Schizophrenia Clinical Trial
Official title:
Efficacy of "Integrated Social Cognitive and Behavioral Skills Therapy" (ISST) in Improving Functional Outcome in Schizophrenia
NCT number | NCT02678858 |
Other study ID # | ISST2015 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | March 2022 |
Verified date | August 2022 |
Source | Heinrich-Heine University, Duesseldorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 177 |
Est. completion date | March 2022 |
Est. primary completion date | February 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Germany | Rheinhessen-Fachklinik Alzey | Alzey | |
Germany | Vivantes Klinikum Am Urban | Berlin | |
Germany | Dept. of Psychiatry and Psychotherapy, University of Bonn | Bonn | |
Germany | Dept. of Psychiatry and Psychotherapy, University of Cologne | Cologne | |
Germany | Dept. of Psychiatry and Psychotherapy, University of Düsseldorf | Duesseldorf | |
Germany | Dept. of Psychiatry and Psychotherapy, University of Tübingen | Tübingen |
Lead Sponsor | Collaborator |
---|---|
Heinrich-Heine University, Duesseldorf | Rheinhessen-Fachklinik Alzey, University Hospital of Cologne, University Hospital Tuebingen, University Hospital, Bonn, University of Cologne, Vivantes Klinikum am Urban, Zentralinstitut für Seelische Gesundheit Mannheim |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All Cause Discontinuation | 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. | 6 months, 12 months | |
Secondary | Treatment Adherence 1 | SES (Service Engagement Scale, Tait, Birchwood & Trower 2002) | 6 months, 12 months | |
Secondary | Treatment Adherence 2 | DAI-10 (Drug Attitude Scale, Goodstadt et al. 1978) | 6 months, 12 months | |
Secondary | Treatment Adherence 3 | PATHEV (Psychotherapy Attitude Scale, Schulte 2005) | 6 months, 12 months | |
Secondary | Psychosocial Functioning 1 | FROGS (Functional Remission of General Schizophrenia, Lorca et al. 2009) | 6 months, 12 months | |
Secondary | Psychosocial Functioning 2 | UPSA-Brief (University of California Performance Based Skills Assessment, Mausbach et al. 2007) | 6 months, 12 months | |
Secondary | WHOQUOL-Bref (Quality of Life) | WHOQUOL-BREF (World Health Organization Quality of Life, WHO 1996) | 6 months, 12 months | |
Secondary | Neurocognitive Performance (verbal memory) | VLMT (verbal learning and memory test, Helmstaedter, Lendt & Lux 2001 | 6 months, 12 months | |
Secondary | Neurocognitive Performance (working memory) | DSF, DSB (digit sequencing forward/backward, Wechsler 1981) | 6 months, 12 months | |
Secondary | Neurocognitive Performance (processing speed 1) | DSST (digit symbol substitution test, Wechsler 1981) | 6 months, 12 months | |
Secondary | Neurocognitive Performance (processing speed 2) | TMT-A, -B (Trail-Making-Test, Reitan 1956) | 6 months, 12 months | |
Secondary | Socialcognitive Performance (affect recognition) | PFA (Picture of Facial Affect Test, Ekman & Friesen 1976) | 6 months, 12 months | |
Secondary | Socialcognitive Performance (theory of mind) | MASC (Movie for the Assessment of Social Cognition, Dziobek et al. 2006) | 6 months, 12 months | |
Secondary | Psychopathology/Symptoms 1 | PANSS (Positive and Negative Syndrome Scale, Kay, Fiszbein & Opler 1987) | 6 months, 12 months | |
Secondary | Psychopathology/Symptoms 2 | CDSS (Calgary Depression Rating Scale for Schizophrenia, Addington, Addington & Maticka-Tyndale 1993) | 6 months, 12 months | |
Secondary | Psychopathology/Symptoms 3 | BSI (Brief Symptom Inventory, Derogatis & Melisaratos 1983) | 6 months, 12 months | |
Secondary | Suicidality | Incidence of suicide/suicide attempt or severe suicidal crisis (CDSS Item 8 = 2) | Assessed every 4-6 weeks from date of randomization until 1 year or until discontinuation (whatever came first) | |
Secondary | Severe symptom worsening | CGI (Clinical Global Impression Scale Item 2 = 6) | Assessed every 4-6 weeks from date of randomization until 1 year or until discontinuation (whatever came first) |
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