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October 1997, Vol 54, No. 10 >
Article | October 1997

A Psychotherapeutic Context for Clinical Trials Is Promising, But Manualization Is Not

Donald F. Klein, MD; Lauren B. Smith
Arch Gen Psychiatry. 1997;54(10):929-930. doi:10.1001/archpsyc.1997.01830220051008
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IN THIS issue of the ARCHIVES, Carroll1 argues for a psychotherapeutic context, standardized by manualization, for pharmacotherapy trials. This may well succeed in lowering the attrition rate and improving compliance,2 but the superiority of detailed manuals over goal-oriented, supportive therapy has not been demonstrated. Therefore, standardization by manuals is premature.

THE ADOPTION OF MANUALS  Manual-based psychotherapy has become standard in psychotherapy research, to provide a distinct, operationalized, replicable structure. In comparative psychotherapy trials, manuals ensure adequate differentiation between therapies, thus allowing strong statements as to what was actually done.3,4 However, since it has not been shown that manuals increase the treatment efficacy or diminish outcome variance, their required use See also page 923 compared with manual-free, supportive psychotherapy has not been shown to be necessary. Such a manual requirement may expensively address a nonexistent problem.

RESEARCH ON THE EFFICACY OF MANUALS  Schulte et al5 compared the

REFERENCES

1 +
Carroll KM.  Manual-guided psychosocial treatment: a new virtual requirement for pharmacotherapy trials? Arch Gen Psychiatry . 1997;;54:923-928.
2 +
Klein DF.  Improvement of phase III psychotropic drug trials with intensive phase II work . Neuropsychopharmacology . 1991;;4:251-258.
3 +
Luborsky L, Woody G, McLellan AT, O'Brien CP, Rosenzweig J.  Can independent judges recognize different psychotherapies? J Consult Clin Psychol . 1982;;50:49-62.
4 +
Elkin I, Parloff MB, Hadley SW, Autry JH.  NIMH Treatment of Depression Collaborative Research Program: background and research program . Arch Gen Psychiatry . 1985;;42:305-316.
5 +
Schulte D, Kunzel R, Pepping G, Schulte-Bahrenberg T.  Tailor-made versus standardized therapy of phobic patients . Adv Behav Res Ther . 1992;;14:67-92.
6 +
Emmelkamp PM, Bouman TK, Blaauw E.  Individualized versus standardized therapy: a comparative evaluation with obsessive-compulsive patients . Clin Psychol Psychother . 1994;;1:95-100.
7 +
Jacobson NS, Schmaling KB, Holtzworth-Munroe A, Katt JL, Wood LF, Follette VM.  Research-structured vs clinically flexible versions of social learning—based marital therapy . Behav Res Ther . 1989;;27:173-180.
8 +
Weisz JR, Donenberg GR, Weiss B, Han SS.  Bridging the gap between laboratory and clinic in child and adolescent psychotherapy . J Clin Consult Psychol . 1995;;63:688-701.
9 +
Wilson GT.  Manual-based treatments: the clinical application of research findings . Behav Res Ther . 1996;;34:295-314.
10 +
Luborsky L, DeRubeis, RJ.  The use of psychotherapy treatment manuals: a small revolution in psychotherapy research style . Clin Psychol Rev . 1984;;4:5-14.
11 +
Roth A, Fonagy P. What Works for Whom? A Critical Review of Psychotherapy Research . New York, NY: Guilford Press; 1996;.
12 +
Crits-Cristoph P, Baranackie K, Kurcias JS, Beck AT, Carroll K, Perry K, Luborsky L, McLellan AT, Woody GE, Thompson L, Gallagher D, Zitrin C.  Meta-analysis of therapist effects in psychotherapy outcome studies . Psychother Res . 1991;;1:81-91.
13 +
Dobson KS, Shaw BF.  The use of treatment manuals in cognitive therapy: experience and issues . J Consult Clin Psychol . 1988;;56:673-680.
14 +
HenryWP, Strupp HH, Butler SF, Schact TE, Binder JL.  Effects of training in time-limited dynamic psychotherapy: changes in therapist behavior . J Consult Clin Psychol . 1993;;61:434-440.
15 +
Henry WP, Schact TE, Strupp HH, Butler SF, Binder JL.  Effects of training in time-limited dynamic psychotherapy: mediators of therapists' responses to training . J Consult Clin Psychol . 1993;;61:441-447.
16 +
Svartberg M, Stiles TC.  Therapeutic alliance, therapist competence, and client change in short-term anxiety-provoking psychotherapy . Psychother Res . 1994;;4:20-33.
17 +
Sifneos PE. Short-term Dynamic Psychotherapy: Evaluation and Technique . New York, NY: Plenum Publishing Corp; 1979;.
18 +
Jacobson NS, Dobson KS, Truax PA, Addis ME, Koerner K, Gollan JK, Gortner E, Prince SE.  A component analysis of cognitive-behavioral treatment for depression . J Consult Clin Psychol . 1996;;64:294-304.

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1 +
Carroll KM.  Manual-guided psychosocial treatment: a new virtual requirement for pharmacotherapy trials? Arch Gen Psychiatry . 1997;;54:923-928.
2 +
Klein DF.  Improvement of phase III psychotropic drug trials with intensive phase II work . Neuropsychopharmacology . 1991;;4:251-258.
3 +
Luborsky L, Woody G, McLellan AT, O'Brien CP, Rosenzweig J.  Can independent judges recognize different psychotherapies? J Consult Clin Psychol . 1982;;50:49-62.
4 +
Elkin I, Parloff MB, Hadley SW, Autry JH.  NIMH Treatment of Depression Collaborative Research Program: background and research program . Arch Gen Psychiatry . 1985;;42:305-316.
5 +
Schulte D, Kunzel R, Pepping G, Schulte-Bahrenberg T.  Tailor-made versus standardized therapy of phobic patients . Adv Behav Res Ther . 1992;;14:67-92.
6 +
Emmelkamp PM, Bouman TK, Blaauw E.  Individualized versus standardized therapy: a comparative evaluation with obsessive-compulsive patients . Clin Psychol Psychother . 1994;;1:95-100.
7 +
Jacobson NS, Schmaling KB, Holtzworth-Munroe A, Katt JL, Wood LF, Follette VM.  Research-structured vs clinically flexible versions of social learning—based marital therapy . Behav Res Ther . 1989;;27:173-180.
8 +
Weisz JR, Donenberg GR, Weiss B, Han SS.  Bridging the gap between laboratory and clinic in child and adolescent psychotherapy . J Clin Consult Psychol . 1995;;63:688-701.
9 +
Wilson GT.  Manual-based treatments: the clinical application of research findings . Behav Res Ther . 1996;;34:295-314.
10 +
Luborsky L, DeRubeis, RJ.  The use of psychotherapy treatment manuals: a small revolution in psychotherapy research style . Clin Psychol Rev . 1984;;4:5-14.
11 +
Roth A, Fonagy P. What Works for Whom? A Critical Review of Psychotherapy Research . New York, NY: Guilford Press; 1996;.
12 +
Crits-Cristoph P, Baranackie K, Kurcias JS, Beck AT, Carroll K, Perry K, Luborsky L, McLellan AT, Woody GE, Thompson L, Gallagher D, Zitrin C.  Meta-analysis of therapist effects in psychotherapy outcome studies . Psychother Res . 1991;;1:81-91.
13 +
Dobson KS, Shaw BF.  The use of treatment manuals in cognitive therapy: experience and issues . J Consult Clin Psychol . 1988;;56:673-680.
14 +
HenryWP, Strupp HH, Butler SF, Schact TE, Binder JL.  Effects of training in time-limited dynamic psychotherapy: changes in therapist behavior . J Consult Clin Psychol . 1993;;61:434-440.
15 +
Henry WP, Schact TE, Strupp HH, Butler SF, Binder JL.  Effects of training in time-limited dynamic psychotherapy: mediators of therapists' responses to training . J Consult Clin Psychol . 1993;;61:441-447.
16 +
Svartberg M, Stiles TC.  Therapeutic alliance, therapist competence, and client change in short-term anxiety-provoking psychotherapy . Psychother Res . 1994;;4:20-33.
17 +
Sifneos PE. Short-term Dynamic Psychotherapy: Evaluation and Technique . New York, NY: Plenum Publishing Corp; 1979;.
18 +
Jacobson NS, Dobson KS, Truax PA, Addis ME, Koerner K, Gollan JK, Gortner E, Prince SE.  A component analysis of cognitive-behavioral treatment for depression . J Consult Clin Psychol . 1996;;64:294-304.

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