MBCT and CBT for Chronic Pain in Multiple Sclerosis

NCT03782246 | Unknown

• 1 other identifier: STUDY00004422
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain is one of the most prevalent, disabling and persistent symptoms affecting people with multiple sclerosis (MS). Different nonpharmacological treatments are known to be beneficial for managing pain, including cognitive behavioral therapy and mindfulness based cognitive therapy. This study compares these two non-pharmacological approaches to pain management in people with Multiple Sclerosis. The purpose of this study is to see if these treatments can help decrease pain and other outcomes (e.g., sleep, fatigue) in persons with Multiple Sclerosis. The study will determine who benefits from these treatments and if these treatments can be given effectively by videoconference.

Conditions

Multiple Sclerosis

Keywords

chronic pain; multiple sclerosis; pain; mindfulness; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• Change in average pain intensity

  0-10 Numerical Pain Scale of average pain intensity in past week (0 = no pain, 10 = worst pain imaginable). Higher scores indicate higher levels of self-reported pain intensity.

  Baseline to 10 weeks (posttreatment; primary endpoint)

Secondary Outcomes (9)

• Pain interference

  baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)

• Average pain intensity - maintenance

  36 weeks (6-month follow up)

• Depressive symptom severity

  baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)

• Patient ratings of global improvement & satisfaction

  baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)

• Fatigue severity

  baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)

Study Arms (3)

Usual Care

NO INTERVENTION

No intervention, participant will continue their usual care for pain and MS. We will collect information about what treatments are used by the usual care participants. They will be offered the opportunity to participate in one of the two active study treatments (MBCT or CBT) after completion of the 6-month followup.

Mindfulness-Based Cognitive Therapy (MBCT)

EXPERIMENTAL

Participants will attend eight, 2-hour group treatment MBCT sessions delivered using free video-conferencing technology. Groups will consist of 6-8 people who also have MS and chronic pain. Participants will be asked to practice skills learned in session between sessions. MBCT integrates mindfulness meditation practices within a CBT-oriented framework to address not only unhelpful pain cognitions and behaviors but also attentional control, decoupling of attention from emotion, mindful cognitions, and meditative behavior.

Behavioral: MBCT

Cognitive Behavioral Therapy (CBT)

EXPERIMENTAL

Participants will attend eight, 2-hour group treatment CBT sessions delivered using free video-conferencing technology. Groups will consist of 6-8 people who also have MS and chronic pain. Participants will be asked to practice skills learned in session between sessions. CBT focuses on increasing adaptive pain coping strategies and reducing unhelpful thoughts and behaviors related to pain. Strategies include relaxation techniques, goal-setting, activity pacing, and changing unhelpful thinking patterns.

Behavioral: CBT

Interventions

MBCT BEHAVIORAL

Mindfulness- based Cognitive Therapy

Mindfulness-Based Cognitive Therapy (MBCT)

CBT BEHAVIORAL

Cognitive Behavioral Therapy

Cognitive Behavioral Therapy (CBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older;
• a diagnosis of clinically definite MS confirmed by participant's provider;
• the presence of chronic pain, defined as average pain intensity in the past week of at least moderate severity (defined as a ≥3 on the 0-10 numerical rating scale) and pain of at least three months duration, with pain reportedly present \> half the days in the past three months;
• reads and speaks English;
• has access and is able to communicate over the telephone; and
• has a computer or digital device with video capabilities (any operating system) and internet access.

You may not qualify if:

• severe cognitive impairment;
• currently in psychotherapy for pain \> once a month; and
• previously participated in a pain study that used CBT or MBCT.

Sponsors & Collaborators

• University of Washington: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

UW Medicine Multiple Sclerosis Center

Seattle, Washington, 98195, United States

Location

Related Publications (73)

• Bogosian A, Chadwick P, Windgassen S, Norton S, McCrone P, Mosweu I, Silber E, Moss-Morris R. Distress improves after mindfulness training for progressive MS: A pilot randomised trial. Mult Scler. 2015 Aug;21(9):1184-94. doi: 10.1177/1352458515576261. Epub 2015 Mar 12.

  PMID: 25767124 BACKGROUND

• Harris MA, Freeman KA, Duke DC. Seeing Is Believing: Using Skype to Improve Diabetes Outcomes in Youth. Diabetes Care. 2015 Aug;38(8):1427-34. doi: 10.2337/dc14-2469. Epub 2015 Jun 1.

  PMID: 26033508 BACKGROUND

• Lion KC, Brown JC, Ebel BE, Klein EJ, Strelitz B, Gutman CK, Hencz P, Fernandez J, Mangione-Smith R. Effect of Telephone vs Video Interpretation on Parent Comprehension, Communication, and Utilization in the Pediatric Emergency Department: A Randomized Clinical Trial. JAMA Pediatr. 2015 Dec;169(12):1117-25. doi: 10.1001/jamapediatrics.2015.2630.

  PMID: 26501862 BACKGROUND

• Foley PL, Vesterinen HM, Laird BJ, Sena ES, Colvin LA, Chandran S, MacLeod MR, Fallon MT. Prevalence and natural history of pain in adults with multiple sclerosis: systematic review and meta-analysis. Pain. 2013 May;154(5):632-642. doi: 10.1016/j.pain.2012.12.002. Epub 2012 Dec 14.

  PMID: 23318126 BACKGROUND

• Ehde DM, Dillworth TM, Turner JA. Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. Am Psychol. 2014 Feb-Mar;69(2):153-66. doi: 10.1037/a0035747.

  PMID: 24547801 BACKGROUND

• Fedoroff IC, Blackwell E, Speed B. Evaluation of group and individual change in a multidisciplinary pain management program. Clin J Pain. 2014 May;30(5):399-408. doi: 10.1097/AJP.0b013e31829ea1f7.

  PMID: 23887341 BACKGROUND

• Turner JA, Turk DC. The significance of clinical significance. Pain. 2008 Jul 31;137(3):467-468. doi: 10.1016/j.pain.2008.03.029. Epub 2008 May 1. No abstract available.

  PMID: 18455313 BACKGROUND

• Morley S, Williams A, Hussain S. Estimating the clinical effectiveness of cognitive behavioural therapy in the clinic: evaluation of a CBT informed pain management programme. Pain. 2008 Jul 31;137(3):670-680. doi: 10.1016/j.pain.2008.02.025. Epub 2008 Apr 3.

  PMID: 18394806 BACKGROUND

• Dysvik E, Kvaloy JT, Stokkeland R, Natvig GK. The effectiveness of a multidisciplinary pain management programme managing chronic pain on pain perceptions, health-related quality of life and stages of change--A non-randomized controlled study. Int J Nurs Stud. 2010 Jul;47(7):826-35. doi: 10.1016/j.ijnurstu.2009.12.001. Epub 2009 Dec 29.

  PMID: 20036362 BACKGROUND

• Ehde DM, Osborne TL, Hanley MA, Jensen MP, Kraft GH. The scope and nature of pain in persons with multiple sclerosis. Mult Scler. 2006 Oct;12(5):629-38. doi: 10.1177/1352458506071346.

  PMID: 17086910 BACKGROUND

• Hadjimichael O, Kerns RD, Rizzo MA, Cutter G, Vollmer T. Persistent pain and uncomfortable sensations in persons with multiple sclerosis. Pain. 2007 Jan;127(1-2):35-41. doi: 10.1016/j.pain.2006.07.015. Epub 2006 Sep 1.

  PMID: 16949751 BACKGROUND

• Khan F, Pallant J. Chronic pain in multiple sclerosis: prevalence, characteristics, and impact on quality of life in an Australian community cohort. J Pain. 2007 Aug;8(8):614-23. doi: 10.1016/j.jpain.2007.03.005. Epub 2007 May 31.

  PMID: 17543586 BACKGROUND

• Ehde DM, Gibbons LE, Chwastiak L, Bombardier CH, Sullivan MD, Kraft GH. Chronic pain in a large community sample of persons with multiple sclerosis. Mult Scler. 2003 Dec;9(6):605-11. doi: 10.1191/1352458503ms939oa.

  PMID: 14664474 BACKGROUND

• O'Connor AB, Schwid SR, Herrmann DN, Markman JD, Dworkin RH. Pain associated with multiple sclerosis: systematic review and proposed classification. Pain. 2008 Jul;137(1):96-111. doi: 10.1016/j.pain.2007.08.024. Epub 2007 Oct 24.

  PMID: 17928147 BACKGROUND

• Alschuler KN, Ehde DM, Jensen MP. The co-occurrence of pain and depression in adults with multiple sclerosis. Rehabil Psychol. 2013 May;58(2):217-21. doi: 10.1037/a0032008.

  PMID: 23713732 BACKGROUND

• Motl RW, McAuley E. Symptom cluster and quality of life: preliminary evidence in multiple sclerosis. J Neurosci Nurs. 2010 Aug;42(4):212-6. doi: 10.1097/jnn.0b013e3181e26c5f.

  PMID: 20804116 BACKGROUND

• Zwibel HL, Smrtka J. Improving quality of life in multiple sclerosis: an unmet need. Am J Manag Care. 2011 May;17 Suppl 5 Improving:S139-45.

  PMID: 21761952 BACKGROUND

• Motl RW, Weikert M, Suh Y, Dlugonski D. Symptom cluster and physical activity in relapsing-remitting multiple sclerosis. Res Nurs Health. 2010 Oct;33(5):398-412. doi: 10.1002/nur.20396.

  PMID: 20725947 BACKGROUND

• Honarmand K, Akbar N, Kou N, Feinstein A. Predicting employment status in multiple sclerosis patients: the utility of the MS functional composite. J Neurol. 2011 Feb;258(2):244-9. doi: 10.1007/s00415-010-5736-8. Epub 2010 Sep 12.

  PMID: 20835872 BACKGROUND

• Hughes AJ, Beier M, Hartoonian N, Turner AP, Amtmann D, Ehde DM. Self-efficacy as a longitudinal predictor of perceived cognitive impairment in individuals with multiple sclerosis. Arch Phys Med Rehabil. 2015 May;96(5):913-9. doi: 10.1016/j.apmr.2015.01.008. Epub 2015 Jan 15.

  PMID: 25597915 BACKGROUND

• Ehde DM, Elzea JL, Verrall AM, Gibbons LE, Smith AE, Amtmann D. Efficacy of a Telephone-Delivered Self-Management Intervention for Persons With Multiple Sclerosis: A Randomized Controlled Trial With a One-Year Follow-Up. Arch Phys Med Rehabil. 2015 Nov;96(11):1945-58.e2. doi: 10.1016/j.apmr.2015.07.015. Epub 2015 Aug 6.

  PMID: 26254948 BACKGROUND

• Jensen MP, Ehde DM, Gertz KJ, Stoelb BL, Dillworth TM, Hirsh AT, Molton IR, Kraft GH. Effects of self-hypnosis training and cognitive restructuring on daily pain intensity and catastrophizing in individuals with multiple sclerosis and chronic pain. Int J Clin Exp Hypn. 2011 Jan;59(1):45-63. doi: 10.1080/00207144.2011.522892.

  PMID: 21104484 BACKGROUND

• Simpson R, Booth J, Lawrence M, Byrne S, Mair F, Mercer S. Mindfulness based interventions in multiple sclerosis--a systematic review. BMC Neurol. 2014 Jan 17;14:15. doi: 10.1186/1471-2377-14-15.

  PMID: 24438384 BACKGROUND

• Jensen MP, Hanley MA, Engel JM, Romano JM, Barber J, Cardenas DD, Kraft GH, Hoffman AJ, Patterson DR. Hypnotic analgesia for chronic pain in persons with disabilities: a case series. Int J Clin Exp Hypn. 2005 Apr;53(2):198-228. doi: 10.1080/00207140590927545.

  PMID: 16025734 BACKGROUND

• Jensen MP, Barber J, Romano JM, Molton IR, Raichle KA, Osborne TL, Engel JM, Stoelb BL, Kraft GH, Patterson DR. A comparison of self-hypnosis versus progressive muscle relaxation in patients with multiple sclerosis and chronic pain. Int J Clin Exp Hypn. 2009 Apr;57(2):198-221. doi: 10.1080/00207140802665476.

  PMID: 19234967 BACKGROUND

• Day MA, Jensen MP, Ehde DM, Thorn BE. Toward a theoretical model for mindfulness-based pain management. J Pain. 2014 Jul;15(7):691-703. doi: 10.1016/j.jpain.2014.03.003.

  PMID: 24985483 BACKGROUND

• Ehde DM, Alschuler KN, Osborne TL, Hanley MA, Jensen MP, Kraft GH. Utilization and patients' perceptions of the effectiveness of pain treatments in multiple sclerosis: A cross-sectional survey. Disabil Health J. 2015 Jul;8(3):452-6. doi: 10.1016/j.dhjo.2015.03.001. Epub 2015 Mar 14.

  PMID: 25899795 BACKGROUND

• Day MA, Ehde DM, Jensen MP. Psychosocial Pain Management Moderation: The Limit, Activate, and Enhance Model. J Pain. 2015 Oct;16(10):947-60. doi: 10.1016/j.jpain.2015.07.003. Epub 2015 Sep 6.

  PMID: 26351009 BACKGROUND

• Aivaliotis VI, Lee Y, Zia J, Wassef W, Abramson M, Park W. Telephone-Based Mindfulness Therapy Intervention for Patients with Chronic Pancreatitis. Dig Dis Sci. 2017 Feb;62(2):502-509. doi: 10.1007/s10620-016-4389-6. Epub 2016 Dec 8.

  PMID: 27933469 BACKGROUND

• Campo RA, Bluth K, Santacroce SJ, Knapik S, Tan J, Gold S, Philips K, Gaylord S, Asher GN. A mindful self-compassion videoconference intervention for nationally recruited posttreatment young adult cancer survivors: feasibility, acceptability, and psychosocial outcomes. Support Care Cancer. 2017 Jun;25(6):1759-1768. doi: 10.1007/s00520-017-3586-y. Epub 2017 Jan 19.

  PMID: 28105523 BACKGROUND

• Dowling GA, Merrilees J, Mastick J, Chang VY, Hubbard E, Moskowitz JT. Life enhancing activities for family caregivers of people with frontotemporal dementia. Alzheimer Dis Assoc Disord. 2014 Apr-Jun;28(2):175-81. doi: 10.1097/WAD.0b013e3182a6b905.

  PMID: 24113564 BACKGROUND

• Gardner-Nix J, Backman S, Barbati J, Grummitt J. Evaluating distance education of a mindfulness-based meditation programme for chronic pain management. J Telemed Telecare. 2008;14(2):88-92. doi: 10.1258/jtt.2007.070811.

  PMID: 18348755 BACKGROUND

• Himle MB, Freitag M, Walther M, Franklin SA, Ely L, Woods DW. A randomized pilot trial comparing videoconference versus face-to-face delivery of behavior therapy for childhood tic disorders. Behav Res Ther. 2012 Sep;50(9):565-70. doi: 10.1016/j.brat.2012.05.009. Epub 2012 Jun 4.

  PMID: 22743661 BACKGROUND

• Clarke G, Yarborough BJ. Evaluating the promise of health IT to enhance/expand the reach of mental health services. Gen Hosp Psychiatry. 2013 Jul-Aug;35(4):339-44. doi: 10.1016/j.genhosppsych.2013.03.013. Epub 2013 May 20.

  PMID: 23701698 BACKGROUND

• Day MA, Thorn BE, Rubin NJ. Mindfulness-based cognitive therapy for the treatment of headache pain: A mixed-methods analysis comparing treatment responders and treatment non-responders. Complement Ther Med. 2014 Apr;22(2):278-85. doi: 10.1016/j.ctim.2013.12.018. Epub 2014 Jan 9.

  PMID: 24731899 BACKGROUND

• Day MA, Thorn BE, Kapoor S. A qualitative analysis of a randomized controlled trial comparing a cognitive-behavioral treatment with education. J Pain. 2011 Sep;12(9):941-52. doi: 10.1016/j.jpain.2011.02.354. Epub 2011 Aug 11.

  PMID: 21839689 BACKGROUND

• Bombardier CH, Ehde DM, Gibbons LE, Wadhwani R, Sullivan MD, Rosenberg DE, Kraft GH. Telephone-based physical activity counseling for major depression in people with multiple sclerosis. J Consult Clin Psychol. 2013 Feb;81(1):89-99. doi: 10.1037/a0031242.

  PMID: 23379265 BACKGROUND

• Ehde DM, Kraft GH, Chwastiak L, Sullivan MD, Gibbons LE, Bombardier CH, Wadhwani R. Efficacy of paroxetine in treating major depressive disorder in persons with multiple sclerosis. Gen Hosp Psychiatry. 2008 Jan-Feb;30(1):40-8. doi: 10.1016/j.genhosppsych.2007.08.002.

  PMID: 18164939 BACKGROUND

• Bombardier CH, Cunniffe M, Wadhwani R, Gibbons LE, Blake KD, Kraft GH. The efficacy of telephone counseling for health promotion in people with multiple sclerosis: a randomized controlled trial. Arch Phys Med Rehabil. 2008 Oct;89(10):1849-56. doi: 10.1016/j.apmr.2008.03.021.

  PMID: 18929012 BACKGROUND

• Muller R, Gertz KJ, Molton IR, Terrill AL, Bombardier CH, Ehde DM, Jensen MP. Effects of a Tailored Positive Psychology Intervention on Well-Being and Pain in Individuals With Chronic Pain and a Physical Disability: A Feasibility Trial. Clin J Pain. 2016 Jan;32(1):32-44. doi: 10.1097/AJP.0000000000000225.

  PMID: 25724020 BACKGROUND

• Bombardier CH, Bell KR, Temkin NR, Fann JR, Hoffman J, Dikmen S. The efficacy of a scheduled telephone intervention for ameliorating depressive symptoms during the first year after traumatic brain injury. J Head Trauma Rehabil. 2009 Jul-Aug;24(4):230-8. doi: 10.1097/HTR.0b013e3181ad65f0.

  PMID: 19625862 BACKGROUND

• Smith DG, Ehde DM, Hanley MA, Campbell KM, Jensen MP, Hoffman AJ, Awan AB, Czerniecki JM, Robinson LR. Efficacy of gabapentin in treating chronic phantom limb and residual limb pain. J Rehabil Res Dev. 2005 Sep-Oct;42(5):645-54. doi: 10.1682/jrrd.2005.05.0082.

  PMID: 16586190 BACKGROUND

• Robinson LR, Czerniecki JM, Ehde DM, Edwards WT, Judish DA, Goldberg ML, Campbell KM, Smith DG, Jensen MP. Trial of amitriptyline for relief of pain in amputees: results of a randomized controlled study. Arch Phys Med Rehabil. 2004 Jan;85(1):1-6. doi: 10.1016/s0003-9993(03)00476-3.

  PMID: 14970960 BACKGROUND

• Wegener ST, Mackenzie EJ, Ephraim P, Ehde D, Williams R. Self-management improves outcomes in persons with limb loss. Arch Phys Med Rehabil. 2009 Mar;90(3):373-80. doi: 10.1016/j.apmr.2008.08.222.

  PMID: 19254599 BACKGROUND

• Guihan M, Bombardier CH, Ehde DM, Rapacki LM, Rogers TJ, Bates-Jensen B, Thomas FP, Parachuri R, Holmes SA. Comparing multicomponent interventions to improve skin care behaviors and prevent recurrence in veterans hospitalized for severe pressure ulcers. Arch Phys Med Rehabil. 2014 Jul;95(7):1246-1253.e3. doi: 10.1016/j.apmr.2014.01.012. Epub 2014 Jan 30.

  PMID: 24486242 BACKGROUND

• Alschuler KN, Jensen MP, Ehde DM. The association of depression with pain-related treatment utilization in patients with multiple sclerosis. Pain Med. 2012 Dec;13(12):1648-57. doi: 10.1111/j.1526-4637.2012.01513.x. Epub 2012 Nov 8.

  PMID: 23137071 BACKGROUND

• Alschuler KN, Jensen MP, Ehde DM. Defining mild, moderate, and severe pain in persons with multiple sclerosis. Pain Med. 2012 Oct;13(10):1358-65. doi: 10.1111/j.1526-4637.2012.01471.x. Epub 2012 Aug 23.

  PMID: 22925457 BACKGROUND

• Ehde DM, Nitsch KP, Smiley JP. Measurement characteristics and clinical utility of the Brief Pain Inventory-Short Form for individuals with multiple sclerosis. Rehabil Psychol. 2015 Nov;60(4):365-6. doi: 10.1037/rep0000065.

  PMID: 26618216 BACKGROUND

• Osborne TL, Jensen MP, Ehde DM, Hanley MA, Kraft G. Psychosocial factors associated with pain intensity, pain-related interference, and psychological functioning in persons with multiple sclerosis and pain. Pain. 2007 Jan;127(1-2):52-62. doi: 10.1016/j.pain.2006.07.017. Epub 2006 Sep 6.

  PMID: 16950570 BACKGROUND

• Kratz AL, Hirsh AT, Ehde DM, Jensen MP. Acceptance of pain in neurological disorders: associations with functioning and psychosocial well-being. Rehabil Psychol. 2013 Feb;58(1):1-9. doi: 10.1037/a0031727.

  PMID: 23437995 BACKGROUND

• Jensen MP. Psychosocial approaches to pain management: an organizational framework. Pain. 2011 Apr;152(4):717-725. doi: 10.1016/j.pain.2010.09.002. Epub 2010 Dec 18.

  PMID: 21168972 BACKGROUND

• Jensen MP, Ehde DM, Day MA. The Behavioral Activation and Inhibition Systems: Implications for Understanding and Treating Chronic Pain. J Pain. 2016 May;17(5):529.e1-529.e18. doi: 10.1016/j.jpain.2016.02.001. Epub 2016 Mar 24.

  PMID: 27052644 BACKGROUND

• Day MA, Ehde DM, Ward LC, Hartoonian N, Alschuler KN, Turner AP, Kraft GH, Jensen MP. An Empirical Investigation of a Biopsychosocial Model of Pain in Multiple Sclerosis. Clin J Pain. 2016 Feb;32(2):155-63. doi: 10.1097/AJP.0000000000000240.

  PMID: 26741742 BACKGROUND

• Day MA, Thorn BE, Ward LC, Rubin N, Hickman SD, Scogin F, Kilgo GR. Mindfulness-based cognitive therapy for the treatment of headache pain: a pilot study. Clin J Pain. 2014 Feb;30(2):152-61. doi: 10.1097/AJP.0b013e318287a1dc.

  PMID: 23446085 BACKGROUND

• Alschuler KN, Wundes A, Dietrich DW, Boskovski B, Kuzmanovski I, Alexander KS, von Geldern G, Stobbe GA. Accelerating international MS care through videoconference-based education and case consultation. Neurology. 2016 Jul 5;87(1):e8-e10. doi: 10.1212/WNL.0000000000002812. No abstract available.

  PMID: 27378811 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gynecol. 2010 May;115(5):1063-1070. doi: 10.1097/AOG.0b013e3181d9d421. No abstract available.

  PMID: 20410783 BACKGROUND

• Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.

  PMID: 15621359 BACKGROUND

• Callahan CM, Unverzagt FW, Hui SL, Perkins AJ, Hendrie HC. Six-item screener to identify cognitive impairment among potential subjects for clinical research. Med Care. 2002 Sep;40(9):771-81. doi: 10.1097/00005650-200209000-00007.

  PMID: 12218768 BACKGROUND

• Osborne TL, Raichle KA, Jensen MP, Ehde DM, Kraft G. The reliability and validity of pain interference measures in persons with multiple sclerosis. J Pain Symptom Manage. 2006 Sep;32(3):217-29. doi: 10.1016/j.jpainsymman.2006.03.008.

  PMID: 16939846 BACKGROUND

• Freynhagen R, Baron R, Gockel U, Tolle TR. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin. 2006 Oct;22(10):1911-20. doi: 10.1185/030079906X132488.

  PMID: 17022849 BACKGROUND

• Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis. 1994 Jan;18 Suppl 1:S79-83. doi: 10.1093/clinids/18.supplement_1.s79.

  PMID: 8148458 BACKGROUND

• Buysse DJ, Yu L, Moul DE, Germain A, Stover A, Dodds NE, Johnston KL, Shablesky-Cade MA, Pilkonis PA. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep. 2010 Jun;33(6):781-92. doi: 10.1093/sleep/33.6.781.

  PMID: 20550019 BACKGROUND

• Amtmann D, Bamer AM, Cook KF, Askew RL, Noonan VK, Brockway JA. University of Washington self-efficacy scale: a new self-efficacy scale for people with disabilities. Arch Phys Med Rehabil. 2012 Oct;93(10):1757-65. doi: 10.1016/j.apmr.2012.05.001. Epub 2012 May 7.

  PMID: 22575393 BACKGROUND

• Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.

  PMID: 8455963 BACKGROUND

• de Bruin EI, Topper M, Muskens JG, Bogels SM, Kamphuis JH. Psychometric properties of the Five Facets Mindfulness Questionnaire (FFMQ) in a meditating and a non-meditating sample. Assessment. 2012 Jun;19(2):187-97. doi: 10.1177/1073191112446654.

  PMID: 22589426 BACKGROUND

• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

  PMID: 3397865 BACKGROUND

• Wicksell RK, Olsson GL, Melin L. The Chronic Pain Acceptance Questionnaire (CPAQ)-further validation including a confirmatory factor analysis and a comparison with the Tampa Scale of Kinesiophobia. Eur J Pain. 2009 Aug;13(7):760-8. doi: 10.1016/j.ejpain.2008.09.003. Epub 2008 Oct 16.

  PMID: 18926744 BACKGROUND

• Gurnani AS, John SE, Gavett BE. Regression-Based Norms for a Bi-factor Model for Scoring the Brief Test of Adult Cognition by Telephone (BTACT). Arch Clin Neuropsychol. 2015 May;30(3):280-91. doi: 10.1093/arclin/acv005. Epub 2015 Feb 27.

  PMID: 25724515 BACKGROUND

• Jensen MP, Barber J, Romano JM, Hanley MA, Raichle KA, Molton IR, Engel JM, Osborne TL, Stoelb BL, Cardenas DD, Patterson DR. Effects of self-hypnosis training and EMG biofeedback relaxation training on chronic pain in persons with spinal-cord injury. Int J Clin Exp Hypn. 2009 Jul;57(3):239-68. doi: 10.1080/00207140902881007.

  PMID: 19459087 BACKGROUND

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  PMID: 17695343 BACKGROUND

• Duff K. Evidence-based indicators of neuropsychological change in the individual patient: relevant concepts and methods. Arch Clin Neuropsychol. 2012 May;27(3):248-61. doi: 10.1093/arclin/acr120. Epub 2012 Feb 29.

  PMID: 22382384 BACKGROUND

• Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. doi: 10.1037//0022-006x.59.1.12.

  PMID: 2002127 BACKGROUND

• Ehde DM, Alschuler KN, Day MA, Ciol MA, Kaylor ML, Altman JK, Jensen MP. Mindfulness-based cognitive therapy and cognitive behavioral therapy for chronic pain in multiple sclerosis: a randomized controlled trial protocol. Trials. 2019 Dec 27;20(1):774. doi: 10.1186/s13063-019-3761-1.

  PMID: 31882017 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dawn Ehde, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Rehabilitation Medicine:Psychology

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 20, 2018
• Study Start: November 28, 2018
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

US (1)