PTSDMRNCT03593772

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

A study testing Mission Reconnect in people with PTSD and Chronic Musculoskeletal Pain, run by VA Office of Research and Development at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: PTSD, Chronic Musculoskeletal Pain
What is being tested?: Mission Reconnect
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 730 participants
Where: 3 sitesUnited States
Study dates: 8 Oct 2019to 31 Oct 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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.

Who cannot join

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

Show all 9Show fewer

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: PTSD, Chronic Musculoskeletal Pain
Being tested: Mission Reconnect
Keywords: chronic pain, PTSD
Medical subject headings: Stress Disorders, Post-Traumatic, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mission ReconnectBehavioural
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.

Study groups in NCT03593772
Study group	Role	What they receive
Treatment arm - Veteran	Active comparator	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. Receives: Behavioral: Mission Reconnect
Control arm - Veteran	No intervention	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.
Treatment arm - Partner	Experimental	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. Receives: Behavioral: Mission Reconnect
Control arm - Partner	No intervention	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 being measured

The primary outcome is the main question the study is designed to answer.

Pain Outcomes Questionnaire (POQ)
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
Measured: Baseline, month 1,2,4

Secondary outcomes (6)

Pain, Stress and Tension Likert
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
Measured: Baseline, Week 1 - 8, Week 16
Defense and Veterans Pain Rating Scale
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
Measured: Baseline, month 1,2,4
PTSD: Posttraumatic Checklist
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
Measured: Baseline, month 1,2,4
Quality of Life Short-form (SF12)
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
Measured: Baseline, month 1,2,4
Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline, month 1,2,4
Compassion for Self and Others Scales
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.
Measured: Baseline, month 1,2,4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 201931 Oct 2022

First posted20 Jul 2018
Study start8 Oct 2019
Primary completion18 Jul 2022
Study completion31 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (62)Papers the sponsor has linked to this study.
Other trials for PTSDStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
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 N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Single group
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)
Enrolment: 730 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03593772
Sponsor's protocol ID: D2775-R
Acronym: MR
Status last verified: Aug 2024
First submitted: 22 May 2018
Last updated: 23 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

Kip KE, Rosenzweig L, Hernandez DF, Shuman A, Diamond DM, Girling SA, Sullivan KL, Wittenberg T, Witt AM, Lengacher CA, Anderson B, McMillan SC. Accelerated Resolution Therapy for treatment of pain secondary to symptoms of combat-related posttraumatic stress disorder. Eur J Psychotraumatol. 2014 May 7;5. doi: 10.3402/ejpt.v5.24066. eCollection 2014.
PubMed 24959325
Goulet JL, Kerns RD, Bair M, Becker WC, Brennan P, Burgess DJ, Carroll CM, Dobscha S, Driscoll MA, Fenton BT, Fraenkel L, Haskell SG, Heapy AA, Higgins DM, Hoff RA, Hwang U, Justice AC, Piette JD, Sinnott P, Wandner L, Womack JA, Brandt CA. The musculoskeletal diagnosis cohort: examining pain and pain care among veterans. Pain. 2016 Aug;157(8):1696-1703. doi: 10.1097/j.pain.0000000000000567.
PubMed 27023420
Seal KH, Shi Y, Cohen G, Cohen BE, Maguen S, Krebs EE, Neylan TC. Association of mental health disorders with prescription opioids and high-risk opioid use in US veterans of Iraq and Afghanistan. JAMA. 2012 Mar 7;307(9):940-7. doi: 10.1001/jama.2012.234.
PubMed 22396516
Kessler RC, Chiu WT, Demler O, Merikangas KR, Walters EE. Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):617-27. doi: 10.1001/archpsyc.62.6.617.
PubMed 15939839
Sharp TJ, Harvey AG. Chronic pain and posttraumatic stress disorder: mutual maintenance? Clin Psychol Rev. 2001 Aug;21(6):857-77. doi: 10.1016/s0272-7358(00)00071-4.
PubMed 11497210
Tsang A, Von Korff M, Lee S, Alonso J, Karam E, Angermeyer MC, Borges GL, Bromet EJ, Demytteneare K, de Girolamo G, de Graaf R, Gureje O, Lepine JP, Haro JM, Levinson D, Oakley Browne MA, Posada-Villa J, Seedat S, Watanabe M. Common chronic pain conditions in developed and developing countries: gender and age differences and comorbidity with depression-anxiety disorders. J Pain. 2008 Oct;9(10):883-91. doi: 10.1016/j.jpain.2008.05.005. Epub 2008 Jul 7.
PubMed 18602869
Clark ME, Walker RL, Gironda RJ, Scholten JD. Comparison of pain and emotional symptoms in soldiers with polytrauma: unique aspects of blast exposure. Pain Med. 2009 Apr;10(3):447-55. doi: 10.1111/j.1526-4637.2009.00590.x.
PubMed 19416436
Smeeding SJ, Bradshaw DH, Kumpfer KL, Trevithick S, Stoddard GJ. Outcome evaluation of the Veterans Affairs Salt Lake City Integrative Health Clinic for Chronic Nonmalignant Pain. Clin J Pain. 2011 Feb;27(2):146-55. doi: 10.1097/AJP.0b013e3181f158e8.
PubMed 20842019
Shi L, Liu J, Zhao Y. Comparative effectiveness in pain-related outcomes and health care utilizations between veterans with major depressive disorder treated with duloxetine and other antidepressants: a retrospective propensity score-matched comparison. Pain Pract. 2012 Jun;12(5):374-81. doi: 10.1111/j.1533-2500.2011.00495.x. Epub 2011 Sep 27.
PubMed 21951787
Lang KP, Veazey-Morris K, Andrasik F. Exploring the role of insomnia in the relation between PTSD and pain in veterans with polytrauma injuries. J Head Trauma Rehabil. 2014 Jan-Feb;29(1):44-53. doi: 10.1097/HTR.0b013e31829c85d0.
PubMed 23835878
Kupersmith J, Lew HL, Ommaya AK, Jaffee M, Koroshetz WJ. Traumatic brain injury research opportunities: results of Department of Veterans Affairs Consensus Conference. J Rehabil Res Dev. 2009;46(6):vii-xvi. doi: 10.1682/jrrd.2009.06.0079. No abstract available.
PubMed 20104393
Bosco MA, Murphy JL, Clark ME. Chronic pain and traumatic brain injury in OEF/OIF service members and Veterans. Headache. 2013 Oct;53(9):1518-22. doi: 10.1111/head.12172. Epub 2013 Jul 12.
PubMed 23848062
Schnurr PP, Lunney CA. Work-related outcomes among female veterans and service members after treatment of posttraumatic stress disorder. Psychiatr Serv. 2012 Nov;63(11):1072-9. doi: 10.1176/appi.ps.201100415.
PubMed 22983600
Westanmo A, Marshall P, Jones E, Burns K, Krebs EE. Opioid Dose Reduction in a VA Health Care System--Implementation of a Primary Care Population-Level Initiative. Pain Med. 2015 May;16(5):1019-26. doi: 10.1111/pme.12699. Epub 2015 Feb 3.
PubMed 25645538
Capehart B, Bass D. Review: managing posttraumatic stress disorder in combat veterans with comorbid traumatic brain injury. J Rehabil Res Dev. 2012;49(5):789-812. doi: 10.1682/jrrd.2011.10.0185.
PubMed 23015586

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03593772
Acronym / sponsor ID: MR / D2775-R
Conditions: PTSD, Chronic Musculoskeletal Pain
Keywords: chronic pain, PTSD
Study type: Interventional
Recruitment status: Completed
Enrolment: 730 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 8 Oct 2019 (actual)
Primary completion: 18 Jul 2022 (actual)
Study completion: 31 Oct 2022 (actual)
First posted: 20 Jul 2018 (actual)
Results: Posted 23 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4
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.

Arm	Type	Receives
Treatment arm - Veteran	Active comparator	Behavioral: Mission ReconnectTreatment 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.
Control arm - Veteran	No intervention	–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.
Treatment arm - Partner	Experimental	Behavioral: Mission ReconnectTreatment 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.
Control arm - Partner	No intervention	–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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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:
For pain scores, the investigators will use the 0-10 numeric pain rating scale that is routinely collected at the VA.

Key exclusion criteria (9 listed)

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

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 ReconnectThis 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.	Behavioural	Treatment arm - Partner, Treatment arm - Veteran

Primary outcome

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

6 secondary outcomes

Pain, Stress and Tension Likert
Time frame: Baseline, Week 1 - 8, Week 16
Defense and Veterans Pain Rating Scale
Time frame: Baseline, month 1,2,4
PTSD: Posttraumatic Checklist
Time frame: Baseline, month 1,2,4
Quality of Life Short-form (SF12)
Time frame: Baseline, month 1,2,4
Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, month 1,2,4
Compassion for Self and Others Scales
Time frame: Baseline, month 1,2,4

Results and safety

Results posted to the registry on 23 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Arm - Veteran	196	106
Treatment Arm - Partner	198	106
Control Arm - Veteran	168	129
Control Arm - Partner	168	129

Primary outcome: Pain Outcomes Questionnaire (POQ)

Time frame: Baseline, month 1,2,4. Least squares mean (95% Confidence Interval). Unit: Units on a scale

Measure	Treatment Arm n = 141	Control Arm n = 136
Total POQ	102.32 (96.6204 to 108.03)	94.9863 (89.3230 to 100.65)
Pain Rating	6.2006 (5.8999 to 6.5014)	6.1251 (5.8330 to 6.4173)
Mobility	21.4893 (19.7487 to 23.2298)	20.2530 (18.5225 to 21.9835)
Activities of Daily Living	12.1675 (10.4442 to 13.8908)	10.4716 (8.7829 to 12.1603)
Vitality	20.2433 (19.3959 to 21.0906)	18.6968 (17.8919 to 19.5018)
Negative Affect	30.7769 (28.9694 to 32.5843)	28.2654 (26.4939 to 30.0369)
Fear	11.5500 (10.8467 to 12.2533)	11.1400 (10.4626 to 11.8174)

Treatment Arm vs Control Arm: Slope: -0.04819, p = 0.0535, Mixed Models Analysis
Treatment Arm vs Control Arm: Slope: -0.00163, p = 0.3729, Mixed Models Analysis
Treatment Arm vs Control Arm: Slope: -0.00593, p = 0.4124, Mixed Models Analysis

Population analysed: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans activated in the protocol. Participants that opted out of responding were not included in the analyses.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline (before the start of the study activities) and 1, 2 & 4 months after study activities). Other adverse events reported at 0.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Arm - Veteran	0 of 196 (0%)	7 of 196 (3.6%)	0 of 196
Treatment Arm - Partner	0 of 198 (0%)	0 of 198 (0%)	0 of 198
Control Arm - Veteran	0 of 168 (0%)	7 of 168 (4.2%)	0 of 168
Control Arm - Partner	0 of 168 (0%)	0 of 168 (0%)	0 of 168

Limitations and caveats (from the sponsor): Demographics were calculated from study dyads who were successfully activated in the study. Successful activation required both Veteran and Partner of a dyad to complete all Baseline measures. Certain dyads consisted of individuals where one partner completed Baseline data collection before either withdrawing or being Lost to Follow Up (unrelated to study activities). Their data, as per study protocol, were still included in the data models, but were not included in Demographic summaries.

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Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24959325Kip KE, Rosenzweig L, Hernandez DF, Shuman A, Diamond DM, Girling SA, Sullivan KL, Wittenberg T, Witt AM, Lengacher CA, Anderson B, McMillan SC. Accelerated Resolution Therapy for treatment of pain secondary to symptoms of combat-related posttraumatic stress disorder. Eur J Psychotraumatol. 2014 May 7;5. doi: 10.3402/ejpt.v5.24066. eCollection 2014.
Background: PubMed 27023420Goulet JL, Kerns RD, Bair M, Becker WC, Brennan P, Burgess DJ, Carroll CM, Dobscha S, Driscoll MA, Fenton BT, Fraenkel L, Haskell SG, Heapy AA, Higgins DM, Hoff RA, Hwang U, Justice AC, Piette JD, Sinnott P, Wandner L, Womack JA, Brandt CA. The musculoskeletal diagnosis cohort: examining pain and pain care among veterans. Pain. 2016 Aug;157(8):1696-1703. doi: 10.1097/j.pain.0000000000000567.
Background: PubMed 22396516Seal KH, Shi Y, Cohen G, Cohen BE, Maguen S, Krebs EE, Neylan TC. Association of mental health disorders with prescription opioids and high-risk opioid use in US veterans of Iraq and Afghanistan. JAMA. 2012 Mar 7;307(9):940-7. doi: 10.1001/jama.2012.234.
Background: PubMed 15939839Kessler RC, Chiu WT, Demler O, Merikangas KR, Walters EE. Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):617-27. doi: 10.1001/archpsyc.62.6.617.
Background: PubMed 11497210Sharp TJ, Harvey AG. Chronic pain and posttraumatic stress disorder: mutual maintenance? Clin Psychol Rev. 2001 Aug;21(6):857-77. doi: 10.1016/s0272-7358(00)00071-4.
Background: PubMed 18602869Tsang A, Von Korff M, Lee S, Alonso J, Karam E, Angermeyer MC, Borges GL, Bromet EJ, Demytteneare K, de Girolamo G, de Graaf R, Gureje O, Lepine JP, Haro JM, Levinson D, Oakley Browne MA, Posada-Villa J, Seedat S, Watanabe M. Common chronic pain conditions in developed and developing countries: gender and age differences and comorbidity with depression-anxiety disorders. J Pain. 2008 Oct;9(10):883-91. doi: 10.1016/j.jpain.2008.05.005. Epub 2008 Jul 7.
Background: PubMed 19416436Clark ME, Walker RL, Gironda RJ, Scholten JD. Comparison of pain and emotional symptoms in soldiers with polytrauma: unique aspects of blast exposure. Pain Med. 2009 Apr;10(3):447-55. doi: 10.1111/j.1526-4637.2009.00590.x.
Background: PubMed 20842019Smeeding SJ, Bradshaw DH, Kumpfer KL, Trevithick S, Stoddard GJ. Outcome evaluation of the Veterans Affairs Salt Lake City Integrative Health Clinic for Chronic Nonmalignant Pain. Clin J Pain. 2011 Feb;27(2):146-55. doi: 10.1097/AJP.0b013e3181f158e8.
Background: PubMed 21951787Shi L, Liu J, Zhao Y. Comparative effectiveness in pain-related outcomes and health care utilizations between veterans with major depressive disorder treated with duloxetine and other antidepressants: a retrospective propensity score-matched comparison. Pain Pract. 2012 Jun;12(5):374-81. doi: 10.1111/j.1533-2500.2011.00495.x. Epub 2011 Sep 27.
Background: PubMed 23835878Lang KP, Veazey-Morris K, Andrasik F. Exploring the role of insomnia in the relation between PTSD and pain in veterans with polytrauma injuries. J Head Trauma Rehabil. 2014 Jan-Feb;29(1):44-53. doi: 10.1097/HTR.0b013e31829c85d0.
Background: PubMed 20104393Kupersmith J, Lew HL, Ommaya AK, Jaffee M, Koroshetz WJ. Traumatic brain injury research opportunities: results of Department of Veterans Affairs Consensus Conference. J Rehabil Res Dev. 2009;46(6):vii-xvi. doi: 10.1682/jrrd.2009.06.0079. No abstract available.
Background: PubMed 23848062Bosco MA, Murphy JL, Clark ME. Chronic pain and traumatic brain injury in OEF/OIF service members and Veterans. Headache. 2013 Oct;53(9):1518-22. doi: 10.1111/head.12172. Epub 2013 Jul 12.
ATLAS.ti: The Qualitative Data Analysis SoftwareLink provided by the sponsor.
Statistical Analysis Software, SAS/STAT \| SASLink provided by the sponsor.
Individual participant dataSharing planned: No. 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.

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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.

Jolie N. Haun, PhD MS BS principal investigator

James A. Haley Veterans' Hospital, Tampa, FL

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mission Reconnect in people with PTSD and Chronic Musculoskeletal Pain, run by VA Office of Research and Development at 3 sites in United States.

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 7 inclusion and 9 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 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pain Outcomes Questionnaire (POQ) (time frame: Baseline, month 1,2,4). 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 NCT03593772, which also lists 62 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 23 Aug 2024.