Table 2 Feasibility outcomes and exploratory clinical outcomes in the Fearfighter™ feasibility trial
Rating scales | Type of outcome | Test | |
|---|---|---|---|
Feasibility outcome | |||
Number of randomised participants/eligible persons | Not relevant | Proportion | Calculate the probability that 64/N can have been obtained in a random sample of N participants obtained from a population of persons where half the eligible persons can be randomised. (N is the observed number of eligible persons necessary to examine to randomise 64 participants) |
Number of participants complying at least 6/9 FearFighter™ sessions/ randomised participants | Not relevant | Proportion | Test analogous to the above feasibility outcome with the difference that now we want to secure that the sample is not from a population being less than 60 % compliant |
Exploratory outcome | |||
Number of participants who no longer fulfil the diagnostic criteria for an anxiety disorder | MINI | Proportion | Fisher’s exact test and logistic regression adjusted by the protocol-specified stratification variable (the result of the latter test is the primary of the 2 tests) |
Severity of anxiety | BAI | Continuous | The general linear univariate model (GLM) taking stratification variables and baseline BAI into account |
Psychological distress and psychopathology | SCL-90-R | Continuous | GLM taking stratification variables and baseline SCL-90-R into account |
Positive well-being | WHO-5 | Ordinal | The proportional odds model for ordinal response taking stratification variables and baseline WHO-5 into account (if conditions are not fulfilled, then nonparametric Mann-Whitney) |
Functional impairment | SDS | Continuous | GLM taking stratification variables and baseline SDS into account. |
Number of randomised receiving psychological treatment during the 9 weeks | Interview | Proportion | Fisher’s exact test and logistic regression adjusted by the protocol-specified stratification variable (the result of the latter test is the primary of the 2 tests). |
Number of participants with one or more adverse event | Interview | Proportion | Fisher’s exact test and logistic regression adjusted by the protocol-specified stratification variable (the result of the latter test is the primary of the 2 tests) |