Cognitive behavioural treatment for persistent positive symptoms in psychotic disorders

ISRCTN	ISRCTN29242879
DOI	https://doi.org/10.1186/ISRCTN29242879
Protocol serial number	N/A
Sponsor	University Hospital Tuebingen (Germany)
Funder	German Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF; 01GV0618)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Stefan Klingberg
Scientific

Osianderstr. 24
Tuebingen
72076
Germany

Primary study design	Interventional
Study design	Randomised, single blind, parallel group, prospective, controlled study comparing a specific treatment with an unspecific, placebo-attention control group
Secondary study design	Randomised controlled trial
Scientific title	-
Study acronym	POSITIVE
Study objectives	Cognitive Behavioural Treatment (CBT ) is more efficacious in reducing positive symptoms than Supportive Therapy (ST).
Ethics approval(s)	Ethics Commitee of the Medical Faculty, University of Tuebingen; date of approval: 27 October 2006
Health condition(s) or problem(s) studied	Psychotic disorders (schizophrenia, schizophreniform, schizoaffective and delusional disorders)
Intervention	Cognitive Behavioural Treatment versus Supportive Therapy
Intervention type	Other
Primary outcome measure(s)	Primary endpoint for efficacy: PANSS positive syndrome (sum of items P1-P7), assessed post treatment (T9).
Key secondary outcome measure(s)	Key secondary endpoints: 1. Additional symptom ratings (e.g. PSYRATS) 2. Social functioning 3. Illness related events 4. Quality of life 5. Questionnaires about self schemata and interpersonal schemata 6. Direct and indirect costs Assessment of safety: 1. Death 2. Suicidal behaviour 3. Severe depressive symptom exacerbation
Completion date	31/12/2008

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	260
Total final enrolment	233
Key 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
Key exclusion criteria	1. Substance abuse or substance dependence as primary clinical problem 2. Organic brain disease
Date of first enrolment	01/01/2007
Date of final enrolment	31/12/2008

Osianderstr. 24

Tuebingen
72076
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	secondary analysis	10/02/2020	12/02/2020	Yes	No
Results article	secondary analysis	23/11/2020	25/11/2020	Yes	No

01/11/2022: Total final enrolment added.
25/11/2020: Publication reference added.
12/02/2020: Publication reference added.