Change from baseline to 2 months and 4 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pittsburgh Sleep Quality Index</measure>
    <time_frame>Baseline, 2 months, 4 months</time_frame>
    <description>Change from baseline to 2 months and 4 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Revised Dyadic Adjustment Scale (RDAS)</measure>
    <time_frame>Baseline, 2 months, 4 months</time_frame>
    <description>Change from baseline to 2 months and 4 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator-generated survey of use of stress reduction practices</measure>
    <time_frame>Weekly for 8 weeks, then at 4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator-generated survey on use of massage and massage effects</measure>
    <time_frame>Weekly for 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator-generated survey on self-efficacy using massage, and satisfaction giving and receiving the use of massage</measure>
    <time_frame>2 months, 4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator-generated ratings of program satisfaction</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">320</enrollment>
  <condition>Stress</condition>
  <condition>Depression</condition>
  <condition>PTSD</condition>
  <condition>Sleep</condition>
  <condition>Compassion</condition>
  <arm_group>
    <arm_group_label>Mission Reconnect only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Autonomous use of the Mission Reconnect multimedia instructional program at home.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PREP only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participation in a standard PREP for Strong Bonds weekend retreat program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PREP plus Mission Reconnect</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participation in a standard PREP for Strong Bonds weekend retreat followed by autonomous use of the Mission Reconnect multimedia instructional program at home.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention, followed by delivery of the Mission Reconnect multimedia program materials for home use after the end of the study period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mission Reconnect</intervention_name>
    <description>Multimedia package (audio, video, and print, web-based and downloadable to mobile devices) comprising an integrated program of (1) guided mind/body stress reduction and relaxation practices, (2) contemplative practices to engender and support appreciation, empathy and forgiveness for oneself and one's loved ones, and (3) video instruction in use of simple massage techniques with a partner for connection and stress reduction.</description>
    <arm_group_label>Mission Reconnect only</arm_group_label>
    <arm_group_label>PREP plus Mission Reconnect</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PREP</intervention_name>
    <description>The Army's &quot;PREP for Strong Bonds&quot; program offers retreats for partnered soldiers to support reintegration and healthy relationships. PREP (Prevention and Relationship Enhancement Program) for Strong Bonds is a standardized, evidence-based program conducted in a weekend residential retreat format with experiential exercises. The Army Chaplain Corps trains chaplains to facilitate the program. The manualized program uses methods from cognitive behavioral therapy and communication-oriented marital enhancement programs developed by Markman et al. at the Denver University Center for Marital and Family Studies. Topics include communication, conflict management, commitment, friendship, sensuality, problem-solving, and emotional supportiveness, among others.</description>
    <arm_group_label>PREP only</arm_group_label>
    <arm_group_label>PREP plus Mission Reconnect</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veteran of deployment in Operation Iraqi Freedom (OIF) or Operation Enduring Freedom&#xD;
             (OEF)&#xD;
&#xD;
          -  Partner or spouse of the veteran (veteran and partner/spouse must participate together&#xD;
             in the project)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Couples are ineligible who have previously attended a PREP for Strong Bonds program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William B Collinge, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Collinge and Associates, Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Janet R Kahn, PhD, LMT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peace Village Projects, Inc.</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://www.missionreconnect.com</url>
    <description>Website home of the Mission Reconnect Program</description>
  </link>
  <reference>
    <citation>Collinge W, Kahn J, Soltysik R. Promoting reintegration of National Guard veterans and their partners using a self-directed program of integrative therapies: a pilot study. Mil Med. 2012 Dec;177(12):1477-85. doi: 10.7205/milmed-d-12-00121.</citation>
    <PMID>23397692</PMID>
  </reference>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>July 31, 2015</last_update_submitted>
  <last_update_submitted_qc>July 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Collinge and Associates, Inc.</investigator_affiliation>
    <investigator_full_name>William Collinge, PhD</investigator_full_name>
    <investigator_title>President</investigator_title>
  </responsible_party>
  <keyword>Veterans</keyword>
  <keyword>Reintegration</keyword>
  <keyword>Resilience</keyword>
  <keyword>Marital</keyword>
  <keyword>Spouse</keyword>
  <keyword>Behavioral intervention</keyword>
  <keyword>PTSD</keyword>
  <keyword>Integrative therapies</keyword>
  <keyword>Complementary therapies</keyword>
  <keyword>Massage</keyword>
  <keyword>Meditation</keyword>
  <keyword>Mindfulness</keyword>
  <keyword>Compassion</keyword>
  <keyword>Mental health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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/NCT01680419
org study id: R44MH088063-02
nct id: NCT01680419
lead sponsor: 
has dmc: No
An urgent and growing need exists for interventions that support the long-term adjustment and
      mental health needs of OIF/OEF veterans and their relationship partners after the return from
      deployment. This project will complete production of a multimedia intervention program for
      autonomous use, delivered by Internet and mobile app technology, that teaches couples
      selected mind/body interventions and massage techniques to promote stress reduction,
      compassion, resiliency and relationship re-integration. A four-armed randomized trial will
      evaluate mental health outcomes as a free-standing program and as complementary to a current
      standard of care structured group program.
There is an urgent and growing need for mental health interventions supporting both short-
      and long-term reintegration of veterans of OIF and OEF into their communities and significant
      relationships. Innovative approaches are needed to support the well-being of veterans who may
      not access or be reached by formal services.

      OBJECTIVES. This Phase II project will complete development and evaluation of a
      self-directed, home-based intervention to be used by OIF/OEF veterans and their loved ones to
      aid in the readjustment process. "Mission Reconnect" is an integrated program of (1) guided
      mind/body stress reduction and relaxation practices, (2) contemplative practices to engender
      and support appreciation, empathy and forgiveness for oneself and one's loved ones, and (3)
      video instruction in use of simple massage techniques with a partner for connection and
      stress reduction. Feasibility was established in Phase I with high user satisfaction and
      significant impact on measures of stress, depression, PTSD, and self-compassion, as well as
      qualitative data. In Phase II We will complete and evaluate the full program in a four-arm
      randomized controlled trial.

      SPECIFIC AIMS. 1. Revise program content based on Phase I quantitative and qualitative data.
      2. Film a diverse group of ten 10 veteran/partner dyads receiving and using revised material;
      use video footage for the final program. 3. Produce high quality audio and video components
      of the revised program. 4. Produce a multi-modal system for delivery of instructional
      components that leverages innovations in web-based and mobile device technologies to maximize
      access, utilization, and data collection. 5. Conduct an RCT with 160 dyads of OIF/OEF
      veterans and their chosen partners. 6. Evaluate impact of intervention on measures of stress,
      depression, PTSD symptoms, sleep quality, self-compassion, social support and relationship
      satisfaction. 7. Evaluate program utilization and satisfaction, massage effects,
      self-efficacy and satisfaction in users of the revised program.

      IMPACT ON THE FIELD. Mission Reconnect offers a convenient, low cost resource helping users
      develop wellness skills to reduce current and future distress, enhance empathy and improve
      quality of life. The intervention can complement formal mental health services, or be used
      alone. This is a potential aid to the two million OIF/OEF veterans, their partners and
      families, as well as the 20 million living veterans of other eras, whose wounds of war can
      last for decades if unaddressed.

      INNOVATION. The project leverages the dyadic relationship as a context for reciprocal and
      mutual use of complementary therapies for health promotion in both the veteran and partner.
      Project technology utilizes state of the art mobile app design, seamless integration across
      multiple devices, automated background data collection, and device-specific reminder alerts.

      COMMERCIAL APPLICATION. The product will be marketed to family support programs of all
      branches of the military, VA system, and the private sector, including non-profit veterans'
      associations.

      PRODUCT. Mission Reconnect is an integrated multimedia program deliverable over the Internet
      and mobile devices, and hard copy (DVD, CD, manual).
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Change in Perceived Stress Scale (PSS-10)
time frame: Baseline, 2 months, 4 months
description: Change from baseline to 2 months and 4 months
measure: Change in Beck Depression Inventory (BDI)
time frame: Baseline, 2 months, 4 months
description: Change from baseline to 2 months and 4 months
measure: Change in Posttraumatic Checklist-Civilian (PCL-C)
time frame: Baseline, 2 months, 4 months
description: Change from baseline to 2 months and 4 months
measure: Change in The Self-Compassion Scale
time frame: Baseline, 2 months, 4 months
description: Change from baseline to 2 months and 4 months
measure: Change in Responses to Stressful Experiences Scale (RSES)
time frame: Baseline, 2 months, 4 months
description: Change from baseline to 2 months and 4 months
measure: Change in Multidimensional Perceived Social Support Scale (MPSSS)
time frame: Baseline, 2 months, 4 months
description: Change from baseline to 2 months and 4 months
measure: Change in Pittsburgh Sleep Quality Index
time frame: Baseline, 2 months, 4 months
description: Change from baseline to 2 months and 4 months
measure: Change in Revised Dyadic Adjustment Scale (RDAS)
time frame: Baseline, 2 months, 4 months
description: Change from baseline to 2 months and 4 months
measure: Investigator-generated survey of use of stress reduction practices
time frame: Weekly for 8 weeks, then at 4 months
measure: Investigator-generated survey on use of massage and massage effects
time frame: Weekly for 8 weeks
measure: Investigator-generated survey on self-efficacy using massage, and satisfaction giving and receiving the use of massage
time frame: 2 months, 4 months
measure: Investigator-generated ratings of program satisfaction
time frame: 4 months
arm group label: Mission Reconnect only
arm group type: Experimental
description: Autonomous use of the Mission Reconnect multimedia instructional program at home.
arm group label: PREP only
arm group type: Active Comparator
description: Participation in a standard PREP for Strong Bonds weekend retreat program.
arm group label: PREP plus Mission Reconnect
arm group type: Active Comparator
description: Participation in a standard PREP for Strong Bonds weekend retreat followed by autonomous use of the Mission Reconnect multimedia instructional program at home.
arm group label: Wait-list control
arm group type: No Intervention
description: No intervention, followed by delivery of the Mission Reconnect multimedia program materials for home use after the end of the study period.
intervention type: Behavioral
intervention name: Mission Reconnect
description: Multimedia package (audio, video, and print, web-based and downloadable to mobile devices) comprising an integrated program of (1) guided mind/body stress reduction and relaxation practices, (2) contemplative practices to engender and support appreciation, empathy and forgiveness for oneself and one's loved ones, and (3) video instruction in use of simple massage techniques with a partner for connection and stress reduction.
arm group label: Mission Reconnect only
arm group label: PREP plus Mission Reconnect
intervention type: Behavioral
intervention name: PREP
description: The Army's "PREP for Strong Bonds" program offers retreats for partnered soldiers to support reintegration and healthy relationships. PREP (Prevention and Relationship Enhancement Program) for Strong Bonds is a standardized, evidence-based program conducted in a weekend residential retreat format with experiential exercises. The Army Chaplain Corps trains chaplains to facilitate the program. The manualized program uses methods from cognitive behavioral therapy and communication-oriented marital enhancement programs developed by Markman et al. at the Denver University Center for Marital and Family Studies. Topics include communication, conflict management, commitment, friendship, sensuality, problem-solving, and emotional supportiveness, among others.
arm group label: PREP only
arm group label: PREP plus Mission Reconnect
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: William B Collinge, PhD, MPH
role: Principal Investigator
affiliation: Collinge and Associates, Inc.
last name: Janet R Kahn, PhD, LMT
role: Principal Investigator
affiliation: Peace Village Projects, Inc.
country: United States
url: http://www.missionreconnect.com
description: Website home of the Mission Reconnect Program
citation: Collinge W, Kahn J, Soltysik R. Promoting reintegration of National Guard veterans and their partners using a self-directed program of integrative therapies: a pilot study. Mil Med. 2012 Dec;177(12):1477-85. doi: 10.7205/milmed-d-12-00121.
PMID: 23397692
responsible party type: Principal Investigator
investigator affiliation: Collinge and Associates, Inc.
investigator full name: William Collinge, PhD
investigator title: President
mesh term: Depression