{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T16:49:47Z","timestamp":1775148587372,"version":"3.50.1"},"reference-count":66,"publisher":"American Spinal Injury Association","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022]]},"abstract":"\n Background<\/jats:title>\n The incidence of anxiety in adults with spinal cord injury\/disorder (SCI\/D) exceeds that of the general population. Heart rate variability (HRV) biofeedback training is a potential treatment associated with a reduction in stress and anxiety, however HRV training has not been explored in the SCI\/D population.<\/jats:p>\n <\/jats:sec>\n \n Objectives<\/jats:title>\n To describe a modified protocol piloting HRV training to reduce anxiety associated with SCI\/D and detail the COVID-19\u2013related modifications.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n To test the feasibility of the biofeedback treatment, 30 adults with SCI\/D will complete this pilot randomized controlled trial. Enrollment started in January 2020, halted in March 2020 due to the COVID-19 pandemic, and resumed in March 2021 with a modified protocol. Protocol modifications are documented using the Framework for Reporting Adaptations and Modifications (FRAME). Participants are allocated to the treatment or control arm and undergo eight sessions of physiological monitoring at home using a commercially available HRV sensor and mobile application, which also delivers biofeedback training for those in the treatment arm. Surveys are administered following each session to capture self-reported stress, anxiety, and mood. The study is approved by the HCA-HealthONE institutional review board and is registered with clinicaltrials.gov (NCT# 03975075).<\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n COVID-19 has changed the research landscape, forcing scientists to rethink their study designs to address patient and staff safety in this new context. Our modified protocol accomplished this by moving the treatment setting and delivery out of the clinic and into the home. In doing so, we address patient and staff safety, increase external validity, and reduce participant burden.<\/jats:p>\n <\/jats:sec>","DOI":"10.46292\/sci22-00012","type":"journal-article","created":{"date-parts":[[2022,11,16]],"date-time":"2022-11-16T12:09:45Z","timestamp":1668600585000},"page":"68-79","source":"Crossref","is-referenced-by-count":1,"title":["Going Remote: A Revised Study Protocol for a Pilot Randomized Controlled Trial for Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury"],"prefix":"10.46292","volume":"28","author":[{"given":"Angela","family":"Philippus","sequence":"first","affiliation":[{"name":"Department of Rehabilitation Medicine, University of Minnesota Medical School, Minneapolis, Minnesota;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jason","family":"Nupp","sequence":"additional","affiliation":[{"name":"Craig Hospital, Englewood, Colorado"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bria","family":"MacIntyre","sequence":"additional","affiliation":[{"name":"Craig Hospital, Englewood, Colorado"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abigail","family":"Welch","sequence":"additional","affiliation":[{"name":"Craig Hospital, Englewood, Colorado"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Asma","family":"Ali","sequence":"additional","affiliation":[{"name":"Craig Hospital, Englewood, Colorado"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer","family":"vanderValk","sequence":"additional","affiliation":[{"name":"Craig Hospital, Englewood, Colorado"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kimberley R.","family":"Monden","sequence":"additional","affiliation":[{"name":"Department of Rehabilitation Medicine, University of Minnesota Medical School, Minneapolis, Minnesota;"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"25425","reference":[{"issue":"10","key":"i1945-5763-28-4-68-b1","series-title":"Paraplegia","doi-asserted-by":"publisher","first-page":"675","DOI":"10.1038\/sc.1994.109","article-title":"A longitudinal investigation into anxiety and depression in the first 2 years following a spinal cord injury","volume":"32","year":"1994","unstructured":"Craig\n AR,\n \n \n Hancock\n KM,\n \n \n Dickson\n HG.\n \n \n A longitudinal investigation into anxiety and depression in the first 2 years following a spinal cord injury.\n\t\t\t\t\tParaplegia.\n\t\t\t\t\t1994;\n\t\t\t\t\t32(\n\t\t\t\t\t10):\n\t\t\t\t\t675\u2013\n\t\t\t\t\t679.\n\t\t\t\t\tdoi:10.1038\/sc.1994.109"},{"issue":"8","key":"i1945-5763-28-4-68-b2","series-title":"Spinal Cord","doi-asserted-by":"publisher","first-page":"570","DOI":"10.1038\/sc.2016.15","article-title":"Anxiety prevalence following spinal cord injury: A meta-analysis","volume":"54","year":"2016","unstructured":"Le\n J,\n \n \n Dorstyn\n D.\n \n \n Anxiety prevalence following spinal cord injury: A meta-analysis.\n\t\t\t\t\tSpinal Cord.\n\t\t\t\t\t2016;\n\t\t\t\t\t54(\n\t\t\t\t\t8):\n\t\t\t\t\t570\u2013\n\t\t\t\t\t578.\n\t\t\t\t\tdoi:10.1038\/sc.2016.15"},{"issue":"7","key":"i1945-5763-28-4-68-b3","series-title":"Arch Phys Med Rehabil","doi-asserted-by":"publisher","first-page":"932","DOI":"10.1053\/apmr.2000.5580","article-title":"Anxiety and depression after spinal cord injury: A longitudinal analysis","volume":"81","year":"2000","unstructured":"Kennedy\n P,\n \n \n Rogers\n BA.\n \n \n Anxiety and depression after spinal cord injury: A longitudinal analysis.\n\t\t\t\t\tArch Phys Med Rehabil.\n\t\t\t\t\t2000;\n\t\t\t\t\t81(\n\t\t\t\t\t7):\n\t\t\t\t\t932\u2013\n\t\t\t\t\t937.\n\t\t\t\t\tdoi:10.1053\/apmr.2000.5580"},{"key":"i1945-5763-28-4-68-b4","series-title":"Am J Obstet Gynecol","first-page":"814","article-title":"Electronic evaluation of the fetal heart rate. 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Published August 30, 2021. 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Ther.\n\t\t\t\t\t1995;\n\t\t\t\t\t33(\n\t\t\t\t\t3):\n\t\t\t\t\t335\u2013\n\t\t\t\t\t343.\n\t\t\t\t\tdoi:10.1016\/0005-7967(94)00075-u"},{"issue":"Pt 2","key":"i1945-5763-28-4-68-b22","series-title":"Br J Clin Psychol","doi-asserted-by":"publisher","first-page":"227","DOI":"10.1348\/014466505X29657","article-title":"The short-form version of the Depression Anxiety Stress Scales (DASS-21): Construct validity and normative data in a large non-clinical sample","volume":"44","year":"2005","unstructured":"Henry\n JD,\n \n \n Crawford\n JR.\n \n \n The short-form version of the Depression Anxiety Stress Scales (DASS-21): Construct validity and normative data in a large non-clinical sample.\n\t\t\t\t\tBr J Clin Psychol.\n\t\t\t\t\t2005;\n\t\t\t\t\t44(\n\t\t\t\t\tPt 2):\n\t\t\t\t\t227\u2013\n\t\t\t\t\t239.\n\t\t\t\t\tdoi:10.1348\/014466505X29657"},{"issue":"2","key":"i1945-5763-28-4-68-b23","series-title":"Psychol 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samples","volume":"35","year":"1997","unstructured":"Brown\n TA,\n \n \n Chorpita\n BF,\n \n \n Korotitsch\n W,\n \n \n Barlow\n DH.\n \n \n Psychometric properties of the Depression Anxiety Stress Scales (DASS) in clinical samples.\n\t\t\t\t\tBehav Res Ther.\n\t\t\t\t\t1997;\n\t\t\t\t\t35(\n\t\t\t\t\t1):\n\t\t\t\t\t79\u2013\n\t\t\t\t\t89.\n\t\t\t\t\tdoi:10.1016\/s0005-7967(96)00068-x"},{"issue":"8","key":"i1945-5763-28-4-68-b25","series-title":"Spinal Cord","doi-asserted-by":"publisher","first-page":"547","DOI":"10.1038\/sj.sc.3102154","article-title":"Screening for depression and anxiety in spinal cord injury with DASS-21","volume":"46","year":"2008","unstructured":"Mitchell\n MC,\n \n \n Burns\n NR,\n \n \n Dorstyn\n DS.\n \n \n Screening for depression and anxiety in spinal cord injury with DASS-21.\n\t\t\t\t\tSpinal Cord.\n\t\t\t\t\t2008;\n\t\t\t\t\t46(\n\t\t\t\t\t8):\n\t\t\t\t\t547\u2013\n\t\t\t\t\t551.\n\t\t\t\t\tdoi:10.1038\/sj.sc.3102154"},{"issue":"1","key":"i1945-5763-28-4-68-b26","series-title":"Appl Psychophysiol Biofeedback","doi-asserted-by":"publisher","first-page":"31","DOI":"10.1007\/s10484-011-9174-x","article-title":"Validity of global physical and emotional SUDS","volume":"37","year":"2012","unstructured":"Tanner\n BA.\n \n \n Validity of global physical and emotional SUDS.\n\t\t\t\t\tAppl Psychophysiol Biofeedback.\n\t\t\t\t\t2012;\n\t\t\t\t\t37(\n\t\t\t\t\t1):\n\t\t\t\t\t31\u2013\n\t\t\t\t\t34.\n\t\t\t\t\tdoi:10.1007\/s10484-011-9174-x"},{"key":"i1945-5763-28-4-68-b27","article-title":"A user guide to: Using the SUDS Scale to measure the intensity of feelings","unstructured":"Molin\n LD.\n \n \n A user guide to: Using the SUDS Scale to measure the intensity of feelings.\n\t\t\t\t\thttps:\/\/inneractions.com.au\/downloads\/SUDS_Scale-Intensity_of_Feelings_Measure.pdf. Accessed January 12, 2022."},{"key":"i1945-5763-28-4-68-b28","series-title":"The Corsini Encyclopedia of Psychology","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1002\/9780470479216.corpsy0943","article-title":"State-Trait Anxiety Inventory","year":"2010","unstructured":"Spielberger\n CD.\n \n \n State-Trait Anxiety Inventory.\n\t\t\t\t\tIn:The Corsini Encyclopedia of Psychology.\n\t\t\t\t\tJohn Wiley & Sons, Ltd;\n\t\t\t\t\t2010:\n\t\t\t\t\t1\u2013\n\t\t\t\t\t1.\n\t\t\t\t\tdoi:10.1002\/9780470479216.corpsy0943"},{"issue":"6","key":"i1945-5763-28-4-68-b29","series-title":"Paraplegia","doi-asserted-by":"publisher","first-page":"349","DOI":"10.1038\/sc.1993.59","article-title":"Anxiety and depression over the first year of spinal cord injury: A longitudinal study","volume":"31","year":"1993","unstructured":"Hancock\n KM,\n \n \n Craig\n AR,\n \n \n Dickson\n HG,\n \n \n Chang\n E,\n \n \n Martin\n J.\n \n \n Anxiety and depression over the first year of spinal cord injury: A longitudinal study.\n\t\t\t\t\tParaplegia.\n\t\t\t\t\t1993;\n\t\t\t\t\t31(\n\t\t\t\t\t6):\n\t\t\t\t\t349\u2013\n\t\t\t\t\t357.\n\t\t\t\t\tdoi:10.1038\/sc.1993.59"},{"key":"i1945-5763-28-4-68-b30","first-page":"143","article-title":"The Brief Pain Inventory","year":"1991","unstructured":"Cleeland\n CS,\n \n \n Ryan\n K.\n \n \n The Brief Pain Inventory.\n\t\t\t\t\tPain Research Group.\n\t\t\t\t\t1991:\n\t\t\t\t\t143\u2013\n\t\t\t\t\t147. https:\/\/oml.eular.org\/sysModules\/obxOml\/docs\/ID_363\/bpi.pdf"},{"issue":"5","key":"i1945-5763-28-4-68-b31","series-title":"Lancet Glob Health","doi-asserted-by":"publisher","first-page":"e711","DOI":"10.1016\/S2214-109X(20)30542\u20138","article-title":"How COVID-19 has fundamentally changed clinical research in global health","volume":"9","year":"2021","unstructured":"Park\n JJH,\n \n \n Mogg\n R,\n \n \n Smith\n GE,\n \n \n .\n\t\t\t\t\tHow COVID-19 has fundamentally changed clinical research in global health.\n\t\t\t\t\tLancet Glob Health.\n\t\t\t\t\t2021;\n\t\t\t\t\t9(\n\t\t\t\t\t5):\n\t\t\t\t\te711\u2013\n\t\t\t\t\te720.\n\t\t\t\t\tdoi:10.1016\/S2214-109X(20)30542\u20138"},{"key":"i1945-5763-28-4-68-b32","article-title":"FDA Guidance on Conduct of clinical trials of medical products during the COVID-19 public health emergency","unstructured":"U.S. Food and Drug Administration.\n \n FDA Guidance on Conduct of clinical trials of medical products during the COVID-19 public health emergency.\n\t\t\t\t\thttps:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency. 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