Computerised Interventions for Thinking and Anxiety in Delusions (CITADEL) Trial (CITADEL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01920685|
Recruitment Status : Completed
First Posted : August 12, 2013
Last Update Posted : March 20, 2017
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 person's 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.
|Condition or disease||Intervention/treatment||Phase|
|Paranoia in People With Schizophrenia-spectrum Diagnosis||Other: Anxiety intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Computerised Interventions for Thinking and Anxiety in Delusions (CITADEL) Trial|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Experimental: Immediate therapy
6 sessions of talking therapy, targeting anxiety processes associated with paranoia, will be delivered for a period of 8 weeks immediately after randomisation.
Other: Anxiety intervention
Therapy will be delayed until 12 weeks following randomisation, and then 6 sessions of talking therapy, targeting anxiety processes associated with paranoia, will be delivered over a period of 8 weeks.
Other: Anxiety intervention
- Green Paranoid Thoughts Scale [ Time Frame: Change from baseline in paranoia scores at 8 weeks and 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920685
|Oxleas NHS Foundation Trust|
|Dartford, Kent, United Kingdom, DA2 7WG|
|South London & Maudsley NHS Foundation Trust|
|London, United Kingdom, SE5 8AF|
|Study Chair:||Philippa Garety, CPsychol, MPhil, PhD, FBPsS||King's College London|