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Table 1 Outcome assessments and assessment time point

From: Effectiveness and cost-effectiveness of a guided Internet- and mobile-based intervention for the indicated prevention of major depression in patients with chronic back pain—study protocol of the PROD-BP multicenter pragmatic RCT

Variables Measurement Screening T0 T1 T2 T3
Inclusion/exclusion criteria
 Chronic Back pain MR + TI x x    
 Depressive symptomatology PHQ-9 x x x x x
 Inclusion criteria a), c), d) TI/SRQ   x    
 Acute/past 6 months depressive episode, dysthymia or bipolar disorder SCID   x    x
 Current/past 6 months/on waiting list for psychotherapy TI   x    
Suicidality SCID/HAM-D/QIDS   x    x
PHQ-9 x x x x x
Primary outcome
 Onset of Depression SCID   x    x
Secondary outcomes
 Severity of depressive symptoms PHQ-9 x x x x x
HAM-D/QIDS x    x
 Quality of life AQOL-6D/EQ-5D-5 L   x x x x
 Pain intensity Rating scale   x x x x
 Pain related disability ODI   x x x x
 Pain self-efficacy PSEQ   x x x x
 Ability to work SPE   x x x x
Economic evaluation
 Costs TiC-P   x   x x
 Quality of life AQOL-6D/EQ-5D-5 L   x x x x
Covariates
 Demographic variables SRQ/MR x x    
 Depression type and chronicity SCID   x    x
 Patient adherence Attrition rate    x x  
 Patient satisfaction CSQ-8a    x   
 Side-effects of intervention INEPa    x x  
 Back Pain type and chronicity MR x     
 Internet affinity IAS   x    
  1. AQol-6D Assessment of Quality of Life, CSQ-8 Client Satisfaction Questionnaire, EQ-5D-5 L European Quality of Life scale, HAM-D Hamilton Rating Scale for Depression, IAS Internet Affinity Scale, INEP Inventory for the Assessment of Negative Effects of Psychotherapy, MR Medical record, ODI Oswestry Disability Index, PHQ-9 Patient Health Questionnaire, PSEQ Pain Self-Efficacy Questionnaire, SCID Structured Clinical Interview for DSM, SPE Subjective Prognostic Employment scale, SRQ Self-report assessment questionnaire, TI telephone interview, TiC-P Trimbos/iMTA questionnaire for costs associated with psychiatric illness
  2. aintervention group only