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Table 4 Safety measures and data collection

From: Individual Placement and Support supplemented with cognitive remediation and work-related social skills training in Denmark: study protocol for a randomized controlled trial

Outcome measure

Source of collection

Assessment

Baseline

18-month follow-up

30 + 60-month register follow-up

Safety measures

Obtained through interview

Psychotic and negative symptoms measured with Scale for the Assessment of Positive Symptoms (SAPS) and Scale for the Assessment of Negative Symptoms (SANS)

X

X

 
 

Obtained through interview

Depressive symptoms measured with Hamilton Depression Scale [36] (HAM-D6)

X

X

 
 

Obtained through interview

Suicidal ideation and actions. Measured with European Parasuicide Study Interview Schedule (EPSIS)

X

X

 
 

Death cause register, Civil Registration System (CPR)

Deaths (all causes)

X

X

X

 

Hospital records

Number and length of hospital admissions both somatic and psychiatric

 

X

X

 

Hospital records

Use of outpatient services

X

X

X