Self-help guided by trained lay providers for generalized anxiety disorder in older adults: study protocol for a randomized controlled trial

Philippe Landreville, Patrick Gosselin, Sébastien Grenier, Pierre-Hugues Carmichael, Philippe Landreville, Patrick Gosselin, Sébastien Grenier, Pierre-Hugues Carmichael

Abstract

Background: Only a small proportion of older patients with generalized anxiety disorder (GAD) seek professional help. Difficulties in accessing treatment may contribute to this problem. Guided self-help based on the principles of cognitive-behavioral therapy (GSH-CBT) is one way of promoting access to psychological treatment. Moreover, because the therapist's role in GSH-CBT is limited to supporting the patient, this role could be assumed by trained and supervised lay providers (LPs) instead of licensed providers. The main goal of this study is to evaluate the efficacy of GSH-CBT guided by LPs for primary threshold or subthreshold GAD in older adults.

Methods: We will conduct a multisite randomized controlled trial comparing an experimental group receiving GSH-CBT guided by LPs (n = 45) to a wait-list control group (n = 45). Treatment will last 15 weeks and will be based on a participant's manual. Weekly telephone sessions with LPs (30 min maximum) will be limited to providing support. Data will be obtained through clinician evaluations and self-assessment questionnaires. Primary outcomes will be the tendency to worry and severity of GAD symptoms. Secondary outcomes will be anxiety symptoms, sleep difficulties, functional deficit, diagnosis of GAD, and cognitive difficulties. For the experimental group, measurements will take place at pre- and post-treatment and at 6 and 12 months post-treatment. For the control group, three evaluations are planned: two pre-treatment evaluations (before and after the waiting period) and after receiving treatment (post-treatment). The efficacy of GSH-CBT will be established by comparing the change in the two groups on the primary outcomes.

Discussion: This project will provide evidence on the efficacy of a novel approach to treat GAD in older adults. If effective, it could be implemented on a larger scale and provide many older adults with much needed mental health treatment through an expanded workforce.

Trial registration: The trial was registered at ClinicalTrials.gov, number NCT03768544 , on December 7, 2018.

Keywords: Cognitive-behavioral therapy; Generalized anxiety disorder; Guided self-help; Lay providers; Older adults; Randomized controlled trial.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Schematic Representation of the Randomized Controlled Trial

References

    1. American Psychiatric Association . Diagnostic and statistical manual of mental disorders: DSM-5. 5. Washington, DC: American Psychiatric Association; 2013.
    1. Zhang X, Norton J, Carrière I, Ritchie K, Chaudieu I, Ancelin M-L. Generalized anxiety in community-dwelling elderly: prevalence and clinical characteristics. J Affect Disord. 2015;172(0):24–29. doi: 10.1016/j.jad.2014.09.036.
    1. Wolitzky-Taylor KB, Castriotta N, Lenze EJ, Stanley MA, Craske MG. Anxiety disorders in older adults: a comprehensive review. Depress Anxiety. 2010;27(2):190–211. doi: 10.1002/da.20653.
    1. Miloyan B, Byrne GJ, Pachana NA. Threshold and subthreshold generalized anxiety disorder in later life. Am J Geriatr Psychiatry. 2015;23(6):633–641. doi: 10.1016/j.jagp.2014.08.010.
    1. Porensky EK, Dew MA, Karp JF, Skidmore E, Rollman BL, Shear MK, Lenze EJ. The burden of late-life generalized anxiety disorder: effects on disability, health-related quality of life, and healthcare utilization. Am J Geriatr Psychiatry. 2009;17(6):473–482. doi: 10.1097/JGP.0b013e31819b87b2.
    1. Haller H, Cramer H, Lauche R, Gass F, Dobos GJ. The prevalence and burden of subthreshold generalized anxiety disorder: a systematic review. BMC Psychiatry. 2014;14(1):128. doi: 10.1186/1471-244X-14-128.
    1. Grenier S, Desjardins F, Raymond B, Payette M-C, Rioux M-È, Landreville P, Gosselin P, Richer M-J, Gunther B, Fournel M, Vasiliadis HM. Six-month prevalence and correlates of generalized anxiety disorder among primary care patients aged 70 years and above: results from the ESA-services study. Int J Geriatr Psychiatry. 2019;34(2):315–323. doi: 10.1002/gps.5023.
    1. Almeida OP, Draper B, Pirkis J, Snowdon J, Lautenschlager NT, Byrne G, Sim M, Stocks N, Kerse N, Flicker L, Pfaff JJ. Anxiety, depression, and comorbid anxiety and depression: risk factors and outcome over two years. Int Psychogeriatr. 2012;24(10):1622–1632. doi: 10.1017/S104161021200107X.
    1. Brenes GA, Miller ME, Stanley MA, Williamson JD, Knudson M, McCall WV. Insomnia in older adults with generalized anxiety disorder. Am J Geriatr Psychiatry. 2009;17(6):465–472. doi: 10.1097/JGP.0b013e3181987747.
    1. Yochim BP, Mueller AE, Segal DL. Late life anxiety is associated with decreased memory and executive functioning in community dwelling older adults. J Anxiety Disord. 2013;27(6):567–575. doi: 10.1016/j.janxdis.2012.10.010.
    1. Moser DK, Dracup K, Evangelista LS, Zambroski CH, Lennie TA, Chung ML, Doering LV, Westlake C, Heo S. Comparison of prevalence of symptoms of depression, anxiety, and hostility in elderly patients with heart failure, myocardial infarction, and a coronary artery bypass graft. Heart Lung. 2010;39(5):378–385. doi: 10.1016/j.hrtlng.2009.10.017.
    1. Oude Voshaar RC, van der Veen DC, Hunt I, Kapur N. Suicide in late-life depression with and without comorbid anxiety disorders. Int J Geriatr Psychiatry. 2016;31(2):146–152. doi: 10.1002/gps.4304.
    1. Vasiliadis H-M, Dionne P-A, Préville M, Gentil L, Berbiche D, Latimer E. The excess healthcare costs associated with depression and anxiety in elderly living in the community. Am J Geriatr Psychiatry. 2013;21(6):536–548. doi: 10.1016/j.jagp.2012.12.016.
    1. Goncalves DC, Byrne GJ. Interventions for generalized anxiety disorder in older adults: systematic review and meta-analysis. J Anxiety Disord. 2012;26(1):1–11. doi: 10.1016/j.janxdis.2011.08.010.
    1. Mackenzie CS, Reynolds K, Chou KL, Pagura J, Sareen J. Prevalence and correlates of generalized anxiety disorder in a national sample of older adults. Am J Geriatr Psychiatry. 2011;19(4):305–315. doi: 10.1097/JGP.0b013e318202bc62.
    1. Byers AL, Arean PA, Yaffe K. Low use of mental health services among older Americans with mood and anxiety disorders. Psychiatr Serv. 2012;63(1):66–72. doi: 10.1176/appi.ps.201100121.
    1. Konnert C, Petrovic-Poljak A. Barriers to mental healthcare utilization. In: Pachana NA, Laidlaw K, editors. The Oxford handbook of clinical geropsychology. New York: Oxford University Press; 2014. pp. 949–969.
    1. Pepin R, Segal DL, Coolidge FL. Intrinsic and extrinsic barriers to mental health care among community-dwelling younger and older adults. Aging Ment Health. 2009;13(5):769–777. doi: 10.1080/13607860902918231.
    1. Gum AM, Iser L, Petkus AJ. Behavioral health service utilization and preferences of older adults receiving home-based aging services. Am J Geriatr Psychiatry. 2010;18(6):491–501. doi: 10.1097/JGP.0b013e3181c29495.
    1. Cully JA, Tolpin L, Henderson L, Jimenez D, Kunik ME, Petersen LA. Psychotherapy in the veterans health administration: missed opportunities? Psychol Serv. 2008;5(4):320–331. doi: 10.1037/a0013719.
    1. Cuijpers P, Donker T, van Straten A, Li J, Andersson G. Is guided self-help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies. Psychol Med. 2010;40(12):1943–1957. doi: 10.1017/S0033291710000772.
    1. Dear BF, Zou JB, Ali S, Lorian CN, Johnston L, Sheehan J, Staples LG, Gandy M, Fogliati VJ, Klein B, Titov N. Clinical and cost-effectiveness of therapist-guided internet-delivered cognitive behavior therapy for older adults with symptoms of anxiety: a randomized controlled trial. Behav Ther. 2015;46(2):206–217. doi: 10.1016/j.beth.2014.09.007.
    1. Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–7.
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–613. doi: 10.1046/j.1525-1497.2001.016009606.x.
    1. Jones SL, Hadjistavropoulos HD, Soucy JN. A randomized controlled trial of guided internet-delivered cognitive behaviour therapy for older adults with generalized anxiety. J Anxiety Disord. 2016;37:1–9. doi: 10.1016/j.janxdis.2015.10.006.
    1. Institute of Medicine . Mental health and substance use workforce for older adults. In whose hands? Washington, DC: Institute of Medicine; 2012.
    1. Kunik ME, Mills WL, Amspoker AB, Cully JA, Kraus-Schuman C, Stanley M, et al. Expanding the geriatric mental health workforce through utilization of non-licensed providers. Aging Ment Health. 2017;21(9):954–60.
    1. Bartels SJ, Naslund JA. The underside of the silver tsunami — older adults and mental health care. N Engl J Med. 2013;368(6):493–496. doi: 10.1056/NEJMp1211456.
    1. Montgomery EC, Kunik ME, Wilson N, Stanley MA, Weiss B. Can paraprofessionals deliver cognitive-behavioral therapy to treat anxiety and depressive symptoms? Bull Menn Clin. 2010;74(1):45–62. doi: 10.1521/bumc.2010.74.1.45.
    1. Boer P, Wiersma D, Russo S, Bosch RJ. Paraprofessionals for anxiety and depressive disorders. Cochrane Database Syst Rev. 2005;2:CD004688.
    1. Stanley MA, Wilson NL, Amspoker AB, Kraus-Schuman C, Wagener PD, Calleo JS, Cully JA, Teng E, Rhoades HM, Williams S, Masozera N, Horsfield M, Kunik ME. Lay providers can deliver effective cognitive behavior therapy for older adults with generalized anxiety disorder: a randomized trial. Depress Anxiety. 2014;31(5):391–401. doi: 10.1002/da.22239.
    1. Freshour JS, Amspoker AB, Yi M, Kunik ME, Wilson N, Kraus-Schuman C, Cully JA, Teng E, Williams S, Masozera N, Horsfield M, Stanley M. Cognitive behavior therapy for late-life generalized anxiety disorder delivered by lay and expert providers has lasting benefits. Int J Geriatr Psychiatry. 2016;31(11):1225–1232. doi: 10.1002/gps.4431.
    1. Landreville P, Gosselin P, Grenier S, Hudon C, Lorrain D. Guided self-help for generalized anxiety disorder in older adults. Aging Ment Health. 2016;20(10):1070–1083. doi: 10.1080/13607863.2015.1060945.
    1. Dugas M, Gagnon F, Ladouceur R, Freeston MH. Generalized anxiety disorder: a preliminary test of a conceptual model. Behav Res Ther. 1998;36(2):215–226. doi: 10.1016/S0005-7967(97)00070-3.
    1. Dugas M, Ladouceur R, Léger E, Freeston MH, Langlois F, Provencher MD, Boisvert JM. Group cognitive-behavioral therapy for generalized anxiety disorder: treatment outcome and long-term follow-up. J Consult Clin Psychol. 2003;71(4):821–825. doi: 10.1037/0022-006X.71.4.821.
    1. Covin R, Ouimet AJ, Seeds, PM, Dozois DJA. A meta-analysis of CBT for pathological worry among clients with GAD. J Anxiety Disord. 2008;22(1):108–16.
    1. Ladouceur R, Léger E, Dugas M, Freeston MH. Cognitive-behavioral treatment of Generalized Anxiety Disorder (GAD) for older adults. Int Psychogeriatr. 2004;16(2):195–207
    1. Polenick CA, Flora SR. Behavioral activation for depression in older adults: theoretical and practical considerations. Behav Anal. 2013;36(1):35–55. doi: 10.1007/BF03392291.
    1. Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;6:487–496. doi: 10.1016/0005-7967(90)90135-6.
    1. Klainin-Yobas P, Oo WN, Suzanne Yew PY, Lau Y. Effects of relaxation interventions on depression and anxiety among older adults: a systematic review. Aging Ment Health. 2015;19(12):1043–1055. doi: 10.1080/13607863.2014.997191.
    1. Stanley MA, Wilson NL, Novy DM, Rhoades HM, Wagener PD, Greisinger AJ, Cully JA, Kunik ME. Cognitive behavior therapy for generalized anxiety disorder among older adults in primary care a randomized clinical trial. JAMA-J Am Med Assoc. 2009;301(14):1460–1467. doi: 10.1001/jama.2009.458.
    1. Newkirk LA, Kim JM, Thompson JM, Tinklenberg JR, Yesavage JA, Taylor JL. Validation of a 26-point telephone version of the mini-mental state examination. J Geriatr Psychiatry Neurol. 2004;17(2):81–87. doi: 10.1177/0891988704264534.
    1. Institut de la statistique du Québec, Quebec City, Canada. 2021. . Accessed 2 Feb 2021.
    1. Dugas M, Freeston MH, Provencher MD, Lachance S, Ladouceur R, Gosselin P. Le Questionnaire sur l'Inquiétude et l'Anxiété: Validation dans des échantillons non cliniques et cliniques. J Thér Comportementale et Cognit. 2001;11(1):31–36.
    1. Brown TA, Barlow DH. Anxiety and related disorders interview schedule for DSM-5 (ADIS-5)® - adult version. New York: Oxford University Press; 2014.
    1. Beck JG, Stanley MA, Zebb BJ. Psychometric properties of the Penn State worry questionnaire in older adults. J Clin Geropsychol. 1995;1(1):33–42.
    1. Wild B, Eckl A, Herzog W, Niehoff D, Lechner S, Maatouk I, Schellberg D, Brenner H, Müller H, Löwe B. Assessing generalized anxiety disorder in elderly people using the GAD-7 and GAD-2 scales: results of a validation study. Am J Geriatr Psychiatry. 2014;22(10):1029–1038. doi: 10.1016/j.jagp.2013.01.076.
    1. Gosselin P, Ladouceur R, Evers A, Laverdière A, Routhier S, Tremblay-Picard M. Evaluation of intolerance of uncertainty: development and validation of a new self-report measure. J Anxiety Disord. 2008;22(8):1427–1439. doi: 10.1016/j.janxdis.2008.02.005.
    1. Robichaud M, Dugas M. Negative problem orientation (part I): psychometric properties of a new measure. Behav Res Ther. 2005;43(3):391–401. doi: 10.1016/j.brat.2004.02.007.
    1. Sexton KA, Dugas M. The cognitive avoidance questionnaire: validation of the English translation. J Anxiety Disord. 2008;22(3):355–370. doi: 10.1016/j.janxdis.2007.04.005.
    1. Gosselin P, Ladouceur R, Langlois F, Freeston MH, Dugas M, Bertrand J. Développement et validation d'un nouvel instrument évaluant les croyances erronées à l'égard des inquiétudes. Rev Européenne Psychol Appliquée. 2003;53:199–211.
    1. Pachana NA, Byrne GJ, Siddle H, Koloski N, Harley E, Arnold E. Development and validation of the geriatric anxiety inventory. Int Psychogeriatr. 2007;19(1):103–114. doi: 10.1017/S1041610206003504.
    1. Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression scale: a preliminary report. J Psychiatr Res. 1983;17:37–49. doi: 10.1016/0022-3956(82)90033-4.
    1. Blais FC, Gendron L, Mimeault V, Morin CM. Évaluation de l'insomnie: validation de trois questionnaires. L'Encéphale. 1997;23(6):447–453.
    1. Bastien CH, Vallieres A, Morin CM. Validation of the insomnia severity index as an outcome measure for insomnia research. Sleep Med. 2001;2(4):297–307. doi: 10.1016/S1389-9457(00)00065-4.
    1. Sheehan DV. The anxiety disease. New York: Scribner's; 1983.
    1. Leon AC, Olfson M, Portera L, Farber L, Sheehan DV. Assessing psychiatric impairment in primary care with the Sheehan disability scale. Int J Psychiatry Med. 1997;27(2):93–105. doi: 10.2190/T8EM-C8YH-373N-1UWD.
    1. Mahoney AEJ, Hobbs MJ, Newby JM, Williams AD, Sunderland M, Andrews G. The worry behaviors inventory: assessing the behavioral avoidance associated with generalized anxiety disorder. J Affect Disord. 2016;203:256–264. doi: 10.1016/j.jad.2016.06.020.
    1. Marcotte-Beaumier G, Hebert EA, Dugas MJ. Le Questionnaire sur les comportements sécurisants du trouble d’anxiété généralisée (QCS-TAG): Validation auprès d’un échantillon clinique. [The Generalised Anxiety Disorder-Safety Behaviours Questionnaire: Validation with a clinical sample.] Can J Behav Sci / Rev Can Sci Comportement. 2020;52(4):324–330. doi: 10.1037/cbs0000181.
    1. Gulliver A, Griffiths MK, Christensen H, Mackinnon A, Calear LA, Parsons A, Bennett K, Batterham JP, Stanimirovic R. Internet-based interventions to promote mental health help-seeking in elite athletes: an exploratory randomized controlled trial. J Med Internet Res. 2012;14(3):e69. doi: 10.2196/jmir.1864.
    1. Sarason IG, Sarason BR, Shearin EN, Pierce GR. A brief measure of social support: practical and theoretical implications. J Soc Pers Relat. 1987;4(4):497–510. doi: 10.1177/0265407587044007.
    1. Ryan RM, Plant RW, O'Malley S. Initial motivations for alcohol treatment: relations with patient characteristics, treatment involvement, and dropout. Addict Behav. 1995;20(3):279–297. doi: 10.1016/0306-4603(94)00072-7.
    1. Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000;31(2):73–86. doi: 10.1016/S0005-7916(00)00012-4.
    1. Corbière M, Bisson J, Lauzon S, Ricard N. Factorial validation of a French short-form of the Working Alliance Inventory. Int J Methods Psychiatr Res. 2006;15(1):36–45. 10.1002/mpr.27.
    1. Jacobson NS, Follette WC, Revenstorf D. Psychotherapy outcome research: methods for reporting variability and evaluating clinical significance. Behav Ther. 1984;15(4):336–352. doi: 10.1016/S0005-7894(84)80002-7.
    1. Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991;59(1):12–19. doi: 10.1037/0022-006X.59.1.12.
    1. Sheehan KH, Sheehan DV. Assessing treatment effects in clinical trials with the Discan metric of the Sheehan disability scale. Int Clin Psychopharmacol. 2008;23(2):70–83. doi: 10.1097/YIC.0b013e3282f2b4d6.
    1. Brenes GA, Danhauer SC, Lyles MF, Hogan PE, Miller ME. Telephone-delivered cognitive behavioral therapy and telephone-delivered nondirective supportive therapy for rural older adults with generalized anxiety disorder: a randomized clinical trial. JAMA Psychiatry. 2015;72(10):1012–1020. doi: 10.1001/jamapsychiatry.2015.1154.
    1. Bixter MT, Blocker KA, Rogers WA. Enhancing social engagement of older adults through technology. In: Pak R, McLaughlin AC, editors. Aging, technology and health. San Diego: Academic Press; 2018. pp. 179–214.

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