Ignite Creation Date:
2024-05-06 @ 1:54 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01920685
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2013-08-05
Brief Title:
Computerised Interventions for Thinking and Anxiety in Delusions CITADEL Trial
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
Computerised Interventions for Thinking and Anxiety in Delusions CITADEL Trial
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CITADEL
Brief Summary:
People with a schizophrenia spectrum diagnosis often experience distressing worries or beliefs about others intending to cause them harm also known as paranoia Paranoid beliefs are associated with significant distress and disruption to the persons life This results in high use of services and costs to mental health providers
The National Institute of Clinical Excellence recommends that cognitive behavioural therapy for psychosis CBTp is offered to everybody with a schizophrenia spectrum psychosis The latest meta analyses report improved outcomes and reduced inpatient stays following CBTp making it a cost effective intervention
Although improved outcomes have been obtained by therapies CBTp has only small to moderate effects on paranoid beliefs Further training therapists to competently deliver CBTp is intensive expensive and takes up to a year CBTp is therefore not widely available to service users resulting in inequalities in access to care
The investigators are seeking to improve outcomes and accessibility of CBTp for people with distressing paranoid beliefs The proposed research programme aims to conduct a feasibility study of a brief therapeutic intervention aimed at targeting and improving anxiety processes that are causally implicated in paranoia Freeman et al 2015
The investigators have preliminary evidence indicating that the pilot intervention with interactive multimedia content reduced distressing beliefs and improved coping Freeman et al 2015 Participants also reported they found the therapy acceptable enjoyable and useful Based on these results the investigators have further modified the intervention The feasibility and efficacy of the therapy will be investigated in a randomised controlled design n 34
Please note the protocol has been been amended to exclude a pilot trial of a second brief intervention targeting reasoning styles in paranoia as since the initial protocol was developed we have obtained data from two randomised pilot studies demonstrating its feasibility and acceptability Garety et al 2015 Waller et al 2015 A further pilot trial of the reasoning styles intervention is therefore not indicated
The National Institute of Clinical Excellence recommends that cognitive behavioural therapy for psychosis CBTp is offered to everybody with a schizophrenia spectrum psychosis The latest meta analyses report improved outcomes and reduced inpatient stays following CBTp making it a cost effective intervention
Although improved outcomes have been obtained by therapies CBTp has only small to moderate effects on paranoid beliefs Further training therapists to competently deliver CBTp is intensive expensive and takes up to a year CBTp is therefore not widely available to service users resulting in inequalities in access to care
The investigators are seeking to improve outcomes and accessibility of CBTp for people with distressing paranoid beliefs The proposed research programme aims to conduct a feasibility study of a brief therapeutic intervention aimed at targeting and improving anxiety processes that are causally implicated in paranoia Freeman et al 2015
The investigators have preliminary evidence indicating that the pilot intervention with interactive multimedia content reduced distressing beliefs and improved coping Freeman et al 2015 Participants also reported they found the therapy acceptable enjoyable and useful Based on these results the investigators have further modified the intervention The feasibility and efficacy of the therapy will be investigated in a randomised controlled design n 34
Please note the protocol has been been amended to exclude a pilot trial of a second brief intervention targeting reasoning styles in paranoia as since the initial protocol was developed we have obtained data from two randomised pilot studies demonstrating its feasibility and acceptability Garety et al 2015 Waller et al 2015 A further pilot trial of the reasoning styles intervention is therefore not indicated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None