Efficacy of ISST in Schizophrenia
- Conditions
- Schizophrenia
- Interventions
- Behavioral: Neurocognitive Remediation TherapyBehavioral: Integrated Social Cognitive and Behavioral Skills Therapy
- Registration Number
- NCT02678858
- Lead Sponsor
- Heinrich-Heine University, Duesseldorf
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 177
- Written informed consent
- DSM-IV-TR diagnosis of schizophrenia (295.10-30, 295.90)
- PANSS at baseline: total score ≤ 75
- Proficiency in German language.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neurocognitive Remediation Therapy Neurocognitive Remediation Therapy The Neurocognitive Remediation Therapy (NCRT) shall target impairments in attention, memory, and executive functions as an active comparator to the ISST. Integrated Social Cognitive and Behavioral Skills Therapy Integrated Social Cognitive and Behavioral Skills Therapy 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.
- Primary Outcome Measures
Name Time Method All Cause Discontinuation 6 months, 12 months All Cause Discontinuation is defined as 1) not keeping appointments to treatment or diagnostic sessions as scheduled for more than 6 weeks and/or (2) not being traceable despite extensive efforts by the intervention team to reengage the patient throughout the entire intended treatment period and/or (3) withdrawal of consent by the patient (4) rater induced discontinuation of the study treatment (eg. for safety criteria) (5) not taking psychotropic drugs as prescribed for more than 14 consecutive days and/or (6) relevant worsening of symptoms.
- Secondary Outcome Measures
Name Time Method WHOQUOL-Bref (Quality of Life) 6 months, 12 months WHOQUOL-BREF (World Health Organization Quality of Life, WHO 1996)
Treatment Adherence 2 6 months, 12 months DAI-10 (Drug Attitude Scale, Goodstadt et al. 1978)
Treatment Adherence 1 6 months, 12 months SES (Service Engagement Scale, Tait, Birchwood \& Trower 2002)
Neurocognitive Performance (working memory) 6 months, 12 months DSF, DSB (digit sequencing forward/backward, Wechsler 1981)
Neurocognitive Performance (processing speed 1) 6 months, 12 months DSST (digit symbol substitution test, Wechsler 1981)
Psychosocial Functioning 1 6 months, 12 months FROGS (Functional Remission of General Schizophrenia, Lorca et al. 2009)
Psychosocial Functioning 2 6 months, 12 months UPSA-Brief (University of California Performance Based Skills Assessment, Mausbach et al. 2007)
Socialcognitive Performance (affect recognition) 6 months, 12 months PFA (Picture of Facial Affect Test, Ekman \& Friesen 1976)
Psychopathology/Symptoms 1 6 months, 12 months PANSS (Positive and Negative Syndrome Scale, Kay, Fiszbein \& Opler 1987)
Treatment Adherence 3 6 months, 12 months PATHEV (Psychotherapy Attitude Scale, Schulte 2005)
Neurocognitive Performance (processing speed 2) 6 months, 12 months TMT-A, -B (Trail-Making-Test, Reitan 1956)
Neurocognitive Performance (verbal memory) 6 months, 12 months VLMT (verbal learning and memory test, Helmstaedter, Lendt \& Lux 2001
Socialcognitive Performance (theory of mind) 6 months, 12 months MASC (Movie for the Assessment of Social Cognition, Dziobek et al. 2006)
Psychopathology/Symptoms 2 6 months, 12 months CDSS (Calgary Depression Rating Scale for Schizophrenia, Addington, Addington \& Maticka-Tyndale 1993)
Psychopathology/Symptoms 3 6 months, 12 months BSI (Brief Symptom Inventory, Derogatis \& Melisaratos 1983)
Severe symptom worsening Assessed every 4-6 weeks from date of randomization until 1 year or until discontinuation (whatever came first) CGI (Clinical Global Impression Scale Item 2 ≥ 6)
Suicidality Assessed every 4-6 weeks from date of randomization until 1 year or until discontinuation (whatever came first) Incidence of suicide/suicide attempt or severe suicidal crisis (CDSS Item 8 ≥ 2)
Trial Locations
- Locations (6)
Vivantes Klinikum Am Urban
🇩🇪Berlin, Germany
Dept. of Psychiatry and Psychotherapy, University of Bonn
🇩🇪Bonn, Germany
Dept. of Psychiatry and Psychotherapy, University of Düsseldorf
🇩🇪Duesseldorf, Germany
Dept. of Psychiatry and Psychotherapy, University of Cologne
🇩🇪Cologne, Germany
Dept. of Psychiatry and Psychotherapy, University of Tübingen
🇩🇪Tübingen, Germany
Rheinhessen-Fachklinik Alzey
🇩🇪Alzey, Germany