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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. Identifier: NCT01920685
Recruitment Status : Completed
First Posted : August 12, 2013
Last Update Posted : March 20, 2017
Information provided by (Responsible Party):
Dr Amy Hardy, King's College London

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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Delayed 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

Primary Outcome Measures :
  1. Green Paranoid Thoughts Scale [ Time Frame: Change from baseline in paranoia scores at 8 weeks and 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Self reported worries about being harmed or at risk from others
  • Non-affective psychosis(ICD10,F20-F29)
  • Age 18-65
  • Symptoms stable no major relapse or crisis in last 3 months prior to consent
  • Sufficient command of English to provide informed consent, complete the measures and participate in the brief interventions
  • Score above the cutoff for clinically significant levels of paranoia on the Green Paranoid Thoughts Scale (Green et al, 2008)
  • Paranoia is triggered by being outside

Exclusion Criteria:

  • Lack of capacity to provide informed consent
  • Primary diagnosis of drug or alcohol use with secondary psychosis
  • Primary diagnosis of mood disorder or bipolar affective disorder
  • Primary diagnosis of learning difficulty
  • Unstable residential arrangements (making a move away during the course of participation in the research likely)

Information from the National Library of Medicine

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 identifier (NCT number): NCT01920685

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United Kingdom
Oxleas NHS Foundation Trust
Dartford, Kent, United Kingdom, DA2 7WG
South London & Maudsley NHS Foundation Trust
London, United Kingdom, SE5 8AF
Sponsors and Collaborators
King's College London
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Study Chair: Philippa Garety, CPsychol, MPhil, PhD, FBPsS King's College London
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Responsible Party: Dr Amy Hardy, Research Clinical Psychologist, King's College London Identifier: NCT01920685    
Other Study ID Numbers: 13/LO/0690
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017
Keywords provided by Dr Amy Hardy, King's College London:
Additional relevant MeSH terms:
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Paranoid Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Behavioral Symptoms