Case I: Can we beat the blues in a more economical way?
The primary research question:
a. Does BtB reduce depressive symptoms substantially over a period of six months,
when compared to treatment as usual in general practice (TAU)?
The secondary research questions:
b. Does BtB reduce the chance of having a depressive disorder, one year after the end
of treatment, when compared to TAU?
c. Is the effect of BtB versus TAU on having a depressive disorder after one year,
modifed by gender?
1) Fill in the CONSORT 2010 flow diagram as provided in appendix A.
Info: You should not take the in- and exclusion criteria from Proudfoot et al. (2003). The
present study is namely not an exact copy of that of Proudfoot et al. There is some info on
this in appendix B.
Although it is coded in the dataset who did and who did not adhere to the protocol (see
variable PP), from the data it is not evident who did or did not continue the intervention. So,
based on the information that you have, it may not be possible to answer all items of the
CONSORT flow diagram.
Concerning the items “follow-up” and “ analysis” in the flow diagram: here you should
consider the 1 year follow up measurements and the analysis for the one year outcomes.
For the “analysis”, report here the number of persons that are actually involved in the
intention-to-treat analyses.
The primary research question:
a. Does BtB reduce depressive symptoms substantially over a period of six months,
when compared to treatment as usual in general practice (TAU)?
The secondary research questions:
b. Does BtB reduce the chance of having a depressive disorder, one year after the end
of treatment, when compared to TAU?
c. Is the effect of BtB versus TAU on having a depressive disorder after one year,
modifed by gender?
1) Fill in the CONSORT 2010 flow diagram as provided in appendix A.
Info: You should not take the in- and exclusion criteria from Proudfoot et al. (2003). The
present study is namely not an exact copy of that of Proudfoot et al. There is some info on
this in appendix B.
Although it is coded in the dataset who did and who did not adhere to the protocol (see
variable PP), from the data it is not evident who did or did not continue the intervention. So,
based on the information that you have, it may not be possible to answer all items of the
CONSORT flow diagram.
Concerning the items “follow-up” and “ analysis” in the flow diagram: here you should
consider the 1 year follow up measurements and the analysis for the one year outcomes.
For the “analysis”, report here the number of persons that are actually involved in the
intention-to-treat analyses.
