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Manual Development
Kathleen M. Carroll and Kathryn F. Nuro, Yale University School of Medicine
There has been controversy surrounding the roles and Maki & Syman, 1997). Manuals are also increasingly pres-
value of psychotherapy manuals in clinical practice since ent in clinical practice as changes in the health care system
their inception. It has been underrecognized that the ap- exert greater pressure on clinicians to define and evaluate
propriate roles and content of manuals should evolve the effectiveness of services they provide (Addis, Wade, &
with the stage of development of a given treatment. This
Hatgis, 1999).
Nonetheless, many manuals, including those that spec-
article proposes a stage model in which manuals are seen
ify psychotherapies with extensive levels of empirical sup-
as evolving with the level of development of the treat-
port, have met only mixed enthusiasm and acceptance by
ment, from the basic outlines necessary for preliminary
the clinical community. Existing treatment manuals have
evaluation of the treatment in early pilot studies (stage I),
been criticized on several grounds, including (1) limited
to highly defined guidelines that demark the internal and applicability to the wide range of populations and problems
external boundaries of treatment for efficacy studies regularly encountered in clinical practice (Abrahamson,
(stage II), and finally to elaborated systems appropriate 1999; Elliot, 1998; Foxhall, 2000; Henry, 1998; Norcross,
for use with diverse clinical populations (stage III). We 1999), (2) excessive emphasis on technique with inade- AQ1
propose guidelines for the content of manuals at the var- quate focus on the working alliance and other important
ious stages, as well as strategies for developing “clinician- common elements of treatment (Addis et al., 1999; Binder
friendly” manuals to facilitate broader use of empirically et al., 1993; Dobson & Shaw, 1988; Elliot, 1998; Fonagy,
supported treatments. 1999; Henry, 1998; Silverman, 1996), (3) restriction of
Key words: treatment manuals, stage model, empiri-
clinical innovation and the clinical expertise of the thera-
pist (Addis et al., 1999; Castonguay, Schut, Constantino, & AQ2
cally supported treatments. [Clin Psychol Sci Prac 9:396–
Halperin, 1999; Elliot, 1998; Henry, 1998; Norcross, 1999;
406, 2002]
Wolfe, 1999), and (4) feasibility when the manual is imple-
mented by clinicians of great diversity regarding experi-
The development of treatment manuals, which specify
ence, discipline, and clinical expertise (Addis et al., 1999).
behavioral therapies and provide guidelines for their im-
Empirically supported treatments fail to find their way
plementation, revolutionized psychotherapy research (Lu-
into clinical practice for a number of reasons. For ex-
borsky & DeRubeis, 1984). Now virtual requirements in
ample, even a highly flexible and sophisticated manual is
treatment efficacy research (Chambless & Hollon, 1998),
not likely to be adopted by clinicians if the treatment it
manuals are more frequently being used as a basis for
describes is not feasible, cost-effective, or acceptable to
training psychologists in clinical programs (Beutler, 1999;
the clinical community. Conversely, however, if a novel
treatment is practical and appealing to clinicians (see Fish-
Address correspondence to Kathleen M. Carroll, Psychotherapy bein, 1995; Fonagy, 1999), a well-written manual may fa-
Development Center, Division of Substance Abuse, Yale Uni- cilitate its acceptance.
versity School of Medicine, 950 Campbell Avenue (151D), One strategy for addressing some of these criticisms and
West Haven, CT 06516. E-mail: kathleen.carroll@yale.edu. encouraging broader use of treatment manuals in clinical
I Preliminary evaluation of Pilot/feasibility trials Initial specification of treatment techniques, goals, and format
feasibility and efficacy Initial specification of theoretical active ingredients
II Randomized clinical trials Efficacy trials Specifications of standards for training and supervision of therapists
Specification of unique versus common elements
Discrimination from comparison/control approaches
Discrimination from other approaches for the disorder
Evaluation of treatment process
III Transportability & dissemination Effectiveness trials Provide detailed guidelines for implementation of the treatment
to clinical community with diverse patient groups and in a range of clinical settings
Provide guidelines for tailoring treatment to different patient subgroups
Explicate limits of treatments effectiveness
clinical experience, but, more important, with process always a virtue in treatment manuals). Treatment develop-
and outcome data. ers may find it helpful to consider each of these issues in
This model is not, however, predicated solely on wide- order to more thoroughly define new treatments.
spread acceptance of the stage model of therapy develop- Very briefly, a bare-bones stage I manual should cover
ment. We have merely attempted to codify a logical the overview, description, and theoretical justification of
sequence of manual development and to emphasize that the treatment; a conception of the nature of the disorder
treatment manual development should not stop with the or problem the treatment targets; the theoretical mecha-
versions of manuals used in stage II efficacy trials. Never- nisms of change; the goals of the treatment; a description
theless, just as an important benefit of the stage model of of how the treatment may be similar to or different from
treatment development is that it fostered support for other existing treatments for the disorder (as a means of
treatment development and pilot studies in stage I and highlighting its unique elements); and specification of the
dissemination studies in stage III (see Onken et al., 1997), treatment’s defining characteristics.
articulation of a parallel model for manual development Other elements critical to a stage I manual include
may foster greater recognition of the need to support the defining the treatment’s overall structure, including dura-
development of stage III manuals to foster broader use of tion, format (e.g., group vs. individual), intensity (num-
manuals in clinical practice. Moreover, we recognize that ber and length of sessions in a given week), level of
this process is likely to result not in the distribution of dis- flexibility versus structure, session format, and so on. De-
crete stage I/stage II/stage III manuals for a given treat- tailed guidelines for the conduct and goals of sessions as
ment but rather in successive editions of the manual over well as major content areas to be conveyed to the patient
several years. should also be provided. Special attention should be de-
voted to clarifying and defining elements of the treatment
Guidelines for a Stage I Treatment Manual likely to distinguish it from the control or comparison ap-
The overall goals of the initial stage of treatment develop- proach to which it may be contrasted in an initial pilot
ment are to specify the treatment and provide an initial feasibility/efficacy study.
evaluation of its feasibility and efficacy. Thus, at this stage, The model Waltz and colleagues (1993) describe for
the treatment developer often has in mind only a general delineating treatments in terms of four defining charac-
outline of the treatment and a rough conception of the teristics (unique and essential elements, essential but not
major contents of sessions. Table 2 provides a general out- unique elements, recommended elements, and proscribed
line for a stage I manual that would define the boundaries, elements) is an excellent one for defining psychotherapies
basic structure, and preliminary contents of a treatment at at all stages. This model is valuable in helping treatment
a level minimally sufficient for a preliminary pilot study developers sharpen the distinctive features of a given
aimed at evaluating its feasibility and efficacy. It may not treatment, in training therapists by highlighting the essen-
be necessary or appropriate to include lengthy descriptions tial defining elements of the approach, and in developing
for each of these topics in any single manual (as brevity is efficient adherence/competence rating systems.
II. Conception of the A. Etiological factors Summary of treatments’ conception of the forces or factors that lead to the
disorder or problem development of the disorder in a particular individual
B. Factors believed to be According to treatment/theory, what factors or processes are thought to be
associated with behavior change associated with change or improvement in the problem or disorder?
C. Agent of change (e.g., patient, What is the hypothesized agent of change?
therapist, group affiliation) Who, or what, is thought to be responsible for change in the disorder?
D. Case formulation What is the conceptual framework around which cases are formulated and understood?
E. How are the disorder/symptoms Therapist strategy for assessment of the disorder/problem
assessed by the therapist? Specification of any standardized assessment to be used
IV. Contrast to other A. Similar approaches What are the available treatments for the disorder or problem that are most similar to this
approaches treatment? How do these differ from this treatment?
B. Dissimilar approaches What treatments for the disorder or problem are most dissimilar to this approach?
V. Specification of A. Unique and essential elements What are the specific active ingredients, which are unique and essential to this treatment?
defining interventions B. Essential but not unique What interventions are essential to this treatment but not unique?
elements
C. Recommended elements What interventions or processes are recommended but not essential or unique?
D. Proscribed elements What interventions or processes are prohibited or not characteristic of this treatment?
What interventions may be harmful or countertherapeutic in the context of this treatment?
VI. Session content Explication of unique & Where appropriate, detailed, session-by-session content with examples and vignettes
essential elements
VII. General format A. Format for delivery Individual, group, family, mixed
If group, closed- or open-ended format?
B. Frequency and How often do sessions occur? How long are sessions?
intensity of sessions How many sessions should be delivered over what period of time?
C. Flexibility in content Are there essential versus “elective” content areas?
Is there flexibility in sequencing session content areas?
D. Session format Length of sessions
Guidelines for within-session structure
E. Level of structure Does the therapist set an agenda for each session? Is this done collaboratively?
How structured are the sessions? What determines the level of structure in this treatment?
Who (therapist or patient) talks more?
F. Extra-session tasks Are extra-session (e.g., homework) tasks a part of this treatment?
What is the purpose of extra-session tasks?
How are specific tasks or assignments selected?
How does the therapist present a rationale for the tasks?
How does the therapist assess patient implementation of tasks?
How does the therapist respond to the patient’s completion of
an assignment? How is it integrated into the work of therapy?
How does the therapist respond to the patient’s failure to complete an assignment?
For example, several of our manuals have incorporated ing in cognitive-behavioral therapy [CBT] for substance
this system; we include sections that, grouped under each use disorders); (2) essential but not unique (e.g., defining
of Waltz’s four categories, provide definitions and detailed sessions goals); (3) recommended (e.g., monitoring sub-
examples of the specific interventions and processes con- stance use through urinalysis); and (4) proscribed (e.g., ex-
sidered to be (1) unique and essential to the treatment and tensive self-disclosure) (see Carroll, 1998, for examples).
thus necessary in all sessions (e.g., provision of skills train- In turn, delineation of the treatment in this way facilitates
I. Elaborated rationale Empirical evidence Summary of data on effectiveness of this population, process findings
supporting effectiveness
of this approach
Variations by subgroups Did preliminary or pilot studies suggest variability in outcome across different patient groups?
II. Troubleshooting Strategies for dealing with Specific guidelines for therapist handling of common issues such as: patient lateness,
common clinical problems missed sessions, recurrent crises, poor motivation, relapse, intoxication, failure to
implement extra-session tasks
Are these strategies “generic” or highly specific to this type of treatment?
III. Managing transitions Guidelines for clinical How does the therapist assess the patient’s readiness to move on to a new stage of
decision-making through the treatment?
stages of treatment How does the therapist determine whether to repeat/review old material or move on?
How does the therapist deal with an apparent clinical impasse?
How does the therapist assess core issues to be targeted during treatment?
How are shifts in the treatment introduced?
How does the therapist handle issues related to termination, including determination of
readiness for termination?
IV. Nonspecific or A. Patient-therapist What is the ideal therapist role in this treatment (educator, collaborator, teacher, peer,
common aspects of relationship adviser)? What is the patient’s role?
treatment What is the nature of the optimal or ideal patient-therapist relationship?
How important is the therapeutic relationship to the outcome of the treatment?
How important are relationship issues relative to other aspects of the therapy?
Strategies the therapist uses to develop desired relationship
Strategies the therapist uses to address poor or weak therapeutic relationship
B. Relationship of common What is the nature of the relationship between unique and common elements?
and unique elements What distinguishes“good” session of this treatment from a poor one?
V. Compatibility with A. Permissibility and limits What adjunctive treatments (e.g. medications, family therapy, case management)
other treatments of adjunctive treatments are permitted, encouraged, or even prohibited?
For permitted treatment adjuncts, are there limits on their frequency or intensity?
B. Role of self-help groups Especially for substance abuse treatments, or those where peer- or community-based
alternatives are available, how are these handled within the treatment (e.g. neutrally,
supportively)?
VI. Therapist selection, A. Therapist selection Education, training, credential, and experience requirements for therapists
training, supervision Ideal personal characteristics of therapists
B. Therapist training Components and goals of training, training materials available
Issues to be covered in didactic training
Number, nature of training cases required
Standards for therapist initial certification
Common problems encountered in training
Standards for determination of therapist adherence and competence
Explication of ratings systems and assessments of therapist adherence and competence
C. Therapist supervision Education, credential, experience, and training requirements of supervisors
Recommendations for frequency, type (group, individual), goals, content and intensity
of supervision
Strategies to address therapist drift in treatment delivery
Strategies to help therapists balance adherence and competence
Strategies for supervision sessions; use of videotapes and rating systems
VII. Clinical care Specification of guidelines How does the therapist assess symptoms use that may have occurred since the
standards for managing clinical issues last session?
How does the therapist assess treatment progress?
How does the therapist respond to lack of progress or clinical deterioration?
How does the therapist assess and respond to expressions of suicidal or homicidal ideation?
How does the therapist respond to a contradiction between a patient’s self-report of
symptoms and a collateral source?
verse, less experienced or committed clinicians are to im- treatment guidelines be, essentially, translated from the
plement the treatment adequately. “ideal conditions” of research to the “reality” of clinical
Thus, a stage III manual would be viable only after the work (Wolfe, 1999). As suggested in Table 4, a stage III
completion of several clinical trials and the resultant accu- manual would provide empirically informed guidance to
mulation of process and outcome data for a variety of therapists regarding how the treatment may be adapted for
patient populations. Such a manual would require that patients typically encountered in clinical settings, defining
I. Issues related to Specification of variations Managing patients with comorbid disorders, including (as appropriate) depression,
patient diversity in the treatment for anxiety and posttraumatic stress disorders, antisocial personality disorder,
managing different types of concurrent substance use, psychotic disorders, cognitive impairments
patient groups, including Managing patients who have concurrent medical problems
limits of the treatment Managing patients who are homeless, have few psychosocial supports
with particular groups Managing patients who are mandated for treatment
Managing patients who are not motivated for treatment
Managing patients from different cultures, ethnic backgrounds
Managing other patient types commonly encountered in this population
II. Program diversity Variability of resources Delivering treatment in a range of settings, time frames
Managing issues such as imposed length of treatment, # of sessions, and so on
Managed care and third-party reimbursement issues
Managing delivery of treatment in a range of treatment frameworks
III. Implementation by Training and supervision Common problems involved in training novice therapists to use this approach
therapists with diverse Common problems encountered in training experienced therapists to use this approach
range of disciplines Common problems encountered in training therapists with a commitment to a particular
and experience orientation to treatment, or conversely to a more eclectic approach
Strategies to help avoid therapist “drift” from adherence to jargon and active ingredients
of the treatment
Learning tools available (e.g., training videotapes, suggested background reading in
theoretical basis of treatment)
the limits on flexibility in tailoring the treatment to meet Therapists may feel more comfortable and competent in
individual patient needs, and offering strategies for tailor- delivering a treatment if they believe the manual can en-
ing the treatment to different settings, formats, and inten- hance, rather than limit, their clinical expertise (Addis &
sities. A critical component here might be the inclusion of Krasnow, 2000; Addis et al., 1999; Fonagy, 1999; Seligman,
guidelines and examples regarding how the therapist 1998). The following recommendations are intended to
might determine that, in altering the treatment to meet help treatment researchers develop more clinician-friendly
the needs of a particular patient, it no longer adequately manuals by anticipating common criticisms.
approximates the treatment defined in the manual (and
thus may have limited efficacy). Anticipate Real-World Problems
A critical component in stage III manual development Treatment manuals sometimes describe theoretically com-
is attention to how the manual may be used by clinicians pelling and elegant approaches that bog down quickly in
of greater diversity than those who typically deliver treat- the complex realities of treating challenging patients who
ment in randomized efficacy trials. Thus, while assump- present with multiple problems. Some manuals, particu-
tion of basic psychotherapy skills, extensive experience larly those for stages I and II, are written as if for ideal pa-
with the patient population, and familiarity with the the- tients without comorbid psychopathology or concurrent
oretical basis of a given treatment might be assured when problems. Clearly, manuals geared only toward ideal or un-
therapies are implemented solely by therapists trained in complicated patients will likely be of limited clinical util-
efficacy trials, stage III manuals will need to articulate, or ity. Moreover, while therapist adherence is likely to be high
at least set minimal standards for, these basics of therapy. with comparatively easy or uncomplicated patients, adher-
ence is likely to be poorer with more impaired, sympto-
DEVELOPING THERAPIST-FRIENDLY MANUALS matic, challenging patients who often (directly or indirectly)
Any treatment manual represents at best a detailed guide- pressure therapists to deviate from manual guidelines
line, or set of instructions, for a highly complex task. Thus, (Foley, O’Malley, & Rounsaville, 1987). Manuals that an-
the clearer, more specific, and more detailed those instruc- ticipate that some patients will be challenging, poorly mo-
tions are, the more likely the treatment as practiced will re- tivated, ambivalent, resistant, inarticulate, or cognitively
flect the intention of the treatment’s originators and foster impaired and that provide explicit guidance for addressing
greater consistency in treatment delivery and quality. these issues are more likely to foster adherence, consistency,