A Phase 2 interventional study of Mission Reconnect and PREP in Stress, Depression and PTSD, sponsored by Collinge and Associates, Inc.. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-04.
Sponsored by Collinge and Associates, Inc. · Phase 2 and Interventional
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.
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).
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 320 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Collinge and Associates, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Autonomous use of the Mission Reconnect multimedia instructional program at home.
Behavioral: Mission Reconnect
Participation in a standard PREP for Strong Bonds weekend retreat program.
Behavioral: PREP
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 · Behavioral: PREP
No intervention, followed by delivery of the Mission Reconnect multimedia program materials for home use after the end of the study period.
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.
Change in Perceived Stress Scale (PSS-10)
Change from baseline to 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change in Beck Depression Inventory (BDI)
Change from baseline to 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change in Posttraumatic Checklist-Civilian (PCL-C)
Change from baseline to 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change in The Self-Compassion Scale
Change from baseline to 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change in Responses to Stressful Experiences Scale (RSES)
Change from baseline to 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change in Multidimensional Perceived Social Support Scale (MPSSS)
Change from baseline to 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change in Pittsburgh Sleep Quality Index
Change from baseline to 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Change in Revised Dyadic Adjustment Scale (RDAS)
Change from baseline to 2 months and 4 months
Time frame: Baseline, 2 months, 4 months
Investigator-generated survey of use of stress reduction practices
Time frame: Weekly for 8 weeks, then at 4 months
Investigator-generated survey on use of massage and massage effects
Time frame: 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
Investigator-generated ratings of program satisfaction
Time frame: 4 months
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This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Collinge and Associates, Inc.