Mission Reconnect-Veterans and Their Partners to Manage Pain and PTSD (MR) (MR)

August 20, 2024 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

730

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • James A. Haley Veterans' Hospital, Tampa, FL
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • VA Ann Arbor Healthcare System, Ann Arbor, MI
    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment arm - Veteran
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with National Institute of Mental Health (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.
No Intervention: Control arm - Veteran
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.
Experimental: Treatment arm - Partner
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.
No Intervention: Control arm - Partner
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Outcomes Questionnaire (POQ)
Time Frame: Baseline, month 1,2,4

20-item questionnaire, used to assess pain, and pain-related subdomains, such as pain intensity, interference with activities, mobility, negative affect, vitality, and pain-related fear.

Higher Scores associated with more adverse pain-related patient reported outcomes.

Pain Range: 0 - 10 Mobility Range: 0 - 40 Activities of Daily Living Range: 0 - 40 Vitality Range: 0 - 30 Negative Affect Range: 0 - 50 Fear Range: 0 - 20 Total Range: 0-190
Baseline, month 1,2,4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain, Stress and Tension Likert
Time Frame: Baseline, Week 1 - 8, Week 16

Three items will assess pain, stress and tension using a 0 to 5-point Likert-type scale.

Higher Scores associated with more adverse patient reported outcomes. Pain Range: 0 - 5 Stress Range: 0 - 5 Tension Range: 0 - 5
Baseline, Week 1 - 8, Week 16
Defense and Veterans Pain Rating Scale
Time Frame: Baseline, month 1,2,4

10-point scale to measure current pain intensity (past 24 hours) and pain interference (past 24 hours) with activity, sleep, mood, and stress.

Higher Scores associated with more adverse pain-related patient reported outcomes.

Pain Range: 0 - 10 Pain Interference with Activity Range: 0 - 10 Pain Interference with Sleep Range: 0 - 10 Pain Interference with Mood Range: 0 - 10 Pain Interference with Stress Range: 0 - 10
Baseline, month 1,2,4
PTSD: Posttraumatic Checklist
Time Frame: Baseline, month 1,2,4

20-item measure of PTSD symptoms Higher Scores associated with more adverse PTSD-related patient reported outcomes.

Posttraumatic Stress Disorder Checklist (PCL-5) Range: 0 - 80
Baseline, month 1,2,4
Quality of Life Short-form (SF12)
Time Frame: Baseline, month 1,2,4

12-items to assess quality of life using physical status and mental health distress.

Scores for the Mental Health and Physical Health domains range from 0 to 100, with higher scores indicating better physical and mental health functioning
Baseline, month 1,2,4
Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, month 1,2,4

19 self-rated questions from which 7 component scores are calculated and summed into a global score to assess sleep quality in the past month.

Each of the domain scores range from 0 (no difficulty) to 3 (severe difficulty).

The global score ranges from 0 to 21. Higher scores indicate worse sleep quality.
Baseline, month 1,2,4
Compassion for Self and Others Scales
Time Frame: Baseline, month 1,2,4

26- item (CSS) and 21- item (COS) measures, that calculate an overall Compassion for Others score, an overall Compassion for Self score, and Compassion for Self subscale scores in the domains of Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness, Overidentification.

CSS subdomain scales and the total score (average of components) range from 0 - 5, with higher scores indicating higher self-compassion.

COS score ranges from 0 - 7, with higher scores indicating higher compassion for others.
Baseline, month 1,2,4

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression: Beck Depression Inventory (BDI)
Time Frame: Baseline, month 1,2,4

21-items, a widely used instrument for measuring depression. Respondents are asked to rate their symptoms and attitudes using a 4-point scale.

Beck Depression Inventory (BDI) scores range from 0 to 63 with higher scores indicating more likely depression diagnosis, and higher prevalence of depression symptoms.
Baseline, month 1,2,4
Stress: Perceived Stress Scale (PSS)
Time Frame: Baseline, month 1,2,4

10 Likert-scaled items, validated and widely used, to determine perceived stress levels.

Perceived Stress Scale (PSS) scaled from 0 to 40 with higher scores indicating higher perceived stress.
Baseline, month 1,2,4
Revised Dyadic Adjustment Scale (RDAS)
Time Frame: Baseline, month 1,2,4

14-item Likert-scaled instrument that contains domains for dyadic Consensus (sub-domain Decision Making, Values, and Affection), dyadic Satisfaction (sub-domain Stability and Conflict), and dyadic Cohesion (sub-domain Activities and Discussion).

Scores on the Revised Dyadic Adjustment Scale (RDAS) range from 0 to 69 with higher scores indicating greater relationship satisfaction and lower scores indicating greater relationship distress.
Baseline, month 1,2,4
MR Program Satisfaction Items
Time Frame: Month 4
11 eleven-point Likert-type items (i.e., 0-10) assess satisfaction using MR components, whether they would recommend MR, and massage satisfaction. Higher scores refer to higher satisfaction with MR.
Month 4
MR Program Utilization
Time Frame: Month 4
Treatment group: weekly report 11-items will assess frequency of use and compliance of the MR mind/body & massage practices. Measure calculated in number of minutes per week the participant performed the activity.
Month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Jolie N. Haun, PhD MS BS, James A. Haley Veterans' Hospital, Tampa, FL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2019

Primary Completion (Actual)

July 18, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

July 10, 2018

First Posted (Actual)

July 20, 2018

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2775-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Dissemination efforts will be led by Drs. Haun, French, and Fowler, in cooperation with VA operational [e.g. Office of Patient Centered Care and Cultural Transformation (OPCCCT) and Office of Connected Care (OCC)], and clinical stakeholders (e.g. mental health and pain clinicians). 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 Veterans Health Administration (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.

IPD Sharing Time Frame

The data will become available to the public after the completion of the study (after December 31, 2022).

IPD Sharing Supporting Information Type

  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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