Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus

Table 3 Definition of treatment adherence in the CBT and sertraline treatment groups

Adherence categories	CBT	Sertraline (randomized sample)	Sertraline (ITT sample)
Adherent	Participation in ≥ 8 sessions of CBT	2 measures SER and corresponding ratio DSER:SER in target range	≥ 5 measures SER and corresponding ratio DSER:SER in target range
Partially non-adherent	Participation in 1–7 sessions of CBT	1 measures SER and corresponding ratio DSER:SER in target range	1-4 measures SER and corresponding ratio DSER:SER in target range
Non-adherent	No participation in any session of CBT	no measures SER and corresponding ratio DSER:SER in target range	no measures SER and corresponding ratio DSER:SER in target range

Note: SER: blood concentration of sertraline. DSER:SER: ratio of desmethylsertraline to sertraline concentrations. Target ranges of SER were defined as concentrations between 10–100 ng/ml [55]. Target ranges of DSER:SER were defined as 0.85–4.25, corresponding to the mean ± 2 standard deviations (M = 2.55, SD = 0.85) derived from 348 samples by Reis et al. [51].

ISSN: 1471-244X