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

July 31, 2015 updated by: William Collinge, PhD, Collinge and Associates, Inc.
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.

Study Overview

Status

Completed

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).

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mission Reconnect only
Autonomous use of the Mission Reconnect multimedia instructional program at home.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Perceived Stress Scale (PSS-10)
Time Frame: Baseline, 2 months, 4 months
Change from baseline to 2 months and 4 months
Baseline, 2 months, 4 months
Change in Beck Depression Inventory (BDI)
Time Frame: Baseline, 2 months, 4 months
Change from baseline to 2 months and 4 months
Baseline, 2 months, 4 months
Change in Posttraumatic Checklist-Civilian (PCL-C)
Time Frame: Baseline, 2 months, 4 months
Change from baseline to 2 months and 4 months
Baseline, 2 months, 4 months
Change in The Self-Compassion Scale
Time Frame: Baseline, 2 months, 4 months
Change from baseline to 2 months and 4 months
Baseline, 2 months, 4 months
Change in Responses to Stressful Experiences Scale (RSES)
Time Frame: Baseline, 2 months, 4 months
Change from baseline to 2 months and 4 months
Baseline, 2 months, 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Multidimensional Perceived Social Support Scale (MPSSS)
Time Frame: Baseline, 2 months, 4 months
Change from baseline to 2 months and 4 months
Baseline, 2 months, 4 months
Change in Pittsburgh Sleep Quality Index
Time Frame: Baseline, 2 months, 4 months
Change from baseline to 2 months and 4 months
Baseline, 2 months, 4 months
Change in Revised Dyadic Adjustment Scale (RDAS)
Time Frame: Baseline, 2 months, 4 months
Change from baseline to 2 months and 4 months
Baseline, 2 months, 4 months
Investigator-generated survey of use of stress reduction practices
Time Frame: Weekly for 8 weeks, then at 4 months
Weekly for 8 weeks, then at 4 months
Investigator-generated survey on use of massage and massage effects
Time Frame: Weekly for 8 weeks
Weekly for 8 weeks
Investigator-generated survey on self-efficacy using massage, and satisfaction giving and receiving the use of massage
Time Frame: 2 months, 4 months
2 months, 4 months
Investigator-generated ratings of program satisfaction
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: William B Collinge, PhD, MPH, Collinge and Associates, Inc.
  • Principal Investigator: Janet R Kahn, PhD, LMT, Peace Village Projects, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

August 31, 2012

First Submitted That Met QC Criteria

September 4, 2012

First Posted (Estimate)

September 7, 2012

Study Record Updates

Last Update Posted (Estimate)

August 4, 2015

Last Update Submitted That Met QC Criteria

July 31, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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