Efficacy of "Integrated Social Cognitive and Behavioral Skills Therapy" (ISST) in Improving Functional Outcome in Schizophrenia

Efficacy of "Integrated Social Cognitive and Behavioral Skills Therapy" (ISST) in Improving Functional Outcome in Schizophrenia - ISST2015

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00010033

Enrollment

180

Registered

2016-03-10

Start date

2016-03-14

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DSM-IV-TR: 295.10-30, 295.90 F20

Interventions

Group 1: Behavioral: Integrated Social Cognitive and Behavioral Skills Therapy The Integrated Social Cognitive and Behavioral Skills Therapy (ISST) is a newly developed treatment program. It is based

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Written informed consent - DSM-IV-TR diagnosis of schizophrenia (295.10-30, 295.90) - PANSS at baseline: total score = 75 - Age between 18 and 65 years - Proficiency in German language. - Individualized medication according to valid treatment guidelines with up to two antipsychotic substances with flexible dosage and mode of administration within recommended dose ranges. With this medication, patients must have been treated for at least 2 weeks prior to enrollment to ensure that the maximum effect of the medication has been achieved. The addition of low- and medium-potent antipsychotic substances as a need medication for the treatment of restlessness and sleep disorders is possible, provided that the daily dosage of 150 chlorpromazine (CPZ) units is not exceeded.

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
All Cause Discontinuation [Time Frame: 6 months after end of treatment] [Safety Issue: No] 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. For a more detailed assessment of adherence the following instruments are used in addition: - SES (Service Engagement Scale, Tait, Birchwood & Trower 2002) - DAI-10 (Drug Attitude Scale, Goodstadt et al. 1978) - PATHEV (Psychotherapy Attitude Scale, Schulte 2005)	—

Measure

Time frame

All Cause Discontinuation [Time Frame: 6 months after end of treatment] [Safety Issue: No] 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. For a more detailed assessment of adherence the following instruments are used in addition: - SES (Service Engagement Scale, Tait, Birchwood & Trower 2002) - DAI-10 (Drug Attitude Scale, Goodstadt et al. 1978) - PATHEV (Psychotherapy Attitude Scale, Schulte 2005)

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Secondary

Measure	Time frame
2. Psychosocial Functioning [Time Frame: at begin and end of the treatment, and 6 month after end of treatment] [Safety Issue: No] measured by the - FROGS (Functional Remission of General Schizophrenia, Lorca et al. 2009) - UPSA-Brief (University of California Performance Based Skills Assesment, Mausbach et al. 2007) 3. Quality of Life [Time Frame: at begin and end of the treatment, and 6 month after end of treatment] [Safety Issue: No] measured by: - WHOQUOL-BREF (World Health Organization Quality of Life, WHO 1996) 4. Neurocognitive Performance [Time Frame: at begin and end of the treatment, and 6 month after end of treatment] [Safety Issue: No] measured by: - VLMT (verbal learning and memory test, Helmstaedter, Lendt & Lux 2001) - DSF, DSB (digit sequencing forward/backward, Wechsler 1981) - DSST (digit symbol substitution test, Wechsler 1981) - TMT-A, -B (Trail-Making-Test, Reitan 1956) 5. Socialcognitive Performance [Time Frame: at begin and end of the treatment, and 6 month after end of treatment] [Safety Issue: No] measured by: - PFA (Picture of Facial Affect Test, Ekman & Friesen 1976) - MASC (Movie for the Assessment of Social Cognition, Dziobek et al. 2006) 6. Psychopathology/Symptoms [Time Frame: at begin and end of the treatment, and 6 month after end of treatment] [Safety Issue: No] measured by: - PANSS (Positive and Negative Syndrome Scale, Kay, Fiszbein & Opler 1987) - CDSS (Calgary Depression Rating Scale for Schizophrenia, Addington, Addington & Maticka-Tyndale 1993) - BSI (Brief Symptom Inventory, Derogatis & Melisaratos 1983) 7. Safety [Time Frame: every 4-6 weeks] [Safety Issue: Yes] Safety parameters are: - suicide/suicide attempt - severe suicidal crisis (CDSS Item 8 = 2) - severe symptom worsening (Clinical Global Impression Scale Item 2 = 6)	—

Measure

Time frame

2. Psychosocial Functioning [Time Frame: at begin and end of the treatment, and 6 month after end of treatment] [Safety Issue: No] measured by the - FROGS (Functional Remission of General Schizophrenia, Lorca et al. 2009) - UPSA-Brief (University of California Performance Based Skills Assesment, Mausbach et al. 2007) 3. Quality of Life [Time Frame: at begin and end of the treatment, and 6 month after end of treatment] [Safety Issue: No] measured by: - WHOQUOL-BREF (World Health Organization Quality of Life, WHO 1996) 4. Neurocognitive Performance [Time Frame: at begin and end of the treatment, and 6 month after end of treatment] [Safety Issue: No] measured by: - VLMT (verbal learning and memory test, Helmstaedter, Lendt & Lux 2001) - DSF, DSB (digit sequencing forward/backward, Wechsler 1981) - DSST (digit symbol substitution test, Wechsler 1981) - TMT-A, -B (Trail-Making-Test, Reitan 1956) 5. Socialcognitive Performance [Time Frame: at begin and end of the treatment, and 6 month after end of treatment] [Safety Issue: No] measured by: - PFA (Picture of Facial Affect Test, Ekman & Friesen 1976) - MASC (Movie for the Assessment of Social Cognition, Dziobek et al. 2006) 6. Psychopathology/Symptoms [Time Frame: at begin and end of the treatment, and 6 month after end of treatment] [Safety Issue: No] measured by: - PANSS (Positive and Negative Syndrome Scale, Kay, Fiszbein & Opler 1987) - CDSS (Calgary Depression Rating Scale for Schizophrenia, Addington, Addington & Maticka-Tyndale 1993) - BSI (Brief Symptom Inventory, Derogatis & Melisaratos 1983) 7. Safety [Time Frame: every 4-6 weeks] [Safety Issue: Yes] Safety parameters are: - suicide/suicide attempt - severe suicidal crisis (CDSS Item 8 = 2) - severe symptom worsening (Clinical Global Impression Scale Item 2 = 6)

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Countries

Germany

Contacts

Public ContactWolfgang Wölwer

Klinik und Poliklinik für Psychiatrie und Psychotherapie,Heinrich-Heine-Universität

woelwer@uni-duesseldorf.de0211/922-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 11, 2026