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Christensen et al. Trials (2015) 16:280 Page 2 of 10
The trial is designed as an investigator-initiated, randomized,
three-arm, assessor-blinded, multi-center trial. A
total of 750 patients with severe mental illness will be
randomly assigned into (1) IPS, (2) IPS enhanced with
cognitive remediation and work-related social skills training,
and (3) service as usual.
The primary hypothesis is that participants allocated
to the IPS intervention group (group 1) will have significantly
higher work or study rates at 18-month follow-up compared with participants allocated to service as usual (group 3).
Furthermore, we assume that an enhancement
of the IPS intervention with cognitive remediation and
work-related social skills training (group 2) will increase
the effects.
To ensure high methodological quality, the
trial is designed and reported according to the SPIRIT
(Standard Protocol Items: Recommendations for Interventional
Trials) Statement and the modified CONSORT
(Consolidated Standards Of Reporting Trials) criteria
for non-pharmacological trials [20, 21].
Recruitment and eligibility criteria
Eligible participants are adults (ages 18–67) diagnosed
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