A pragmatic randomized controlled trial of a group self-management support program versus treatment-as-usual for anxiety disorders: study protocol

Pasquale Roberge, Janie Houle, Jean-Rémy Provost, Simon Coulombe, Annie Beaudin, Peter Bower, Félix Camirand Lemyre, Martin Drapeau, Marc-Simon Drouin, Catherine Hudon, Martin D Provencher, Helen-Maria Vasiliadis, Pasquale Roberge, Janie Houle, Jean-Rémy Provost, Simon Coulombe, Annie Beaudin, Peter Bower, Félix Camirand Lemyre, Martin Drapeau, Marc-Simon Drouin, Catherine Hudon, Martin D Provencher, Helen-Maria Vasiliadis

Abstract

Background: The integration of a personal recovery-oriented practice in mental health services is an emerging principle in policy planning. Self-management support (SMS) is an intervention promoting recovery that aims at educating patients on the nature of their mental disorder, improving their strategies to manage their day-to-day symptoms, fostering self-efficacy and empowerment, preventing relapse, and promoting well-being. While SMS is well established for chronic physical conditions, there is a lack of evidence to support the implementation of structured SMS programs for common mental disorders, and particularly for anxiety disorders. This study aims to examine the effectiveness of a group-based self-management support program for anxiety disorders as an add-on to treatment-as-usual in community-based care settings.

Methods/design: We will conduct a multicentre pragmatic randomized controlled trial with a pre-treatment, post-treatment (4-month post-randomization), and follow-ups at 8, 12 and 24-months. TREATMENT AND CONTROL GROUPS: a) group self-management support (10 weekly 2.5-h group web-based sessions with 10-15 patients with two trained facilitators); b) treatment-as-usual. Participants will include adults meeting DSM-5 criteria for Panic Disorder, Agoraphobia, Social Anxiety Disorder, and/or Generalized Anxiety Disorder. The primary outcome measure will be the Beck Anxiety Inventory; secondary outcome measures will comprise self-reported instruments for anxiety and depressive symptoms, recovery, self-management, quality of life, and service utilisation.

Statistical analysis: Data will be analysed based on intention-to-treat with a mixed effects regression model accounting for between and within-subject variations in the effects of the intervention.

Discussion: This study will contribute to the limited knowledge base regarding the effectiveness of structured group self-management support for anxiety disorders. It is expected that changes in patients' self-management behaviour will lead to better anxiety management and, consequently, to improved patient outcomes.

Trial registration: ClinicalTrials.gov: NCT05124639 . Prospectively registered 18 November 2021.

Keywords: Anxiety disorders; Group intervention; Pragmatic trial; Self-management support; Transdiagnostic; Web-based intervention.

Conflict of interest statement

Relief is a non-profit organization whose mission is to support people living with anxiety, depression or bipolarity, and their loved ones, so they can keep moving forward. Relief has developed the group self-management support intervention for anxiety disorders.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Flow of participants

References

    1. Katzman MA, Bleau P, Blier P, Chokka P, Kjernisted K, Van Ameringen M, et al. Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders. BMC Psychiatry. 2014;14(Suppl 1):S1–S83. doi: 10.1186/1471-244x-14-s1-s1.
    1. American Psychiatric Association . Diagnostic and statistical manual of mental disorders. 5. Arlington: American Psychiatric Publishing; 2013.
    1. Barlow DH. Anxiety and its disorders. The nature and treatment of anxiety and panic. NY: The Guilford Press; 2002.
    1. Kessler RC, Ruscio AM, Shear K, Wittchen HU. Epidemiology of anxiety disorders. Curr Top Behav Neurosci. 2010;2:21–35. doi: 10.1007/7854_2009_9.
    1. Brown TA, Campbell LA, Lehman CL, Grisham JR, Mancill RB. Current and lifetime comorbidity of the DSM-IV anxiety and mood disorders in a large clinical sample. J Abnorm Psychol. 2001;110(4):585–599. doi: 10.1037//0021-843x.110.4.585.
    1. Lamers F, van Oppen P, Comijs HC, Smit JH, Spinhoven P, van Balkom AJ, et al. Comorbidity patterns of anxiety and depressive disorders in a large cohort study: the Netherlands Study of Depression and Anxiety (NESDA) J Clin Psychiat. 2011;72(3):341–348. doi: 10.4088/JCP.10m06176blu.
    1. Conway KP, Compton W, Stinson FS, Grant BF. Lifetime comorbidity of DSM-IV mood and anxiety disorders and specific drug use disorders: results from the National Epidemiologic Survey on Alcohol and Related Conditions. J Clin Psychiat. 2006;67(2):247–257. doi: 10.4088/jcp.v67n0211.
    1. Roy-Byrne PP, Davidson KW, Kessler RC, Asmundson GJ, Goodwin RD, Kubzansky L, et al. Anxiety disorders and comorbid medical illness. Gen Hosp Psychiatry. 2008;30(3):208–225. doi: 10.1016/j.genhosppsych.2007.12.006.
    1. Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007;146(5):317–325. doi: 10.7326/0003-4819-146-5-200703060-00004.
    1. Greenberg PE, Sisitsky T, Kessler RC, Finkelstein SN, Berndt ER, Davidson JR, et al. The economic burden of anxiety disorders in the 1990s. J Clin Psychiat. 1999;60(7):427–435. doi: 10.4088/jcp.v60n0702.
    1. McLean CP, Asnaani A, Litz BT, Hofmann SG. Gender differences in anxiety disorders: prevalence, course of illness, comorbidity and burden of illness. J Psychiatr Res. 2011;45(8):1027–1035. doi: 10.1016/j.jpsychires.2011.03.006.
    1. Wiebenga JXM, Dickhoff J, Merelle SYM, Eikelenboom M, Heering HD, Gilissen R, et al. Prevalence, course, and determinants of suicide ideation and attempts in patients with a depressive and/or anxiety disorder: A review of NESDA findings. J Affect Disord. 2021;283:267–277. doi: 10.1016/j.jad.2021.01.053.
    1. Roberge P, Fournier L, Duhoux A, Nguyen CT, Smolders M. Mental health service use and treatment adequacy for anxiety disorders in Canada. Soc Psychiatry Psychiatr Epidemiol. 2011;46(4):321–330. doi: 10.1007/s00127-010-0186-2.
    1. Baxter AJ, Vos T, Scott KM, Ferrari AJ, Whiteford HA. The global burden of anxiety disorders in 2010. Psychol Med. 2014;44(11):2363–2374. doi: 10.1017/S0033291713003243.
    1. National Institute for Health and Care Excellence (NICE) Common mental health disorders. Identification and pathway to care. London: The British Psychological Society and The Royal College of Psychiatrists; 2011.
    1. Durham RC, Higgins C, Chambers JA, Swan JS, Dow MG. Long-term outcome of eight clinical trials of CBT for anxiety disorders: symptom profile of sustained recovery and treatment-resistant groups. J Affect Disord. 2012;136(3):875–881. doi: 10.1016/j.jad.2011.09.017.
    1. Yonkers KA, Bruce SE, Dyck IR, Keller MB. Chronicity, relapse, and illness-course of panic disorder, social phobia, and generalized anxiety disorder: findings in men and women from 8 years of follow-up. Depress Anxiety. 2003;17(3):173–179. doi: 10.1002/da.10106.
    1. van Dis EAM, van Veen SC, Hagenaars MA, Batelaan NM, Bockting CLH, van den Heuvel RM, et al. Long-term Outcomes of Cognitive Behavioral Therapy for Anxiety-Related Disorders: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2020;77(3):265–273. doi: 10.1001/jamapsychiatry.2019.3986.
    1. Batelaan NM, Bosman RC, Muntingh A, Scholten WD, Huijbregts KM, van Balkom AJLM. Risk of relapse after antidepressant discontinuation in anxiety disorders, obsessive-compulsive disorder, and post-traumatic stress disorder: systematic review and meta-analysis of relapse prevention trials. BMJ. 2017;358:j3927. doi: 10.1136/bmj.j3927.
    1. Levy HC, O'Bryan EM, Tolin DF. A meta-analysis of relapse rates in cognitive-behavioral therapy for anxiety disorders. J Anxiety Disord. 2021;81:102407. doi: 10.1016/j.janxdis.2021.102407.
    1. Rodriguez BF, Weisberg RB, Pagano ME, Bruce SE, Spencer MA, Culpepper L, et al. Characteristics and predictors of full and partial recovery from generalized anxiety disorder in primary care patients. J Nerv Ment Dis. 2006;194(2):91–97. doi: 10.1097/01.nmd.0000198140.02154.32.
    1. Kelly KM, Mezuk B. Predictors of remission from generalized anxiety disorder and major depressive disorder. J Affect Disord. 2017;208:467–474. doi: 10.1016/j.jad.2016.10.042.
    1. Coulombe S, Radziszewski S, Trepanier SG, Provencher H, Roberge P, Hudon C, et al. Mental health self-management questionnaire: Development and psychometric properties. J Affect Disord. 2015;181:41–49. doi: 10.1016/j.jad.2015.04.007.
    1. Coulombe S, Radziszewski S, Meunier S, Provencher H, Hudon C, Roberge P, et al. Profiles of recovery from mood and anxiety disorders: A person-centered exploration of people's engagement in self-management. Front Psychol. 2016;7:584. doi: 10.3389/fpsyg.2016.00584.
    1. Houle J, Gascon-Depatie M, Belanger-Dumontier G, Cardinal C. Depression self-management support: a systematic review. Patient Educ Couns. 2013;91(3):271–279. doi: 10.1016/j.pec.2013.01.012.
    1. Anthony WA. Recovery from mental illness: The guiding vision of the mental health service system in the 1990s. Psychosoc Rehabil J. 1993;16(4):11–23.
    1. Coleman K, Austin BT, Brach C, Wagner EH. Evidence on the Chronic Care Model in the new millennium. Health Aff. 2009;28(1):75–85. doi: 10.1377/hlthaff.28.1.75.
    1. Corrigan PW. Person-centered care for mental illness: The evolution of adherence and self-determination. Washington, DC: American Psychological Association; 2015.
    1. Panagioti M, Richardson G, Small N, Murray E, Rogers A, Kennedy A, et al. Self-management support interventions to reduce health care utilisation without compromising outcomes: a systematic review and meta-analysis. BMC Health Serv Res. 2014;14:356. doi: 10.1186/1472-6963-14-356.
    1. Mental Health Commission of Canada . Guidelines for recovery-oriented practice. Ottawa: Mental Health Commission of Canada; 2015.
    1. Villaggi B, Provencher H, Coulombe S, Meunier S, Radziszewski S, Hudon C, et al. Self-management strategies in recovery from mood and anxiety disorders. Glob Qual Nurs Res. 2015;2:1–13. doi: 10.1177/2333393615606092.
    1. Brady TJ, Murphy L, O’Colmain BJ, Beauchesne D, Daniels B, Greenberg M, et al. A Meta-Analysis of Health Status, Health Behaviors, and Health Care Utilization Outcomes of the Chronic Disease Self-Management Program. Prev Chronic Dis. 2013;10:120112. doi: 10.5888/pcd10.120112.
    1. Cook JA, Copeland ME, Hamilton MM, Jonikas JA, Razzano LA, Floyd CB, et al. Initial outcomes of a mental illness self-management program based on wellness recovery action planning. Psychiatr Serv. 2009;60(2):246–249. doi: 10.1176/appi.ps.60.2.246.
    1. Lorig KR, Ritter PL, Pifer C, Werner P. Effectiveness of the chronic disease self-management program for persons with a serious mental illness: a translation study. Community Ment Health J. 2014;50(1):96–103. doi: 10.1007/s10597-013-9615-5.
    1. Houle J, Gauvin G, Collard B, Meunier S, Frasure-Smith N, Lespérance F, et al. Empowering Adults in Recovery from Depression: A Community- Based Self-Management Group Program. Can J Commun Ment Health. 2016;35(2):55–68. doi: 10.7870/cjcmh-2016-033.
    1. Lam RW, McIntosh D, Wang J, Enns MW, Kolivakis T, Michalak EE, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 1. Disease Burden and Principles of Care. Can J Psychiatr. 2016;61(9):510–523. doi: 10.1177/0706743716659416.
    1. Cook JA, Copeland ME, Floyd CB, Jonikas JA, Hamilton MM, Razzano L, et al. A randomized controlled trial of effects of Wellness Recovery Action Planning on depression, anxiety, and recovery. Psychiatr Serv. 2012;63(6):541–547. doi: 10.1176/appi.ps.201100125.
    1. Zimmermann T, Puschmann E, van den Bussche H, Wiese B, Ernst A, Porzelt S, et al. Collaborative nurse-led self-management support for primary care patients with anxiety, depressive or somatic symptoms: Cluster-randomised controlled trial (findings of the SMADS study) Int J Nurs Stud. 2016;63:101–111. doi: 10.1016/j.ijnurstu.2016.08.007.
    1. Zoun MHH, Koekkoek B, Sinnema H, van der Feltz-Cornelis CM, van Balkom AJLM, Schene AH, et al. Effectiveness of a self-management training for patients with chronic and treatment resistant anxiety or depressive disorders on quality of life, symptoms, and empowerment: results of a randomized controlled trial. BMC Psychiatry. 2019;19(1):46. doi: 10.1186/s12888-019-2013-y.
    1. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59(Suppl 20):22–33.
    1. Cyr C, McKee H, O’Hagan M, Priest R, for the Mental Health Commission of Canada. Making the case for peer support: Report to the Peer Support Project Committee of the Mental Health Commission of Canada(2010 first edition / 2016 second edition). Available from: Retrieved from: .
    1. Mead S, Hilton D, Curtis L. Peer support: a theoretical perspective. Psychiatr Rehabil J. 2001;25(2):134–141. doi: 10.1037/h0095032.
    1. Solomon P. Peer support/peer provided services underlying processes, benefits, and critical ingredients. Psychiatr Rehabil J. 2004;27(4):392–401. doi: 10.2975/27.2004.392.401.
    1. Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–1097. doi: 10.1001/archinte.166.10.1092.
    1. Connor KM, Davidson JR, Churchill LE, Sherwood A, Foa E, Weisler RH. Psychometric properties of the Social Phobia Inventory (SPIN). New self-rating scale. Br J Psychiatry. 2000;176:379–386. doi: 10.1192/bjp.176.4.379.
    1. Radomsky AS, Ashbaugh AR, Saxe ML, Ouimet AJ, Golden ER, Lavoie SL, O'Connor KP. Psychometric Properties of the French and English Versions of the Social Phobia Inventory. Can J Behav Sci. 2006;38(4):354–360. doi: 10.1037/cjbs2006021.
    1. Houck PR, Spiegel DA, Shear MK, Rucci P. Reliability of the self-report version of the panic disorder severity scale. Depress Anxiety. 2002;15(4):183–185. doi: 10.1002/da.10049.
    1. Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988;56(6):893–897. doi: 10.1037/0022-006X.56.6.893.
    1. Freeston MH, Ladouceur R, Thibodeau N, Gagnon F, Rheaume J. The Beck Anxiety Inventory. Psychometric properties of a French translation. Encephale. 1994;20(1):47–55.
    1. Oei TP, McAlinden NM. Changes in quality of life following group CBT for anxiety and depression in a psychiatric outpatient clinic. Psychiatry Res. 2014;220(3):1012–1018. doi: 10.1016/j.psychres.2014.08.036.
    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. Richardson JRJ, Peacock SJ, Hawthorne G, Iezzi A, Elsworth G, Day NA. Construction of the descriptive system for the assessment of quality of life AQoL-6D utility instrument. Health Qual Life Outcomes. 2012;10(1):38. doi: 10.1186/1477-7525-10-38.
    1. Bayliss EA, Ellis JL, Steiner JF. Subjective assessments of comorbidity correlate with quality of life health outcomes: initial validation of a comorbidity assessment instrument. Health Qual Life Outcomes. 2005;3:51. doi: 10.1186/1477-7525-3-51.
    1. Poitras M-E, Fortin M, Hudon C, Haggerty J, Almirall J. Validation of the disease burden morbidity assessment by self-report in a French-speaking population. BMC Health Serv Res. 2012;12:35. doi: 10.1186/1472-6963-12-35.
    1. Corrigan PW, Giffort D, Rashid F, Leary M, Okeke I. Recovery as a psychological construct. Community Ment Health J. 1999;35(3):231–239. doi: 10.1023/a:1018741302682.
    1. Giffort D, Schmook A, Woody C, Vollendorf C, Gervain M. Construction of a Scale to Measure Consumer Recovery. Springfield: Department of Health and Human Services, Office of Mental Health; 1995.
    1. Salzer MS, Brusilovskiy E. Advancing recovery science: reliability and validity properties of the Recovery Assessment Scale. Psychiatr Serv. 2014;65(4):442–453. doi: 10.1176/appi.ps.201300089.
    1. Pelletier J-F, Corbière M, Lecomte T, Briand C, Corrigan P, Davidson L, et al. Citizenship and recovery: two intertwined concepts for civic-recovery. BMC Psychiatry. 2015;15(1):37. doi: 10.1186/s12888-015-0420-2.
    1. Horvath AO, Greenberg LS. Development and validation of the Working Alliance Inventory. J Couns Psychol. 1989;36(2):223–233. doi: 10.1037/0022-0167.36.2.223.
    1. Corbiere 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. doi: 10.1002/mpr.27.
    1. Tracey TJ, Kokotovic AM. Factor structure of the working alliance inventory. Psychol Assess. 1989;1(3):207–210. doi: 10.1037/1040-3590.1.3.207.
    1. Stokes JP. Toward an understanding of cohesion in personal change groups. Int J Group Psychother. 1983;33:449–467. doi: 10.1080/00207284.1983.11491345.
    1. Creswell J, Plano Clark VL. Designing and Conducting Mixed Methods Research. 3. Thousand Oaks: SAGE Publications; 2017.
    1. Patton MQ. Qualitative Research & Evaluation Methods. 4. Thousand Oaks: SAGE Publications; 2014.
    1. Miles MB, Huberman AM, Saldana J. Qualitative Data Analysis: a Methods Sourcebook. 3. Thousand Oaks: SAGE Publications; 2014.
    1. QSR International Pty Ltd . NVivo (Version 12) 2018.
    1. Tango T. On the repeated measures designs and sample sizes for randomized controlled trials. Biostatistics. 2016;17(2):334–349. doi: 10.1093/biostatistics/kxv047.
    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. Roberge P, Provencher MD, Gaboury I, Gosselin P, Vasiliadis HM, Benoit A, et al. Group transdiagnostic cognitive-behavior therapy for anxiety disorders: a pragmatic randomized clinical trial. Psychol Med. 2020:1–11. 10.1017/S0033291720004316.
    1. Pals SL, Murray DM, Alfano CM, Shadish WR, Hannan PJ, Baker WL. Individually randomized group treatment trials: a critical appraisal of frequently used design and analytic approaches. Am J Public Health. 2008;98(8):1418–1424. doi: 10.2105/AJPH.2007.127027.
    1. Hooper R, Teerenstra S, de Hoop E, Eldridge S. Sample size calculation for stepped wedge and other longitudinal cluster randomised trials. Stat Med. 2016;35(26):4718–4728. doi: 10.1002/sim.7028.
    1. The Shiny CRT Calculator: power and sample size for cluster randomised trials. . Accessed 27 Oct 2021.
    1. van Buuren S. In: Flexible Imputation of Missing Data. Hall C, editor. Boca Raton: Taylor & Francis Group; 2012.
    1. Little RJ, Rubin DB. Statistical analysis with missing data. 3rd ed. Hoboken: John Wiley & Sons; 2019.
    1. Pincus T, Miles C, Froud R, Underwood M, Carnes D, Taylor SJC. Methodological criteria for the assessment of moderators in systematic reviews of randomised controlled trials: a consensus study. BMC Med Res Methodol. 2011;11(1):14. doi: 10.1186/1471-2288-11-14.
    1. Canadian Agency for Drugs and Technologies in Health (CADTH). Canadian guidelines for the economic evaluation of health technologies. 3rd ed. Ottawa: The Canadian Agency for Drugs and Technologies in Health (CADTH); 2006.
    1. Vasiliadis H-M, Latimer E, Dionne PA, Préville M. The costs associated with antidepressant use in depression and anxiety in community-living older adults. Can J Psychiatr. 2013;58(4):201–209. doi: 10.1177/070674371305800405.
    1. Vasiliadis H-M, Briand C, Lesage A, Reinharz D, Stip E, Nicole L, et al. Health care resource use associated with integrated psychological treatment. J Ment Health Policy Econ. 2006;9(4):201–207.
    1. Lave JR, Frank RG, Schulberg HC, Kamlet MS. Cost-effectiveness of treatments for major depression in primary care practice. Arch Gen Psychiatry. 1998;55(7):645–651. doi: 10.1001/archpsyc.55.7.645.
    1. Richardson J, Khan MA, Iezzi A, Maxwell A. Comparing and explaining differences in the magnitude, content, and sensitivity of utilities predicted by the EQ-5D, SF-6D, HUI 3, 15D, QWB, and AQoL-8D multiattribute utility instruments. Med Decis Mak. 2015;35(3):276–291. doi: 10.1177/0272989x14543107.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner