Efficacy of ISST in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The ISST study investigates whether integrated social cognitive remediation and social
      behavioral skills therapy is more efficacious in improving functional outcome and treatment
      adherence than an active control treatment comprising drill-and-practice oriented
      neurocognitive remediation.
    

Detailed description: 
      Deficits in social functioning are a defining, very burdening feature of schizophrenia
      precluding patients from participating in a satisfying life. Traditional drug and
      psychosocial therapy and available specific treatment strategies that directly target single
      key determinants of functional outcome like neurocognition, social cognition, and social
      behavioral skills have produced only moderate effects leaving an urgent need for further
      optimization. The present trial aims to more efficaciously improve functional outcome by
      integrating social behavioral and social cognitive treatment strategies. Six months of
      "Integrated Social Cognitive and Behavioral Skills Therapy (ISST)" will be compared with
      "Neurocognitive Remediation Therapy (NCRT)" as active control condition in a randomized
      multicenter clinical trial using a two group pre-post design with 2x90 patients in the
      remitted early phase of schizophrenia. Beyond "all-cause-discontinuation" as common primary
      outcome of all clinical trials of the ESPRIT-consortium, measures of functional outcome and
      subjective quality of life, patient experience as well as neurocognitive, social-cognitive
      and social behavioral measures will be assessed at baseline (V0), after completion of
      treatment (V6), and after 6 months follow-up (V12). ISST is expected to reduce the one-year
      discontinuation rate by 20% compared with NCRT, and to be superior in functional outcome
      measures by an effect size of at least d=0.42.
    

Intervention name(s): Integrated Social Cognitive and Behavioral Skills Therapy; Neurocognitive Remediation Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Integrated Social Cognitive and Behavioral Skills Therapy (ISST) is a newly developed treatment program. It is based on the Training of Affect Recognition (Wölwer et al. 2005) and common social skills trainings, which are combined in an integrated rather than a sequenced manner. ISST uses both repeated practice and strategy-based training, and consists of 12 individual sessions, 5 group sessions and 1 individual final session over a period of 6 months.; The Neurocognitive Remediation Program (NCRT) is based on a neurocognitive training already used as active control condition in our earlier studies (Wölwer et al. 2005, Klingberg et al. 2011). The present version of NCRT is matched in dose, mode and scheme of application to the ISST, but differs from the ISST regarding targeted cognitive domains and preferred training strategy (predominantly drill and practice based). The NCRT provides the same amount of group interaction and companionship as well as the same amount of guided community activity as in the ISST, but is structured in such a way that interactional behavior is secondary (e.g. by competition-like tasks rather than cooperative tasks). Thus therapeutic attention and commitment are held constant across study conditions.
Other intervention name(s): ISST; NCRT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: social cognition; social skills; cognitive remediation; functional outcome; treatment adherence