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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01680419
• Other study ID #: R44MH088063-02
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2012
• Last updated: July 31, 2015
• Start date: September 2012
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Collinge and Associates, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Compassion
• Depression
• PTSD
• Sleep
• Stress

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Collinge and Associates, Inc.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Perceived Stress Scale (PSS-10)	Change from baseline to 2 months and 4 months	Baseline, 2 months, 4 months	No
Primary	Change in Beck Depression Inventory (BDI)	Change from baseline to 2 months and 4 months	Baseline, 2 months, 4 months	No
Primary	Change in Posttraumatic Checklist-Civilian (PCL-C)	Change from baseline to 2 months and 4 months	Baseline, 2 months, 4 months	No
Primary	Change in The Self-Compassion Scale	Change from baseline to 2 months and 4 months	Baseline, 2 months, 4 months	No
Primary	Change in Responses to Stressful Experiences Scale (RSES)	Change from baseline to 2 months and 4 months	Baseline, 2 months, 4 months	No
Secondary	Change in Multidimensional Perceived Social Support Scale (MPSSS)	Change from baseline to 2 months and 4 months	Baseline, 2 months, 4 months	No
Secondary	Change in Pittsburgh Sleep Quality Index	Change from baseline to 2 months and 4 months	Baseline, 2 months, 4 months	No
Secondary	Change in Revised Dyadic Adjustment Scale (RDAS)	Change from baseline to 2 months and 4 months	Baseline, 2 months, 4 months	No
Secondary	Investigator-generated survey of use of stress reduction practices		Weekly for 8 weeks, then at 4 months	No
Secondary	Investigator-generated survey on use of massage and massage effects		Weekly for 8 weeks	No
Secondary	Investigator-generated survey on self-efficacy using massage, and satisfaction giving and receiving the use of massage		2 months, 4 months	No
Secondary	Investigator-generated ratings of program satisfaction		4 months	No

External Links

•   Additional project information
•   Phase II study data presented at the AMSUS Conference, 12/5/14, Washington DC
•   Website home of the Mission Reconnect Program