Cognitive mechanisms of change in delusions
| ISRCTN | ISRCTN59501939 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59501939 |
| Protocol serial number | 5048; 085396 |
| Sponsor | Kings College London (KCL) (UK) |
| Funder | The Wellcome Trust (UK) (grant ref: 085396) |
- Submission date
- 28/05/2010
- Registration date
- 28/05/2010
- Last edited
- 01/12/2017
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Suzanne Jolley
Scientific
Scientific
Institute of Psychiatry
Department of Psychology (PO77)
16 De Crespigny Park
London
SE5 8AF
United Kingdom
| s.jolley@iop.kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Cognitive mechanisms of change in delusions: a multicentre randomised investigation of two experimental interventions |
| Study objectives | 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(s) | South West London REC 3 (formerly Wandsworth REC) 17/10/2007, ref: 07/H0803/140 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Change in anxiety and cognitive processes associated with paranoia, measured immediately post-intervention. |
| Key secondary outcome measure(s) |
Change in thinking style and cognitive processes associated with unusual and distressing beliefs, measured immediately post-intervention. |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key 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 |
| Key exclusion criteria | 1. Primary diagnosis of alcohol or drug dependency 2. Organic syndrome 3. Learning disability |
| Date of first enrolment | 20/03/2009 |
| Date of final enrolment | 30/09/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Institute of Psychiatry
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2015 | Yes | No | |
| Results article | results | 01/07/2015 | Yes | No |
Editorial Notes
01/12/2017: Publication references added.
28/04/2016: No publications found, verifying study status with principal investigator
