Mission Reconnect: Promoting Resilience and Reintegration of Post-Deployment Veterans and Their Families

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by Collinge and Associates
Sponsor:
Information provided by (Responsible Party):
Collinge and Associates
ClinicalTrials.gov Identifier:
NCT01680419
First received: August 31, 2012
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Veterans Health
Combat Stress Disorders
Resilience, Psychological
Marital Conflict
Mental Health
Behavioral: Mission Reconnect
Behavioral: PREP
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Mission Reconnect: Promoting Resilience and Reintegration of Post-Deployment Veterans and Their Families

Resource links provided by NLM:


Further study details as provided by Collinge and Associates:

Primary Outcome Measures:
  • Change in Perceived Stress Scale (PSS-10) [ Time Frame: Baseline, 2 months, 4 months ] [ Designated as safety issue: No ]
    Change from baseline to 2 months and 4 months

  • Change in Beck Depression Inventory (BDI) [ Time Frame: Baseline, 2 months, 4 months ] [ Designated as safety issue: No ]
    Change from baseline to 2 months and 4 months

  • Change in Posttraumatic Checklist-Civilian (PCL-C) [ Time Frame: Baseline, 2 months, 4 months ] [ Designated as safety issue: No ]
    Change from baseline to 2 months and 4 months

  • Change in The Self-Compassion Scale [ Time Frame: Baseline, 2 months, 4 months ] [ Designated as safety issue: No ]
    Change from baseline to 2 months and 4 months

  • Change in Responses to Stressful Experiences Scale (RSES) [ Time Frame: Baseline, 2 months, 4 months ] [ Designated as safety issue: No ]
    Change from baseline to 2 months and 4 months


Secondary Outcome Measures:
  • Change in Multidimensional Perceived Social Support Scale (MPSSS) [ Time Frame: Baseline, 2 months, 4 months ] [ Designated as safety issue: No ]
    Change from baseline to 2 months and 4 months

  • Change in Pittsburgh Sleep Quality Index [ Time Frame: Baseline, 2 months, 4 months ] [ Designated as safety issue: No ]
    Change from baseline to 2 months and 4 months

  • Change in Revised Dyadic Adjustment Scale (RDAS) [ Time Frame: Baseline, 2 months, 4 months ] [ Designated as safety issue: No ]
    Change from baseline to 2 months and 4 months

  • Investigator-generated survey of use of stress reduction practices [ Time Frame: Weekly for 8 weeks, then at 4 months ] [ Designated as safety issue: No ]
  • Investigator-generated survey on use of massage and massage effects [ Time Frame: Weekly for 8 weeks ] [ Designated as safety issue: No ]
  • Investigator-generated survey on self-efficacy using massage, and satisfaction giving and receiving the use of massage [ Time Frame: 2 months, 4 months ] [ Designated as safety issue: No ]
  • Investigator-generated ratings of program satisfaction [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: December 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mission Reconnect only
Autonomous use of the Mission Reconnect multimedia instructional program at home.
Behavioral: Mission Reconnect
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.
Active Comparator: PREP only
Participation in a standard PREP for Strong Bonds weekend retreat program.
Behavioral: PREP
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.
Active Comparator: PREP plus Mission Reconnect
Participation in a standard PREP for Strong Bonds weekend retreat followed by autonomous use of the Mission Reconnect multimedia instructional program at home.
Behavioral: Mission Reconnect
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.
Behavioral: PREP
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.
No Intervention: Wait-list control
No intervention, followed by delivery of the Mission Reconnect multimedia program materials for home use after the end of the study period.

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Veteran of deployment in Operation Iraqi Freedom (OIF) or Operation Enduring Freedom (OEF)
  • Partner or spouse of the veteran (veteran and partner/spouse must participate together in the project)

Exclusion Criteria:

  • Couples are ineligible who have previously attended a PREP for Strong Bonds program
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680419

Contacts
Contact: William B Collinge, PhD, MPH (207)423-0640 william@collinge.org
Contact: Janet R Kahn, PhD, LMT 802-658-8525 jkahn@igc.org

Locations
United States, Maine
Collinge and Associates Not yet recruiting
Kittery, Maine, United States, 03904
Contact: William B Collinge, PhD, MPH    207-423-0640    william@collinge.org   
Contact: Janet R Kahn, PhD, LMT    802-658-8525    jkahn@igc.org   
Principal Investigator: William B Collinge, PhD, MPH         
Principal Investigator: Janet R Kahn, PhD, LMT         
United States, Oregon
Collinge and Associates Not yet recruiting
Eugene, Oregon, United States, 97405
Contact: William B Collinge, PhD, MPH    207-423-0640    william@collinge.org   
Contact: Janet R Kahn, PhD, LMT    802-658-8525    jkahn@igc.org   
Principal Investigator: William B Collinge, PhD, MPH         
Principal Investigator: Janet R Kahn, PhD, LMT         
Sponsors and Collaborators
Collinge and Associates
Investigators
Principal Investigator: William B Collinge, PhD, MPH Collinge and Associates
Principal Investigator: Janet R Kahn, PhD, LMT Peace Village Projects, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Collinge and Associates
ClinicalTrials.gov Identifier: NCT01680419     History of Changes
Other Study ID Numbers: R44MH088063-02
Study First Received: August 31, 2012
Last Updated: September 4, 2012
Health Authority: United States: National Institutes of Health

Keywords provided by Collinge and Associates:
Veterans
Reintegration
Resilience
Marital
Spouse
Behavioral intervention
PTSD
Integrative therapies
Complementary therapies
Massage
Meditation
Mindfulness
Compassion
Mental health

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Combat Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014