The TANDEM cognitive behavioural intervention for Chronic Obstructive Pulmonary Disease (COPD): Can a pre-pilot phase aid development of the intervention?
The development phase of behavioural interventions is outlined in the MRC framework for design and evaluation of complex interventions and its importance is increasingly recognized, although often under-reported. Success in this phase underpins the potential effectiveness of the intervention and efficiency of future evaluations. The current study aimed to develop a tailored cognitive behavioural intervention, delivered by respiratory health care professionals (HCPs), for individuals with COPD and mild/moderate depression and/or anxiety, that focuses both on mood and self-management principles and leads onto routine pulmonary rehabilitation. We developed an initial version of both the HCP training and patient facing intervention and tested these in a pre-pilot study to enable revisions to be made before more formal piloting.
The TANDEM intervention brought together previous interventions for this population (The Lung Manual and SPACE), combining both psychological and self-management approaches for individuals with comorbid COPD and anxiety and/or depression. In addition a method for tailoring the intervention to provide targeted care based on severity and presenting problem (depression or anxiety) was integrated. TANDEM was presented to 8 health care professionals and 7 patients through interviews or focus groups to elicit reactions to the intervention, and challenges to be considered. A pre-pilot study was then conducted including training 3 respiratory nurses, with differing levels of cognitive behavioural expertise, before delivery to 6 patients. Interviews with the trained HCP, and qualitative analysis of audio-recorded treatment sessions, were subsequently used to refine the intervention.
Initial interviews and focus groups found that all participants endorsed the TANDEM intervention. Recommendations for improvement to patient facing materials, such as adding some literature for carers, were made and responded to. Pre-pilot training identified a preference for certain approaches such as individualized video-feedback rather than group role-play. The need to assess HCPs’ interpersonal skills and competency using standardized assessment was also identified. Trialing intervention delivery highlighted minimizing the period between intervention training and delivery to avoid deterioration in self-efficacy amongst HCP. The vital role of supervision was also apparent.
The current approach to intervention development, including pre-pilot study, has enabled significant refinement of the TANDEM intervention prior to piloting. This may prove key to successful, cost-effective, implementation within the larger planned randomized controlled trial. This model of intervention development also has implications for other trials of complex behavioural or psychological interventions.