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Rounsaville. A Stage of Behavioral Therapies Research
Rounsaville. A Stage of Behavioral Therapies Research
Rounsaville. A Stage of Behavioral Therapies Research
The progressively rigorous methodological requirements Administration standard pharmacotherapy trials, this
of conducting clinical trials of behavioral treatments has approach has generated methods for specifying the behav-
placed a large burden on individual investigators, as treat- ioral techniques to be evaluated, for training therapists to
ment manuals, methods of evaluating treatment quality use techniques consistently, and for monitoring the actual
and fidelity, and persuasive evidence of the treatment’s delivery of these techniques over the course of clinical
promise are now virtual requirements of receiving sup- trials.
Although the technology model approach has in-
port for conducting a clinical trial of a new or adapted
creased internal validity, generalizability, and replicability
treatment. A Stage Model of Behavioral Therapies re-
of psychotherapy studies, it has placed a large burden on
search, by articulating the progressive stages of develop-
individual investigators whose goal is to improve available
ment and evaluation for behavioral treatments, recog-
treatments by refining current methods or developing
nizes the scientific merit and need for support for new therapies. For example, before fully developed effi-
treatment development and initial evaluation designated cacy studies can be undertaken, investigators must have on
as stage I. This article describes the conduct of stage I hand a number of elements now considered requirements
research, including issues addressed in stage I research, of efficacy research, including (a) training manuals speci-
major design decisions confronted by investigators, the fying techniques to be used and excluded, (b) training
close relationship of stage I to stage II research and pro- programs to impart the requisite skills to study clinicians,
poses a time line for stage I research. (c) process measures to evaluate therapists’ competence
Key words: clinical trials, behavioral therapies, stage and adherence to manualized guidelines, and (d) prelimi-
model, study design, methodology. [Clin Psychol Sci Prac nary findings on the acceptability and promise of the new
8:133–142, 2001]
or revised therapy.
Recognizing the large amount of preparation required
to conduct full-scale efficacy trials, Onken and colleagues
W H Y D O W E N E E D A S TA G E M O D E L ?
(1997) proposed a Stage Model of Behavioral Therapies
Research on efficacy and active components of behavioral
research, demarcating three divisions in a rigorous sci-
treatments was revolutionized 20 years ago by the articu-
entific process that leads from initial clinical innovation
lation of the technology model of research as exemplified
through efficacy research to effectiveness research. Stage
by the National Institute of Mental Health Treatment of
I consists of pilot/feasibility testing, manual writing, train-
Depression Collaborative Research Program (Carroll &
ing program development, and adherence/competence
Rounsaville, 1990; Waskow, 1984). Akin to specifying the
measure development for new and untested treatments.
formulation and dosage of medications in Food and Drug
Stage I can also involve the incorporation of basic behav-
Address correspondence to Bruce J. Rounsaville, M.D., VA ioral research into research on the development of new
Connecticut Healthcare, 950 Campbell Ave., Mail Route 151D, behavioral interventions. Such research may have the dual
West Haven, CT 06516. Electronic mail may be sent to goals of understanding behavioral change process as well
bruce.rounsaville@yale.edu. as developing interventions to promote positive change