Frequency and change mechanisms of psychotherapy among depressed patients: study protocol for a multicenter randomized trial comparing twice-weekly versus once-weekly sessions of CBT and IPT

BMC Psychiatry

Marcus J. H. Huibers²  Gerdien Franx⁷  Arnoud Arntz⁹  Pim Cuijpers²  Pieter Dingemanse⁵  Michael van den Boogaard¹  Patricia van Oppen³  Steven D. Hollon⁸  Frenk P. M. L. Peeters⁶  Judith Bosmans⁴  Sanne J. E. Bruijniks² 

[1] PsyQ, Parnassia Groep, Hague, Netherlands;Department of Clinical Psychology, VU University Amsterdam, and EMGO Institute, Amsterdam, The Netherlands;Department of Psychiatry, VU Medical Centre/GGZ ingeest, and the EMGO Institute, Amsterdam, The Netherlands;Department of Health Sciences, EMGO Institute for Health and Care Research, Faculty of Earth and Life Sciences, Section of Health Economics and Health Technology Assessment, VU University Amsterdam, Amsterdam, The Netherlands;Altrecht Institute for Mental Health Care, Utrecht, Netherlands;Department of Psychiatry and Psychology, University Hospital Maastricht; School for Mental Health and Neuroscience, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands;Trimbos-institute, Netherlands Institute of Mental Health and Addiction, Utrecht, The Netherlands;Department of Psychology, Vanderbilt University, Nashville, Tennessee, USA;Department of Clinical Psychology, University of Amsterdam, Amsterdam, The Netherlands

关键词: Multicenter randomized controlled trial;    Physiology;    Psychotherapy;    Change mechanisms;    Intensity;    Depression;   

Others  :  1217931
DOI  :  10.1186/s12888-015-0532-8

 received in 2015-05-13, accepted in 2015-06-16,  发布年份 2015

【 摘 要 】

Background

Cognitive behavioral therapy (CBT) and interpersonal therapy (IPT) are among the most well established therapies for the treatment of depression. However, some major questions remain unanswered. First, it is unknown what session frequency results in the most optimal (cost) effectiveness in psychotherapy. Second, the debate as to what mechanisms underlie the effect of psychotherapy has not yet been resolved. Enhancing knowledge about the optimal session frequency and mechanisms of change seems crucial in order to optimize the (cost) effectiveness of psychotherapy for depression. This study aims to compare treatment outcome of twice-weekly versus once-weekly sessions of CBT and IPT. We expect twice-weekly sessions to be more effective and lead to more rapid recovery of depressive symptoms in comparison to once-weekly sessions. Both therapy-specific and non-specific process measures will be included to unravel the mechanisms of change in psychotherapy for depression. Besides the use of self-reports and behavioral observations, this study will also examine underlying biological processes by collecting blood samples.

Method

In a multicenter randomized trial, two hundred depressed patients will be recruited from Dutch specialized mental healthcare centers and randomized into one of the following groups, all receiving a maximum of 20 sessions in different frequencies: a) twice-weekly sessions at the start of CBT, b) twice-weekly sessions at the start of IPT, c) once-weekly sessions at the start of CBT, d) once-weekly sessions at the start of IPT. Primary outcome measures are depression severity, cost-effectiveness and quality of life. Process measures include therapeutic alliance, recall, therapy-specific skills, motivation and compliance. Assessments will take place during baseline, monthly during treatment and follow-up at month 9, 12 and 24. In addition, at 12 and 24 months, the frequency of depressive episodes in the previous year will be assessed. Blood samples will be taken pre- and post-treatment. The study has been ethically approved and registered.

Discussion

Finding that twice-weekly sessions are more effective or lead to more rapid recovery of depressive symptoms could lead to treatment adaptations that have the potential to reduce the personal and societal burden of depression. In addition, insight into the mechanisms of change and physiological processes in psychotherapy will enable us to optimize treatments and may help to understand human functioning beyond the context of treatment.

Trial registration

The study has been registered on October 21th, 2014 at the Netherlands Trial Register, part of the Dutch Cochrane Centre (NTR4856).

【 授权许可】

   
2015 Bruijniks et al.

【 图 表 】

Fig. 1.

Fig. 2.

【 参考文献 】

• [1]Beck AT, et al.: Cognitive therapy of depression. Guilford, New York; 1979.
• [2]Klerman GL, et al.: Interpersonal psychotherapy for depression. Basic Books, New York; 1984.
• [3]Cuijpers P, van Straten A, Andersson G, van Oppen P: Psychotherapy for depression in adults: a meta-analysis of comparative outcome studies. J Consult Clin Psychol 2008, 76(6):909.
• [4]Butler AC, Chapman JE, Forman EM, Beck AT: The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev 2006, 26(1):17-31.
• [5]Cuijpers P, Geraedts AS, van Oppen P, Andersson G, Markowitz JC, van Straten A: Interpersonal psychotherapy of depression: a meta-analysis. Am J Psychiatry 2011, 168:581-92.
• [6]Richtlijnen GGZ. Multidisciplinaire Richtlijn Depressie. 2010. Retrieved on July, 4th, 2014 from. http://www.ggzrichtlijnen.nl/ webcite
• [7]Cuijpers P, Huibers M, Daniel Ebert D, Koole SL, Andersson G: How much psychotherapy is needed to treat depression? A metaregression analysis. J Affect Disord 2013, 149(1–3):1-13.
• [8]Garratt G, Ingram RE, Rand KL, Sawalani G: Cognitive processes in cognitive therapy: Evaluation of the mechanisms of change in the treatment of depression. Clinical Psychology: Science and Practice 2007, 14(3):224-39.
• [9]Budd R, Hughes I: The Dodo Bird Verdict—controversial, inevitable and important: a commentary on 30 years of meta‐analyses. Clin Psychol Psychother 2009, 16(6):510-22.
• [10]Pachankis JE, Goldfried MR: On the next generation of process research. Clin Psychol Rev 2007, 27(6):760-8.
• [11]Murphy R, Cooper Z, Hollon SD, Fairburn CG: How do psychological treatments work? Investigating mediators of change. Behav Res Ther 2009, 47(1):1-5.
• [12]Luborsky L, Rosenthal R, Diguer L, Andrusyna TP, Berman JS, Levitt JT, Krause ED: The dodo bird verdict is alive and well—mostly. Clinical Psychology: Science and Practice 2002, 9(1):2-12.
• [13]Kazdin AE: Mediators and mechanisms of change in psychotherapy research. Annu Rev Clin Psychol 2007, 3:1-27.
• [14]Lorenzo-Luaces L, German R. E, DeRubeis R. J. It's complicated: The relation between cognitive change procedures, cognitive change, and symptom change in cognitive therapy for depression. Clinical psychology review. 2014, doi:10.1016/j.cpr.2014.12.003.
• [15]NIMH Research Domain Criteria (RDoC). Retrieved on 10th June, 2014 at. http://www.nimh.nih.gov/research-priorities/rdoc/index.shtml webcite
• [16]Abramowitz JS, Foa EB, Franklin ME: Exposure and ritual prevention for obsessive-compulsive disorder: Effects of intensive versus twice-weekly sessions. J Consult Clin Psychol 2003, 71(2):394.
• [17]Herbert JD, Rheingold AA, Gaudiano BA, Myers VH: Standard versus extended cognitive behavior therapy for social anxiety disorder: A randomized-controlled trial. Behav Cogn Psychother 2004, 32(02):131-47.
• [18]Reese RJ, Toland MD, Hopkins NB: Replicating and extending the good-enough level model of change: Considering session frequency. Psychother Res 2011, 21(5):608-19.
• [19]DeRubeis RJ, Hollon SD, Amsterdam JD, Shelton RC, Young PR, Salomon RM, O’Reardon JP, Lovett ML, Gladis MM, Brown LL, Gallop R: Cognitive therapy vs. medications in the treatment of moderate to severe depression. Arch Gen Psychiatry 2005, 62:409-16.
• [20]Dimidjian S, Hollon SD, Dobson KS, Schmaling KB, Kohlenberg RJ, Addis ME, Gallop R, McGlinchey JB, Markley DK, Gollan JK, Atkins DC, Dunner DL, Jacobson NS: Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. J Consult Clin Psychol 2006, 74:658-70.
• [21]Jakobsen JC, Hansen JL, Simonsen S, Simonsen E, Gluud C: Effects of cognitive therapy versus interpersonal psychotherapy in patients with major depressive disorder: a systematic review of randomized clinical trials with meta-analyses and trial sequential analyses. Psychol Med 2012, 42(07):1343-57.
• [22]Kazdin AE: Understanding how and why psychotherapy leads to change. Psychother Res 2009, 19(4–5):418-28.
• [23]Preacher KJ, Zhang Z, Zyphur MJ: Alternative methods for assessing mediation in multilevel data: The advantages of multilevel SEM. Structural Equation Modeling 2011, 18(2):161-82.
• [24]Bordin ES: The generalizability of the psychoanalytic concept of the working alliance. Psychotherapy: Theory, Research & Practice 1979, 16(3):252.
• [25]Lambert MJ, Barley DE: Research summary on the therapeutic relationship and psychotherapy outcome. Psychotherapy: Theory, Research, Practice, Training 2001, 38(4):357.
• [26]Flückiger C, Del Re AC, Wampold BE, Symonds D, Horvath AO: How central is the alliance in psychotherapy? A multilevel longitudinal meta-analysis. J Couns Psychol 2012, 59(1):10.
• [27]Samstag L. W, Batchelder S. T, Muran J. C, Safran J. D. Winston A. Early identification of treatment failures in short-term psychotherapy: An assessment of therapeutic alliance and interpersonal behavior. J Psychotherapy Practice & Res. 1998;7(2):126-143.
• [28]Henn FA, Vollmayr B: Neurogenesis and depression: etiology or epiphenomenon? Biol Psychiatry 2004, 56(3):146-50.
• [29]Shimizu E, Hashimoto K, Okamura N, Koike K, Komatsu N, Kumakiri C, Iyo M: Alterations of serum levels of brain-derived neurotrophic factor (BDNF) in depressed patients with or without antidepressants. Biol Psychiatry 2003, 54(1):70-5.
• [30]Brunoni AR, Lopes M, Fregni F: A systematic review and meta-analysis of clinical studies on major depression and BDNF levels: implications for the role of neuroplasticity in depression. Int J Neuropsychopharmacol 2008, 11(08):1169-80.
• [31]Perroud N, Salzmann A, Prada P, Nicastro R, Hoeppli ME, Furrer S, Malafosse A: Response to psychotherapy in borderline personality disorder and methylation status of the BDNF gene. Translational Psychiatry 2013, 3(1):207.
• [32]Fuchikami M, Morinobu S, Segawa M, Okamoto Y, Yamawaki S, Ozaki N, Terao T: DNA methylation profiles of the brain-derived neurotrophic factor (BDNF) gene as a potent diagnostic biomarker in major depression. PLoS One 2011., 6(8) Article ID e23881
• [33]Slattery DA, Neumann ID: Oxytocin and major depressive disorder: experimental and clinical evidence for links to aetiology and possible treatment. Pharmaceuticals 2010, 3(3):702-24.
• [34]Scantamburlo G, Hansenne M, Fuchs S, Pitchot W, Maréchal P, Pequeux C, Legros JJ: Plasma oxytocin levels and anxiety in patients with major depression. Psychoneuroendocrinology 2007, 32(4):407-10.
• [35]Zetzsche T, Frasch A, Jirikowski G, Murck H, Steiger A: Nocturnal oxytocin secretion is reduced in major depression. Biol Psychiatry 1996, 39(7):584.
• [36]Redei EE, Andrus BM, Kwasny MJ, Seok J, Cai X, Ho J, Mohr DC: Blood transcriptomic biomarkers in adult primary care patients with major depressive disorder undergoing cognitive behavioral therapy. Translational Psychiatry 2014, 4(9):e442.
• [37]Beck AT, Steer RA, Carbin MG: Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clin Psychol Rev 1988, 8(1):77-100.
• [38]Beck AT, Steer R, Brown GK. Beck Depression Inventory II. Manual Boston: Hartcourt Brace; 1996.
• [39]van der Does W: BDI-II-NL: Handleiding; De Nederlandse versie van de Beck Depressie Inventory. 2nd edition. Ipskamp, Enschede; 2002.
• [40]First MB, Spitzer RL, Gibbon M, Williams JB: Structured Clinical Interview for DSM-IV® Axis I Disorders (SCID-I), Clinician Version. Administration Booklet, American Psychiatric Pub; 2012.
• [41]Van Vliet, IM, Leroy, H, Van Megen, HJGM. MINI plus. MINI Internationaal Neuropsychiatrisch Interview, Nederlandse versie 5.0. 0. 2000.
• [42]Whisman, M. A, Perez, J. E, Ramel W. Factor structure of the Beck Depression Inventory—Second Edition (BDI-II) in a student sample. J Clinical Psychology. 2000;56(4):545-551.
• [43]EuroQol G: EuroQol--a new facility for the measurement of health-related quality of life. Health policy (Amsterdam, Netherlands) 1990, 16(3):199.
• [44]Lamers LM, McDonnell J, Stalmeier PF, Krabbe PF, Busschbach JJ: The Dutch tariff: results and arguments for an effective design for national EQ‐5D valuation studies. Health Econ 2006, 15(10):1121-32.
• [45]Zimmerman M, Martinez JH, Attiullah N, Friedman M, Toba C, Boerescu DA: The remission from depression questionnaire as an outcome measure in the treatment of depression. Depress Anxiety 2013, 31(6):533-8.
• [46]Peeters F, Nicolson N, Wichers M, Hacker P: Dutch translation RDQ. Dep. of Psychiatry and Psychology, Maastricht; 2013.
• [47]Veenhoven R, 2014. Happiness Questionnaire. Retrieved on May 2014 at. http://worlddatabaseofhappiness.eur.nl/hap_quer/hqs_fp.htm webcite
• [48]van der Zee KI, Sanderman R: Het meten van de algemene gezondheidstoestand met de RAND-36: een handleiding Groningen: Noordelijk Centrum voor Gezondheidsvraagstukken. 1993.
• [49]Keller MB, Lavori PW, Friedman B, Nielsen E, Endicott J, McDonald-Scott P, et al.: The Longitudinal Interval Follow-up Evaluation: A Comprehensive Method for Assessing Outcome in Prospective Longitudinal Studies. Arch Gen Psychiatry 1987, 44:540-8.
• [50]Warshaw MG, Dyck I, Allsworth J, Stout RL, Keller MB: Maintaining reliability in a long-term psychiatric study: an ongoing inter-rater reliability monitoring program using the longitudinal interval follow-up evaluation. J Psychiatr Res 2001, 35:297-305.
• [51]Warshaw MG, Keller MB, Stout RL: Reliability and Validity of the Longitudinal interval follow-up evaluation for assessing outcome of anxiety disorders. J Psychiatr Res 1994, 28:531-45.
• [52]Hakkaart-van Roijen L: Handleiding Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TiC-P). Trimbos/iMTA, Rotterdam; 2010.
• [53]Hakkaart-van Roijen L, Tan SS, Bouwmans CAM: Handleiding voor kostenonderzoek: Methoden en standaard kostprijzen voor economische evaluaties in de gezondheidszorg. Geactualiseerde versie 2010 [Dutch manual for costing in economic evaluations]. College voor zorgverzekeringen (CVZ), Diemen; 2011.
• [54]Z-index S: G-Standaard. Z-index, Den Haag; 2006.
• [55]Horvath AO, Greenberg LS: Development and validation of the Working Alliance Inventory. J Couns Psychol 1989, 36(2):223.
• [56]Busseri MA, Tyler JD: Interchangeability of the Working Alliance Inventory and Working Alliance Inventory, Short Form. Psychol Assess 2003, 15(2):193.
• [57]Tichenor V, Hill CE: A comparison of six measures of working alliance. Psychotherapy: Theory, Research, Practice, Training 1989, 26(2):195.
• [58]Tracey TJ, Kokotovic AM: Factor structure of the Working Alliance Inventory. Psychol Assess 1989, 1(3):207.
• [59]Vertommen H, Vervaeke GAC: Werkalliantievragenlijst (wav). In Vertaling voor experimenteel gebruik van de wai (Horvath & Greenberg 1986). Niet-gepubliceerde vragenlijst. Departement Psychologie, kuLeuven; 1990.
• [60]Horvath A. O. Short Form Hatcher Therapist. Retrieved on December, 8th, 2014 at. http://wai.profhorvath.com/Downloads webcite
• [61]Zuroff DC, Koestner R, Moskowitz DS, McBride C, Marshall M, Bagby MR: Autonomous motivation for therapy: A new common factor in brief treatments for depression. Psychother Res 2007, 17(2):137-47.
• [62]Williams GC, Freedman ZR, Deci EL: Supporting autonomy to motivate patients with diabetes for glucose control. Diabetes Care 1998, 21(10):1644-51.
• [63]Raes F, Hoes D, Van Gucht D, Kanter JW, Hermans D: The Dutch version of the behavioral activation for depression scale (BADS): Psychometric properties and factor structure. J Behav Ther Exp Psychiatry 2010, 41(3):246-50.
• [64]Hill CE, O’Grady KE, Elkin I: Applying the Collaborative Study Psychotherapy Rating Scale to rate therapist adherence in cognitive-behavior therapy, interpersonal therapy, and clinical management. J Consult Clin Psychol 1992, 60(1):73.
• [65]ACS. 2014. Retrieved on May 2014 at. http://www.sjdm.org/dmidi/Action-State_Orientation.html webcite
• [66]Diefendorff JM, Hall RJ, Lord RG, Strean ML: Action–state orientation: Construct validity of a revised measure and its relationship to work-related variables. J Applied Psychology 2000, 85(2):250.
• [67]Strunk DR, Hollars SN, Adler AD, Goldstein LA, Braun JD. Assessing Patients’ Cognitive Therapy Skills: Initial Evaluation of the Competencies of Cognitive Therapy Scale. Cognitive Therapy and Res. 2014;1–11.
• [68]Strunk DR, DeRubeis RJ, Chiu AW, Alvarez J: Patients’ competence in and performance of cognitive therapy skills: relation to the reduction of relapse risk following treatment for depression. J Consult Clin Psychol 2007, 75(4):523.
• [69]Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Zule W: Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl 2003, 27(2):169-90.
• [70]Scher CD, Stein MB, Asmundson GJ, McCreary DR, Forde DR: The childhood trauma questionnaire in a community sample: psychometric properties and normative data. J Trauma Stress 2001, 14(4):843-57.
• [71]Thombs BD, Bernstein DP, Lobbestael J, Arntz A: A validation study of the Dutch Childhood Trauma Questionnaire-Short Form: Factor structure, reliability, and known-groups validity. Child Abuse Negl 2009, 33(8):518-23.
• [72]Steer RA, Beck AT, Clark DA, Beck JS: Psychometric properties of the Cognition Checklist with psychiatric outpatients and university students. Psychol Assess 1994, 6(1):67.
• [73]Braver TS, Cohen JD, Nystrom LE, Jonides J, Smith EE, Noll DC: A parametric study of prefrontal cortex involvement in human working memory. Neuroimage 1997, 5(1):49-62.
• [74]Moradveisi L, Huibers M, Renner F, Arntz A: The influence of patients’ preference/attitude towards psychotherapy and antidepressant medication on the treatment of major depressive disorder. J Behav Ther Exp Psychiatry 2014, 45(1):170-7.
• [75]Jacobson NS, Truax P: Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol 1991, 59(1):12.
• [76]Evans C, Margison F, Barkham M: The contribution of reliable and clinically significant change methods to evidence-based mental health. Evidence Based Mental Health 1998, 1(3):70-2.
• [77]Lemmens LJHM, Galindo-Garre F, Arntz A, Peeters F, Hollon SD, DeRubeis R.J, Huibers MJH. Exploring Mechanisms of Change in Cognitive Therapy and Interpersonal Psychotherapy for adult Depression. (submitted).
• [78]Fenwick E, O’Brien BJ, Briggs A: Cost‐effectiveness acceptability curves–facts, fallacies and frequently asked questions. Health Econ 2004, 13(5):405-15.