Condition category
Mental and Behavioural Disorders
Date applied
28/05/2010
Date assigned
28/05/2010
Last edited
28/04/2016
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

Ms Suzanne Jolley

ORCID ID

Contact details

Institute of Psychiatry
Department of Psychology (PO77)
16 De Crespigny Park
London
SE5 8AF
United Kingdom
-
s.jolley@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5048; 085396

Study information

Scientific title

Cognitive mechanisms of change in delusions: a multicentre randomised investigation of two experimental interventions

Acronym

Study hypothesis

Psychosis is acknowledged to be a complex disorder, with multiple causes. Recent advances in understanding, using cognitive models and epidemiological research have identified new candidate cognitive, social and emotional processes as causes of symptoms, identified with greater specificity and a firmer basis in evidence than five years ago. Increased understanding of the factors leading to better outcomes is of huge potential importance, in terms both of individual suffering and disability, and of burden on families and societies. This is well recognised by the NHS, and the proposed research should pave the way for developing more effective psychological treatments leading to important improvements in individual patient management.

The aim of this project is to conduct research to bridge the gap between experimental research into theoretically derived hypotheses concerning mechanisms of psychotic symptoms and clinical development, leading to the development of new more effective components of cognitive behavioural approaches. The research is based on a cognitive model of psychosis from which specific hypotheses are derived.

We propose to concentrate on selected key cognitive, emotional, and social processes which are causally implicated in persecutory delusions and hallucinations: jumping to conclusions reasoning bias, anxiety, negative beliefs, and social exposure.

Ethics approval

South West London REC 3 (formerly Wandsworth REC) 17/10/2007, ref: 07/H0803/140

Study design

Multicentre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Mental Health Research Network; Subtopic: Schizophrenia, Psychosis; Disease: Psychosis

Intervention

1. Computer package: designed to change particular thinking styles
2. Manipulating anxiety: to investigate the impact on cognitive processes associated with paranoia

Both interventions have an active control.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Change in anxiety and cognitive processes associated with paranoia, measured immediately post-intervention.

Secondary outcome measures

Change in thinking style and cognitive processes associated with unusual and distressing beliefs, measured immediately post-intervention.

Overall trial start date

20/03/2009

Overall trial end date

30/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Psychosis, non-affective (International Classification of Diseases version 10 [ICD-10], chapter F2)
2. Current delusion on Schedules for the Clinical Assessment in Neuropsychiatry (SCAN) (for study 2: a persecutory delusion)
3. Rated greater than 0 on visual analogue distress
4. Aged 18 - 65 years, either sex
5. Symptoms stable (no major relapse or crisis in last 3 months) before allocation
6. Sufficient grasp of English to complete measures and participate in manipulations

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 200; UK sample size: 200

Participant exclusion criteria

1. Primary diagnosis of alcohol or drug dependency
2. Organic syndrome
3. Learning disability

Recruitment start date

20/03/2009

Recruitment end date

30/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychiatry
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

Kings College London (KCL) (UK)

Sponsor details

Institute Of Psychiatry
16 De Crespigny Park
London
SE5 8AF
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 085396)

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

28/04/2016: No publications found, verifying study status with principal investigator