NCT01680419

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

August 4, 2015

Status Verified

July 1, 2015

Enrollment Period

2.7 years

First QC Date

August 31, 2012

Last Update Submit

July 31, 2015

Conditions

Keywords

VeteransReintegrationResilienceMaritalSpouseBehavioral interventionPTSDIntegrative therapiesComplementary therapiesMassageMeditationMindfulnessCompassionMental health

Outcome Measures

Primary Outcomes (5)

  • Change in Perceived Stress Scale (PSS-10)

    Change from baseline to 2 months and 4 months

    Baseline, 2 months, 4 months

  • Change in Beck Depression Inventory (BDI)

    Change from baseline to 2 months and 4 months

    Baseline, 2 months, 4 months

  • Change in Posttraumatic Checklist-Civilian (PCL-C)

    Change from baseline to 2 months and 4 months

    Baseline, 2 months, 4 months

  • Change in The Self-Compassion Scale

    Change from baseline to 2 months and 4 months

    Baseline, 2 months, 4 months

  • Change in Responses to Stressful Experiences Scale (RSES)

    Change from baseline to 2 months and 4 months

    Baseline, 2 months, 4 months

Secondary Outcomes (7)

  • Change in Multidimensional Perceived Social Support Scale (MPSSS)

    Baseline, 2 months, 4 months

  • Change in Pittsburgh Sleep Quality Index

    Baseline, 2 months, 4 months

  • Change in Revised Dyadic Adjustment Scale (RDAS)

    Baseline, 2 months, 4 months

  • Investigator-generated survey of use of stress reduction practices

    Weekly for 8 weeks, then at 4 months

  • Investigator-generated survey on use of massage and massage effects

    Weekly for 8 weeks

  • +2 more secondary outcomes

Study Arms (4)

Mission Reconnect only

EXPERIMENTAL

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

Behavioral: Mission Reconnect

PREP only

ACTIVE COMPARATOR

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

Behavioral: PREP

PREP plus Mission Reconnect

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.

Behavioral: Mission ReconnectBehavioral: PREP

Wait-list control

NO INTERVENTION

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

Interventions

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.

Mission Reconnect onlyPREP plus Mission Reconnect
PREPBEHAVIORAL

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.

PREP onlyPREP plus Mission Reconnect

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Couples are ineligible who have previously attended a PREP for Strong Bonds program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 23397692BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

DepressionStress Disorders, Post-TraumaticPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPersonal Satisfaction

Study Officials

  • William B Collinge, PhD, MPH

    Collinge and Associates, Inc.

    PRINCIPAL INVESTIGATOR
  • Janet R Kahn, PhD, LMT

    Peace Village Projects, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

August 31, 2012

First Posted

September 7, 2012

Study Start

September 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 4, 2015

Record last verified: 2015-07