- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01680419
Mission Reconnect: Promoting Resilience and Reintegration of Post-Deployment Veterans and Their Families
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
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
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R44MH088063-02 (U.S. NIH Grant/Contract)
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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