Randomised controlled trial of the Caring Connections intervention to reduce loneliness and perceived social isolation in persons with spinal cord injuries and disorders: study protocol

Sherri L LaVela, Robert W Motl, Beverly Gonzalez, Elizabeth Tarlov, Keith Aguina, Charles H Bombardier, Sherri L LaVela, Robert W Motl, Beverly Gonzalez, Elizabeth Tarlov, Keith Aguina, Charles H Bombardier

Abstract

Introduction: Perceived social isolation and loneliness are understudied in individuals with spinal cord injuries and disorders (SCI/D). The few existing studies reported that they are common, yet poorly treated, in persons with SCI/D. We developed an intervention called Caring Connections (CC) aimed at reducing loneliness and perceived social isolation in persons with SCI/D. CC is a peer-based, recurrent letter writing programme designed to provide moments of positivity. We will conduct and evaluate a randomised controlled trial (RCT) to assess changes in loneliness and social isolation outcomes between the CC intervention and control conditions in community-dwelling individuals with SCI/D.

Methods and analysis: RCT to compare outcomes of community-dwelling individuals with SCI/D undergoing the CC intervention to an attention control group (receiving informational materials on life domains important to a good quality of life). Eligible participants include adults with chronic SCI/D who have been injured for >1 year. The primary outcome is loneliness, measured using the UCLA (University of California, Los Angeles) 3-item Loneliness Scale. Other outcomes include perceived social isolation and social support. A post-trial process evaluation will assess perceived benefits, negative impacts and satisfaction with the intervention, and areas for improvement. We will test the hypotheses of reduced loneliness and perceived social isolation in the CC intervention arm from baseline to 6 months and will also measure the magnitude of effect (difference between CC arm and attention control arm). We will use generalised linear models for repeated measures. We will assume a one-tailed, α=0.05 level of significance for comparisons. Process outcomes will be analysed using mixed methods, including frequencies for the rating items and thematic analysis for open-ended item responses.

Ethics and dissemination: This study has received Hines Veterans Affairs Institutional Review Board approval (#1673654). Findings will be disseminated widely through healthcare organisations, peer-reviewed publications and conferences.

Trial registration number: NCT05295108.

Keywords: MENTAL HEALTH; Neurological injury; PUBLIC HEALTH; REHABILITATION MEDICINE.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study flow diagram showing trial design. SCI/D, spinal cord injuries and disorders; US Department of Veterans Affairs

References

    1. Cigna . US loneliness index. survey of 20,000 Americans. examining behaviors driving loneliness in the US, 2018. Available: [Accessed 15 Feb 2022].
    1. Holt-Lunstad J, Smith TB, Baker M, et al. . Loneliness and social isolation as risk factors for mortality: a meta-analytic review. Perspect Psychol Sci 2015;10:227–37. 10.1177/1745691614568352
    1. Cacioppo JT, Hawkley LC, Norman GJ, et al. . Social isolation. Ann N Y Acad Sci 2011;1231:17. 10.1111/j.1749-6632.2011.06028.x
    1. Smith BJ, Lim MH. How the COVID-19 pandemic is focusing attention on loneliness and social isolation. Public Health Res Pract 2020;30:3022008. 10.17061/phrp3022008
    1. Dury R. Social isolation and loneliness in the elderly: an exploration of some of the issues. Br J Community Nurs 2014;19:125–8. 10.12968/bjcn.2014.19.3.125
    1. Gerst-Emerson K, Jayawardhana J. Loneliness as a public health issue: the impact of loneliness on health care utilization among older adults. Am J Public Health 2015;105:1013–9. 10.2105/AJPH.2014.302427
    1. National seniors Council report on the social isolation of seniors. Available: [Accessed 1 Feb 2022].
    1. Mullen RA, Tong S, Sabo RT, et al. . Loneliness in primary care patients: a prevalence study. Ann Fam Med 2019;17:108–15. 10.1370/afm.2358
    1. Stickley A, Koyanagi A. Loneliness, common mental disorders and suicidal behavior: findings from a general population survey. J Affect Disord 2016;197:81–7. 10.1016/j.jad.2016.02.054
    1. Taube E, Kristensson J, Sandberg M, et al. . Loneliness and health care consumption among older people. Scand J Caring Sci 2015;29:435–43. 10.1111/scs.12147
    1. Agarwal G, Lee J, McLeod B, et al. . Social factors in frequent callers: a description of isolation, poverty and quality of life in those calling emergency medical services frequently. BMC Public Health 2019;19:684. 10.1186/s12889-019-6964-1
    1. Molloy GJ, McGee HM, O'Neill D, O’Neill D, et al. . Loneliness and emergency and planned hospitalizations in a community sample of older adults. J Am Geriatr Soc 2010;58:1538–41. 10.1111/j.1532-5415.2010.02960.x
    1. Hanratty B, Stow D, Collingridge Moore D, Moore DC, et al. . Loneliness as a risk factor for care home admission in the English longitudinal study of ageing. Age Ageing 2018;47:896–900. 10.1093/ageing/afy095
    1. Guilcher SJT, Catharine Craven B, Bassett-Gunter RL, et al. . An examination of objective social disconnectedness and perceived social isolation among persons with spinal cord injury/dysfunction: a descriptive cross-sectional study. Disabil Rehabil 2021;43:69–75. 10.1080/09638288.2019.1616328
    1. Robinson-Whelen S, Taylor HB, Feltz M, et al. . Loneliness among people with spinal cord injury: exploring the psychometric properties of the 3-Item loneliness scale. Arch Phys Med Rehabil 2016;97:1728–34. 10.1016/j.apmr.2016.04.008
    1. Newman SD, Li C, Krause JS. Social isolation after spinal cord injury: indicators from the longitudinal aging study. Rehabil Psychol 2016;61:408–16. 10.1037/rep0000112
    1. Hitzig SL, Cimino SR, Alavinia M, et al. . Examination of the relationships among social networks and loneliness on health and life satisfaction in people with spinal cord Injury/Dysfunction. Arch Phys Med Rehabil 2021;102:2109–16. 10.1016/j.apmr.2021.03.030
    1. Tough H, Brinkhof MWG, Siegrist J, et al. . The impact of loneliness and relationship quality on life satisfaction: a longitudinal dyadic analysis in persons with physical disabilities and their partners. J Psychosom Res 2018;110:61–7. 10.1016/j.jpsychores.2018.04.009
    1. Tzonichaki L, Kleftaras G. Paraplegia from spinal cord injury: self-esteem, loneliness, and life satisfaction. OTJR 2002;22:96–103. 10.1177/153944920202200302
    1. Barclay L, McDonald R, Lentin P, et al. . Facilitators and barriers to social and community participation following spinal cord injury. Aust Occup Ther J 2016;63:19–28. 10.1111/1440-1630.12241
    1. Guilcher SJT, Casciaro T, Lemieux-Charles L, et al. . Social networks and secondary health conditions: the critical secondary team for individuals with spinal cord injury. J Spinal Cord Med 2012;35:330–42. 10.1179/2045772312Y.0000000035
    1. Cimino SR, Hitzig SL, Craven BC, et al. . An exploration of perceived social isolation among persons with spinal cord injury in Ontario, Canada: a qualitative study. Disabil Rehabil 2022;44:3400–9. 10.1080/09638288.2020.1861485
    1. Isaksson G, Skär L, Lexell J. Women's perception of changes in the social network after a spinal cord injury. Disabil Rehabil 2005;27:1013–21. 10.1080/09638280500030431
    1. LaVela SL, Etingen B, Miskevics S, et al. . What determines low satisfaction with life in individuals with spinal cord injury? J Spinal Cord Med 2019;42:236–44. 10.1080/10790268.2018.1466480
    1. Battalio SL, Jensen MP, Molton IR. Secondary health conditions and social role satisfaction in adults with long-term physical disability. Health Psychol 2019;38:445–54. 10.1037/hea0000671
    1. Piatt JA, Nagata S, Zahl M, et al. . Problematic secondary health conditions among adults with spinal cord injury and its impact on social participation and daily life. J Spinal Cord Med 2016;39:693–8. 10.1080/10790268.2015.1123845
    1. Bombardier CH, Azuero CB, Fann JR. Management of mental health disorders, substance use disorders, and suicide in adults with spinal cord injury. J Spinal Cord Med 2021;44:102–62. 10.1080/10790268.2021.1863738
    1. Kharicha K, Iliffe S, Manthorpe J, et al. . What do older people experiencing loneliness think about primary care or community based interventions to reduce loneliness? A qualitative study in England. Health Soc Care Community 2017;25:1733–42. 10.1111/hsc.12438
    1. Goetter EM, Bui E, Weiner TP, et al. . Pilot data of a brief veteran peer intervention and its relationship to mental health treatment engagement. Psychol Serv 2018;15:453–6. 10.1037/ser0000151
    1. Wittleder S, Smith S, Wang B, et al. . Peer-Assisted lifestyle (pal) intervention: a protocol of a cluster-randomised controlled trial of a health-coaching intervention delivered by veteran Peers to improve obesity treatment in primary care. BMJ Open 2021;11:e043013. 10.1136/bmjopen-2020-043013
    1. Long JA, Ganetsky VS, Canamucio A, et al. . Effect of peer mentors in diabetes self-management vs usual care on outcomes in US veterans with type 2 diabetes: a randomized clinical trial. JAMA Netw Open 2020;3:e2016369. 10.1001/jamanetworkopen.2020.16369
    1. Chinman M, Oberman RS, Hanusa BH, et al. . A cluster randomized trial of adding peer specialists to intensive case management teams in the Veterans health administration. J Behav Health Serv Res 2015;42:109–21. 10.1007/s11414-013-9343-1
    1. Stineman MG, Streim JE. The biopsycho-ecological paradigm: a foundational theory for medicine. Pm R 2010;2:1035–45. 10.1016/j.pmrj.2010.06.013
    1. Fredrickson BL. The role of positive emotions in positive psychology. The broaden-and-build theory of positive emotions. Am Psychol 2001;56:218–26. 10.1037//0003-066x.56.3.218
    1. Fredrickson BL. Positive emotions broaden and build. Adv Exper Social Psych 2013;47:1–53.
    1. LaVela SL, Heinemann AW, Etingen B, et al. . Relational empathy and holistic care in persons with spinal cord injuries. J Spinal Cord Med 2017;40:30–42. 10.1080/10790268.2015.1114227
    1. Krause JS, Broderick L. Outcomes after spinal cord injury: comparisons as a function of gender and race and ethnicity. Arch Phys Med Rehabil 2004;85:355–62. 10.1016/s0003-9993(03)00615-4
    1. Jackson AB, Dijkers M, Devivo MJ, et al. . A demographic profile of new traumatic spinal cord injuries: change and stability over 30 years. Arch Phys Med Rehabil 2004;85:1740–8. 10.1016/j.apmr.2004.04.035
    1. Hughes ME, Waite LJ, Hawkley LC, et al. . A short scale for measuring loneliness in large surveys: results from two population-based studies. Res Aging 2004;26:655–72. 10.1177/0164027504268574
    1. Basu A, Kim HH, Basaldua R, et al. . A cross-national study of factors associated with women's perinatal mental health and wellbeing during the COVID-19 pandemic. PLoS One 2021;16:e0249780. 10.1371/journal.pone.0249780
    1. Dickson A, Ward R, O'Brien G, et al. . Difficulties adjusting to post-discharge life following a spinal cord injury: an interpretative phenomenological analysis. Psychol Health Med 2011;16:463–74. 10.1080/13548506.2011.555769
    1. Masi CM, Chen H-Y, Hawkley LC, et al. . A meta-analysis of interventions to reduce loneliness. Pers Soc Psychol Rev 2011;15:219–66. 10.1177/1088868310377394
    1. O'Rourke HM, Collins L, Sidani S. Interventions to address social connectedness and loneliness for older adults: a scoping review. BMC Geriatr 2018;18:214. 10.1186/s12877-018-0897-x
    1. Mohr DC, Ho J, Hart TL, et al. . Control condition design and implementation features in controlled trials: a meta-analysis of trials evaluating psychotherapy for depression. Transl Behav Med 2014;4:407–23. 10.1007/s13142-014-0262-3
    1. Model Systems Knowledge Translation Center . Spinal cord injury Factsheets. Available: [Accessed 2 Feb 2022].
    1. Lifecourse nexus library. Available: [Accessed 2 Feb 2022].
    1. Agarwal G, Pirrie M, Gao A, et al. . Subjective social isolation or loneliness in older adults residing in social housing in Ontario: a cross-sectional study. CMAJ Open 2021;9:E915–25. 10.9778/cmajo.20200205
    1. Steptoe A, Shankar A, Demakakos P, et al. . Social isolation, loneliness, and all-cause mortality in older men and women. Proc Natl Acad Sci U S A 2013;110:5797–801. 10.1073/pnas.1219686110
    1. Health Measures . Social isolation item bank. PROMIS. Available: [Accessed 14 Apr 2021].
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 2006;3:77–101. 10.1191/1478088706qp063oa

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