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Mission Reconnect- Delivering a Mobile and Web Based Self Directed Complementary And Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD (MR)

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ClinicalTrials.gov Identifier: NCT03593772
Recruitment Status : Not yet recruiting
First Posted : July 20, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
This project is responsive to RR&D's current special areas of interest for non-pharmacological activity-based interventions for chronic pain impacting pain reduction, function and quality of life. This project aligns with the VA mandate for complementary and integrative health (CIH) care for Veterans and their families. CIH complements traditional care for Veterans managing chronic conditions, such as chronic pain and PTSD. Mission Reconnect (MR) is a user-driven, dyadic, CIH self-care management program delivered remotely that teaches techniques the Veteran/partner dyad can use to reduce pain, anxiety and stress, promote well-being and improve relationship quality. The research goal is to evaluate MR as an approach to manage chronic pain and PTSD symptoms, for potential subsequent implementation. This study will possibly provide a model for establishing remote access and sustainable implementation of CIH within VA.

Condition or disease Intervention/treatment Phase
PTSD Chronic Musculoskeletal Pain Behavioral: Mission Reconnect Not Applicable

Detailed Description:

Chronic pain is one of the most prevalent medical conditions in the Veteran population. Pain often presents with comorbid conditions, specifically post-traumatic stress disorder (PTSD). Comorbid chronic pain and PTSD significantly impact the quality of life of Veterans and their families. Multi-faceted therapies leveraging complementary and integrative health (CIH) are mandated within VA to complement clinical practice guidelines improve Veterans' quality of life and ability to function. This research will evaluate a CIH intervention to manage pain and PTSD related outcomes within a bio-psychosocial framework. The proposed intervention, Mission Reconnect (MR), a user-driven, dyadic, self-care management program delivered online and by mobile app that has previously shown to be effective in a non-clinically defined community-based Veteran/military population. This research is needed to test MR's effects in a clinically defined population as a complement to clinical services to assess for potential subsequent implementation within the Department of Veterans Affairs (VA).

This proposal resubmission is responsive to Veterans' reported desire for CIH and several VA initiatives, including RR&D's current special areas of interest for non-pharmacological activity-based interventions for chronic pain impacting pain reduction, function and quality of life. The VA Secretary of Health Strategic Priorities and the emerging VA Whole Health Program identify access to CIH for pain and self-care management as a priority to achieve optimal Veteran health. To be responsive to these priorities the 2016 VA State-of-the-Art Conference (SOTA) and Comprehensive Addiction Recovery Act (CARA) mandated VA's commitment to conduct rigorous research to integrate non-pharmacological and CIH approaches into care, with emphasis on pain management. This proposal is also responsive to the VA's Opioid Safety Initiative (OSI) and Pain Care Mission which prioritize the need for nonpharmacological treatment options for pain. The short-term goal of this study is to determine the effects of MR on (1) chronic pain, PTSD and related outcomes and (2) relationship outcomes for Veterans and their partners. The long-term goal is to determine the effectiveness and sustainability of using CIH self-care management programs like MR to improve outcomes for Veterans with chronic pain and PTSD, and their partners. The investigators propose a four-year mixed-methods randomized controlled trial of MR with two arms (treatment & wait-list control) in a clinical sample of Veterans with comorbid pain and PTSD, and their partners (e.g., spouse). The specific aims are to: (Aim 1) Determine MR effectiveness for physical (pain, sleep), PTSD (intrusion, arousal, avoidance, numbing), and psychological (depression, stress, anxiety) symptoms, and global health (quality of life); (Aim 2) Determine MR effectiveness for social (relationship satisfaction, compassion for self/others) outcomes among Veterans and their partners; and (Aim 3) Describe Veteran and partner perceived value of MR in a sub-sample of participants. The sample will consist of Veteran and partner dyads (N = 228) at the Ann Arbor, Puget Sound, and Tampa VA facilities. Aim 1 & 2 data collection will include self-report assessment of 4-data points over a 4-month period to evaluate physical, psychological, and social outcomes. Eight weekly reports will also be collected for the first two months of MR use to assess MR utilization, and pain and stress levels. Aim 3 data collection will include telephone interviews from a randomly selected sub-sample of MR treatment group dyads (n = 42) to examine MR user experiences and their suggestions making MR useful for Veterans and their partners.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This research study will evaluate a CIH intervention to manage pain and PTSD related outcomes within a bio-psychosocial framework. The proposed intervention, Mission Reconnect (MR), a user-driven, dyadic, self-care management program delivered online and by mobile app that has previously shown to be effective in a non-clinically defined community-based Veteran/military population.
Masking: None (Open Label)
Masking Description: There are no masked roles
Primary Purpose: Other
Official Title: Delivering a Mobile and Web Based Self Directed Complementary And Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD
Estimated Study Start Date : August 5, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Active Comparator: Treatment arm
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Behavioral: Mission Reconnect
This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.

Placebo Comparator: Control arm
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Behavioral: Mission Reconnect
This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.




Primary Outcome Measures :
  1. Mission Reconnect effectiveness for physical symptoms [ Time Frame: 24 months ]
    Measured by collecting number of participants that self-report pain outcomes after Mission Reconnect is used. Scale of 0 (no pain) -5 (worst pain) will identify intensity of pain. Activity tracking form will indicate number or participants.

  2. Mission Reconnect effectiveness for PTSD symptoms [ Time Frame: 24 months ]
    Measured by collecting number of participants that self-report PTSD symptoms after Mission Reconnect is used. Activity tracking form will indicate number or participants.

  3. Mission Reconnect effectiveness for psychological symptoms [ Time Frame: 24 months ]
    Measured by collecting number of participants that self-report psychological symptoms after Mission Reconnect is used. Activity tracking form will indicate number or participants.

  4. Mission Reconnect effectiveness for global health [ Time Frame: 24 months ]
    Measured by collecting number of participants that self-report global health stress outcomes after Mission Reconnect is used. Scale of 0 (no stress) to 5 (worst stress) will identify level of stress. Activity tracking form will indicate number or participants.


Secondary Outcome Measures :
  1. Mission Reconnect effectiveness for social outcomes among Veterans [ Time Frame: 24 months ]
    Measured by collecting number of participants that self-report social outcomes after Mission Reconnect is used. Activity tracking form will indicate number or participants.

  2. Mission Reconnect effectiveness for social outcomes among Veterans' partners [ Time Frame: 24 months ]
    Measured by collecting number of participants that self-report social outcomes after Mission Reconnect is used. Activity tracking form will indicate number or participants.


Other Outcome Measures:
  1. Veteran perceived value of Mission Reconnect in a sub-sample of Veteran participants [ Time Frame: 18 months ]
    Measured by collecting what are the experiences of participants using MR. Scale for satisfaction of MR program will be used, measurements include 1 (strongly disagree ) to 10 (strongly agree).

  2. Veteran perceived value of Mission Reconnect in a sub-sample of Veteran participants [ Time Frame: 18 months ]
    Measured by collecting type of recommendations participants have for promoting use of MR. Scale for satisfaction of MR program will be used, measurements include 1 (strongly disagree ) to 10 (strongly agree).

  3. Veteran perceived value of Mission Reconnect in a sub-sample of Veteran participants [ Time Frame: 18 months ]
    Measured by collecting number of domains/taxonomies related to participants' experiences with MR use. Scale for satisfaction of MR program will be used, measurements include 1 (strongly disagree ) to 10 (strongly agree).

  4. Veterans' partners perceived value of Mission Reconnect in a sub-sample of Veteran participants [ Time Frame: 18 months ]
    Measured by collecting what are the experiences of participants using MR. Scale for satisfaction of MR program will be used, measurements include 1 (strongly disagree ) to 10 (strongly agree).

  5. Veterans' partners perceived value of Mission Reconnect in a sub-sample of Veteran participants [ Time Frame: 18 months ]
    Measured by collecting type of recommendations participants have for promoting use of MR. Scale for satisfaction of MR program will be used, measurements include 1 (strongly disagree ) to 10 (strongly agree).

  6. Veterans' partners perceived value of Mission Reconnect in a sub-sample of Veteran participants [ Time Frame: 18 months ]
    Measured by collecting number of domains/taxonomies related to participants' experiences with MR use. Scale for satisfaction of MR program will be used, measurements include 1 (strongly disagree ) to 10 (strongly agree).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English-speaking Veterans with chronic musculoskeletal pain.
  • Veteran is considered to have chronic musculoskeletal pain if he or she meeting either of two validated criteria:

    • (1) Having 2+ occurrences of any of targeted musculoskeletal ICD-9-CM codes "likely to represent chronic pain" recorded at visits separated by at least 30 days within past six months
    • (2) Having high impact chronic pain = 2+ occurrences of targeted musculoskeletal ICD-9-CM codes separated by at least 30 days within the past six months previous to study recruitment and two or more pain scores greater than or equal to 4 separated by at least 30 days within past six months.
  • For pain scores, the investigators will use the 0-10 numeric pain rating scale that is routinely collected at the VA.

    • The investigators will count two ICD-9-CM codes or pain scores recorded on the same day as one code/score.
    • Veteran is considered to have PTSD if he or she has a flag in his/her record indicating confirmed condition by the VA Compensation and Benefits program, has at least two outpatient visits in the year with the primary diagnosis being listed as PTSD (ICD-9-CM code 309.81) and/or had PTSD listed on the problem list], Veteran must also have PTSD (defined by PTSD diagnosis-ICD-9-CM 309.81), the ability to access and use an electronic platform (e.g. Mobile device, internet, DVD) for MR delivery, with a willing partner to also participate in the study and MR program.

Exclusion Criteria:

  • Moderate to severe TBI
  • Diagnosis or documented treatment for psychosis in previous 6 months
  • Currently in substance use disorder treatment
  • Non-English speaking
  • Visual, hearing, cognitive impairment that prevent participation or ability to consent
  • And/or lack of access to internet service
  • These individuals will be excluded due to medical, language, and technology access issues that would prevent safe and full study participation.
  • Pain and PTSD treatment will not be factored as an inclusion/exclusion criteria but will be evaluated as covariates.
  • Potential participants who screen for aggression or violence will also be excluded from study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593772


Contacts
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Contact: Jolie N Haun, PhD MS BS (813) 558-7622 jolie.haun@va.gov

Locations
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United States, Florida
James A. Haley Veterans' Hospital, Tampa, FL Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Nicole Antinori, MBA BS    813-558-3953    Nicole.Antinori@va.gov   
Contact: Margaret R Covar    (813) 903-4407    Margaret.Covar@va.gov   
Principal Investigator: Jolie N. Haun, PhD MS BS         
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI Not yet recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Carol Fletcher    734-845-3610    Carol.Fletcher@va.gov   
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA Not yet recruiting
Seattle, Washington, United States, 98108
Contact: Leila Kozak    425-765-1096    Leila.Kozak@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Jolie N. Haun, PhD MS BS James A. Haley Veterans' Hospital, Tampa, FL

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03593772     History of Changes
Other Study ID Numbers: D2775-R
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Dissemination efforts will be led by Drs. Haun, Kligler, Paykel and Taylor in cooperation with VA operational (e.g. OPCCCT and CCO), clinical stakeholders (e.g. mental health and pain clinicians), and the Tampa CINDRR VEC. The investigators will publish findings in peer-reviewed journals and present findings at national and international meetings including Medicine 2.0, the international conference for internet-based health research (Haun) and Association of Military Surgeons of the United States (AMSUS) Annual Continuing Education Meeting. Dissemination activities will inform VHA operational initiatives and clinical practice. The deployment of Whole Health models of care nationally will provide a natural setting for dissemination. The Tampa VEC will support dissemination efforts to Veterans, their families, and to Veteran Service Organizations.
Supporting Materials: Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The data will become available to the public after the completion of the study (after December 31, 2022).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
chronic pain
PTSD

Additional relevant MeSH terms:
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Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms