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
Status: | Not yet recruiting |
---|---|
Conditions: | Chronic Pain, Psychiatric |
Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology |
Healthy: | No |
Age Range: | Any - 17 |
Updated: | 4/6/2019 |
Start Date: | May 1, 2019 |
End Date: | December 31, 2022 |
Contact: | Jolie N Haun, PhD MS BS |
Email: | jolie.haun@va.gov |
Phone: | (813) 558-7622 |
Delivering a Mobile and Web Based Self Directed Complementary And Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD
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.
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.
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.
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.
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.
We found this trial at
3
sites
Seattle, Washington 98108
Phone: 425-765-1096
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Tampa, Florida 33612
Principal Investigator: Jolie N. Haun, PhD MS BS
Phone: 813-558-3953
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