Mission Reconnect-Veterans and Their Partners to Manage Pain and PTSD (MR)
NCT ID: NCT03593772
Last Updated: 2024-08-23
Study Results
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View full resultsBasic Information
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COMPLETED
NA
730 participants
INTERVENTIONAL
2019-10-08
2022-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* Potential participants who screen for aggression or violence will also be excluded from study.
18 Years
ALL
Yes
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Jolie N. Haun, PhD MS BS
Role: PRINCIPAL_INVESTIGATOR
James A. Haley Veterans' Hospital, Tampa, FL
Locations
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James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Engel GL. The clinical application of the biopsychosocial model. Am J Psychiatry. 1980 May;137(5):535-44. doi: 10.1176/ajp.137.5.535.
Gatchel RJ, Peng YB, Peters ML, Fuchs PN, Turk DC. The biopsychosocial approach to chronic pain: scientific advances and future directions. Psychol Bull. 2007 Jul;133(4):581-624. doi: 10.1037/0033-2909.133.4.581.
Geisser ME, Roth RS, Bachman JE, Eckert TA. The relationship between symptoms of post-traumatic stress disorder and pain, affective disturbance and disability among patients with accident and non-accident related pain. Pain. 1996 Aug;66(2-3):207-14. doi: 10.1016/0304-3959(96)03038-2.
Raichle KA, Romano JM, Jensen MP. Partner responses to patient pain and well behaviors and their relationship to patient pain behavior, functioning, and depression. Pain. 2011 Jan;152(1):82-88. doi: 10.1016/j.pain.2010.09.015. Epub 2010 Oct 13.
Verbosky SJ, Ryan DA. Female partners of Vietnam veterans: stress by proximity. Issues Ment Health Nurs. 1988;9(1):95-104. doi: 10.3109/01612848809140912. No abstract available.
Keefe FJ, Caldwell DS, Baucom D, Salley A, Robinson E, Timmons K, Beaupre P, Weisberg J, Helms M. Spouse-assisted coping skills training in the management of osteoarthritic knee pain. Arthritis Care Res. 1996 Aug;9(4):279-91. doi: 10.1002/1529-0131(199608)9:43.0.co;2-6.
Abbasi M, Dehghani M, Keefe FJ, Jafari H, Behtash H, Shams J. Spouse-assisted training in pain coping skills and the outcome of multidisciplinary pain management for chronic low back pain treatment: a 1-year randomized controlled trial. Eur J Pain. 2012 Aug;16(7):1033-43. doi: 10.1002/j.1532-2149.2011.00097.x. Epub 2012 Jan 19.
Baucom DH, Shoham V, Mueser KT, Daiuto AD, Stickle TR. Empirically supported couple and family interventions for marital distress and adult mental health problems. J Consult Clin Psychol. 1998 Feb;66(1):53-88. doi: 10.1037//0022-006x.66.1.53.
Monson CM, Macdonald A, Brown-Bowers A. Couple/family therapy for posttraumatic stress disorder: review to facilitate interpretation of VA/DOD Clinical Practice Guideline. J Rehabil Res Dev. 2012;49(5):717-28. doi: 10.1682/jrrd.2011.09.0166.
Church D, Brooks AJ. CAM and energy psychology techniques remediate PTSD symptoms in veterans and spouses. Explore (NY). 2014 Jan-Feb;10(1):24-33. doi: 10.1016/j.explore.2013.10.006. Epub 2013 Oct 17.
Kahn JR, Collinge W, Soltysik R. Post-9/11 Veterans and Their Partners Improve Mental Health Outcomes with a Self-directed Mobile and Web-based Wellness Training Program: A Randomized Controlled Trial. J Med Internet Res. 2016 Sep 27;18(9):e255. doi: 10.2196/jmir.5800.
Denneson LM, Corson K, Dobscha SK. Complementary and alternative medicine use among veterans with chronic noncancer pain. J Rehabil Res Dev. 2011;48(9):1119-28. doi: 10.1682/jrrd.2010.12.0243.
Herman PM, Sorbero ME, Sims-Columbia AC. Complementary and Alternative Medicine Services in the Military Health System. J Altern Complement Med. 2017 Nov;23(11):837-843. doi: 10.1089/acm.2017.0236. Epub 2017 Oct 17.
Peterson K, Anderson J, Ferguson L, Mackey K. Evidence Brief: The Comparative Effectiveness of Selected Complementary and Integrative Health (CIH) Interventions for Preventing or Reducing Opioid Use in Adults with Chronic Neck, Low Back, and Large Joint Pain [Internet]. Washington (DC): Department of Veterans Affairs (US); 2016 Apr. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK409241/
Haun JN, Graham-Pole J, Shortley B. Children with cancer and blood diseases experience positive physical and psychological effects from massage therapy. Int J Ther Massage Bodywork. 2009 Jun 29;2(2):7-14. doi: 10.3822/ijtmb.v2i2.12.
Cherkin DC, Eisenberg D, Sherman KJ, Barlow W, Kaptchuk TJ, Street J, Deyo RA. Randomized trial comparing traditional Chinese medical acupuncture, therapeutic massage, and self-care education for chronic low back pain. Arch Intern Med. 2001 Apr 23;161(8):1081-8. doi: 10.1001/archinte.161.8.1081.
Moyer CA, Rounds J, Hannum JW. A meta-analysis of massage therapy research. Psychol Bull. 2004 Jan;130(1):3-18. doi: 10.1037/0033-2909.130.1.3.
Tsao JC. Effectiveness of massage therapy for chronic, non-malignant pain: a review. Evid Based Complement Alternat Med. 2007 Jun;4(2):165-79. doi: 10.1093/ecam/nel109. Epub 2007 Feb 5.
Crawford C, Boyd C, Paat CF, Price A, Xenakis L, Yang E, Zhang W; Evidence for Massage Therapy (EMT) Working Group. The Impact of Massage Therapy on Function in Pain Populations-A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part I, Patients Experiencing Pain in the General Population. Pain Med. 2016 Jul 1;17(7):1353-1375. doi: 10.1093/pm/pnw099.
Sharpe PA, Williams HG, Granner ML, Hussey JR. A randomised study of the effects of massage therapy compared to guided relaxation on well-being and stress perception among older adults. Complement Ther Med. 2007 Sep;15(3):157-63. doi: 10.1016/j.ctim.2007.01.004. Epub 2007 Feb 20.
Moraska A, Pollini RA, Boulanger K, Brooks MZ, Teitlebaum L. Physiological adjustments to stress measures following massage therapy: a review of the literature. Evid Based Complement Alternat Med. 2010 Dec;7(4):409-18. doi: 10.1093/ecam/nen029. Epub 2008 May 7.
Haun J, Patel N, Schwartz G, Ritenbaugh C. Evaluating the use of gas discharge visualization to measure massage therapy outcomes. J Complement Integr Med. 2015 Sep;12(3):231-9. doi: 10.1515/jcim-2014-0014.
Stephenson KR, Simpson TL, Martinez ME, Kearney DJ. Changes in Mindfulness and Posttraumatic Stress Disorder Symptoms Among Veterans Enrolled in Mindfulness-Based Stress Reduction. J Clin Psychol. 2017 Mar;73(3):201-217. doi: 10.1002/jclp.22323. Epub 2016 May 6.
Garland EL, Manusov EG, Froeliger B, Kelly A, Williams JM, Howard MO. Mindfulness-oriented recovery enhancement for chronic pain and prescription opioid misuse: results from an early-stage randomized controlled trial. J Consult Clin Psychol. 2014 Jun;82(3):448-459. doi: 10.1037/a0035798. Epub 2014 Feb 3.
Serpa JG, Taylor SL, Tillisch K. Mindfulness-based stress reduction (MBSR) reduces anxiety, depression, and suicidal ideation in veterans. Med Care. 2014 Dec;52(12 Suppl 5):S19-24. doi: 10.1097/MLR.0000000000000202.
Nash WP, Watson PJ. Review of VA/DOD Clinical Practice Guideline on management of acute stress and interventions to prevent posttraumatic stress disorder. J Rehabil Res Dev. 2012;49(5):637-48. doi: 10.1682/jrrd.2011.10.0194.
Elwy AR, Johnston JM, Bormann JE, Hull A, Taylor SL. A systematic scoping review of complementary and alternative medicine mind and body practices to improve the health of veterans and military personnel. Med Care. 2014 Dec;52(12 Suppl 5):S70-82. doi: 10.1097/MLR.0000000000000228.
Engel GL. The need for a new medical model: a challenge for biomedicine. Science. 1977 Apr 8;196(4286):129-36. doi: 10.1126/science.847460.
Cohen S, Wills TA. Stress, social support, and the buffering hypothesis. Psychol Bull. 1985 Sep;98(2):310-57. No abstract available.
Collinge W, Kahn J, Soltysik R. Promoting reintegration of National Guard veterans and their partners using a self-directed program of integrative therapies: a pilot study. Mil Med. 2012 Dec;177(12):1477-85. doi: 10.7205/milmed-d-12-00121.
Tian TY, Zlateva I, Anderson DR. Using electronic health records data to identify patients with chronic pain in a primary care setting. J Am Med Inform Assoc. 2013 Dec;20(e2):e275-80. doi: 10.1136/amiajnl-2013-001856. Epub 2013 Jul 31.
Sandelowski M. Sample size in qualitative research. Res Nurs Health. 1995 Apr;18(2):179-83. doi: 10.1002/nur.4770180211.
Ritenbaugh C, Nichter M, Nichter MA, Kelly KL, Sims CM, Bell IR, Castaneda HM, Elder CR, Koithan MS, Sutherland EG, Verhoef MJ, Warber SL, Coons SJ. Developing a patient-centered outcome measure for complementary and alternative medicine therapies I: defining content and format. BMC Complement Altern Med. 2011 Dec 29;11:135. doi: 10.1186/1472-6882-11-135.
Thompson JJ, Kelly KL, Ritenbaugh C, Hopkins AL, Sims CM, Coons SJ. Developing a patient-centered outcome measure for complementary and alternative medicine therapies II: refining content validity through cognitive interviews. BMC Complement Altern Med. 2011 Dec 29;11:136. doi: 10.1186/1472-6882-11-136.
Corrigan JD, Bogner J. Initial reliability and validity of the Ohio State University TBI Identification Method. J Head Trauma Rehabil. 2007 Nov-Dec;22(6):318-29. doi: 10.1097/01.HTR.0000300227.67748.77.
Busija L, Pausenberger E, Haines TP, Haymes S, Buchbinder R, Osborne RH. Adult measures of general health and health-related quality of life: Medical Outcomes Study Short Form 36-Item (SF-36) and Short Form 12-Item (SF-12) Health Surveys, Nottingham Health Profile (NHP), Sickness Impact Profile (SIP), Medical Outcomes Study Short Form 6D (SF-6D), Health Utilities Index Mark 3 (HUI3), Quality of Well-Being Scale (QWB), and Assessment of Quality of Life (AQoL). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S383-412. doi: 10.1002/acr.20541. No abstract available.
Polomano RC, Galloway KT, Kent ML, Brandon-Edwards H, Kwon KN, Morales C, Buckenmaier C' 3rd. Psychometric Testing of the Defense and Veterans Pain Rating Scale (DVPRS): A New Pain Scale for Military Population. Pain Med. 2016 Aug;17(8):1505-19. doi: 10.1093/pm/pnw105. Epub 2016 Jun 6.
Clark ME, Gironda RJ, Young RW. Development and validation of the Pain Outcomes Questionnaire-VA. J Rehabil Res Dev. 2003 Sep-Oct;40(5):381-95. doi: 10.1682/jrrd.2003.09.0381.
Bovin MJ, Marx BP, Weathers FW, Gallagher MW, Rodriguez P, Schnurr PP, Keane TM. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in veterans. Psychol Assess. 2016 Nov;28(11):1379-1391. doi: 10.1037/pas0000254. Epub 2015 Dec 14.
Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13.
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Ten Have TR, Normand SL, Marcus SM, Brown CH, Lavori P, Duan N. Intent-to-Treat vs. Non-Intent-to-Treat Analyses under Treatment Non-Adherence in Mental Health Randomized Trials. Psychiatr Ann. 2008 Dec;38(12):772-783. doi: 10.3928/00485713-20081201-10. No abstract available.
Lew HL, Otis JD, Tun C, Kerns RD, Clark ME, Cifu DX. Prevalence of chronic pain, posttraumatic stress disorder, and persistent postconcussive symptoms in OIF/OEF veterans: polytrauma clinical triad. J Rehabil Res Dev. 2009;46(6):697-702. doi: 10.1682/jrrd.2009.01.0006.
Haun JN, Fowler CA, Venkatachalam HH, Alman AC, Ballistrea LM, Schneider T, Benzinger RC, Melillo C, Alexander NB, Klanchar SA, Lapcevic WA, Bair MJ, Taylor SL, Murphy JL, French DD. Outcomes of a Remotely Delivered Complementary and Integrative Health Partnered Intervention to Improve Chronic Pain and Posttraumatic Stress Disorder Symptoms: Randomized Controlled Trial. J Med Internet Res. 2024 Oct 18;26:e57322. doi: 10.2196/57322.
Haun JN, Venkatachalam HH, Fowler CA, Alman AC, Ballistrea LM, Schneider T, Benzinger RC, Melillo C, Alexander NB, Klanchar SA, Lapcevic W, French DD. Mobile and Web-Based Partnered Intervention to Improve Remote Access to Pain and Posttraumatic Stress Disorder Symptom Management: Recruitment and Attrition in a Randomized Controlled Trial. J Med Internet Res. 2023 Oct 3;25:e49678. doi: 10.2196/49678.
Haun JN, Ballistrea LM, Melillo C, Standifer M, Kip K, Paykel J, Murphy JL, Fletcher CE, Mitchinson A, Kozak L, Taylor SL, Glynn SM, Bair M. A Mobile and Web-Based Self-Directed Complementary and Integrative Health Program for Veterans and Their Partners (Mission Reconnect): Protocol for a Mixed-Methods Randomized Controlled Trial. JMIR Res Protoc. 2019 May 13;8(5):e13666. doi: 10.2196/13666.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Related Links
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ATLAS.ti: The Qualitative Data Analysis Software
Statistical Analysis Software, SAS/STAT \| SAS
Other Identifiers
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D2775-R
Identifier Type: -
Identifier Source: org_study_id
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