The POSE study - panic control treatment versus panic-focused psychodynamic psychotherapy under randomized and self-selection conditions: study protocol for a randomized controlled trial

Rolf Sandell, Martin Svensson, Thomas Nilsson, Håkan Johansson, Gardar Viborg, Sean Perrin, Rolf Sandell, Martin Svensson, Thomas Nilsson, Håkan Johansson, Gardar Viborg, Sean Perrin

Abstract

Background: Panic disorder with or without agoraphobia is a commonly occurring disorder affecting 2 to 3% of the population in Sweden. Untreated, panic disorder is a chronic condition that significantly increases the risk for psychiatric comorbidity, morbidity and mortality, employment difficulties, and healthcare utilization. Cognitive behavioral approaches are the recommended first-line treatment for panic disorder; however, many patients in routine care receive another evidence-based psychotherapy, including psychodynamic therapy. Allowing patients to choose among evidence-based approaches to panic disorder may improve outcomes and reduce overall health costs. Trials comparing the 'gold standard' treatment for panic disorder to other evidence-based psychotherapies are needed, and also trials that can separate patient preferences for treatment from randomization effects on outcome, disability and healthcare utilization in the longer term.

Methods/design: A phase 2/3 doubly-randomized controlled trial carried out in routine care with 216 adults (aged 18 to 70 years) with a primary diagnosis of DSM-IV Panic Disorder (with or without Agoraphobia). Within each clinic, patients are randomized to self-selection, random assignment of treatment, or wait-list. Patients choose or are randomly assigned to either Panic Control Treatment or Panic-Focused Psychodynamic Psychotherapy. Primary outcomes are changes in panic symptom severity, occupational status, and sickness-related absences from work at post-treatment and 6, 12 and 24 months post-treatment. Secondary outcomes include changes in agoraphobic avoidance, psychiatric comorbidity, disability, and healthcare utilization. The study also employs elements of an effectiveness trial as therapist and service-related effects on outcome will be estimated. Putative change mechanisms for the two treatments are also assessed.

Discussion: Cognitive behavioral and psychodynamic therapies are both evidence-based approaches that are routinely offered to panic disordered patients in Sweden. However, little is known about the relative effectiveness of these two approaches for panic/agoraphobia, work-related disability and healthcare utilization over the longer term. The current trial (POSE) also addresses the important but understudied issue of whether patient preference for a particular psychotherapeutic approach moderates outcome.

Trial registration: ClinicalTrials.gov NCT01606592 (registered 19 March 2012).

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials (CONSORT) flow chart. *Number of participants choosing PCT and PFPP in Self-selection condition is hypothetical and based on available studies.

References

    1. American Psychiatric Association . Diagnostic and statistical manual of mental disorders. 4. Arlington, VA: American Psychiatric Association; 2005.
    1. American Psychiatric Association . Diagnostic and statistical manual of mental disorders. 5. Arlington, VA: American Psychiatric Association; 2013.
    1. Goodwin RD, Faravelli C, Rosi S, Cosci F, Truglia E, De Graaf R, et al. The epidemiology of panic disorder and agoraphobia in Europe. Eur Neuropsychopharmacol. 2005;15:435–43. doi: 10.1016/j.euroneuro.2005.04.006.
    1. Kessler RC, Chiu WT, Jin R, Ruscio AM, Shear K, Walters EE. The epidemiology of panic attacks, panic disorder, and agoraphobia in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2006;63:415–24. doi: 10.1001/archpsyc.63.4.415.
    1. Statens Beredning för medicinsk utvärdering (SBU). Behandling av ångestsyndrom. Stockholm: SBU-rapport number 171; 2005.
    1. Batelaan N, Smit F, De Graaf R, Van Balkom A, Vollebergh W, Beekman A. Economic costs of full-blown and subthreshold panic disorder. J Affect Disord. 2007;104(1–3):127–36. doi: 10.1016/j.jad.2007.03.013.
    1. Batelaan NM, De Graaf R, Spijker J, Smit JH, van Balkom AJ, Vollebergh WA, et al. The course of panic attacks in individuals with panic disorder and subthreshold panic disorder: a population-based study. J Affect Disord. 2010;121(1–2):30–8. doi: 10.1016/j.jad.2009.05.003.
    1. De Graaf R, Tuithof M, Van Dorsselaer S, Ten Have M. Comparing the effects on work performance of mental and physical disorders. Soc Psychiatry Psychiatr Epidemiol. 2012;47:1873–83. doi: 10.1007/s00127-012-0496-7.
    1. Nepon J, Belik SL, Bolton J, Sareen J. The relationship between anxiety disorders and suicide attempts: findings from the National Epidemiologic Survey on Alcohol and Related Conditions. Depress Anxiety. 2010;27:791–8. doi: 10.1002/da.20674.
    1. Sherbourne CD, Sullivan G, Craske MG, Roy-Byrne P, Golinelli D, Rose RD, et al. Functioning and disability levels in primary care out-patients with one or more anxiety disorders. Psychol Med. 2010;40:2059–68. doi: 10.1017/S0033291710000176.
    1. Salvador-Carulla L, Segui J, Fernandez-Cano P. Costs and offset effect in panic disorders. Brit J Psychiatry. 1995;66:23–8.
    1. American Psychiatric Association . Practice guideline for the treatment of patients with panic disorder. 2. Arlington, VA: American Psychiatric Association; 2009.
    1. NICE. Generalised anxiety disorder and panic disorder (with or without agoraphobia) in adults: management in primary, secondary and community care. NICE Clinical Guideline 113. 2011. . Accessed 11 March 2015.
    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(1):S1. doi: 10.1186/1471-244X-14-S1-S1.
    1. Furukawa TA, Watanabe N, Churchill R. Combined psychotherapy plus antidepressants for panic disorder with or without agoraphobia. Cochrane Database Syst Rev. 2007;1:CD004364.
    1. Hofmann SG, Smits JA. Cognitive-behavioral therapy for adult anxiety disorders: a meta-analysis of randomized placebo-controlled trials. J Clin Psychiatry. 2008;69:621–32. doi: 10.4088/JCP.v69n0415.
    1. Sánchez-Meca J, Rosa-Alcázar AI, Marín-Martínez F, Gómez-Conesa A. Psychological treatment of panic disorder with or without agoraphobia: a meta-analysis. Clin Psychol Rev. 2010;30(1):37–50. doi: 10.1016/j.cpr.2009.08.011.
    1. Haby MM, Donnelly M, Corry J, Vos T. Cognitive behavioural therapy for depression, panic disorder and generalized anxiety disorder: a meta-regression of factors that may predict outcome. Aust N Z J Psychiatry. 2006;40:9. doi: 10.1080/j.1440-1614.2006.01736.x.
    1. Farach FJ, Pruitt LD, Jun JJ, Jerud AB, Zoellner LA, Roy-Byrne PP. Pharmacological treatment of anxiety disorders: current treatments and future directions. J Anxiety Disord. 2012;26(8):833–43. doi: 10.1016/j.janxdis.2012.07.009.
    1. Arch JJ, Craske MG. First-line treatment: a critical appraisal of cognitive behavioral therapy developments and alternatives. Psychiatr Clin North Am. 2009;32(3):525–47. doi: 10.1016/j.psc.2009.05.001.
    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):875–81. doi: 10.1016/j.jad.2011.09.017.
    1. Gloster AT, Hauke C, Höfler M, Einsle F, Fydrich T, Hamm A, et al. Long-term stability of cognitive behavioral therapy effects for panic disorder with agoraphobia: a two-year follow-up study. Behav Res Ther. 2013;51(12):830–9. doi: 10.1016/j.brat.2013.09.009.
    1. Fava GA, Rafanelli C, Grandi S, Conti S, Ruini C, Mangelli L, et al. Long-term outcome of panic disorder with agoraphobia treated by exposure. Psychol Med. 2001;31(5):891–8.
    1. Knekt P, Lindfors O, Laaksonen MA, Raitasalo R, Haaramo P, Järvikoski A, et al. Effectiveness of short-term and long-term psychotherapy on work ability and functional capacity - a randomized clinical trial on depressive and anxiety disorders. J Affect Disord. 2008;107(1–3):95–106. doi: 10.1016/j.jad.2007.08.005.
    1. Elfering A. Work-related outcome assessment instruments. Eur Spine J. 2006;15:32–43. doi: 10.1007/s00586-005-1047-7.
    1. Lazar A, Sandell R, Grant J. Subjective health and ill health-related behaviour. Psychol Psychother. 2007;80(Pt 2):297–309. doi: 10.1348/147608306X132955.
    1. Mintz J, Mintz LI, Arruda MJ, Hwang SS. Treatments of depression and the functional capacity to work. Arch Gen Psychiatry. 1992;49:761–8. doi: 10.1001/archpsyc.1992.01820100005001.
    1. Cowley DS, Ha EH, Roy-Byrne PP. Determinants of pharmacologic treatment failure in panic disorder. J Clin Psychiatry. 1997;58:555–61. doi: 10.4088/JCP.v58n1208.
    1. Marcus SM, Gorman J, Shear MK, Lewin D, Martinez J, Ray S, et al. A comparison of medication side effect reports by panic disorder patients with and without concomitant cognitive behavior therapy. Am J Psychiatry. 2007;164(2):273–5. doi: 10.1176/ajp.2007.164.2.273.
    1. Issakidis C, Andrews G. Pretreatment attrition and dropout in an outpatient clinic for anxiety disorders. Acta Psychiatr Scand. 2004;109:426. doi: 10.1111/j.1600-0047.2004.00264.x.
    1. Busch FN, Milrod BL. The ongoing struggle for psychoanalytic research: some steps forward. Psychoanal Psychother. 2010;24(4):306–14. doi: 10.1080/02668734.2010.519234.
    1. Shedler J. The efficacy of psychodynamic psychotherapy. Am Psychol. 2010;65(2):98–109. doi: 10.1037/a0018378.
    1. Fonagy P, Roth A, Higgitt A. The outcome of psychodynamic psychotherapy for psychological disorders. Clin Neurosci Res. 2005;4:367–77. doi: 10.1016/j.cnr.2005.03.005.
    1. Abbass AA, Hancock JT, Henderson J, Kisely S. Short-term psychodynamic psychotherapies for common mental disorders. Cochrane Database Syst Rev. 2006;4:CD004687.
    1. Abbass AA, Kisely SR, Town JM, Leichsenring F, Driessen E, De Maat S, et al. Short‐term psychodynamic psychotherapies for common mental disorders. Cochrane Database Syst Rev. 2014;7:CD004687.
    1. Keefe JR, Mccarthy KS, Dinger U, Zilcha-mano S, Barber JP. A meta-analytic review of psychodynamic therapies for anxiety disorders. Clin Psychol Rev. 2014;34(4):309–23. doi: 10.1016/j.cpr.2014.03.004.
    1. Leichsenring F, Rabung S, Leibing E. The efficacy of short-term psychodynamic psychotherapy in specific psychiatric disorders: a meta-analysis. Arch Gen Psychiatry. 2004;61:1208–16. doi: 10.1001/archpsyc.61.12.1208.
    1. Leichsenring F, Rabung S. Effectiveness of long-term psychodynamic psychotherapy: a meta-analysis. J Am Med Assoc. 2008;300:1551–65. doi: 10.1001/jama.300.13.1551.
    1. Milrod BL, Busch FN, Cooper AM, Shapiro T. Manual of panic-focused psychodynamic psychotherapy. Washington, DC: American Psychiatric Press; 1997.
    1. Milrod B, Busch F, Leon AC, Shapiro T, Aronson A, Roiphe J, et al. Open trial of psychodynamic psychotherapy for panic disorder: a pilot study. Am J Psychiatry. 2000;157(11):1878–80. doi: 10.1176/appi.ajp.157.11.1878.
    1. Milrod B, Busch F, Leon AC, Aronson A, Roiphe J, Rudden M, et al. A pilot open trial of brief psychodynamic psychotherapy for panic disorder. J Psychother Pract Res. 2001;10(4):239–45.
    1. Milrod B, Leon AC, Busch F, Rudden M, Schwalberg M, Clarkin J, et al. A randomized controlled clinical trial of psychoanalytic psychotherapy for panic disorder. Am J Psychiatry. 2007;164(2):265–72. doi: 10.1176/ajp.2007.164.2.265.
    1. Beutel ME, Scheurich V, Knebel A, Michal M, Wiltink J, Graf-Morgenstern M, et al. Implementing panic-focused psychodynamic psychotherapy into clinical practice. Can J Psychiatry. 2013;58(6):326–34.
    1. Brewin CR, Bradley C. Patient preferences and randomised controlled trials. Br Med J. 1989;299:313–5. doi: 10.1136/bmj.299.6694.313.
    1. Nilsson T, Svensson M, Sandell R, Clinton D. Patients’ experiences of change in cognitive-behavioural therapy and psychodynamic therapy: a qualitative comparative study. Psychother Res. 2007;17:553–66. doi: 10.1080/10503300601139988.
    1. Bragesjö M, Clinton D, Sandell R. The credibility of psychodynamic, cognitive and cognitive-behavioural psychotherapy in a randomly selected sample of the general public. Psychol Psychother. 2004;77(Pt 3):297–307. doi: 10.1348/1476083041839358.
    1. Frövenholt J, Bragesjö M, Clinton D, Sandell R. How do experiences of psychiatric care affect the perceived credibility of different forms of psychotherapy? Psychol Psychother. 2007;80(Pt 2):205–15. doi: 10.1348/147608306X116098.
    1. Sandell R, Clinton D, Frövenholt J, Bragesjö M. Credibility clusters, preferences, and helpfulness beliefs for specific forms of psychotherapy. Psychol Psychother. 2011;84(4):425–41. doi: 10.1111/j.2044-8341.2010.02010.x.
    1. Long Q, Little RJ, Lin X. Causal inference in hybrid intervention trials involving treatment choice. J Am Stat Assoc. 2008;103:474–84. doi: 10.1198/016214507000000662.
    1. Arnkoff DB, Glass CR, Shapiro SJ. Expectations and preferences. In: Norcross JC, editor. Psychotherapy relationships that work. New York: Oxford University Press; 2002. pp. 335–56.
    1. Swift JK, Callahan JL. The impact of client treatment preferences on outcome: a meta-analysis. J Clin Psychol. 2009;65(4):368–81. doi: 10.1002/jclp.20553.
    1. Watzke B, Rüddel H, Jürgensen R, Koch U, Kriston L, Grothgar B, et al. Effectiveness of systematic treatment selection for psychodynamic and cognitive-behavioural therapy: randomised controlled trial in routine mental healthcare. Br J Psychiatry. 2010;197(2):96–105. doi: 10.1192/bjp.bp.109.072835.
    1. Le QA, Doctor JN, Zoellner LA, Feeny NC. Cost-effectiveness of prolonged exposure therapy versus pharmacotherapy and treatment choice in posttraumatic stress disorder (the Optimizing PTSD Treatment Trial): a doubly randomized preference trial. J Clin Psychiatry. 2014;75(3):222–30. doi: 10.4088/JCP.13m08719.
    1. Shear MK, Maser JD. Standardized assessment for panic disorder research: a conference report. Arch Gen Psychiatry. 1994;51:346–54. doi: 10.1001/archpsyc.1994.03950050006001.
    1. First MB, Spitzer RL, Gibbon M, Williams JBW. Structured clinical interview for DSM-IV Axis I. New York: Biometrics Research, New York State Psychiatric Institute; 1996.
    1. Shear MK, Brown TA, Barlow DH, Money R, Sholomskas DE, Woods SW, et al. Multicenter collaborative panic disorder severity scale. Am J Psychiatry. 1997;154(11):1571–5. doi: 10.1176/ajp.154.11.1571.
    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):183–5. doi: 10.1002/da.10049.
    1. First MB, Spitzer RL, Gibbon M, Williams JBW, Benjamin LS. Structured clinical interview for DSM-IV Axis II personality disorders (Version 2.0) New York: Biometrics Research, New York State Psychiatric Institute; 1997.
    1. Chambless DL, Caputo GC, Jasin SE, Gracely EJ, Williams C. The Mobility Inventory for Agoraphobia. Behav Res Ther. 1985;23(1):35–44. doi: 10.1016/0005-7967(85)90140-8.
    1. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134:382–9. doi: 10.1192/bjp.134.4.382.
    1. Sheehan DV. The anxiety disease. New York: Charles Scribner and Sons; 1983.
    1. Evans C, Mellor-Clark J, Margison F, Barkham M, Audin K, Connell J, et al. CORE: clinical outcomes in routine evaluation. J Men Health. 2007;9:247–55. doi: 10.1080/713680250.
    1. Ilmarinen J, Tuomi K, Klockars M. Changes in the work ability of active employees over an 11-year period. Scan J Work Env Health. 1997;23:49–57.
    1. Barlow DH, Craske MG. Mastery of your anxiety and panic. San Antonio: Graywind/ Psychological Corporation; 1994.
    1. Perepletchikova F, Treat TA, Kazdin AE. Treatment integrity in psychotherapy research: analysis of the studies and examination of the associated factors. J Consult Clin Psychol. 2007;75(6):829–41. doi: 10.1037/0022-006X.75.6.829.
    1. Swift JK, Callahan JL, Vollmer BM. Preferences. J Clin Psychol. 2011;67(2):155–65. doi: 10.1002/jclp.20759.
    1. Bosker RJ, Snijders TAB, Guldemond H. PINT (Power IN Two-level designs): estimating standard errors of regression coefficients in hierarchical linear models for power calculations. User’s manual (Version 2.1) Groningen: University of Groningen; 2003.
    1. Snijders TAB, Bosker RJ. Standard errors and sample sizes for two-level research. J Educ Stat. 1998;18:237–59.
    1. Brazier JE, Dixon S, Ratcliffe J. The role of patient preferences in cost-effectiveness analysis: a conflict of values? Pharmacoeconomics. 2009;27(9):705–12. doi: 10.2165/11314840-000000000-00000.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir