There is a growing body of evidence supporting the use of cognitive behavioral treatment within behavioral medicine. There are several limitations to the current body of literature, including external validity of findings from randomized controlled trials, dissemination of findings, and the use of CBT when patients are unmotivated to make behavior change. The current paper proposes several future directions to address these limitations. Solutions to be explored in future research include practical behavioral trials, stepped care approaches, remote technology approaches such as telephone and Internet-based treatments, and the integration of motivational interviewing into cognitive behavioral treatment.
Keywords: behavioral medicine; cognitive behavior therapy; health interventions; health psychology; psychotherapy
An abundance of data exist for the efficacy of cognitive-behavioral therapy (CBT) approaches for psychological disorders, such as anxiety and depression (Butler, Chapman, Forman, & Beck, 2006; Hoffman & Smits, 2008). Moreover, several studies support the efficacy of CBT for treating psychological disorders and reducing psychological distress in behavioral medicine populations, such as patients with cancer (e.g., Osborn, Demoncada, & Feuerstein, 2006), HIV/AIDS (e.g., Safren et al., 2009), type 2 diabetes (e.g., Lustman, Griffith, Freedland, Kissel, & Clouse, 1998), multiple sclerosis (e.g., Mohr et al., 2005), primary insomnia (e.g., Edinger, Wohlgemuth, Radtke, Marsh, & Quillian, 2001), and chronic pain (e.g., McCracken & Turk, 2002). The studies presented in this special issue of the Journal of Cognitive Psychotherapy add to our knowledge by demonstrating the efficacy and utility of CBT approaches for patients with cancer (Greer, Park, Prigerson, & Safren, 2009; Hopko & Johanson, 2009), cardiovascular disease (Irvine et al., 2009), diabetes (Gonzalez et al., 2009), and HIV (Brown, Vanable, Carey, & Elin, in press) in the rapidly changing world of chronic disease management.
Although the current studies do provide support to the notion that "CBT works" to reduce depression and distress in those with medical illnesses, it is important to note that there are a number of studies that run counter. For example, a systematic review showed scant support for the efficacy of CBT to reduce anxiety and depression in those with chronic obstructive pulmonary disease (Coventry & Gellatly, 2008). In poststroke patients, CBT did not significantly improve mood compared to an attention placebo condition or a usual care condition (Lincoln & Flannaghan, 2003). And, in the Enhancing Recovery in Coronary Heart Disease (ENRICHD) trial, which compared CBT to usual care for depressed patients postmyocardial infarction, CBT produced significant decreases in depression at the 6-month follow-up, but those improvements were not maintained at the 2.5-year follow-up (Writing Committee for the ENRICHD Investigators, 2003).
Why does CBT not always "work" as well as we expect it to? How can we, as CBT researchers and practitioners, continue to advance the field in behavioral medicine? There are a number of limitations to the current literature on CBT in behavioral medicine. First, one shortcoming of the CBT research conducted to date (both in the psychopathology and behavioral medicine literatures) is the emphasis on internal validity to the detriment of external validity (see Glasgow, 2008, for a discussion). Although both types of validity are critical, we lack data as to how the findings of our randomized controlled trial (RCT) apply to other settings and populations. As clinicians, we lack information as to what extent a particular treatment will actually produce results in our clinical setting or with the particular population of patients whom we treat.
Another limitation of CBT research with behavioral medicine populations is in the shortage of data that provide support for the use of CBT to promote health behavior change. CBT does not always emphasize the role of motivation for health behavioral change; a key problem may be the lack of attention and approaches within CBT for patients who are unmotivated to change their health behaviors. The present paper will explore these current challenges for CBT within behavioral medicine, and will propose some potential solutions to these problems by examining alternative research designs and integrative treatment methodologies.
THE PROBLEM OF EXTERNAL VALIDITY
Both the designing of and reporting results from RCTs generally require an air-tight design that controls for multiple factors that could compromise internal validity. Indeed, these are important factors by which grant proposals and scientific manuscripts are judged, but often at the cost of minimizing external validity (Glasgow, 2008). Recently, efforts are being made to encourage the evaluation of external validity in behavioral medicine RCTs. For example, RE-AIM (see www. re-aim.org) is a work group of scientists devoted to enhancing the reach and dissemination of health promotion interventions. In addition, the U.S. National Institutes of Health has sponsored conferences on the "Science of Dissemination and Implementation" in 2007 and 2009, to encourage scientists to design RCTs that are responsive to community and research needs, as well as to improve evidence-based practice in real-world settings.
PRACTICAL BEHAVIORAL TRIALS
An important supplement to the standard RCT design for CBT researchers is the practical behavioral trial (PBT; Glasgow, Davidson, Dobkin, Ockene, & Spring, 2006). The PBT maintains internal validity, but also addresses four critical external validity points (Glasgow, 2008). The first is that the PBT includes representative patients, which are heterogeneous, diverse, and allow for an evaluation of the treatment across key subgroups. The second point is that the trial is conducted in multiple settings and with multiple interventionists. The treatment needs to produce change in the average patient seen in a typical practice; this point requires that fewer exclusion criteria are used and that inclusion criteria are broadened. Having fewer exclusion criteria and broader inclusion criteria has the effect of opening recruitment to patients with multiple physical or psychological diagnoses (e.g., substance abusers, severe depression) as well as those with low education or low health literacy; patients typically excluded from many forms of research (Ford et al., 2008). Importantly, the PBT also upholds fidelity to treatment, thus maintaining control over internal validity.
Glasgow et al. (2006) note that a key question to be answered by a PBT is "should this intervention be adopted?" Therefore, the third external validity point is that the comparison arm of the PBT represents the current standard of care (compared to the no treatment or placebo controls typically used in standard RCTs). The final point is that the PBT assesses multiple concerns relevant to clinicians, decision makers, and stakeholders, which include feasibility, costs, range of applicability, and the impact on patient health-related quality of life. For a PBT to reach these goals, key stakeholders, clinicians, and members of the community should be involved in project development as well as dissemination of findings. Otherwise, it is unlikely that these treatments will be adopted in the community.
The PBT has been used successfully for providing treatment to improve health behaviors in chronically ill populations. The Improving Diabetes Across Language and Literacy (IDEALL; Schillinger, Handley, Wang, & Hammer, 2009) project is a good example of a successful PBT that used principles of the RE-AIM framework just described. Specifically, the investigators sought to estimate their reach in clinic participation, clinician and patient participation, representativeness of enrolled patients, and patient engagement in the program (see Schillinger et al., 2008 for a discussion). In this trial, diabetes patients were randomized to one of three conditions: 1) usual care, or two self-management treatments; 2) interactive weekly automated telephone self-management support with nurse follow-up; or 3) monthly group medical visits facilitated by physicians and health educators. Compared to the usual care arm, the two selfmanagement treatments demonstrated significant improvements in diabetes self-management care and functional status. Importantly, more than half of patients in the trial had limited English language skills, were uninsured, and had low education, thus enhancing external validity. The trial also improved on the external validity of a standard RCT because it was conducted in the integrated community health care system of the San Francisco Department of Public Health. Both of the self-management treatments were developed with extensive input from diabetes patients as well as nurse and health educators. As can be seen, the IDEALL trial makes a significant contribution to the literature in that it not only provides evidence for a diabetes self-management program, but it also addresses each of the four external validity points outlined by Glasgow (2008).
As already noted, the PBT is not yet a commonly used design in behavioral medicine, nor has it been extensively used for CBT trials in behavioral medicine. However, with greater emphasis on external validity for behavioral RCTs from journal editors and reviewers, study sections, and the NIH, the PBT may offer behavioral medicine researchers and CBT researchers an excellent alternative to the standard RCT design. Moreover, the PBT still allows for tight control over threats to internal validity.
STEPPED CARE APPROACHES TO TREATMENT
Due to the costs involved in providing face-to-face psychotherapy, stepped care approaches (also known as stepwise treatment) are also being increasingly used in clinical settings. Defined broadly, a stepped care approach to psychotherapy presents patients with the simplest, least intrusive intervention available. More intensive approaches are employed only if needed (Scogin, Hanson, & Welsh, 2003). The "Staying Free" program is an example of an effective stepped care approach for inpatients to stop cigarette smoking (Miller, Smith, DeBusk, Sobel, & Taylor, 1997; Smith, Singh, Infante, Khandat, & Kloos, 2002; Taylor, Miller, Cameron, Fagans, & Das, 2005). Patients first receive a standardized message from their physician, and meet with a counselor for smoking cessation for one hour during hospitalization. Patients then receive a CBT-focused workbook and audio-CD, and counselor advises them how to cope with situations where they are at high risk to smoke. Those who have significant nicotine withdrawal symptoms or high tobacco dependence are offered pharmacotherapy prior to discharge. Finally, after discharge, standardized phone contacts are initiated by a nurse at specific set times. As this trial generated compelling data on efficacy, effectiveness, feasibility, and cost, the research team developed standards (in conjunction with the Joint Commission of Accreditation of Healthcare Organizations) to require hospitals to assess preadmission cigarette use for all patients, and if needed, to provide counseling (Taylor & Chang, 2008).
Stepped care approaches have also been shown to be effective with a number of psychological disorders, such as generalized anxiety disorder (Newman, 2000), panic disorder (Otto, Pollack, & Maki, 2000), and alcohol abuse (Sobell & Sobell, 2000). Often, self-administered treatments (e.g., bibliotherapy) are typically used as the first rung in stepped care for depression (Scogin et al., 2003), and there is evidence for their efficacy (McKendree-Smith, Floyd, & Scogin, 2003). Although stepped care approaches have yet to be adequately tested to change health behaviors or reduce psychological morbidity in behavioral medicine populations, these may provide a fruitful future direction in behavioral medicine research design. Careful research is needed to examine the acceptability of the stepped care approach with chronically ill patients.
REMOTE COMMUNICATION TECHNOLOGIES AND CBT
Given the problems raised regarding external validity of psychotherapy RCTs, CBT conducted via remote communication technologies, such as the telephone or the Internet, has multiple practical advantages over face-to-face therapy. With the use of remote communication technologies, hard-to-reach populations can have access to a treatment that would otherwise not be available to them. These populations include those in rural geographic areas, those without access to transportation or child care, patients concerned about the social stigma of attending a psychotherapy session, or those with physical immobility or disability due to their chronic health condition (Griffiths, Lindenmeyer, Powell, Lowe, & Thorogood, 2006). Adding to these findings, a study of depressed primary care patients showed that 74% reported one or more barriers that made it very difficult or impossible for them to attend weekly psychotherapy sessions (Mohr et al., 2006). Consequently, external validity may be greater in CBT trials conducted via the telephone or Internet. Moreover, a review by Cuijpers, van Straten, and Andersson (2008) noted that Internet interventions have the benefits of reducing wait list times, saving travel time, and eliminating session scheduling difficulties. As well, Internet interventions allow patients to work at their own speed and provide quick feedback on patient progress (Cuijpers et al., 2008).
One important benefit of telephone psychotherapy for depression is the extremely low attrition rate compared to face-to-face therapies. In a meta-analysis of twelve studies of telephone psychotherapy for depression, nine of which employed CBT, the mean attrition rate was 7.56% (Mohr, Vella, Hart, Heckman, & Simon, 2008). In comparison, Wierzbicki and Pekarik's metaanalysis (Wierzbicki & Pekarik, 1993) of 125 face-to-face psychotherapy studies reported a mean attrition rate of 46.9%. Mohr et al.'s telephone psychotherapy meta-analysis found significant improvements in depression (Cohen's d = 0.81) from pretreatment to posttreatment. Importantly, eight of these twelve studies recruited patients with chronic illness, such as cancer, HIV/AIDS, multiple sclerosis, and lung transplant candidates. Overall, these data suggest telephone CBT can improve depression among behavioral medicine populations, but whether this modality has a significant effect on other psychological outcomes for chronically ill patients is yet unknown.
Cuijpers et al.'s (2008) meta-analysis of Internet-based CBT for health problems (e.g., headache, pain) showed a significant effect size (Cohen's d = 0.58). The main outcomes in the Cuijpers et al. meta-analysis of twelve studies primarily focused on reduction of symptoms, such as pain, headache, or functional limitations. Only five of the twelve studies assessed the effect of Internet CBT on psychological outcomes, such as quality of life in breast cancer patients (d = 0.22; Owen et al., 2005), coping with pain in chronic back pain patients (d = 0.79; Buhrman, Faltenhag, Strom, & Andersson, 2004), distress from tinnitus in tinnitus patients (d = 0.26, Andersson, Stromgren, Strom, & Lyttkens, 2002), and loneliness in those with physical disabilities (d = 0.46; Hopps, Pepin, & Boisvert, 2003). Further, only one study utilized a usual care comparison group. Interestingly, the Cohen's d of 0.58 from Cuijpers et al. (2008) appears smaller than the effect size found in a meta-analysis of Internet CBT (with a therapist support component via e-mail or telephone) for anxiety (d = 0.96) or depression (d = 1.00) (Spek et al., 2007). However, it is notable that the effect sizes for depression from Spek et al. were even smaller (d = 0.26) when examining the Internet CBT studies that did not include a therapist support component.
Future Directions for CBT Delivered via Remote Communication in Behavioral Medicine
Taken together, data suggest that Internet CBT may be helpful in reducing anxiety and depression and that telephone CBT may be effective in reducing depression. Given the possibilities of reaching previously unexamined subgroups, such as rural, disabled, and low-literacy patients, PBTs utilizing Internet or telephone CBT in behavioral medicine are a logical next step for researchers. In regions with sufficient Internet coverage, Internet therapy may have three major advantages over telephone therapy. Two advantages are that Internet therapy can be tailored effectively for patient preferences and facilitate the conduct of dismantling studies, since the contents of Internet therapy may be easier to control than in a face-to-face treatment (Andersson, Carlbring, Berger, Almlov, & Cuijpers, 2009). In addition, Internet CBT has the advantage of being largely "selfadministered." Consequently, this type of treatment may be an excellent first step in stepped care approaches to managing distress and psychological morbidity in behavioral medicine populations. Despite these possibilities, Internet CBT requires much more testing of its efficacy within behavioral medicine populations.
INTEGRATING MOTIVATIONAL TECHNIQUES INTO CBT
CBT May not Adequately Address Lack of Motivation
An important conceptual limitation of CBT within behavioral medicine is that cognitive behavioral theory may not sufficiently address the needs of patients who lack motivation to make behavior change. For example, witness the profound differences in the efficacy of CBT for egodystonic disorders, such as anxiety disorders, mood disorders, and bulimia versus the relative lack of efficacy data on CBT for ego-syntonic disorders, such as narcissistic personality disorder, antisocial personality disorder, and anorexia nervosa (Butler et al., 2006). Similarly, the scientific literature provides greater empirical support for using CBT with distressed medical patients (e.g., Edinger et al., 2001; Lustman et al., 1998; McCracken & Turk, 2002; Mohr et al., 2005; Osborn et al., 2006; Safren et al., 2009) than for CBT with patients who may not be distressed about their behavior. Some examples of individuals who may not be motivated to change their health behaviors include those who may need to quit smoking (e.g., Kleinjan, van der Eijnden, Dijkstra, Brug, & Engels, 2006) or reduce risky sexual behaviors (e.g., Kershaw et al., 2004). The improvement of health behaviors is increasingly important in an age where behavioral risk factors such as smoking, obesity, lack of exercise, and poor diet are some of the top changeable risk factors for medical morbidity and mortality across Western countries, and increasingly in other countries as well (Mokdad, Marks, Stroup, & Gerberding, 2004; Yusuf et al., 2004).
Use of Motivational Interviewing to Improve CBT Outcomes
Along with the need for new theoretical models that incorporate motivation more easily into a cognitive behavioral framework, there is a need for techniques that specifically help patients to improve their motivation for behavior change. For example, Mansergh et al. (2009) found that HIV-positive men who were less concerned about HIV due to availability of effective treatments were more likely to engage in unprotected receptive anal sex. Given that HIV has indeed transformed from a death sentence to a chronic but severe disease due to combination antiretroviral therapies, it would be mistaken for a therapist to label this decreased concern about HIV solely as irrational thinking. Strict cognitive restructuring approaches may therefore fail to address a patient's lack of motivation to make needed behavioral changes.
One solution is the addition of motivational interviewing before beginning CBT (e.g., Barrowclough et al., 2001; DiLillo, Siegfriend, & West, 2003; Parsons, Rosof, Punzalan, & Di Maria, 2005; Westra & Dozois, 2006). Motivational interviewing is designed to induce rapid, internally motivated change by using the participants' own change resources (Carey & Carey, 1997; Kalichman et al., 2005). The specific steps include: 1) eliciting from the participant his or her ideas about how a behavior can be changed, 2) enhancing the participant's confidence in being able to make the desired change, while 3) constantly attempting to help the participant locate and express his own reasons for wanting to change (e.g., Rollnick, Miller, & Butler, 2008; Shernoff, 2006). Motivational interviewing also tailors the intervention toward a participant's stage of readiness to make change (Prochaska & DiClemente, 1983; Rollnick et al., 2008). A meta-analysis found motivational interviewing to be equivalent to other active treatments, including CBT, in the management of problem behaviors including alcohol abuse, drug addiction, and changing diet and exercise (Burke, Arkowitz, & Menchola, 2003). In addition, motivational interviewing has equal effects on physiologically based (e.g., diabetes) versus psychological (e.g., depression) disorders (Rubak, Sandbaek, Lauritzen, & Christensen, 2005).
Evidence Base for Integrated Motivational Interviewing/CBT Approaches
Integrated motivational interviewing/cognitive behavioral therapy treatments have demonstrated promising outcomes in a variety of populations, including schizophrenia and substance use (Barrowclough et al., 2001), medication adherence and substance use among HIV-positive patients (Parsons et al., 2005), and anxiety patients (Westra & Dozois, 2006). In a preliminary study on CBT for 55 anxiety patients, those who received three sessions of motivational interviewing before CBT had higher expectancies for anxiety control and greater homework adherence, compared to CBT without motivational interviewing before CBT. Furthermore, the combined motivational interviewing/CBT condition had a significantly higher number of CBT responders (Westra & Dozois, 2006). Although more research is clearly needed to examine whether there are specific effects of motivational interviewing before CBT versus other pre-CBT treatments (see Wilson & Schlam, 2004), the literature suggests that integrating motivational interviewing into CBT approaches may be feasible and may lead to improved outcomes in behavioral medicine populations as well as for psychological disorders.
On a final note, motivational interviewing may work best as an adjunct to CBT as opposed to a replacement for CBT with behavioral medicine populations. A meta-analysis found that the effect of motivational interviewing tends to diminish rapidly after a year of follow-up when administered as a stand-alone treatment (d = 0.77 at post-treatment and 0.11 at follow-ups > 12 months; Hettema, Steele, & Miller, 2005). However, when motivational interviewing is added to other treatments, the effect of motivational interviewing in improving outcome is maintained or increased over time (d = 0.60).
Although by no means a comprehensive review, we have identified two important limitations of the CBT research within behavioral medicine populations. First, as CBT research has been limited in its generalizability to date, using alternative research designs like the PBT or stepped care approaches help to maximize external validity while maintaining internal validity. In addition, CBT conducted via remote communication technologies may prove to be an important method for accessing hard-to-reach behavioral medicine populations who otherwise would not have access to CBT. Second, CBT techniques may not consistently support health behavior change, which is a major goal for many clinicians and researchers in behavioral medicine. Integrated motivational interviewing/CBT treatments are an important future direction to be tested and researched more extensively within behavioral medicine. There is clearly room for continued impact of CBT for medical and medically at-risk populations, and the solutions proposed may assist in the future growth of CBT within behavioral medicine.
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Stacey L. Hart, PhD
Ryerson University and St. Michael's Hospital, Toronto
Trevor A. Hart, PhD
Ryerson University and University of Toronto
Correspondence regarding this article should be directed to Trevor A. Hart, PhD, Department of Psychology, Ryerson University, 350 Victoria Street, Toronto, ON M5B 2K3, Canada. E-mail: email@example.com…