Completed

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

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What is being tested

Mission Reconnect

+ PREP

+ Mission Reconnect

Behavioral
Who is being recruted

Trauma and Stressor Related Disorders+6

+ Behavior

+ Mental Disorders

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Phase 2
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorCollinge and Associates, Inc.
Last updated: August 4, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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).

Principal SponsorCollinge and Associates, Inc.
Last updated: August 4, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

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

320 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Trauma and Stressor Related DisordersBehaviorMental DisordersBehavioral SymptomsPersonal SatisfactionStress Disorders, TraumaticPsychological Well-BeingDepressionStress Disorders, Post-Traumatic

Criteria

2 inclusion criteria required to participate
Partner or spouse of the veteran (veteran and partner/spouse must participate together in the project)

Veteran of deployment in Operation Iraqi Freedom (OIF) or Operation Enduring Freedom (OEF)

1 exclusion criteria prevent from participating
Couples are ineligible who have previously attended a PREP for Strong Bonds program

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Group III

Active Comparator
Participation in a standard PREP for Strong Bonds weekend retreat followed by autonomous use of the Mission Reconnect multimedia instructional program at home.

Group IV

No Intervention
No intervention, followed by delivery of the Mission Reconnect multimedia program materials for home use after the end of the study period.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers