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Cognitive behavioural treatment for persistent positive symptoms in psychotic disorders

Not Applicable
Completed
Conditions
Psychotic disorders (schizophrenia, schizophreniform, schizoaffective and delusional disorders)
Mental and Behavioural Disorders
Registration Number
ISRCTN29242879
Lead Sponsor
niversity Hospital Tuebingen (Germany)
Brief Summary

2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32041577 secondary analysis (added 12/02/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33228583/ secondary analysis (added 25/11/2020)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
233
Inclusion Criteria

1. Schizophrenia, schizophreniform, schizoaffective, delusional disorders (according to Diagnostic and Statistical Manual of Mental Disorders - fourth edition [DSM-IV])
2. Score of four or more on the Positive and Negative Syndrome Scale (PANSS)-items ?delusions? or ?hallucinations?
3. Presence of these symptoms for at least three months

Exclusion Criteria

1. Substance abuse or substance dependence as primary clinical problem
2. Organic brain disease

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary endpoint for efficacy: PANSS positive syndrome (sum of items P1-P7), assessed post treatment (T9).
Secondary Outcome Measures
NameTimeMethod
<br> Key secondary endpoints:<br> 1. Additional symptom ratings (e.g. PSYRATS)<br> 2. Social functioning<br> 3. Illness related events<br> 4. Quality of life<br> 5. Questionnaires about self schemata and interpersonal schemata<br> 6. Direct and indirect costs<br><br> Assessment of safety:<br> 1. Death<br> 2. Suicidal behaviour<br> 3. Severe depressive symptom exacerbation<br>
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