for anxiety disorders:
a protocol for effectiveness studies in front line settings
- Joakim Ekberg Author
- Toomas Timpka,
- Magnus Bång,
- Anders Fröberg,
- Karin Halje and
- Henrik Eriksson
© Ekberg et al; licensee BioMed Central Ltd. 2011
Reviews of randomized controlled trials (RCTs) of cognitive behavioural therapy (CBT) for anxiety disorders have reported large pre- to post-treatment within-group effect sizes on measures of anxiety when supplied in therapist consultations and in technology-supported settings. However, the stringent experimental control of RCTs results in a lack of external validity, which limits the generalizability of findings to real-world frontline clinical practice. We set out to examine the specification of a protocol for study of the effectiveness of cell phone-supported CBT for in situ management of anxiety disorders.
Methods and design
Nominal group methods were used for requirements analysis and protocol design. Making a distinction between different forms of technology-supported therapy, examination of therapists’ role, and implementing trials in existing organizational and community contexts were found to be the central requirements in the protocol.
The resulting protocol (NCT01205191 at clinicaltrials.gov) for use in frontline clinical practice in which effectiveness, adherence, and the role of the therapists are analyzed, provides evidence for what are truly valuable cell phone-supported CBT treatments and guidance for the broader introduction of CBT in health services.
Ample evidence indicates that anxiety is under treated in western societies, and that large numbers of the population suffer needlessly. The World Health Organization (WHO) has estimated that 40% of disability attributed to anxiety reflects the fact that many potential anxiety patients never reach health care. A major factor contributing to this shortcoming is that evidence-based psychotherapies are not practiced widely in community settings. For instance, less than a quarter of those with anxiety disorders in the United Kingdom receive treatment of any sort. In the United States, only about 40% of patients with mood or anxiety disorders receive any treatment. It is in this context that expectations of cognitive behavioural therapy (CBT) are high. CBT methodology has the advantage of using well-defined treatment practices that can be easily taught to a variety of therapists and whose implementation can be monitored. Reviews of randomized controlled trials (RCTs) of CBT for anxiety disorders have reported large pre- to post-treatment within-group effect sizes on measures of anxiety when supplied in therapist consultations, in computer-supported sessions at practices, and over the Internet . In Sweden, CBT is the current treatment of choice for mild to moderate anxiety disorder.
Despite its proven efficacy, CBT still seems to be neglected in practice settings. In this study, we address 2 possible reasons for this situation. The first is that most of the research has been conducted using samples with isolated (rather than comorbid) disorders, but most therapists help individuals with multiple comorbid problems. It is not known if CBT techniques adapted to a particular client’s needs by a skilled therapist in a community setting achieve a better result than a therapist following a structured routine. It does seem that experienced therapists prefer to select from a variety of techniques rather than to follow a regimented program. Moreover, patient non-adherence is a persistent and complex phenomenon in frontline CBT practice. The refractory nature of this problem is reflected by the fact that a large proportion of non-adherence has come to be routinely accepted when planning interventions. Critics argue that RCTs’ stringent experimental controls (e.g. patients with homogenous diagnoses and highly trained and supervised therapists) result in a lack of external validity, which limits the generalizability of findings to real-world or frontline clinical practice. In addition, studies of the effectiveness of CBT for anxiety disorders have consistently reported lower patient adherence than RCTs.
The second possible reason for under utilization is that a fundamental principle in CBT is to document and adjust behaviour and thought processes when and where they occur. Accordingly, a goal in developing novel applications of CBT should be to assist therapy in situ, that is, exactly when it is needed. Using participatory design methods, we have developed a set of such applications. In this process, we acknowledge that adherence to mental health services is no longer only a matter of complying with a decided course of treatment in a clinical setting, but of reaching, connecting to, motivating, and sharing health decisions with patients and populations (Figure 1). The perspective on health service provision thereby shifts from biomedicine to infomedicine; patients and health workers join in informed, shared decision-making and governance.
We conclude that there is a need to examine carefully the external validity and effectiveness of CBT treatments for anxiety that have already been shown to be Cell Phone and CBT efficacious, and to identify factors that reduce non-adherence. In this study, we used these presumptions to plan for the examination of a new generation of CBT programs. With this understanding, we set out to define a protocol for examination of the effectiveness of cell phone-supported CBT for anxiety disorders in front line settings that also allows to evaluate adherence to therapy. Specifically, the aims of this study were to define a protocol for assessment of
the superiority of cell phone-supported CBT (CBT-cell phone) treatment against anxiety disorders compared with CBT treatment as usual (CBT-TAU), and
adherence with CBT-cell phone compared with CBT-TAU and CBT provided with access to a placebo technical device (CBT-placebo).
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