Cognitive Behavioural Suicide Prevention for psychosis

ISRCTN	ISRCTN16939126
DOI	https://doi.org/10.1186/ISRCTN16939126
Secondary identifying numbers	6329

Submission date: 21/05/2010
Registration date: 21/05/2010
Last edited: 09/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Nick Tarrier
Scientific

Zochonis Building
Brunswick Street
Oxford Road
Manchester
M13 9PL
United Kingdom

Phone	+44 161 306 6000
Email	nicholas.tarrier@manchester.ac.uk

Study information

Study design	Multicentre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Prevention of Suicide risk in patients with psychosis through the development of a focused and conceptually-driven intervention
Study acronym	CBSPp
Study objectives	Study aims: 1. To confirm and describe the psychological architecture that drives suicide behaviour, this consists of: information processing biases, suicide schema and appraisal systems. We intend to investigate hypotheses relating to determine the role of these in suicide behaviour specifically we will use information processing tasks such as autobiographical memory tasks to investigate bias; standardised assessment to investigate appraisal and schema. 2. To derive a method of assessing this architecture through semi-structured interview that will have clinical utility 3. To formulate and develop a manualised cognitive behavioural treatment programme for suicide prevention in psychosis and to test the clinical acceptance and feasibility of this intervention. It is hypothesised that the treatment will be acceptable, feasible and reduce suicide behaviour. 4. At the end of the programme we will be in position to design a clinical trial to test the efficacy of the intervention
Ethics approval(s)	Stockport REC , 12/12/2008, ref: 08/H1012/97
Health condition(s) or problem(s) studied	Topic: Mental Health Research Network; Subtopic: Psychosis; Disease: Psychosis
Intervention	Those allocated to the experimental treatment will receive CBSPp as described in the manual in addition to treatment as usual (TAU). Treatment will take place over 12 weeks. Participants will be seen twice weekly. The control group will receive TAU alone. All participants will be re-assessed at 4 months and at 6 months. Study entry: single randomisation only
Intervention type	Other
Primary outcome measure	Suicidal behaviour, measured at 4 months and 6 months
Secondary outcome measures	Measured at baseline, 4 months and 6 months: 1. Beck Anxiety Inventory (BAI) to assess level of anxiety 2. Beck Hopelessness Scale 3. Calagary Depression Scale for Schizophrenia 4. Global assessment of functioning (DSM-IV) to assess overall functioning 5. Positive And Negative Symptoms Scale (PANSS) to assess severity of symptoms 6. Psychotic Symptom Rating Scales (PSYRATS) to assess control over symptoms 7. Questionnaire about the Process of Recovery (QPR) 8. Self Esteem Rating Scale 9. The Subjective Experiences of Psychotic Symptoms Scale (SEPSS)
Overall study start date	01/02/2009
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 60; UK sample size: 60
Key inclusion criteria	1. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder or psychotic disorder not otherwise specified (NOS) 2. Have had previous suicide attempts or current suicidal ideation 3. Are not currently acutely suicidal or considered a danger to themselves or others 4. Are receiving appropriate anti-psychotic medication 5. Are under the care of an appropriate clinical team and have contact with mental health service 6. Males and females aged between 18 and 65 years
Key exclusion criteria	Not providing informed consent
Date of first enrolment	01/02/2009
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Zochonis Building

Manchester
M13 9PL
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

Oxford Road
Manchester
M13 9PL
England
United Kingdom

Website	http://www.manchester.ac.uk/
"ROR"	https://ror.org/027m9bs27

Funders

Funder type

Government

National Insititute for Health Research (NIHR) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

09/09/2016: No publications found in PubMed, verifying study status with principal investigator.