StressPhase 2NCT01680419
Mission Reconnect: Promoting Resilience and Reintegration of Post-Deployment Veterans and Their Families
A Phase 2 study testing Mission Reconnect and PREP in people with Stress and Depression, run by Collinge and Associates, Inc..
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Depression, PTSD
- What is being tested?
- Mission Reconnect and PREP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to May 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Couples are ineligible who have previously attended a PREP for Strong Bonds program
About this study
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.
Read the 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).
- Conditions
- Stress, Depression, PTSD, Sleep, Compassion
- Being tested
- Mission Reconnect, PREP
- Keywords
- Veterans, Reintegration, Resilience, Marital, Spouse, Behavioral intervention, PTSD, Integrative therapies, Complementary therapies, Massage, Meditation, Mindfulness, Compassion, Mental health
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mission ReconnectBehavioural
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.
PREPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mission Reconnect only | Experimental | Autonomous use of the Mission Reconnect multimedia instructional program at home. Receives: Behavioral: Mission Reconnect |
| PREP only | Active comparator | Participation in a standard PREP for Strong Bonds weekend retreat program. Receives: 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. Receives: Behavioral: Mission Reconnect; Behavioral: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress Scale (PSS-10)
Change from baseline to 2 months and 4 months
Measured: Baseline, 2 months, 4 months
Change in Beck Depression Inventory (BDI)
Change from baseline to 2 months and 4 months
Measured: Baseline, 2 months, 4 months
Change in Posttraumatic Checklist-Civilian (PCL-C)
Change from baseline to 2 months and 4 months
Measured: Baseline, 2 months, 4 months
Change in The Self-Compassion Scale
Change from baseline to 2 months and 4 months
Measured: Baseline, 2 months, 4 months
Change in Responses to Stressful Experiences Scale (RSES)
Change from baseline to 2 months and 4 months
Measured: Baseline, 2 months, 4 months
Secondary outcomes (7)
Change in Multidimensional Perceived Social Support Scale (MPSSS)
Change from baseline to 2 months and 4 months
Measured: Baseline, 2 months, 4 months
Change in Pittsburgh Sleep Quality Index
Change from baseline to 2 months and 4 months
Measured: Baseline, 2 months, 4 months
Change in Revised Dyadic Adjustment Scale (RDAS)
Change from baseline to 2 months and 4 months
Measured: Baseline, 2 months, 4 months
Investigator-generated survey of use of stress reduction practices
Measured: Weekly for 8 weeks, then at 4 months
Investigator-generated survey on use of massage and massage effects
Measured: Weekly for 8 weeks
Investigator-generated survey on self-efficacy using massage, and satisfaction giving and receiving the use of massage
Measured: 2 months, 4 months
Investigator-generated ratings of program satisfaction
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collinge and Associates, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Collinge, PhD, Collinge and Associates, Inc.
- Investigators
- William B Collinge, PhD, MPH, Principal investigator, Collinge and Associates, Inc.Janet R Kahn, PhD, LMT, Principal investigator, Peace Village Projects, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680419
- Sponsor's protocol ID
- R44MH088063-02
- Status last verified
- Jul 2015
- First submitted
- 31 Aug 2012
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23397692Kahn 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.
PubMed 27678169
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mission Reconnect: Promoting Resilience and Reintegration of Post-Deployment Veterans and Their Families
- ClinicalTrials.gov ID
- NCT01680419
- Acronym / sponsor ID
- R44MH088063-02
- Conditions
- Stress, Depression, PTSD, Sleep, Compassion
- Keywords
- Veterans, Reintegration, Resilience, Marital, Spouse, Behavioral intervention, PTSD, Integrative therapies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Collinge and Associates, Inc.University, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mission Reconnect only | Experimental | Behavioral: Mission ReconnectAutonomous use of the Mission Reconnect multimedia instructional program at home. |
| PREP only | Active comparator | Behavioral: PREPParticipation in a standard PREP for Strong Bonds weekend retreat program. |
| PREP plus Mission Reconnect | Active comparator | Behavioral: Mission Reconnect, Behavioral: PREPParticipation in a standard PREP for Strong Bonds weekend retreat followed by autonomous use of the Mission Reconnect multimedia instructional program at home. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Couples are ineligible who have previously attended a PREP for Strong Bonds program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mission ReconnectMultimedia 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. | Behavioural | Mission Reconnect only, PREP plus Mission Reconnect |
| PREPThe 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. | Behavioural | PREP only, PREP plus Mission Reconnect |
Primary outcome
Change in Perceived Stress Scale (PSS-10)
Time frame: Baseline, 2 months, 4 months
Change from baseline to 2 months and 4 months
Change in Beck Depression Inventory (BDI)
Time frame: Baseline, 2 months, 4 months
Change from baseline to 2 months and 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
Change in The Self-Compassion Scale
Time frame: Baseline, 2 months, 4 months
Change from baseline to 2 months and 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
7 secondary outcomes
Change in Multidimensional Perceived Social Support Scale (MPSSS)
Time frame: Baseline, 2 months, 4 months
Change in Pittsburgh Sleep Quality Index
Time frame: Baseline, 2 months, 4 months
Change in Revised Dyadic Adjustment Scale (RDAS)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
- Background: PubMed 23397692Collinge 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.
- Derived from this study: PubMed 27678169Kahn 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.
- Website home of the Mission Reconnect ProgramLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William B Collinge, PhD, MPH principal investigator
Collinge and Associates, Inc.
Janet R Kahn, PhD, LMT principal investigator
Peace Village Projects, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mission Reconnect and PREP in people with Stress and Depression, run by Collinge and Associates, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress Scale (PSS-10) (time frame: Baseline, 2 months, 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01680419, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2015.