Efficacy of Integrated Social Cognitive Remediation vs. Neurocognitive Remediation in Improving Functional Outcome in Schizophrenia: Concept and Design of a Multicenter, Single-Blind RCT (The ISST Study)

Wölwer, Wolfgang; Frommann, Nicole; Lowe, Agnes; Kamp, Daniel; Weide, Karolin; Bechdolf, Andreas; Brockhaus-Dumke, Anke; Hurlemann, Rene; Muthesius, Ana; Klingberg, Stefan; Hellmich, Martin; Schmied, Sabine; Meyer-Lindenberg, Andreas (2022). Efficacy of Integrated Social Cognitive Remediation vs. Neurocognitive Remediation in Improving Functional Outcome in Schizophrenia: Concept and Design of a Multicenter, Single-Blind RCT (The ISST Study). Frontiers in psychiatry, 13 Frontiers 10.3389/fpsyt.2022.909370

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Background: Although clinically effective treatment is available for schizophrenia,
recovery often is still hampered by persistent poor psychosocial functioning, which
in turn is limited by impairments in neurocognition, social cognition, and social
behavioral skills. Although cognitive remediation has shown general efficacy in improving
cognition and social functioning, effects still need to be improved and replicated in
appropriately powered, methodologically rigorous randomized controlled trials (RCTs).
Existing evidence indicates that effects can most likely be optimized by combining
treatment approaches to simultaneously address both social cognitive and social
behavioral processes.
Objectives: To assess whether Integrated Social Cognitive and Behavioral Skill Therapy
(ISST) ismore efficacious in improving functional outcome in schizophrenia than the active
control treatment Neurocognitive Remediation Therapy (NCRT).
Methods: The present study is a multicenter, prospective, rater-blinded, two-arm RCT
being conducted at six academic study sites in Germany. A sample of 180 at least partly
remitted patients with schizophrenia are randomly assigned to either ISST or NCRT. ISST
is a compensatory, strategy-based program that targets social cognitive processes and
social behavioral skills. NCRT comprisesmainly drill and practice-oriented neurocognitive
training. Both treatments consist of 18 sessions over 6 months, and participants are subsequently followed up for another 6 months. The primary outcome is all-cause
discontinuation over the 12-month study period; psychosocial functioning, quality of life,
neurocognitive and social cognitive performance, and clinical symptoms are assessed as
secondary outcomes at baseline before randomization (V1), at the end of the six-month
treatment period (V6), and at the six-month follow-up (V12).
Discussion: This RCT is part of the German Enhancing Schizophrenia Prevention and
Recovery through Innovative Treatments (ESPRIT) research network, which aims at using
innovative treatments to enhance prevention and recovery in patients with schizophrenia.
Because this study is one of the largest and methodologically most rigorous RCTs on
the efficacy of cognitive remediation approaches in schizophrenia, it will not only help
to identify the optimal treatment options for improving psychosocial functioning and thus
recovery in patients but also allow conclusions to be drawn about factors influencing and
mediating the effects of cognitive remediation in these patients.

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