Efficacy of Integrated Social Cognitive and Behavioral Skills Therapy (ISST) inImproving Functional Outcome in Schizophrenia
- Conditions
- DSM-IV-TR: 295.10-30, 295.90F20Schizophrenia
- Registration Number
- DRKS00010033
- Lead Sponsor
- Klinik und Poliklinik für Psychiatrie und Psychotherapie,Heinrich-Heine-Universität
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- 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
- 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.
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
- Not specified
- Primary Outcome Measures
Name Time Method All Cause Discontinuation<br>[Time Frame: 6 months after end of treatment] [Safety Issue: No]<br><br>All Cause Discontinuation is defined as <br>(1) not keeping appointments to treatment or diagnostic sessions as scheduled for more than 6 weeks and/or <br>(2) not being traceable despite extensive efforts by the intervention team to reengage the patient throughout the entire intended treatment period and/or <br>(3) withdrawal of consent by the patient <br>(4) rater induced discontinuation of the study treatment (eg. for safety criteria) <br>(5) not taking psychotropic drugs as prescribed for more than 14 consecutive days and/or <br>(6) relevant worsening of symptoms.<br><br>For a more detailed assessment of adherence the following instruments are used in addition:<br>- SES (Service Engagement Scale, Tait, Birchwood & Trower 2002)<br>- DAI-10 (Drug Attitude Scale, Goodstadt et al. 1978)<br>- PATHEV (Psychotherapy Attitude Scale, Schulte 2005)<br>
- Secondary Outcome Measures
Name Time Method