Contact information
Type
Scientific
Primary contact
Prof Nick Tarrier
ORCID ID
Contact details
Zochonis Building
Brunswick Street
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 161 306 6000
nicholas.tarrier@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6329
Study information
Scientific title
Prevention of Suicide risk in patients with psychosis through the development of a focused and conceptually-driven intervention
Acronym
CBSPp
Study hypothesis
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
Stockport REC , 12/12/2008, ref: 08/H1012/97
Study design
Multicentre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/02/2009
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 60; UK sample size: 60
Participant exclusion criteria
Not providing informed consent
Recruitment start date
01/02/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Zochonis Building
Manchester
M13 9PL
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
Oxford Road
Manchester
M13 9PL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Insititute for Health Research (NIHR) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary