Simons 2015.

Study characteristics
Methods	Randomised trial, the Netherlands
Participants	102 depressed out‐patients receiving psychopharmacological treatment
Interventions	Three arms: (i) an experimental group receiving six weeks of experience sampling method (ESM) self‐monitoring combined with weekly feedback sessions, (ii) a pseudo‐experimental group participating in six weeks of ESM self‐monitoring without feedback, and (iii) a control group (treatment as usual only).   Intervention features Multiple complex feedback (multiple PROMs at multiple times)  PROM(s) used as intervention: Experience sampling method (ESM) a validated, structured diary technique consisting of repeated in‐the‐moment micro‐measurements of affect and context Constructs measured: Symptoms, Functioning Instrument categories/domains: Domain/Disease specific (mental health)   Administration features Where PROMs administered: Non‐clinical setting How administered: Self‐administered Format of PROMs questionnaire(s): Electronic   Feedback features Format of PROMs feedback: Paper How often information fed back: 6 feedback sessions over 6 weeks Who information fed back to: Clinicians, Patients Information fed back: Scores, Previous scores, Interpretation guidance
Outcomes	Main outcomes: empowerment (Dutch Empowerment questionnaire, economic evaluation, depression (HDRS), quality adjusted life years (QALYs)
Notes	The study was funded by the Dutch Health Research Council (ZON‐MW) (grants nos. 171001002 and 91501003). The study recruited between 2010 and February 2012. Conflicts of interest were not reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Stratified randomisation method.
Allocation concealment (selection bias)	Low risk	Allocation took place using opaque, sealed, sequentially numbered envelopes (prepared by an independent research coordinator) with a number sequence produced by an electronic random sequence generator (http://www.random.org), in blocks of six.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Owing to the nature of the intervention, it was not possible to blind participants.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Interviewers were not blind to the patients’ treatment allocation due to nature of the intervention.
Baseline outcome measurements similar	Low risk	There was no significant difference in baseline HDRS depressive symptoms between patients who fully completed the intervention period and those who did not.
Baseline characteristics similar	Low risk	Baseline characteristics of the study and control providers are reported and similar.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Of the 69 patients allocated to the experimental or pseudo‐experimental group, 59 (85.5%) completed the six‐week intervention period; Pre‐intervention empowerment scores were available for respectively 32 of 33 (control), 35 of 36 (pseudo‐experimental), and 33 of 33 (experimental) participants. Post‐intervention empowerment scores were available for 30 (control), 32 (pseudo‐ experimental), and 27 (experimental) participants. Two participants had incomplete assessments of empowerment (front page only, i.e. 15 items), their total scores (mean item score 40) were retained in the analyses.
Was study protected against contamination	High risk	As the psychologist or psychiatrist performing the interview were aware that the patient was a participant in the study.
Selective reporting (reporting bias)	Low risk	None apparent.