Condition category
Mental and Behavioural Disorders
Date applied
21/05/2010
Date assigned
21/05/2010
Last edited
09/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.manchester.ac.uk/

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

Publication citations

Additional files

Editorial Notes

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