Efficacy of ISST in Schizophrenia

Heinrich-Heine University, Duesseldorf

Status: Completed

Conditions: Schizophrenia

Treatments: Behavioral: Neurocognitive Remediation Therapy; Behavioral: Integrated Social Cognitive and Behavioral Skills Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02678858

ISST2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 177 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• DSM-IV-TR diagnosis of schizophrenia (295.10-30, 295.90)
• PANSS at baseline: total score ≤ 75
• Proficiency in German language.

Exclusion criteria

• Lack of accountability
• Positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
• Serious suicidal risk at screening visit
• Other relevant axis 1-diagnoses according to diagnostic interview (MINI);
• Other relevant neurological or somatic disorders
• Verbal IQ<80 (MWT-B)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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177 participants in 2 patient groups

Integrated Social Cognitive and Behavioral Skills Therapy

Experimental group

Description:

The Integrated Social Cognitive and Behavioral Skills Therapy (ISST) shall target expressive and interactional behavior skills together with those social cognitive domains (facial and prosodic affect recognition, social perception, theory-of-mind) known to be most impaired (Savla, 2012) and most closely associated with functional outcome (Fett, 2012) in schizophrenia.

Treatment:

Behavioral: Integrated Social Cognitive and Behavioral Skills Therapy

Neurocognitive Remediation Therapy

Active Comparator group

Description:

The Neurocognitive Remediation Therapy (NCRT) shall target impairments in attention, memory, and executive functions as an active comparator to the ISST.

Treatment:

Behavioral: Neurocognitive Remediation Therapy