Wie adhärent wird Clinical Management in randomisierten, kontrollierten Studien durchgeführt?

Zusammenfassung

Clinical Management (CM) stellt in der Depressionsforschung eine häufig verwendete Kontrollbedingung dar. In dieser Arbeit wurde erstmals die Adhärenz von standardisiertem CM und dessen Einfluss auf das Behandlungsergebnis bei Depressiven untersucht. 43 Patienten mit einer Major Depression erhielten im Rahmen einer randomisierten, kontrollierten Studie fünf Wochen lang neben einer medikamentösen Standardtherapie dreimal wöchentlich CM-Sitzungen. Insgesamt wurden 167 zufällig ausgewählte, über den gesamten Behandlungsverlauf verteilte Audioaufnahmen dieser Sitzungen mithilfe einer Adhärenzskala ausgewertet. Der Behandlungserfolg wurde anhand der Hamilton-Depressionsskala eingeschätzt. Die Psychiater führten insgesamt hochqualitatives CM mit stark supportiven Anteilen durch. Die vorgegebene maximale Sitzungslänge wurde dabei überschritten. Reines CM war mit einer höheren Responserate assoziiert. Die Zusatzdiagnose einer Persönlichkeitsstörung sowie die klinische Erfahrung des Behandlers in Jahren waren Prädiktoren für weniger adhärente Behandlung, hatten jedoch keine Moderatorfunktion.

Abstract

CM is increasingly used as a control condition in depression research. In the present study, the adherence of standardized CM sessions and their influence on outcome in depressed inpatients was investigated for the first time. In a randomized controlled trial, 43 inpatients with a diagnosis of Major Depression received medication treatment plus three-weekly CM sessions for 5 weeks. The 17-item version of the Hamilton Depression Rating Scale was the outcome measure. A total of 167 randomly selected audiotapes of CM sessions were evaluated using an adherence scale. The CM sessions delivered by psychiatric residents showed overall a high quality and included extensive support by the physician. The length of sessions was extended. The purity of sessions was associated with higher response rates. A diagnosis of Axis II-disorders or -traits and the clinical experience of the physician in years were predictors for less adherend treatments. However, both of them did not function as moderator variables.

clinical management - adherence - depression

Literatur

• 1 Elkin I, Shea T, Watkins J T. et al . National Institute of Mental Health Treatment of Depression Collaborative Research Program general effectiveness of treatments.  Arch Gen Psychiatry. 1989;  46 971-982
• 2 Elkin I, Parloff M, Hadley S. et al . NIMH Treatment of Depression Collaborative Research Program. Background and research plan.  Arch Gen Psychiatry. 1985;  42 305-316
• 3 Fawcett J, Epstein P, Fiester S. et al . Clinical management-impiramine/placebo administration manual. NIMH treatment of depression collaborative research program.  Psychopharmacol Bull. 1987;  23 309-324
• 4 Miller I W, Norman W H, Keitner G I. Combined treatment for patients with double depression.  Psychother u. Psychosom. 1999;  68 180-185
• 5 Elkin I. The NIMH treatment of Depression collaborative Research Program: where we began and where we are. In: Bergin A, Garfield S (eds) Handbook of Psychotherapy and Behavior Change. New York; Wiley 1994: pp 114-139
• 6 Reesal R T, Lam R W. Clinical guidelines for the treatment of depressive disorders. II. Principles of management.  Can J Psychiatry. 2001;  46, Suppl 1 21S-28S
• 7 Malt U F, Robak O H, Madsbu H P. et al . The Norwegian naturalistic treatment study of depression in general practice (NORDEP)-I: randomised double blind study.  BMJ. 1999;  318 1180-1184
• 8 Lesperance F, Frasure-Smith N, Koszycki D. et al . Effects of citalopram and interpersonal psychotherapy on depression in patients with coronary artery disease: the Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) trial.  JAMA. 2007;  297 367-379
• 9 Hill C E, O'Grady K E, 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 73-79
• 10 Markowitz J C, Spielman L A, Scarvalone P A. et al . Psychotherapy adherence of therapists treating HIV-positive patients with depressive symptoms.  J Psychother Pract Res. 2000;  9 75-80
• 11 Frank E, Kupfer D J, Wagner E F. et al . Efficacy of interpersonal psychotherapy as a maintenance treatment of recurrent depression. Contributing factors.  Arch Gen Psychiatry. 1991;  48 1053-1059
• 12 Luborsky L, McLellan A T, Woody G E. et al . Therapist success and its determinants.  Arch Gen Psychiatry. 1985;  42 602-611
• 13 O'Malley S S, Foley S H, Rounsaville B J. et al . Therapist competence and patient outcome in interpersonal psychotherapy of depression.  J Consult Clin Psychol. 1988;  56 496-501
• 14 Crits-Christoph P, Cooper A, Luborsky L. The accuracy of therapists' interpretations and the outcome of dynamic psychotherapy.  J Consult Clin Psychol. 1988;  56 490-495
• 15 Parker G, Fletcher K. Treating depression with the evidence-based psychotherapies: a critique of the evidence.  Acta Psychiatr Scand. 2007;  115 352-359
• 16 Wampold B E, Minami T, Tierney S C. et al . The placebo is powerful: estimating placebo effects in medicine and psychotherapy from randomized clinical trials.  J Clin Psychol. 2005;  61 835-854
• 17 Klein D F. A psychotherapeutic context for clinical trials is promising, but manualization is not.  Arch Gen Psychiatry. 1997;  54 929-930
• 18 Duncan B, Miller S. Treatment Manuals Do Not Improve Outcomes. Evidence-based practices in mental health: Debate and dialogue on the fundamental questions. Washington, DC; APA Press 2005
• 19 Arnow B A, Constantino M J. Effectiveness of psychotherapy and combination treatment for chronic depression.  J Clin Psychol. 2003;  59 893-905
• 20 Miller S, Binder J. The effects of manual based training on treatment fidelity and outcome.  Psychotherapy. 2002;  39 184-198
• 21 Rounsaville B J, Chevron E S, Prusoff B A. et al . The relation between specific and general dimensions of the psychotherapy process in interpersonal psychotherapy of depression.  J Consult Clin Psychol. 1987;  55 379-384
• 22 Bryant M, Simons A, Thase M. Therapist skill and patient variables in homework compliance: controlling an uncontrolled variable in cognitive therapy outcome research.  Cognit Ther Res. 1999;  23 381-399
• 23 Shaw B F, Elkin I, Yamaguchi J. et al . Therapist competence ratings in relation to clinical outcome in cognitive therapy of depression.  J Consult Clin Psychol. 1999;  67 837-846
• 24 Joyce P R, Mulder R T, Luty S E. et al . Borderline personality disorder in major depression: symptomatology, temperament, character, differential drug response, and 6-month outcome.  Compr Psychiatry. 2003;  44 35-43
• 25 Mulder R T, Joyce P R, Luty S E. The relationship of personality disorders to treatment outcome in depressed outpatients.  J Clin Psychiatry. 2003;  64 259-264
• 26 Joyce P R, McKenzie J M, Carter J D. et al . Temperament, character and personality disorders as predictors of response to interpersonal psychotherapy and cognitive-behavioural therapy for depression.  Br J Psychiatry. 2007;  190 503-508
• 27 Schramm E, van Calker D, Dykierek P. et al . An intensive treatment program of interpersonal psychotherapy plus pharmacotherapy for depressed inpatients: acute and long-term results.  Am J Psychiatry. 2007;  164 768-777
• 28 Wittchen H-U, Zaudig M, Fydrich T. Strukturiertes Klinisches Interview für DSM-IV. Göttingen; Hogrefe 1997
• 29 Hamilton M A. A rating scale for depression.  J Neurol Neurosurg Psychiatry. 1960;  23 56-63
• 30 Frank E, Prien R F, Jarrett R B. et al . Conceptualization and rationale for consensus definitions of terms in major depressive disorder. Remission, recovery, relapse, and recurrence.  Arch Gen Psychiatry. 1991;  48 851-855
• 31 Holmbeck G N. Toward terminological, conceptual, and statistical clarity in the study of mediators and moderators: examples from the child-clinical and pediatric psychology literatures.  J Consult Clin Psychol. 1997;  65 599-610
• 32 Fawcett J. Compliance: definitions and key issues.  J Clin Psychiatry. 1995;  56, Suppl 1 4-8, discussion 9 – 10
• 33 Weiss M, Gaston L, Propst A. et al . The role of the alliance in the pharmacologic treatment of depression.  J Clin Psychiatry. 1997;  58 196-204
• 34 de Jong-Meyer R, Hautzinger M, Rudolf G AE. et al . Die Überprüfung der Wirksamkeit einer Kombination von Antidepressiva- und Verhaltenstherapie bei endogen depressiven Patienten: Varianzanalytische Ergebnisse zu den Haupt- und Nebenkriterien des Therapieerfolgs.  Zeitschrift für Klinische Psychologie. 1996;  25 93-109
• 35 Wagner E, Frank E, Steiner S C. Discriminating maintenance treatments for recurrent depression: development and implementation of a rating scale.  J Psychother Prac Res. 1992;  1 280-290
• 36 Borkovec T D, Sibrava N J. Problems with the use of placebo conditions in psychotherapy research, suggested alternatives, and some strategies for the pursuit of the placebo phenomenon.  J Clin Psychol. 2005;  61 805-818