Protocol for the ADDITION-Plus study: a randomised controlled trial of an individually-tailored behaviour change intervention among people with recently diagnosed type 2 diabetes under intensive UK general practice care.

BACKGROUND: The increasing prevalence of type 2 diabetes poses both clinical and public health challenges. Cost-effective approaches to prevent progression of the disease in primary care are needed. Evidence suggests that intensive multifactorial interventions including medication and behaviour change can significantly reduce cardiovascular morbidity and mortality among patients with established type 2 diabetes, and that patient education in self-management can improve short-term outcomes. However, existing studies cannot isolate the effects of behavioural interventions promoting self-care from other aspects of intensive primary care management. The ADDITION-Plus trial was designed to address these issues among recently diagnosed patients in primary care over one year. METHODS/DESIGN: ADDITION-Plus is an explanatory randomised controlled trial of a facilitator-led, theory-based behaviour change intervention tailored to individuals with recently diagnosed type 2 diabetes. 34 practices in the East Anglia region participated. 478 patients with diabetes were individually randomised to receive (i) intensive treatment alone (n = 239), or (ii) intensive treatment plus the facilitator-led individual behaviour change intervention (n = 239). Facilitators taught patients key skills to facilitate change and maintenance of key behaviours (physical activity, dietary change, medication adherence and smoking), including goal setting, action planning, self-monitoring and building habits. The intervention was delivered over one year at the participant's surgery and included a one-hour introductory meeting followed by six 30-minute meetings and four brief telephone calls. Primary endpoints are physical activity energy expenditure (assessed by individually calibrated heart rate monitoring and movement sensing), change in objectively measured dietary intake (plasma vitamin C), medication adherence (plasma drug levels), and smoking status (plasma cotinine levels) at one year. We will undertake an intention-to-treat analysis of the effect of the intervention on these measures, an assessment of cost-effectiveness, and analyse predictors of behaviour change in the cohort. DISCUSSION: The ADDITION-Plus trial will establish the medium-term effectiveness and cost-effectiveness of adding an externally facilitated intervention tailored to support change in multiple behaviours among intensively-treated individuals with recently diagnosed type 2 diabetes in primary care. Results will inform policy recommendations concerning the management of patients early in the course of diabetes. Findings will also improve understanding of the factors influencing change in multiple behaviours, and their association with health outcomes.RIGHTS : This article is licensed under the BioMed Central licence at http://www.biomedcentral.com/about/license which is similar to the 'Creative Commons Attribution Licence'. In brief you may : copy, distribute, and display the work; make derivative works; or make commercial use of the work - under the following conditions: the original author must be given credit; for any reuse or distribution, it must be made clear to others what the license terms of this work are

Clients’ experiences of dynamic interpersonal therapy (DIT): Opportunities and challenges for brief, manualised psychodynamic therapy in the NHS

Dynamic interpersonal therapy (DIT) is a brief manualised psychodynamic intervention for depression. This is a first study exploring clients’ experiences of DIT specifically and brief, manualised psychodynamic psychotherapy (PP) in general. Interpretative phenomenological analysis was the methodology employed. Five participants completed a semi-structured interview, three weeks to ten months after completing DIT. The scores of pre- and post-therapy outcome measures of depression and anxiety were also available. Two emerging superordinate themes are presented here: (1) ‘The Distinct Features of DIT’, referring to how its therapeutic style and time limitations were experienced and (2) the ‘Impact of Therapy’, referring to perceived outcomes. While previous findings showed that therapist’s perceived limited activity in long-term PP was experienced as hindering/unhelpful, the perceived sense of direction in DIT appeared adequate to most participants. Secondly, the time limitations provoked complex responses. Reactions to the distinct elements of DIT are to be treated both as therapeutic opportunities and as challenges. Further, in line with psychoanalytic theory, most participants described relational changes that went beyond symptom relief and remained in progress after therapy ended. Intriguingly, there was no consistency between participants’ qualitative accounts of change and the scores of the outcome measures

Response to Invited Commentaries: The Opportunity for Integration Remains

The invited commentaries to Hobbis and Sutton (this issue) show that we achieved our aim of stimulating debate about the development of new approaches to health behaviour change. Diverse opinions were expressed, including discussion of the feasibility of integrating techniques used in Cognitive Behaviour Therapy (CBT) into interventions based on the Theory of Planned Behaviour (TPB), commenton the integration of the two models at a theoretical level and consideration of CBT as an alternative to the TPB in health behaviour change. While we felt that an apparent bias towards the TPB precluded acknowledgement of the potential benefits associated with utilizing techniques used in CBT, we were encouraged by the general recognition that further research linking these two approaches is warranted

Are Techniques Used in Cognitive Behaviour Therapy Applicable to Behaviour Change Interventions Based on the Theory of Planned Behaviour?

The Theory of Planned Behaviour (TPB) is increasingly being used to inform the development of interventions to promote health behaviour change. However, although the theory can be used to identify the determinants of particular health-related behaviours, it offers little guidance on how to change these determinants and hence how to promote behaviour change. There is evidence that Cognitive Behaviour Therapy (CBT) can be used to support health behaviour change. This article discusses the similarities and differences between the two approaches, and considers whether techniques used in CBT are applicable to interventions based on the TPB