Exploration of primary and secondary outcome measures for a full RCT
REGRESSION
Data from all questionnaires at each time point are included in the S1 Questionnaire data and include the levels of missing data. Changes from baseline and differences between groups: Findings from the multi-level linear regression models for the outcome measures are provided in Health service use and costs: The ACT group had fewer hospital admissions (0 percent vs 13 percent), A&E visits (7.6 percent vs 20 percent), social worker visits (0 percent vs 7 percent), district nurse or health visitor visits (0 percent vs 6 percent), and visits to ‘therapy in the community’ (0 percent vs 6 percent) (0 percent vs 7 percent). They were more likely to visit an outpatient hospital (46 percent vs 26 percent), a GP (69 percent vs 40 percent) or a practise nurse (46 percent vs 27 percent), any telephone consultation (31 percent vs 20 percent), any day centre visit (38 percent vs 7 percent), a chiropractor (7 percent vs 0 percent), or any counselling, psychiatry, or community mental health visit (8 percent vs 7 percent). Except for any day centre visit (p = 0.04), no differences between groups were statistically significant (please see The cost of providing ACT services includes one hour of clinical psychologist time (£70) divided among ten patients. The training costs approximately £2.25 per patient (£450 per year for 200 patients). As a result, the total cost of providing ACT services is £72.25 per patient. SGC service delivery costs include one hour of assistant psychologist time (£34) divided among ten patients. This equates to £3.4 per patient or £34 for ten sessions. Last year, the ACT group spent £560 on medical expenses, while the usual care group spent £441. The intervention cost £633 for the ACT group and £475 for the usual/standard care group.QALYs (Quality-adjusted Life Years): The unadjusted mean QALYs from baseline to 12 month follow-up were: ACT group = 0.61 (SD = 0.26); SGC = 0.59 SD = 0.37. The study only included 32 patients with baseline and 12-month EQ-5D measurements (19 in the usual care group and 13 in the ACT group). We then used a regression analysis to estimate the differences in QALY between two groups, adjusting for patients’ age, gender, baseline health-related quality of life, and body mass index. The ACT group was associated with a 0.07 point reduction in QALY (P>0.05) in the adjusted analysis. The regression results were summarised in 