Tailored, psychological intervention for anxiety and/or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): statistical analysis plan for a randomised controlled trial

Table 1 Study data collection

Type of data	Time of data collection^a	Source and method of data collection	Outcome measure and type
Patient participants
Demographics	Baseline	Patient participants; supervised self-complete questionnaire
Clinical: Breathlessness	Baseline	Patient participants; supervised self-complete questionnaire	mMRC Breathlessness scale; categorical
Clinical: Smoking status	Baseline 6 months 12 months	Patient participants; supervised self-complete questionnaire	Smoking status; categorical
Health status measures	Screening 6 months 12 months	Patient participants; supervised self-complete questionnaire	HADS-A and HADS-D; continuous
Health status measures	Baseline 6 months 12 months	Patient participants; supervised self-complete questionnaire	BDI II, BAI, B-IPQ, SGRQ, heiQ, Time Use Survey (adapted); continuous
PR attendance and completion data	Once following completion of intervention delivery	PR service teams	Attendance and completion data
CBA attendance and completion data	Attendance or failure to deliver recorded at each session during CBA intervention period	Study team/CBA facilitators	Attendance and completion data
Carer participants
Demographics	Baseline	Carer; self-complete questionnaire
Wellbeing measures	Baseline 6 months 12 months	Carer; self-complete questionnaires	ZBI, WEMWBS; continuous

^aNote that for participant 6- and 12-month assessment, every effort is made to collect data at the scheduled time period, but in some cases, follow-up period may need to be extended ± 4 weeks for logistical/practical reasons
Abbreviations: HADS Hospital Anxiety and Depression Scale (D depression sub-scale, A anxiety subscale) [3], mMRC modified MRC breathlessness scale [12], BAI Beck Anxiety Inventory [5], BDI II Beck Depression Inventory II [4], SGRQ St George’s Respiratory Questionnaire [6], heiQ University of Melbourne Health Education Impact Questionnaire social engagement scale [8], B-IPQ The brief illness perception questionnaire [7], ZBI Zarit Caregiver Burden Inventory [10], WEMWBS Warwick Edinburgh Mental Well-Being Scale [11]

ISSN: 1745-6215