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

NCT03593772 | Completed Results

• 1 other identifier: D2775-R
• Study Type: interventional
• Target: 730
• Locations: 1 country
• Sites: 3

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.

Conditions

PTSD; Chronic Musculoskeletal Pain

Keywords

chronic pain; PTSD

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, month 1,2,4

Secondary Outcomes (6)

• Pain, Stress and Tension Likert

  Baseline, Week 1 - 8, Week 16

• Defense and Veterans Pain Rating Scale

  Baseline, month 1,2,4

• PTSD: Posttraumatic Checklist

  Baseline, month 1,2,4

• Quality of Life Short-form (SF12)

  Baseline, month 1,2,4

• Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)

  Baseline, month 1,2,4

Other Outcomes (5)

• Depression: Beck Depression Inventory (BDI)

  Baseline, month 1,2,4

• Stress: Perceived Stress Scale (PSS)

  Baseline, month 1,2,4

• Revised Dyadic Adjustment Scale (RDAS)

  Baseline, month 1,2,4

Study Arms (4)

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.

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.

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.

Interventions

Mission Reconnect BEHAVIORAL

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.

Treatment arm - Partner; Treatment arm - Veteran

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Potential participants who screen for aggression or violence will also be excluded from study.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

Related Publications (62)

• 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.

  PMID: 24959325 BACKGROUND

• 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.

  PMID: 27023420 BACKGROUND

• 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.

  PMID: 22396516 BACKGROUND

• 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.

  PMID: 15939839 BACKGROUND

• 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.

  PMID: 11497210 BACKGROUND

• 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.

  PMID: 18602869 BACKGROUND

• 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.

  PMID: 19416436 BACKGROUND

• 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.

  PMID: 20842019 BACKGROUND

• 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.

  PMID: 21951787 BACKGROUND

• 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.

  PMID: 23835878 BACKGROUND

• 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.

  PMID: 20104393 BACKGROUND

• 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.

  PMID: 23848062 BACKGROUND

• 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.

  PMID: 22983600 BACKGROUND

• 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.

  PMID: 25645538 BACKGROUND

• 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.

  PMID: 23015586 BACKGROUND

• 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.

  PMID: 7369396 BACKGROUND

• 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.

  PMID: 17592957 BACKGROUND

• 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.

  PMID: 8880842 BACKGROUND

• 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.

  PMID: 20947249 BACKGROUND

• 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.

  PMID: 3356550 BACKGROUND

• 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.

  PMID: 8997917 BACKGROUND

• 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.

  PMID: 22337646 BACKGROUND

• 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.

  PMID: 9489262 BACKGROUND

• 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.

  PMID: 23015582 BACKGROUND

• 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.

  PMID: 24439093 BACKGROUND

• 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.

  PMID: 27678169 BACKGROUND

• 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.

  PMID: 22234716 BACKGROUND

• 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.

  PMID: 29039681 BACKGROUND

• 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/

  PMID: 28102991 BACKGROUND

• 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.

  PMID: 21589728 BACKGROUND

• 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.

  PMID: 11322842 BACKGROUND

• 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.

  PMID: 14717648 BACKGROUND

• 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.

  PMID: 17549233 BACKGROUND

• 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.

  PMID: 27165971 BACKGROUND

• 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.

  PMID: 17709060 BACKGROUND

• 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.

  PMID: 18955340 BACKGROUND

• 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.

  PMID: 26087069 BACKGROUND

• 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.

  PMID: 27152480 BACKGROUND

• 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.

  PMID: 24491075 BACKGROUND

• 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.

  PMID: 25397818 BACKGROUND

• 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.

  PMID: 23015576 BACKGROUND

• 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.

  PMID: 25397827 BACKGROUND

• 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.

  PMID: 847460 BACKGROUND

• Cohen S, Wills TA. Stress, social support, and the buffering hypothesis. Psychol Bull. 1985 Sep;98(2):310-57. No abstract available.

  PMID: 3901065 BACKGROUND

• 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.

  PMID: 23397692 BACKGROUND

• 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.

  PMID: 23904323 BACKGROUND

• Sandelowski M. Sample size in qualitative research. Res Nurs Health. 1995 Apr;18(2):179-83. doi: 10.1002/nur.4770180211.

  PMID: 7899572 BACKGROUND

• 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.

  PMID: 22206345 BACKGROUND

• 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.

  PMID: 22206409 BACKGROUND

• 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.

  PMID: 18025964 BACKGROUND

• 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.

  PMID: 22588759 BACKGROUND

• 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.

  PMID: 27272528 BACKGROUND

• 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.

  PMID: 15080223 BACKGROUND

• 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.

  PMID: 26653052 BACKGROUND

• 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.

  PMID: 8991972 BACKGROUND

• 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.

  PMID: 6668417 BACKGROUND

• 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.

  PMID: 2748771 BACKGROUND

• 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.

  PMID: 20717484 BACKGROUND

• 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.

  PMID: 20104399 RESULT

• 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.

  PMID: 39422992 DERIVED

• 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.

  PMID: 37788078 DERIVED

• 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.

  PMID: 31094345 DERIVED

Related Links

• ATLAS.ti: The Qualitative Data Analysis Software
• Statistical Analysis Software, SAS/STAT \| SAS

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Chronic Pain

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Jolie Haun
• Organization: James A. Haley Veteran Hospital Research Service

Jolie.Haun@va.gov

904-377-6796

Study Officials

• Jolie N. Haun, PhD MS BS

  James A. Haley Veterans' Hospital, Tampa, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There are no masked roles
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: July 20, 2018
• Study Start: October 8, 2019
• Primary Completion: July 18, 2022
• Study Completion: October 31, 2022
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)