Clinical and cost-effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): study protocol of a 36-month follow-up pragmatic randomized controlled trial

Braun, Lina; Titzler, Ingrid; Ebert, David Daniel; Buntrock, Claudia; Terhorst, Yannik; Freund, Johanna; Thielecke, Janika; Baumeister, Harald

doi:10.1186/s12888-019-2244-y

Table 1 Overview of the assessments

From: Clinical and cost-effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): study protocol of a 36-month follow-up pragmatic randomized controlled trial

Instruments	Aim	Time of measurement
Instruments	Aim	Screening	T0	T1	T2	T3	T4	T5
Screening Instruments
PHQ-9	Patient Health Questionnaire	✔
CPG	Chronic Pain Grade Questionnaire	✔
Chronicity of Pain	Pain longer for 6 months (yes/no)	✔
Primary Outcome
QIDS-SR16	Quick Inventory for Depressive Symptomatology		✔	✔^a	✔	✔	✔	✔
Secondary Outcomes
Adapted items from CIDI 3.0, CIDI-SC, and Epi-Q Screening Survey	Prevalence of major depression and bipolar disorder		✔	✔	✔	✔	✔	✔
PSS-10	Perceived Stress Scale		✔	✔	✔	✔	✔	✔
ISI	Insomnia Severity Index		✔	✔	✔	✔	✔	✔
GAD-7	Generalized Anxiety Disorder		✔	✔	✔	✔	✔	✔
PAS	Panic and Agoraphobia Scale		✔	✔	✔	✔	✔	✔
MPI	Multidimensional Pain Inventory		✔	✔	✔	✔	✔	✔
NRS	Pain Intensity (0–10)		✔	✔	✔	✔	✔	✔
AUDIT-10	Alcohol use disorder identification test		✔	✔	✔	✔	✔	✔
MBI-GS	Maslach-Burnout-Inventory (subscale emotional exhaustion)		✔	✔		✔
AQoL-8D	Quality of life		✔	✔	✔	✔	✔	✔
SPE	Subjective prognosis of employment		✔	✔	✔	✔	✔	✔
Cost measurement
TiC-P	Utilisation of health services, work-related productivity		✔	✔	✔	✔	✔	✔
Intervention-related Outcomes
WAI-SR^b, WAI-SRT^c	Therapeutic relationship			✔		✔
TAI-OT^b	Technological alliance			✔	✔
CSQ-I	Patient satisfaction			✔
INEP^b	Inventory of negative effects in psychotherapy			✔	✔	✔
Negative effects^b	Negative effects in psychotherapy			✔	✔	✔
Other assessments
Other questions	Socio-demographics		✔
Other questions	Predictors for development of major depression		✔
Diabetes	Diabetes diagnosis (yes/no)		✔
BDI-II	Suicidality-Item	✔	✔	✔	✔	✔	✔	✔

^aPrimary outcome is the standardized mean difference between intervention and control group at T1. QIDS-SR16 will also be assessed at T0 and T2-T5
^bRecorded in intervention group only
^cRecorded in e-coaches only
T0 Baseline, T1 9 weeks, T2 6 months, T3 12 months, T4 24 months, T5 36 months

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