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

NCT ID: NCT01680419

Last Updated: 2015-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Depression PTSD Sleep Compassion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mission Reconnect only

Autonomous use of the Mission Reconnect multimedia instructional program at home.

Group Type EXPERIMENTAL

Mission Reconnect

Intervention Type BEHAVIORAL

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.

PREP only

Participation in a standard PREP for Strong Bonds weekend retreat program.

Group Type ACTIVE_COMPARATOR

PREP

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Mission Reconnect

Intervention Type BEHAVIORAL

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.

PREP

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Collinge and Associates, Inc.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

William Collinge, PhD

President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

William B Collinge, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Collinge and Associates, Inc.

Janet R Kahn, PhD, LMT

Role: PRINCIPAL_INVESTIGATOR

Peace Village Projects, Inc.

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23397692 (View on PubMed)

Kahn JR, Collinge W, Soltysik R. Post-9/11 Veterans and Their Partners Improve Mental Health Outcomes with a Self-directed Mobile and Web-based Wellness Training Program: A Randomized Controlled Trial. J Med Internet Res. 2016 Sep 27;18(9):e255. doi: 10.2196/jmir.5800.

Reference Type DERIVED
PMID: 27678169 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.missionreconnect.com

Website home of the Mission Reconnect Program

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R44MH088063-02

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Improving Cognitive Rehabilitation Outcomes
NCT07055633 NOT_YET_RECRUITING NA