Clinical trial NCT03593772: Mission Reconnect-Veterans and Their Partners to Manage Pain and PTSD (MR)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Chronic Musculoskeletal Pain
Keywords: chronic pain
PTSD
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-07-20
Enrollment: 730
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

Brief summary: This project is responsive to Rehabilitation Research and Development's (RR\&D) 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.

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 = 336) 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.

Eligibility 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 traumatic brain injury (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.

Primary outcomes:
measure: Pain Outcomes Questionnaire (POQ)
timeFrame: Baseline, month 1,2,4
Secondary outcomes:
measure: Pain, Stress and Tension Likert
timeFrame: Baseline, Week 1 - 8, Week 16
measure: Defense and Veterans Pain Rating Scale
timeFrame: Baseline, month 1,2,4
measure: PTSD: Posttraumatic Checklist
timeFrame: Baseline, month 1,2,4
measure: Quality of Life Short-form (SF12)
timeFrame: Baseline, month 1,2,4
measure: Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, month 1,2,4
measure: Compassion for Self and Others Scales
timeFrame: Baseline, month 1,2,4
Other outcomes:
measure: Depression: Beck Depression Inventory (BDI)
timeFrame: Baseline, month 1,2,4
measure: Stress: Perceived Stress Scale (PSS)
timeFrame: Baseline, month 1,2,4
measure: Revised Dyadic Adjustment Scale (RDAS)
timeFrame: Baseline, month 1,2,4
measure: MR Program Satisfaction Items
timeFrame: Month 4
measure: MR Program Utilization
timeFrame: Month 4
Locations:
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: James A. Haley Veterans' Hospital, Tampa, FL
name: Jolie N. Haun, PhD MS BS
role: PRINCIPAL_INVESTIGATOR
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