Step 3: Identify the specific elements of currently existing treatment approaches for the disorder (e.g. BED) to avoid the use of known active techniques in the comparison therapy
A credible control treatment must avoid theoretical and procedural elements of active treatments. In addition to CBT and IPT, currently existing treatment approaches to BED include behavioral weight loss treatment (BWLT) (See for example Agras et al., 1994
; Marcus, Wing, & Fairburn, 1995
), pharmacological treatment (See review by Carter et al., 2003
), and psychodynamically-based treatment (Ciano, Rocco, Angarano, Biasin, & Balestrieri, 2002
). To avoid content and procedural overlap with CBT (Fairburn, 1995
; Marcus, 1997
), our comparison therapy must not include: a) a focus on cognitions that identify irrational negative thoughts associated with binge eating episodes); b) a focus on the link between restrained eating and binge eating; c) a guide for patients to make specific changes to normalize their eating habits (e.g eating 3 meals and 2-3 snacks per day); and d) the prescription of behavioral (e.g. food logs) or cognitive (e.g. thought records) assignments.
Similarly, to avoid content overlap with IPT (Klerman & Weissman, 1993
; Wilfley et al., 1993
; Wilfley et al., 2002
), our comparison therapy must avoid systematic linkages between recent life events or relationships (e.g. interpersonal disputes, grief, interpersonal deficits, role transitions) and binge eating as well as the active systematic pursuit of specific interpersonal change strategies, including role playing to rehearse suggested changes in interpersonal behavior. To avoid content overlap with BWLT (Agras et al., 1994
; Marcus et al., 1995
), our comparison therapy must not focus on a behavioral approach to weight loss and must avoid provision of specific weight loss strategies, goals, etc. This should not be misunderstood to preclude participants from discussing attempts to stop binge eating and to express hope that eventual weight loss might ensue with binge abstinence. Yet because DBT, like most psychotherapeutic treatments for BED, focuses on the goal of cessation of binge eating rather than weight-loss, a credible comparison must similarly avoid instruction in weight loss strategies.
There have been few randomized trials evaluating psychodynamic group treatments for BED. One of the available randomized studies, by Ciano and colleagues (2002)
, is not only quite small (five participants per condition) but it compared 28 weeks of psychoanalytic group therapy to 10 weeks of psychoeducational group treatment—an arguably unequally matched comparison condition. However, because psychodynamically-based treatments focus directly on the expression and “working-through” of emotional content, a comparison treatment based on these tenets would lack internal validity in terms of content overlap with DBT’s emotion regulation focus. Therapists in our comparison condition, therefore, must refrain from offering transference interpretations or other direct psychodynamically informed interpretations (e.g. intepretation of dreams). However, therapists are not prohibited from facilitating patient initiated discussions of their feelings about binge eating and its impact on their lives. Indeed, as identified in Step 1, a credible comparison treatment must include the common factor of emotional expression and the ventilation of affect. However, therapists must refrain from organizing the material in ways that would overlap with other emotion focused treatments such as DBT or psychodynamic treatments.
Finally, while concrete overlap with pharmacological treatments is obviously avoided by the fact that no pharmacological agents were dispensed with either treatment, our comparison therapy must avoid a focused presentation of a biological or medical model of eating disorders, such as a “chemical imbalance” (e.g. low serotonin) model.
Step 4: Develop a credible comparison therapy
Our goal was to develop a comparison therapy whose rationale and procedures would be credible enough to generate the common factors in full measure while lacking the specific elements of DBT for BED (identified in Step 2) and the specific elements of other BED approaches (identified in Step 3) (Horvath, 1988
, p.217). A constant tension was meeting the above goals and producing a viable psychotherapeutic intervention (maintaining external validity without developing an entirely new specialty treatment for BED).
Our first consideration involved using a supportive-expressive control. Careful consideration of existing manuals for supportive expressive treatments, such as those used in treating breast cancer (Classen et al., 1993
) revealed the unacceptability of such an approach due to its overt emotion evoking emphasis. We then considered basing our comparison treatment on the “nonprescriptive” treatment manual that served as a control against CBT group therapy for obese women with Type II diabetes (Kenardy, Mensch, Bowen, Green, & Walton, 2002
). As part of that treatment manual, therapists are instructed to inform clients that “triggers of binge eating episodes are often related to a negative feeling which has not been directly acknowledged” —a form of the affect regulation model. The manual trains therapists to use an emotion-focused technique – a five step procedure entitled “focused unfolding.”
The Kenardy et al. choice of a control usefully illustrates the real-world challenges facing researchers designing control treatments. We saw for ourselves that no specific control treatment could serve as an adequate comparison for all experimental treatments but must be designed carefully in relation to the experimental treatment under investigation (see, for example, Lohr et al., 2003
). Kenardy et al.’s nonprescriptive treatment was specifically designed to serve as a comparison treatment to CBT. Its designation as a “nonprescriptive” therapy must be accepted with caution, however. While a focus on increasing awareness and acceptance of negative emotions may not be considered a prescriptive or active technique according to CBT theory, it clearly has the potential of being seen as active according to an alternative theoretical conceptualization. As Stevens et al. note: “One researcher’s specific treatment may well be another’s nonspecific, common factor” (Stevens, 2000
p.284). The fact that CBT showed no significant differences from the control at post-treatment (though did show significantly lower relapse rates at 3 month follow-up) (Kenardy et al., 2002
) may be due to the lack of a specific therapeutic effect of CBT or to the incorporation of an active treatment rationale into the control condition.
In our search to find a control of sufficient power to credibly represent the common factors while avoiding content overlap with the affect regulation model of DBT or any known active treatment, we then turned to a manual written by John Markowitz and Michael Sacks (2002)
. Originally intended to serve as a supportive psychotherapy control condition for a chronic depression study, the manual instructs therapists to follow a Rogerian approach (Rogers, 1951
). Therapists are to encourage patients to find answers within themselves instead of offering patients specific techniques or skills. Self-esteem and self-efficacy are bolstered by highlighting patients’ strengths over exploring their weaknesses. We believed the Markowitz & Sacks manual’s therapeutic rationale could be credibly adapted for binge eating (i.e. bolstering self-esteem to enhance the ability to stop binge eating) while avoiding DBT’s specific elements. In addition, our comparison therapy’s specific ingredients (i.e. bolstering self-esteem) would seem to be indistinguishable from those evoked by the common factors of the therapeutic alliance and development of therapeutic optimism.
The final development of our comparison treatment included a pilot phase to allow for “road-testing” and potential revision. Unlike DBT’s treatment manual, which we knew to be acceptable to therapists and patients from prior research, our newly designed comparison treatment manual had never been tested.
This pilot phase utilized two co-therapists (serving as the therapists for both the DBT and comparison conditions) and 14 participants (7 per condition) recruited from advertisements. Of particular interest was treatment acceptability. What did patients spontaneously express about the treatment? How did the therapists describe their own experiences? Except for an initial rating of patient expectations at the beginning of treatment, such “data” were not gathered via quantitative measures but were culled from therapist supervision sessions and careful review of audiotapes and transcripts of the sessions. We wanted to make sure, in our efforts to avoid designing an entirely new treatment with active elements that potentially exceeded the common factors, that our treatment’s therapeutic rationale was sufficiently believable. We took seriously concerns expressed by researchers such as Westen, Novotny, and Thompson-Brenner (2004)
about researchers’ use of “intent-to-fail” conditions (ie control treatments not designed to maximize their efficacy) and findings, such as those reported by Luborsky and colleagues (Luborsky et al., 1999
), that the therapy allegiance of a study’s researcher is strongly associated with the outcome of a comparative study.
At the initiation of our pilot phase, patients were encouraged to focus on their strengths in other areas of their lives as a way of bolstering their low self-esteem, thereby enhancing their ability to stop binge eating. In ways that we had not anticipated, the presentation of our treatment model was missing an essential ingredient. This became clear in Session 5, in which a noticeable shift in optimism about the credibility of the treatment rationale was observed.
Therapist: [in response to a patient’s description of a non-binge related success from the past] It really shows you’re capable of doing some very difficult things. So I think the question is, and we talked about this last time too I think, how to apply the things you know in certain areas …
Patient: I know there’re other things I’ve conquered, there’re other things I’ve done that I can give myself credit for. I realize all that, but when I think about not eating when I want all those things, it doesn’t help me. I can’t apply it to that. I’m really reaching the point right now where I’m getting really discouraged because coming here was like “Ok, maybe this will help,” and we’re just far enough along where I’m going “But it isn’t!” I don’t think I care enough anymore
Second patient:Yeah, it isn’t helping
Third patient: Yeah I know
Fourth patient: It should be helping me
Fifth patient: Exactly
Patient: Then I get more frustrated and eat. I think I should be getting something here so that I don’t keep doing this and I guess I haven’t found it yet, whatever it is. And I don’t know how to build from other successes and apply it to this because I’ve sort of even tried that. Because like years ago I drank too much and then I decided “No, that was not a good thing” and I was able to stop. I used to smoke, I don’t smoke anymore. I did all those things, but it almost doesn’t seem to have any relationship to what I’m trying to overcome now.
The demoralization the patients expressed in the pilot study, which was echoed by the therapists in the subsequent weekly team meeting, concerned us, especially as there was no counterpart demoralization being voiced in the DBT group. It could be argued that patients’ optimism about treatment must only be equivalent at the beginning of treatment and that one’s comparison treatment, in lacking specific active elements, is required to be relatively inefficacious. From this standpoint, an intervention to increase the level of any of the common factors, such as therapeutic optimism, would potentially be “loading the dice” in favor of our comparison treatment.
We would argue that such a strong expression of demoralization so early in treatment (Session 5 of 20) seriously threatens our requirement that our comparison treatment be a credible comparison to DBT. Adequate credibility, in our opinion, would mean that a comparison treatment would be believable enough to allow patients to express faith in it not only at the beginning of treatment but also throughout. While this would not require that our comparison therapy’s ability to generate therapeutic optimism must equal that of DBT at session 5 (or session 20, for that matter), adequate believability should exist such that the majority of patients would not drop out of our “credible” comparison treatment.
Hence, we felt it necessary to reexamine our comparison therapy’s treatment rationale carefully. During the initial screening process, many patients spontaneously identified themselves as having low self-esteem and spontaneously referred to this playing a major role in their binge eating. This appeared to indicate that the rationale itself was sufficiently plausible. The problem seemed not to lie in the rationale itself but in a delivery that lacked an ingredient we had not anticipated was necessary: the presence of sufficient focus, both during the initial delivery and during the following discussions referring to the rationale. In other words, it seemed as if without maintaining focus to adequately generate the common factor of a therapeutic rationale, the treatment was not able to subsequently generate the common factors of optimism and positive expectancy for change. Something specific needed to take place in our comparison therapy in order to generate a sense of hope and consequent movement. Our therapists needed to provide this focus without using a DBT or other specific known therapeutic rationale.
We were reminded that the DBT for BED treatment begins with a flow chart explicitly detailing the relationship between emotional dysregulation and binge eating. A similarly explicit flow-chart of the comparison treatment’s therapeutic rationale was thus developed to provide missing structure for those patients who especially seemed to note its absence. Also, to heighten the comparability to our experimental treatment and to provide additional sources of therapeutic focus, patients were to update the group on their successes and failures in stopping binge eating during the prior week and to bring up difficulties about which they would like the group’s support. Therapists were instructed to facilitate any patient-initiated discussions of binge eating and related topics (e.g. therapeutic goals) and to highlight the relationship between patients’ self-esteem and binge eating when appropriate.
We found patients responded quite well to these changes and the demoralization did not recur. Interestingly, therapist attention to providing the discussion with focus was less and less necessary over time with patients bringing up all manner of topics. Upon provision of an adequate focus, the sense of structure appeared self- generating.