Clinical Trials Logo

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.


Clinical Trial 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 Design

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


Related Conditions & MeSH terms


NCT number NCT01680419
Study type Interventional
Source Collinge and Associates, Inc.
Contact
Status Completed
Phase Phase 2
Start date September 2012
Completion date May 2015

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A